Downloads: 1
| # | nctid | status | why_stop | label | phase | diseases | icdcodes | drugs | smiless | criteria |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT00082810 | completed | 0 | phase 2 | ['estrogen receptor-positive breast cancer', 'recurrent breast cancer', 'stage iiib breast cancer', 'stage iiic breast cancer', 'stage iv breast cancer'] | ["['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']", "['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']", "['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']", "['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']", "['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']"] | ['fulvestrant', 'tipifarnib'] | ['[H][C@@]12CC[C@H](O)[C@@]1(C)CC[C@]1([H])C3=CC=C(O)C=C3C[C@@H](CCCCCCCCCS(=O)CCCC(F)(F)C(F)(F)F)[C@@]21[H]', 'CN1C=NC=C1[C@@](N)(C1=CC=C(Cl)C=C1)C1=CC2=C(C=C1)N(C)C(=O)C=C2C1=CC(Cl)=CC=C1'] | Inclusion Criteria: - Patients must have histologically or cytologically confirmed adenocarcinoma of the breast - Patients must be postmenopausal - Patients must have stage IV disease or inoperable locally advanced disease - Patients must have ER- and/or PR-positive disease as determined by their local pathology laboratory - Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral CT scan; all sites of disease should be noted and followed - Prior hormonal therapy as adjuvant therapy and/or for metastatic disease is permitted; patients previously treated with two or more prior doses of fulvestrant are not eligible; patients who have received one prior dose of fulvestrant within 28 days are eligible so long as they meet other eligibility criteria - Patients must have ECOG performance status 0-2 (Karnofsky >= 60%) - Patients must have life expectancy of greater than 3 months - Leukocytes >= 3,000/uL - Absolute neutrophil count >= 1,500/uL - Platelets >= 100,000/uL - Total bilirubin =< 2 mg/dL - AST(SGOT)/ALT(SGPT) =< 2.5 x institutional upper limit of normal - Creatinine less than or equal to 1.5 times the institutional upper limits of normal - Patients must be disease-free of prior invasive malignancies for >= 5 years with the exception of: curatively-treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix - Patients must have the ability to understand and the willingness to sign a written informed consent document - Patients who have had previous therapy with farnesyltransferase inhibitor Exclusion Criteria: - Patients who have had radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier; patients who have had prior chemotherapy for metastatic disease are not eligible; prior adjuvant or neoadjuvant chemotherapy is allowed - Patients may not be receiving any other investigational agents - History of allergic reactions attributed to compounds of similar chemical or biologic composition to tipifarnib (R115777, Zarnestra™) or other agents used in the study (e.g., imidazoles, quinolones) - Presence of rapidly progressive, life-threatening metastases; this includes patients with extensive hepatic involvement (> 50% of the liver involved), symptomatic lymphangitic metastases, or brain or leptomeningeal involvement - Concomitant anticancer treatment with the following exceptions: (1) bisphosphonates for bone metastases, (2) a GnRH analog is permitted if the patient had progressive disease on a GnRH analog plus a SERM or an AI; the GnRH analog may continue but the SERM or AI must be discontinued - Grade 2 or more peripheral neuropathy - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements - HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with tipifarnib or other agents administered during the study.; appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated | |
| 2 | NCT01265511 | completed | 1 | phase 2 | ['hepatitis c infection'] | ["['B17.0']"] | ['placebo', 'scy-635', 'pegasys', 'copegus'] | ['CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O', 'CC[C@@H]1NC(=O)[C@H]([C@H](O)[C@H](C)C\\C=C\\C)N(C)C(=O)[C@H](C(C)C)N(C)C(=O)[C@H](CC(C)C)N(C)C(=O)[C@H](CC(C)C)N(C)C(=O)[C@@H](C)NC(=O)[C@H](C)NC(=O)[C@H](CC(C)C)N(C)C(=O)[C@@H](NC(=O)[C@H](CC(C)(C)O)N(C)C(=O)[C@@H](SCCN(C)C)N(C)C1=O)C(C)C', 'NC(=O)C1=NN(C=N1)[C@@H]1O[C@H](CO)[C@@H](O)[C@H]1O'] | Inclusion Criteria: - Quantifiable serum levels of HCV-specific RNA in excess of 100,000 IU/mL - Chronic HCV status - HCV genotype 1 infection and IL28B genotype of C/T or T/T - Liver biopsy results within 3 years prior to screening indicating the absence of cirrhosis *If no previous biopsy is available, a biopsy must be performed during the screening period to qualify for randomization - Body mass index (BMI) between 18 and 38 kg/m2 - Laboratory variables within acceptable ranges: - ALT/AST < 3 × ULN; - HgB > 12g/dL for females, > 13 g/dL for males; - total WBC count > 3000/mm3 and ANC > 1500/mm3; - platelets > 100,000/mm3; - prothrombin time (or INR) ≤ 1.2 × ULN; - serum albumin ≥ 3.4 g/dL; - total bilirubin WNL; - serum creatinine WNL; if serum creatinine is > ULN, then calculated creatinine clearance must be > 100 mL/min (by Cockcroft-Gault formula) for subject to be eligible - Subjects of childbearing potential (i.e., not surgically sterile or postmenopausal) must agree to use 2 forms of contraception from Screening until 24 weeks after completion of treatment with RBV - Negative urine testing for amphetamines and cocaine at Screening. - If female, the subject has a negative pregnancy test at Screening and on study Day 1 Exclusion Criteria: - History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease - Females who are pregnant or breastfeeding - Males with partners who are pregnant or are planning to become pregnant - HCV genotype other than genotype 1 and an IL28B genotype of C/C - Seropositive for HIV-1 or HIV-2 or hepatitis B virus (HBV) surface antigen (HBsAg) - Use of any investigational agent within 3 months prior to dosing - Received any prior FDA-approved or investigational drug or drug regimen for the treatment of hepatitis C - Evidence of cirrhosis on a previous liver biopsy - Evidence of decompensated liver disease - Recipient of an organ transplant - Evidence of hepatocellular carcinoma - Evidence of ongoing alcohol or substance abuse - Poorly-controlled diabetes mellitus - Congestive heart failure or unstable cardiopulmonary condition, renal disease, or hemoglobinopathy (sickle cell anemia or thalassemia - History of seizure disorder - History of severe psychiatric illness, including severe depression, history of suicidal ideation, suicidal attempts, related hospitalizations, bipolar disorder, or psychosis requiring medication - Concurrent medical condition or laboratory abnormality that would constitute a contra-indication for interferon use - History of unstable thyroid disease that would preclude administration of interferon-based therapy - Medical condition that requires use of systemic corticosteroids - Received warfarin or other anticoagulants during the 21 days immediately prior to Screening, or is expected to require warfarin or other anticoagulants during the study. - One or more additional known primary or secondary causes of liver disease, other than hepatitis C - Any other concurrent medical condition likely to preclude compliance with the schedule of evaluations, or likely to confound the efficacy or safety observations - 12-lead ECG showing the following: - Corrected QTc interval ≥ 450 msec (Bazett's correction); - QRS > 120 msec; - Clinically significant abnormalities; - Severe retinopathy or other significant ophthalmological disorder - Use of any herbal supplements within 28 days prior to dosing. - The use of CYP3A inducers or inhibitors for at least 2 weeks prior to initiation of treatment through Week 6 | |
| 3 | NCT00600353 | completed | 1 | phase 2 | ['myeloma, plasma-cell', 'lymphoma, malignant'] | ["['S33.110S', 'S33.111S', 'S33.120S', 'S33.121S', 'S33.130S', 'S33.131S', 'S33.140S']"] | ['palonosetron', 'aprepitant', 'dexamethasone'] | ['[H][C@]12CCCC3=C1C(=CC=C3)C(=O)N(C2)[C@@H]1CN2CCC1CC2', '[H][C@@]12C[C@@H](C)[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])CCC2=CC(=O)C=C[C@]12C', 'C[C@@H](O[C@H]1OCCN(CC2=NNC(=O)N2)[C@H]1C1=CC=C(F)C=C1)C1=CC(=CC(=C1)C(F)(F)F)C(F)(F)F'] | Inclusion Criteria: 1. Patients with multiple myeloma and lymphoma deemed by the treating institution to be candidates for high dose chemotherapy and autologous hematopoietic stem cell transplant. 2. Both males and females are eligible. 3. Patients should be 18 years old; multiple myeloma patients up to age 75 and lymphoma patients up to age 65 are eligible. 4. Patients with Karnofsky performance status of 60% or better. 5. Patients should have at least 2.5 x 106 cyropreserved CD34+ cells per kilogram available for transplantation. 6. Patients with adequate bone marrow function as defined as ANC ≥1000 cells/mm3 , platelet ≥ 75,000 cells/mm3. 7. Lymphoma patient must have adequate renal function as defined by a calculated creatinine clearance of 50% measured in ml/min. 8. The criteria for renal function does not apply for multiple myeloma patients. Multiple myeloma patients undergoing hemodialysis are eligible. 9. All patients must have a MUGA scan indicating a left ventricular ejection fraction (LVEF) of greater or equal to 48% within 42 days prior to registration. 10. Patients must have adequate pulmonary function as defined by room air pulse oximetry equal to or greater than 93%, and pulmonary function tests (FEV1 and DLCO) equal to or greater than 50% of predicted values. 11. Patients with adequate hepatic function as defined by serum bilirubin lower than 2.5 mg/dL and liver function tests to not exceed greater than 1.5x of the institutions ULN. 12. All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with the institutional and federal guidelines. 13. Patients must be able to complete the anti-emesis assessment questionnaire. A Spanish questionnaire will be available for Hispanic-speaking patients. Exclusion Criteria: 1. Patients with nausea and have emetic episodes, and are receiving any anti-emetic medication taken within 24 hours of receiving antibiotics. 2. Active infection involving intravenous antibiotics. 3. Patients with known active hepatitis B and/or hepatitis C infections are excluded. 4. Patients with known HIV infection. 5. Primary or secondary brain neoplasms with increased intracranial pressure. 6. Received intrathecal chemotherapy within 24 hours of first dose of conditioning chemotherapy. 7. Patients who are nursing mothers or pregnant. Females of childbearing age are required to have a negative serum B-HCG pregnancy test 24 hours prior to enrollment on the study. 8. Patients with previous malignancies at other sites except surgically treated nonmelanomatous skin cancers, prostate cancer or superficial cervical cancers, or other cancer from which the patient had been disease free for 5 or more years. 9. Patients with uncontrolled medical problems such as diabetes mellitus, cardiac (i.e. congestive heart failure, coronary heart disease, arrhythmias), pulmonary hepatic and renal disease unless renal insufficiency is felt to be secondary to multiple myeloma, 10. Myocardial infarction within 6 months of enrollment in the study. 11. Major surgery within 4 weeks of enrollment. 12. Morbid obesity (BMI>40) 13. Patients with psychiatric or central nervous systems disorders interfering with ability to comply with study protocol. 14. Patients receiving therapeutic anticoagulant therapy for venous thromboembolic episode or other hypercoaguable states. Coumadin at 1 mg as prophylaxis for central venous catheter is allowed. 15. Known hypersensitivity to 5-HT3 antagonists and Aprepitant and their components. 16. Use of non-prescription and herbal-type medications within 72 hours of enrollment on the study. Their use are not allowed during the study. Multivitamins, nutritional supplements such as Boost, and other electrolyte replacements are allowed. | |
| 4 | NCT00538824 | terminated | low enrollment | 0 | phase 2 | ['multiple myeloma'] | ["['C90.01', 'C90.02', 'C90.00']"] | ['dexamethasone', 'thalidomide', 'lenalidomide'] | ['C[C@@H](O[C@H]1OCCN(CC2=NNC(=O)N2)[C@H]1C1=CC=C(F)C=C1)C1=CC(=CC(=C1)C(F)(F)F)C(F)(F)F', 'CC(C)NCC(O)COC1=CC=CC2=C1C=CC=C2', 'NC1=CC=CC2=C1CN(C1CCC(=O)NC1=O)C2=O'] | Inclusion Criteria: - Subject must voluntarily sign and understand written informed consent. - Age > 18 years at the time of signing the consent form. - Histologically confirmed Salmon-Durie stage II or III MM. Stage I MM patients will be eligible if they display poor prognostic factors (ß2M ≥5.5 mg/L, plasma cell proliferation index ≥5%, albumin of less then 3.0, and unfavorable cytogenetics). - Relapsed or refractory myeloma as defined by Appendix II, table 1, progression of disease either after prior therapy or lack of response to currently used therapy. - Prior treatment with prior lenalidomide and thalidomide as single agents or in combination with dexamethasone, but not in combination with each other. - No anti-myeloma therapy within 14 days prior to initiation of study treatment. Patients may be receiving adjuvant antiresorptive therapy (i.e., pamidronate or zoledronic acid) as routine care. - Measurable disease as defined by > 1.0 g/dL serum monoclonal protein, >0.1 g/dL serum free light chains, >0.2 g/24 hrs urinary M-protein excretion, and/or measurable plasmacytoma(s). - Karnofsky performance status ≥70% (>60% if due to bony involvement of myeloma. - All study participants must be registered into the mandatory RevAssist® and S.T.E.P.S.® programs, and be willing and able to comply with the requirements of the RevAssist® and S.T.E.P.S.® programs. - Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours of prescribing lenalidomide and thalidomide (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 4 weeks before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with females of child bearing potential even if they have had a successful vasectomy. - Able to take aspirin daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin). - Life expectancy ≥ 3 months - Subjects must meet the following laboratory parameters: - Absolute neutrophil count (ANC) ≥1000 cells/mm3 (1.0 x 109/L) - Platelets count ≥ 75,000/mm3 (75 x 109/L) - Serum SGOT/AST <3.0 x upper limits of normal (ULN) - Serum SGPT/ALT <3.0 x upper limits of normal (ULN) - Serum creatinine <2.5 mg/dL (221 µmol/L) - Serum total bilirubin <2.0 mg/dL (34 µmol/L) Exclusion Criteria: - Patients with non-secretory MM (no measurable monoclonal protein, free light chains, and/or M-spike in blood or urine). - Prior history of other malignancies (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless disease free for ≥ 5 years. - Myocardial infarction within 6 months prior to enrollment , or NYHA(New York Hospital Association) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, electrocardiographic evidence of acute ischemia or active conduction system abnormalities. - Pregnant or lactating females are ineligible. - Given the potential of the study drugs to trigger or worsen HIV viremia and the incidence of opportunistic infections inpatients infected with the HIV virus, HIV-1 or HIV-2 positive patients will be excluded. The interactions of HAART with study drugs have not been determined. - Active hepatitis B or hepatitis C infection. - Active viral or bacterial infections or any coexisting medical problem that would significantly increase the risks of this treatment program. - Any coexisting medical problem or laboratory evaluation that, in the treating physician's or principal investigator's opinion, makes the patient unsuitable to participate in this clinical trial. - Known hypersensitivity to dexamethasone, lenalidomide, or thalidomide. - History of thromboembolic event within the past 6 months prior to enrollment. |
| 5 | NCT00445068 | terminated | 0 | phase 2 | ['multiple myeloma'] | ["['C90.01', 'C90.02', 'C90.00']"] | ['lbh589'] | ['[H]\\C(=C(\\[H])C1=CC=C(CNCCC2=C(C)NC3=CC=CC=C23)C=C1)C(O)=NO'] | Inclusion criteria: 1. Adults ≥ 18 years old 2. Diagnosis of symptomatic multiple myeloma (per IMWG see Kyle et al 2003) 3. Subjects must have received at least two prior lines of therapy and be refractory to the most recent line of therapy 4. Subjects must have previously been treated with : bortezomib or lenalidomide 5. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2 6. Patients must have adequate laboratory values 7. Baseline left ventricular ejection fraction LVEF ≥ the lower limit of the institutional normal Exclusion criteria: 1. Prior therapy with a histone deacetylase inhibitor (HDAC) 2. Impaired cardiac function or clinically significant cardiac diseases 3. Impairment of gastrointestinal function (GI) function or GI disease that may significantly alter the absorption of LBH589 4. Patients with unresolved diarrhea > Common Terminology Criteria for Adverse Events (CTCAE) grade 1 5. Concomitant use of certain medications 6. Patients who have received chemotherapy, radiation therapy or any investigational drugs, bortezomib or other immunomodulatory therapy or immunotherapy ≤ 3 weeks prior to starting study drug or who have not recovered from side effects of such therapy 7. Patients who have received steroids ≤ 2 weeks prior to starting study treatment or who have not recovered from side effects of such therapy. 8. Patients who have received high-dose corticosteroids as the only component of their most recent line of therapy 9. Patients who have undergone major surgery ≤ 4 weeks prior to starting study drug or who have not recovered from side effects of such therapy 10. Women who are pregnant or breast feeding or women of childbearing potential not using an effective method of birth control. Other protocol-defined inclusion/exclusion criteria may apply | |
| 6 | NCT01020305 | terminated | decision by funding sponsor due to poor accrual | 0 | phase 1/phase 2 | ['prostate cancer', 'prostatic neoplasms', 'castrate-resistant prostate cancer (crpc)', 'androgen-insensitive prostate cancer', 'hormone-refractory prostate cancer', 'metastatic disease'] | ["['C61', 'D29.1', 'D40.0', 'Z15.03', 'Z80.42', 'Z85.46', 'Z12.5']", "['B38.81', 'N42.31', 'Z87.430', 'N40.0', 'N40.1']", "['C61', 'D29.1', 'D40.0', 'Z15.03', 'Z80.42', 'Z85.46', 'Z12.5']", "['C61', 'D29.1', 'D40.0', 'Z15.03', 'Z80.42', 'Z85.46', 'Z12.5']", "['C61', 'D29.1', 'D40.0', 'Z15.03', 'Z80.42', 'Z85.46', 'Z12.5']"] | ['temsirolimus', 'casodex (bicalutamide)'] | ['CN1N=NC2=C(N=CN2C1=O)C(N)=O', 'CC(O)(CS(=O)(=O)C1=CC=C(F)C=C1)C(=O)NC1=CC(=C(C=C1)C#N)C(F)(F)F'] | INCLUSION CRITERIA - Histologically-confirmed adenocarcinoma of the prostate, characterized as symptomatic castration-resistant prostate cancer (CRPC) - Serum PSA ≥ 2 ng/mL - Rising PSA on 3 consecutive occasions at least 1 week apart (not limited to the 30-day screening period) - Failure of bilateral orchiectomy and/or therapy with an LHRH agonist and bicalutamide - Castrate level of testosterone (< 50 ng/dL) - Currently being treated with bicalutamide - No prior antiandrogen therapy except bicalutamide - Age ≥ 18 years - Life expectancy > 6 months - Performance status - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - OR - Karnofsky performance status ≥ 80% - Ability to understand and the willingness to sign a written informed consent EXCLUSION CRITERIA - Radiotherapy for prostate cancer within 28 days prior to Day 1, except single-fraction radiotherapy for pain control - Prior treatment with mTOR inhibitors - Prior treatment with chemotherapy for prostate cancer - Symptomatic bone metastases (ie, asymptomatic bone metastases are eligible) - Visceral metastases - Absolute neutrophil count (ANC) < 1500/uL - Platelet count ≤ 100 x 10e9/L - Total bilirubin ≥ 1.5 x Upper Limit of Normal (ULN) - Alkaline phosphatase > 2.5 x ULN - AST > 2.5 x ULN - ALT > 2. 5x ULN - Serum creatinine > 2.0 mg/dL - Hemoglobin < 9 g/dL - Men with reproductive potential who do not agree to use an accepted and effective method of contraception during the study treatment period and for at least 3 months after completion of the study treatment - History of other malignancies within 5 years except for tumors with a negligible risk for metastasis or death, such as adequately-controlled basal cell carcinoma, squamous-cell carcinoma of the skin, or early-stage bladder cancer - Participation in another experimental drug study either planned or within 4 weeks of the first study treatment - Persistent Grade ≥ 1 AEs due to prior drug therapy, including investigational drugs, administered more than 14 days before study enrollment - Previously treated or other known brain metastases - Ongoing or active infection - Symptomatic congestive heart failure, New York Heart Association Grade II or greater - Unstable angina pectoris - Cardiac arrhythmia - Significant vascular disease (eg, aortic aneurysm, aortic dissection) - Symptomatic peripheral vascular disease - Psychiatric illness/social situations that would limit compliance with study requirements - Other uncontrolled intercurrent illness - Known to be positive for the human immunodeficiency virus (HIV) infection and receiving antiretroviral therapies (HIV positive not requiring antiretroviral therapy iseligible if all other entry criteria are meet) - Inability to comply with study and/or follow-up procedures |
| 7 | NCT00513435 | completed | 0 | phase 2 | ['metastatic squamous neck cancer with occult primary squamous cell carcinoma', 'recurrent metastatic squamous neck cancer with occult primary', 'recurrent squamous cell carcinoma of the hypopharynx', 'recurrent squamous cell carcinoma of the larynx', 'recurrent squamous cell carcinoma of the lip and oral cavity', 'recurrent squamous cell carcinoma of the nasopharynx', 'recurrent squamous cell carcinoma of the oropharynx', 'recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity', 'recurrent verrucous carcinoma of the larynx', 'recurrent verrucous carcinoma of the oral cavity', 'stage iii squamous cell carcinoma of the hypopharynx', 'stage iii squamous cell carcinoma of the larynx', 'stage iii squamous cell carcinoma of the lip and oral cavity', 'stage iii squamous cell carcinoma of the nasopharynx', 'stage iii squamous cell carcinoma of the oropharynx', 'stage iii squamous cell carcinoma of the paranasal sinus and nasal cavity', 'stage iii verrucous carcinoma of the larynx', 'stage iii verrucous carcinoma of the oral cavity', 'stage iv squamous cell carcinoma of the hypopharynx', 'stage iv squamous cell carcinoma of the nasopharynx', 'stage iva squamous cell carcinoma of the larynx', 'stage iva squamous cell carcinoma of the lip and oral cavity', 'stage iva squamous cell carcinoma of the oropharynx', 'stage iva squamous cell carcinoma of the paranasal sinus and nasal cavity', 'stage iva verrucous carcinoma of the larynx', 'stage iva verrucous carcinoma of the oral cavity', 'stage ivb squamous cell carcinoma of the larynx', 'stage ivb squamous cell carcinoma of the lip and oral cavity', 'stage ivb squamous cell carcinoma of the oropharynx', 'stage ivb squamous cell carcinoma of the paranasal sinus and nasal cavity', 'stage ivb verrucous carcinoma of the larynx', 'stage ivb verrucous carcinoma of the oral cavity', 'stage ivc squamous cell carcinoma of the larynx', 'stage ivc squamous cell carcinoma of the lip and oral cavity', 'stage ivc squamous cell carcinoma of the oropharynx', 'stage ivc squamous cell carcinoma of the paranasal sinus and nasal cavity', 'stage ivc verrucous carcinoma of the larynx', 'stage ivc verrucous carcinoma of the oral cavity', 'tongue cancer'] | ["['C67.5', 'C76.0', 'C44.40', 'D23.4', 'C44.49', 'C47.0', 'C49.0']", "['C22.0', 'C4A.9', 'C7B.1', 'C4A.0', 'C4A.31', 'C4A.51', 'C4A.8']", "['C22.0', 'C4A.9', 'C7B.1', 'C4A.0', 'C4A.31', 'C4A.51', 'C4A.8']", "['C22.0', 'C4A.9', 'C7B.1', 'C4A.0', 'C4A.31', 'C4A.51', 'C4A.8']", "['C22.0', 'C4A.9', 'C7B.1', 'C4A.0', 'C4A.31', 'C4A.51', 'C4A.8']", "['C22.0', 'C4A.9', 'C7B.1', 'C4A.0', 'C4A.31', 'C4A.51', 'C4A.8']", "['C22.0', 'C4A.9', 'C7B.1', 'C4A.0', 'C4A.31', 'C4A.51', 'C4A.8']", "['C22.0', 'C22.1', 'C4A.9', 'C7B.1', 'D09.9', 'C4A.0', 'C4A.31']", "['C22.0', 'C22.1', 'C4A.9', 'C7B.1', 'D09.9', 'C4A.0', 'C4A.31']", "['C22.0', 'C4A.9', 'C7B.1', 'C4A.0', 'C4A.31', 'C4A.51', 'C4A.8']", "['C22.0', 'C4A.9', 'C7B.1', 'C4A.0', 'C4A.31', 'C4A.51', 'C4A.8']", "['C22.0', 'C4A.9', 'C7B.1', 'C4A.0', 'C4A.31', 'C4A.51', 'C4A.8']", "['C22.0', 'C4A.9', 'C7B.1', 'C4A.0', 'C4A.31', 'C4A.51', 'C4A.8']", "['C22.0', 'C4A.9', 'C7B.1', 'C4A.0', 'C4A.31', 'C4A.51', 'C4A.8']", "['C22.0', 'C22.1', 'C4A.9', 'C7B.1', 'D09.9', 'C4A.0', 'C4A.31']", "['C22.0', 'C22.1', 'C4A.9', 'C7B.1', 'D09.9', 'C4A.0', 'C4A.31']", "['C22.0', 'C4A.9', 'C7B.1', 'C4A.0', 'C4A.31', 'C4A.51', 'C4A.8']", "['C22.0', 'C4A.9', 'C7B.1', 'C4A.0', 'C4A.31', 'C4A.51', 'C4A.8']", "['C22.0', 'C4A.9', 'C7B.1', 'C4A.0', 'C4A.31', 'C4A.51', 'C4A.8']", "['C22.0', 'C4A.9', 'C7B.1', 'C4A.0', 'C4A.31', 'C4A.51', 'C4A.8']", "['C22.0', 'C4A.9', 'C7B.1', 'C4A.0', 'C4A.31', 'C4A.51', 'C4A.8']", "['C22.0', 'C22.1', 'C4A.9', 'C7B.1', 'D09.9', 'C4A.0', 'C4A.31']", "['C22.0', 'C22.1', 'C4A.9', 'C7B.1', 'D09.9', 'C4A.0', 'C4A.31']", "['C22.0', 'C4A.9', 'C7B.1', 'C4A.0', 'C4A.31', 'C4A.51', 'C4A.8']", "['C22.0', 'C4A.9', 'C7B.1', 'C4A.0', 'C4A.31', 'C4A.51', 'C4A.8']", "['C22.0', 'C4A.9', 'C7B.1', 'C4A.0', 'C4A.31', 'C4A.51', 'C4A.8']", "['C22.0', 'C22.1', 'C4A.9', 'C7B.1', 'D09.9', 'C4A.0', 'C4A.31']", "['C22.0', 'C22.1', 'C4A.9', 'C7B.1', 'D09.9', 'C4A.0', 'C4A.31']", "['C22.0', 'C4A.9', 'C7B.1', 'C4A.0', 'C4A.31', 'C4A.51', 'C4A.8']", "['C22.0', 'C4A.9', 'C7B.1', 'C4A.0', 'C4A.31', 'C4A.51', 'C4A.8']", "['C22.0', 'C4A.9', 'C7B.1', 'C4A.0', 'C4A.31', 'C4A.51', 'C4A.8']", "['C22.0', 'C22.1', 'C4A.9', 'C7B.1', 'D09.9', 'C4A.0', 'C4A.31']", "['C22.0', 'C22.1', 'C4A.9', 'C7B.1', 'D09.9', 'C4A.0', 'C4A.31']", "['D10.1', 'C02.9', 'C01', 'C02.1', 'D37.02', 'C02.0', 'C02.2']"] | ['saracatinib'] | ['CN1CCN(CCOC2=CC3=C(C(NC4=C(Cl)C=CC5=C4OCO5)=NC=N3)C(OC3CCOCC3)=C2)CC1'] | Inclusion Criteria: - Histologically or cytologically confirmed squamous cell carcinoma of the head and neck - Persistent, recurrent, or metastatic disease that is not amenable to curative-intent therapy with surgery or radiation - Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) ≥ 20 mm with conventional techniques or ≥ 10 mm with spiral computed tomography (CT) scan - Karnofsky performance status ≥ 60% - White blood cell (WBC) ≥ 3,000/mcL - Absolute neutrophil count ≥ 1,500/mcL - Platelets ≥ 100,000/mcL - Hemoglobin > 9 g/dL - Total bilirubin within upper institutional limits of normal (ULN) - Aspartate aminotransferase (AST) /alanine aminotransferase (ALT) ≤ 2.5 x ULN - Creatinine within ULN OR creatinine clearance ≥ 60 mL/min - Patients must agree to use adequate birth control for the duration of study participation and for at least 8 weeks after discontinuation of study drug - May have received 1 prior cytotoxic chemotherapy regimen for recurrent or metastatic disease Exclusion Criteria: - Known brain metastases - History of allergic reactions attributed to compounds of similar chemical or biological composition to AZD0530 - Urine protein: creatinine ratio ≥ 1.0 OR 24-hour urine protein ≥ 1,000 mg - QTc prolongation ≥ 480 msecs - Intercurrent symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia - History of myocardial infarction within the past year - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements - Pregnant or breastfeeding women - Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy - Pulmonary fibrosis ≥ grade 2, pleural effusion (non-malignant) ≥ grade 2, or pneumonitis/pulmonary infiltrates ≥ grade 2 - Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study - Patients who have not recovered from adverse events due to agents administered more than 4 weeks earlier - Use of specifically prohibited cytochrome P450 3A4 (CYP3A4)-active agents or substances - Prohibited drugs should be discontinued 7 days prior to the administration of the first dose of AZD0530 and for 7 days following discontinuation of AZD0530 - Patients receiving any other investigational agents | |
| 8 | NCT01245088 | withdrawn | sponsor withdrew support after no patients enrolled | 0 | phase 1/phase 2 | ["crohn's disease"] | ["['K50.90', 'K50.913', 'K50.914', 'K50.911', 'K50.912', 'K50.918', 'K50.919']"] | ['chondroitin sulfate'] | ['OC(=O)CC(O)(CC(O)=O)C(O)=O'] | Inclusion Criteria: - 1. Colonic or ileocolonic CD diagnosed for at least 3 months. 2. Active CD, defined as a Crohn's Disease Activity Index (CDAI; Appendix A) [Best 1976] of greater than 200 but less than 320 at the time entry into the study. 3. Age > 18 years. 4. Patients receiving oral or topical 5-aminosalicylates must be on a stable dose for four weeks prior to enrollment. 5. Patients on azathioprine, 6-mercaptopurine, or methotrexate must be on stable doses for 14 weeks prior to enrollment. 6. Patients on corticosteroids must be on stable doses for 2 weeks prior to enrollment. 7. Patients receiving corticosteroid enemas must be on a stable dose for 3 weeks prior to enrollment. 8. Patient on biologic therapy with infliximab, adalimumab, or certolizumab must be on stable therapy for 12 weeks prior to enrollment 9. Patient must sign informed consent. Exclusion Criteria: - 1. Patients with only small bowel CD, fistulizing CD, or gastroduodenal CD without colonic involvement. 2. Patients with known ulcerative colitis. 3. Patients expected to require surgery within 30 days for complications of CD. 4. Patients with CD and an intraabdominal abscess. 5. Patients requiring continuous antibiotics; antibiotics may be taken up to the point of enrollment into the study. 6. Patients with severe cardiac, pulmonary, or renal disease. 7. Patients with a h/o malignancy other than resected basal cell carcinoma of the skin 8. Patients who have participated in another clinical research study in the past 8 weeks. 9. Patients who are pregnant. |
| 9 | NCT01224860 | completed | 0 | phase 2 | ['renal transplant'] | ["['N25.0', 'Q61.4', 'N23', 'N26.9', 'P96.0', 'Q60.0', 'Q60.1']"] | ['telmisartan', 'losartan'] | ['CCCC1=NC2=C(C=C(C=C2C)C2=NC3=CC=CC=C3N2C)N1CC1=CC=C(C=C1)C1=CC=CC=C1C(O)=O', 'CCCCC1=NC(Cl)=C(CO)N1CC1=CC=C(C=C1)C1=CC=CC=C1C1=NNN=N1'] | Inclusion Criteria: - Informed consent; - Age > 18 years; - Single renal transplant or dual marginal > 6 months duration; - Blood pressure >130/85 mmHg or need for anti-hypertensive therapy; - Stable renal function (changes in serum creatinine < 30%) and no acute rejection episodes in the last six months; - Stable (for at least six months) dual or triple immunosuppressive therapy including corticosteroids or calcineurin inhibitors; - Legal capacity. Exclusion Criteria: - Vascular disease of the kidney; - Heart failure: NYHA classification class III-IV on ACE or AII inhibitor therapy; - Cerebral haemorrhage, stroke or TIA within three months prior to study enrolment; - Myocardial infarction within three months prior to study enrolment; - Unstable angina pectoris; - Severe hepatic disease; - Pregnancy or women of child-bearing potential without following a scientifically accepted form of contraception; - Overt diabetes or concomitant treatment with oral antidiabetic agents and/or insulin; - Specific clinical indication (other than arterial hypertension) to be treated with ACE inhibitors or AII receptor antagonists; - Specific contraindications or history of hypersensitivity to the study drugs, glitazones, ACE inhibitors or AII receptor antagonists; - Participation to other clinical trials over the last three months; - Legal incapacity; - Previous diagnosis of: intellectual disability/mental retardation, dementia, schizophrenia. | |
| 10 | NCT00420342 | completed | 0 | phase 2 | ['postmenopause', 'hypertension', 'pre-hypertension'] | ["['I15.0', 'I97.3', 'K76.6', 'P29.2', 'G93.2', 'H40.053', 'I10']", "['O11.1', 'O11.2', 'O11.3', 'O11.4', 'O11.9', 'O11.5', 'O10.02']"] | ['drospirenone/17ß-estradiol (angeliq, bay86-4891)', 'drospirenone/17ß-estradiol (angeliq, bay86-4891)', 'sh k 00641 c - medroxyprogesterone acetate / conjugated equine (prempro tm)'] | ['[H][C@@]12CC[C@H](O)[C@@]1(C)CC[C@]1([H])C3=C(CC[C@@]21[H])C=C(O)C=C3', '[H][C@@]12CC[C@H](O)[C@@]1(C)CC[C@]1([H])C3=C(CC[C@@]21[H])C=C(O)C=C3', '[H][C@@]12CC[C@](OC(C)=O)(C(C)=O)[C@@]1(C)CC[C@@]1([H])[C@@]2([H])C[C@H](C)C2=CC(=O)CC[C@]12C'] | Inclusion Criteria: - Postmenopausal women 45 - 65 years old with prehypertension Exclusion Criteria: - Hormone therapy (estrogen/progestin) | |
| 11 | NCT00396201 | completed | 1 | phase 2 | ["hodgkin's disease"] | ["['C81.77', 'C81.97', 'C81.17', 'C81.27', 'C81.37', 'C81.47', 'C81.70']"] | ['g-csf plus plerixafor'] | ['C(N1CCCNCCNCCCNCC1)C1=CC=C(CN2CCCNCCNCCCNCC2)C=C1'] | Inclusion Criteria: - Diagnosis of HD eligible for autologous transplantation - No more than 3 prior regimens of chemotherapy (Rituximab is not considered chemotherapy for the purpose of this study.) - 4 weeks since last cycle of chemotherapy - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - The patient has recovered from all acute toxic effects of prior chemotherapy - White blood cell count (WBC) >3.0*10^9/L - Absolute polymorphonuclear cells (PMN) count >1.5*10^9/L - Platelet (PLT) count >100*10^9/L - Serum creatinine ≤2.2 mg/DL - Serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT) and total bilirubin <2 x upper limit of normal (ULN) - Left ventricle ejection fraction >45% by normal echocardiogram or multiple-gated acquisition (MUGA) scan - Forced expiratory volume of the lung in the first second (FEV1) >60% of predicted or diffusing capacity of the lung for carbon monoxide (DLCO) >45% of predicted - Negative for human immunodeficiency virus (HIV) Exclusion Criteria: - A co-morbid condition which, in the view of the investigator, renders the patient at high risk for treatment complications - Patients who have failed previous collections - A residual acute medical condition resulting from prior chemotherapy - Hodgkin's disease involving the central nervous system - Acute infection - Fever (temp >38°C/100.4°F) - Patients whose actual body weight exceeds 150% of their ideal body weight - History of ventricular arrhythmias - History of paresthesias - Patients who previously received experimental therapy within 4 weeks of enrolling in this study or who are currently enrolled in another experimental study during the mobilization period | |
| 12 | NCT00098371 | terminated | ctep initiated action. | 1 | phase 2 | ['b-cell chronic lymphocytic leukemia', 'prolymphocytic leukemia', 'refractory chronic lymphocytic leukemia'] | ["['C91.11', 'C91.12', 'C91.10']", "['C91.31', 'C91.32', 'C91.61', 'C91.62', 'C91.30', 'C91.60']", "['A87.2', 'K52.832', 'D72.111', 'C91.11', 'C91.12', 'C91.10']"] | ['alvocidib'] | ['CN1CC[C@@H]([C@H](O)C1)C1=C(O)C=C(O)C2=C1OC(=CC2=O)C1=CC=CC=C1Cl'] | Inclusion Criteria: - Histologically confirmed B-cell chronic lymphocytic leukemia (CLL) or prolymphocytic leukemia (PLL) arising from CLL - No de novo PLL - Lymphocyte count > 5,000/mm^3 at some point since initial diagnosis of CLL - B-cells co-expressing CD5 AND CD19 or CD20 - If no dim serum immunoglobulin or CD23 expression on leukemia cells, must be examined for cyclin D1 overexpression OR t(11;14) to rule out mantle cell lymphoma - Requiring therapy, defined by any of the following: - Massive or progressive splenomegaly and/or lymphadenopathy - Anemia (hemoglobin < 11 g/dL) OR thrombocytopenia (platelet count < 100,000/mm^3) - Weight loss > 10% within the past 6 months - Grade 2 or 3 fatigue - Fevers > 100.5°C or night sweats for > 2 weeks with no evidence of infection - Progressive lymphocytosis with an increase of > 50% over a 2-month period OR an anticipated doubling time < 6 months - Received ≥ 1 prior chemotherapy regimen that included fludarabine or nucleoside equivalent OR alternative therapy if contraindication to fludarabine exists (i.e., autoimmune hemolytic anemia) - Performance status - ECOG 0-2 - More than 2 years - See Disease Characteristics - Baseline cytopenias allowed - WBC ≤ 200,000/mm^3 - Bilirubin ≤ 1.5 times upper limit of normal (ULN) (unless due to Gilbert's disease, hemolysis, or disease infiltration of the liver) - AST ≤ 2 times ULN (unless due to hemolysis or disease infiltration of the liver) - Creatinine ≤ 2.0 mg/dL - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No other malignancy that would limit life expectancy - See Disease Characteristics - No other concurrent chemotherapy - No concurrent chronic corticosteroids or corticosteroids as antiemetics - No concurrent hormonal therapy except steroids for new adrenal failure or hormones for nondisease-related conditions (e.g., insulin for diabetes) - No concurrent radiotherapy |
| 13 | NCT00385099 | completed | 0 | phase 2 | ['irritable colon'] | ["['K58.2', 'K58.8', 'K58.0', 'K58.1', 'K58.9']"] | ['gw876008'] | ['CC1=NC=C2CN=C(C3=CC=CC=C3F)C3=C(C=CC(Cl)=C3)N12'] | Inclusion criteria: - Must have irritable bowel syndrome. Exclusion criteria: - Subjects who have been taking any medication for the treatment of irritable bowel syndrome within 6 months prior to the start of the study. | |
| 14 | NCT01009801 | terminated | due to slow patient recruitement. | 0 | phase 1/phase 2 | ['liver cancer'] | ["['D13.4', 'Z85.05', 'C22.8', 'C78.7', 'C22.9', 'D37.6']"] | ['doxorubicin-eluting beads', 'everolimus'] | ['COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O', '[H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\\C=C(C)\\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\\C=C\\C=C\\C=C(C)\\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC'] | DISEASE CHARACTERISTICS: - Histologically, cytologically, or radiologically confirmed hepatocellular carcinoma - Intermediate stage B (according to Barcelona Clinic Liver Cancer classification) - Child-Pugh score < 8 - No tumor involvement > 50% of whole liver - No advanced stage disease (i.e., either portal invasion [segmental portal obstruction] or extrahepatic spread) - No presence or history of metastatic disease - Candidate for transarterial chemoembolization after multidisciplinary discussion (tumor board) - Not on an active waiting list for liver transplantation PATIENT CHARACTERISTICS: - WHO performance status 0-1 - Hemoglobin ≥ 90 g/L - Absolute neutrophil count ≥ 1.5 x 10^9/L - Platelet count ≥ 100 x 10^9/L - Bilirubin ≤ 1.5 x upper limit of normal (ULN) - ALT ≤ 4 x ULN - INR ≤ 2 - Creatinine ≤ 1.5 x ULN - Not pregnant or nursing - Fertile patients must use effective contraception during and for 12 months after completion of study therapy - Negative pregnancy test - None of the following contraindications: - Complete portal vein thrombosis - Large arterio-portal or arterio-venous fistula within the liver - Allergy to contrast media - Contraindication to hepatic artery catheterization, such as severe peripheral vascular disease precluding catheterization - No active heart disease, including any of the following: - NYHA class II-IV congestive heart failure - Active coronary artery disease (myocardial infarction > 6 months prior to trial entry allowed) - Cardiac arrhythmias requiring anti-arrhythmic therapy (beta-blockers or digoxin permitted) - Uncontrolled hypertension - No hypertension, defined as systolic blood pressure (BP) > 150 mm Hg or diastolic BP > 90 mm Hg despite optimal medical management - No thrombotic or embolic events within the past 6 months including any of the following: - Cerebrovascular accident (including transient ischemic attacks) - Pulmonary embolism - Deep vein thrombosis - No serious non-healing wounds, including wounds healing by secondary intention, acute or non-healing ulcers, or bone fractures within 3 months of fracture - No evidence of bleeding diathesis - No history of hemoptysis - No clinically serious infection > grade 2 (NCI CTCAE Version 3.0) except for HBV and HCV infection - No known HIV infection - No CTCAE acute adverse events grade > 2 after prior TACE therapy - No other prior or concurrent malignancy that is distinct in primary site or histology from HCC, except carcinoma in situ of the cervix, treated nonmelanoma skin cancer, superficial bladder tumor (Ta, Tis, T1), or any cancer curatively treated > 3 years prior to entry - No psychiatric disorder precluding understanding of information on trial related topics, giving informed consent, filling out QL forms, or interfering with compliance for oral drug intake - No serious underlying medical condition, at the judgment of the investigator, which could impair the ability of the patient to participate in the trial (e.g., active autoimmune disease, uncontrolled diabetes) - No known hypersensitivity to trial drugs or hypersensitivity to any other component of the trial drugs - No contraindication to have MRI (e.g., pacemaker) - No organ allograft - No known impairment of swallowing that would preclude administration of everolimus - Completed baseline quality of life, BL-HEA, and EQ5D questionnaires (Phase II only) - Able to comply and have geographic proximity to allow proper staging and follow-up PRIOR CONCURRENT THERAPY: - At least 4 weeks since prior transarterial embolization/chemoembolization [limited to 5 treatments], radiofrequency ablation, cryoablation, radiation therapy or percutaneous ethanol injection - At least 4 weeks since prior sorafenib - At least 30 days since treatment with other experimental drugs or other anticancer therapy, or treatment in another clinical trial - At least 30 days since use of biologic response modifiers (e.g., G-CSF and other hematopoietic growth factors) - More than 4 weeks since prior and no concurrent major surgery - More than 3 weeks since prior and no concurrent radiotherapy - Concurrent erythropoietin allowed provided no dose adjustment is undertaken within 1 month prior to the trial or during the trial - No concurrent anticancer drugs (e.g., bevacizumab, and any drugs that target VEGF or VEGF receptors) - No concurrent investigational drugs - No concurrent known strong CYP3A4 inhibitors (e.g., ketoconazole, fluconazole, itraconazole, voriconazole, erythromycin, clarithromycin, diltiazem, verapamil, and protease inhibitors) - No concurrent known strong CYP3A4 inducers (e.g., carbamazepine, continuous treatment with dexamethasone [> 2 mg/day for > 7 days], phenobarbital, phenytoin, rifampicin, and St. John's wort) - No concurrent grapefruit, grapefruit juice, and products containing bitter oranges - No concurrent systemic corticosteroids (e.g., > 1 mg/kg prednisolone) for more than 2 weeks - No concurrent angiotensin converting enzyme inhibitors (ACE-I) |
| 15 | NCT00706953 | withdrawn | 0 | phase 2 | ['multiple myeloma'] | ["['C90.01', 'C90.02', 'C90.00']"] | ['bortezomib; pegylated liposomal doxorubicin'] | ['COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O'] | Inclusion Criteria: - Confirmed diagnosis of Multiple Myeloma - Received prior courses of bortezomib (VELCADE)-based therapy - Greater than or equal to 50% reduction in M-Protein sustained for a minimum of 60 days and no evidence of progression of disease while on the most recent course of VELCADE-based therapy - 60 days or more since the patient's last VELCADE dose - Life expectancy > 3 months - Progressive disease defined by new or worsening lytic bone lesions or plasmacytoma or hypercalcemia or a >25% increase in M-protein Exclusion Criteria: - No patients with progressive disease while receiving an anthracycline-based regimen - No patients with >2 prior regimens for the treatment of multiple myeloma - No major surgery within 2 weeks before screening - No patients with history of allergic reaction to compounds containing boron, mannitol, anthracycline, or liposomal formulations of any agent - No patients known to be human immunodeficiency virus (HIV) positive - No patients with poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness - No patients with an active systemic infection requiring treatment | |
| 16 | NCT00545766 | completed | 0 | phase 2 | ['prostate cancer'] | ["['C61', 'D29.1', 'D40.0', 'Z15.03', 'Z80.42', 'Z85.46', 'Z12.5']"] | ['vinflunine'] | ['CC[C@@]12C=CCN3CC[C@@]4([C@H]13)[C@@H](N(C)C1=CC(OC)=C(C=C41)[C@]1(C[C@@H]3C[C@H](C[N@@](C3)CC3=C1NC1=CC=CC=C31)C(C)(F)F)C(=O)OC)[C@](O)([C@@H]2OC(C)=O)C(=O)OC'] | Inclusion Criteria: Men age 18 years of age or older who have HRPC are eligible for this study based on the following inclusion criteria: 1. Histologically confirmed adenocarcinoma of the prostate. 2. Progressive hormone refractory locally advanced or metastatic disease. - (Definition of HRPC): Clinical or serological evidence of disease progression despite adequate anti-androgen therapy, documented by castrate levels of serum testosterone (<50 ng/mL). - Patients on medical castration therapy should continue on treatment to maintain castrate levels of serum testosterone. Patients receiving anti-androgen or estrogen therapy should either be maintained on it, or have documented progression 4 weeks after withdrawal of all agents (except nilutamide and bicalutamide), which requires 6 weeks. 3. Disease Progression, documented by any of the following: - PSA Progression, documented by an elevated PSA level (>5 ng/mL), which has risen serially from the baseline PSA value (PSA value #1) on two occasions, each at least 1 week apart (these will be considered PSA values #2 and #3). (Note: if the level of PSA value #3 is less than the level of PSA value #2, a subsequent PSA value must be obtained (PSA value #4) at least 1 week after PSA value #3 was measured. In order for this event to be considered a PSA progression, the level of this final PSA value (PSA value #4) must be greater than the PSA level that was observed for PSA value #2. - Progressive metastatic prostate carcinoma, documented by computed tomography (CT), magnetic resonance imaging (MRI), or radiograph of non osseous lesions (see Section 7.2). - Bone Scan Progression, documented by the appearance of at least one or more new lesions that are not believed to be secondary to tumor flare phenomenon. 4. Patients with bone only disease must have a PSA level >=5 ng/mL; patients with stable lesions must have evidence of PSA progression. Patients must have radiographically or clinically demonstrable metastatic disease. 5. Receipt of either 1 or 2 previous chemotherapy regimens; one of these regimens must have included docetaxel. 6. ECOG performance status of 0-2. 7. Adequate bone marrow function, defined by: white blood cells >=3,500/uL, hemoglobin >=8 g/dL, platelet count >=100,000/uL. 8. Adequate renal function, defined by: serum creatinine <1.8 mg/dL, or calculated or measured creatinine clearance (GFR) of >=60 cc/min. Patients with a creatinine clearance of >30 mL/min but <60 mL/min may also be enrolled, but will require an initial adjusted dose (see Section 5.1) 9. Adequate hepatic function, defined by: total bilirubin <1.5 x the upper limit of normal, AST <2 x the upper limit of normal. 10. Patients must be able to comprehend the nature of the study and provide written informed consent. 11. Partners of women of childbearing potential must use effective contraception while on treatment and for at least 3 months thereafter. Women of childbearing potential include females who have experienced menarche and have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or are not post-menopausal (i.e., amenorrhea >12 months). 12. Patients on bisphosphonate therapy (at the discretion of the investigator). Exclusion Criteria: 1. History of other prior malignancy in the past 5 years (excluding resected basal cell or squamous cell skin cancer). 2. History of second- or third-degree heart block, uncontrolled angina, uncontrolled hypertension, or recent myocardial infarction or congestive heart failure (New York Heart Association Class III-IV) within the past 6 months (see Appendix F) 3. Cerebral vascular accident within the past 6 months. 4. Peripheral neuropathy > grade 2 per Common Terminology Criteria for Adverse Events (CTCAE) v3.0. 5. Patients with rising PSA but no demonstrable metastases. 6. Previous radiotherapy, outside of standard portals, utilized for prostate cancer (if total amount of radiotherapy encompasses >25% of bone marrow containing osseous regions). 7. Prior therapy with Strontium 90, Samarium 150, or other injectable therapeutic radioisotopes. 8. History of prior allergic reaction to any vinca alkaloid. 9. Use of chemotherapy or investigational drugs within 4 weeks prior to the first dose of study drug. 10. Treatment with ketoconazole, itraconazole, ritonavir, amprenavir, or indinavir within 4 weeks prior to the first dose of study drug. 11. Previous treatment with an anthracycline. 12. Patients who are unable to receive chemotherapy on a basis of once every three weeks as a result of physical, environmental, or co existent medical problems. | |
| 17 | NCT01222572 | terminated | slow accrual due to restrictive eligibility criteria | 0 | phase 1/phase 2 | ['non-small cell lung cancer', 'lung cancer', 'nsclc'] | ["['C78.00', 'C78.01', 'C78.02', 'D14.30', 'D14.31', 'D14.32', 'C34.2']", "['C78.00', 'C78.01', 'C78.02', 'D14.30', 'D14.31', 'D14.32', 'C34.2']"] | ['etoposide', 'cisplatin'] | ['OCCOCCN1CCN(CC1)C(C1=CC=CC=C1)C1=CC=C(Cl)C=C1', '[H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC'] | Inclusion Criteria: - Histologically or cytologically confirmed stage II or stage III non-small cell lung cancer, or stage IV non-small cell lung cancer that will be treated with curative intent - Evaluated by a surgeon and deemed inoperable - Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension as 10mm or greater with chest CT scan. - No active malignancy within the past 5 years, except for non-melanoma skin cancers or carcinoma in situ of the cervix - 18 years or older - Life expectancy of greater then 6 months - Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 - Normal organ and marrow function as outlined in the protocol - Forced expiratory volume (FEV1) of 1 L or greater OR 50% or greater of predicted Exclusion Criteria: - Primary tumor size greater then 6cm - Prior history of thoracic radiotherapy - May not be receiving any other study agents - History of pulmonary fibrosis - History of allergic reactions attributed to compounds of similar chemical or biologic composition to cisplatin or etoposide - Primary tumor < 1.5 cm beyond hilar lymphadenopathy (if any) and 1.5 cm from proximal bronchial tree, defined as the trachea, right and left mainstem bronchus, and lobar bronchi until the 1st lobar segment - Uncontrolled intercurrent illness including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements - Pregnant or breast feeding women - Individuals with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin - Human immunodeficiency virus (HIV)-positive individuals on combination antiretroviral therapy - Patients who are planned to receive the following medication: granulocyte colony-stimulating factor (G-CSF), bevacizumab, cetuximab, cyclosporine, anti-tumor necrosis factor agents, amifostine. |
| 18 | NCT01554579 | completed | 1 | phase 2 | ['osteoarthritis of the knee'] | ["['M15.4', 'M15.0', 'M16.9', 'M17.9', 'M19.011', 'M19.012', 'M19.019']"] | ['gefapixant', 'sugar pill'] | ['OC[C@H]1O[C@@](CO)(O[C@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O)[C@@H](O)[C@@H]1O'] | Inclusion Criteria: - Men or women - Women of child bearing potential must not be pregnant during the study and must use two forms of birth control - Men and their female partners must use two forms of birth control - Clinical and radiographic evidence of chronic knee osteoarthritis - An average NPRS score of >=5 and <=9 over a 4-7 day washout period of their previous osteoarthritis medications - Ambulatory - Have provided written informed consent | |
| 19 | NCT00317070 | terminated | poor recruitment, poor patient compliance, lack of funding | 0 | phase 2 | ['interstitial cystitis', 'bladder diseases'] | ["['N30.10', 'N30.11']"] | ['dimethyl sulfoxide', 'ic cocktail'] | ['CS(C)=O', 'CNC[C@H](O)C1=CC(O)=C(O)C=C1'] | Inclusion Criteria: 1. Participants should be of age eighteen years or older 2. Participant has painful bladder syndrome and a score of 8 or greater on the painful bladder syndrome symptom index (O'Leary-Sant) 3. Participant should have frequency and urgency of micturition and bladder pain for at least 6 months 4. Participant should have voids at least 8 times during a 24 hour period and at least once during the night as documented in the voiding diary and questionnaire. 5. Urine culture should not show any evidence of urinary tract infection. 6. Participant should be able to understand, speak, and read English. 7. Participant should be willing to take part in the study, including signing this form after carefully reading it. 8. Participant consents to use a medically acceptable method of birth control throughout the entire study period and for four weeks after the study is completed. Medically acceptable methods of contraception that may be used by the study participants and/or their partners include abstinence, birth control pills or patches, diaphragm with spermicide, intrauterine device (IUD), condom and vaginal spermicide, surgical sterilization, vasectomy, or progestin implants or injections. 9. Failure of other treatments for PBS/IC like pentosan polysulfate (failure is defined as a score of +1 [slightly improved] or less on a global assessment response [GRA] 23 question to previous therapy) Exclusion Criteria: 1. Participants who have undergone cystoscopy within 4 weeks of screening visit 2. Participants had other treatment given into the bladder in the past 4 weeks 3. Participants have used a new drug in the past 4 weeks which could affect bladder symptoms (some antidepressants, anticholinergics, antihistamines) 4. Past history of treatment with cyclophosphamide 5. A positive pregnancy test at the time of screening 6. Currently breast feeding 7. History of uterine, cervical, or vaginal cancer during the past 3 years 8. History of significant vaginitis 9. History of major surgery in the last 6 months 10. Positive tests for HIV, hepatitis B virus (HBV), and hepatitis C virus (HCV) 11. History of immune deficiency diseases 12. History of bleeding disorders 13. History of serious social, mental, or medical conditions that would stop patient from taking part in the study 14. History of alcohol or drug abuse within the last 5 years 15. Participants who have history of prostate cancer or are being treated for chronic bacterial prostatitis 16. History of liver disease or significant medical problem which the investigator considers a risk for patient to be a part of the study 17. History of any of the following: neurogenic bladder radiation to pelvic area, inflammation of the bladder wall because of tuberculosis, schistosomiasis, bladder or ureteric calculi, or active genital herpes within 3 months of screening 18. Known hypersensitivity to one of the agents used in the intravesical instillation 19. Use of any investigational drug or device in the last 6 months 20. Participants who are unwilling or unable to abide by the requirements of the study |
| 20 | NCT00307164 | completed | 0 | phase 2/phase 3 | ['hiv infections', 'lipoatrophy'] | ["['Z21']"] | ['nucleomaxx', 'nucleomaxx placebo'] | ['CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - HIV-1 infected - Stable ART containing zidovudine or stavudine for at least 12 consecutive weeks prior to study entry - Cumulative ART with zidovudine or stavudine for at least 24 weeks prior to study entry - Viral load of 5,000 copies/ml or less within 45 days prior to study entry - Lipoatrophy in at least two of the following areas: face, arms, legs, OR buttocks - Not planning to add to or change current vitamin supplementation - Willing to use acceptable forms of contraception Exclusion Criteria: - Life expectancy of less than 12 months - Currently enrolled in or planning to enroll in an ART interruption study - Plans to change current ART regimen - Liver failure at anytime prior to study entry - Greater than Grade 2 diarrhea or vomiting within 7 days prior to study entry - Current AIDS-defining opportunistic infection or illness. Individuals with cutaneous Kaposi's sarcoma not requiring chemotherapy are not excluded. - Currently receiving insulin or oral hypoglycemic products for diabetes mellitus - Systemic cancer chemotherapy or immunomodulating agents within 30 days prior to study entry - Systemic steroids for a cumulative duration of longer than 4 weeks within the 6 months prior to study entry - Known allergy or sensitivity to study drug or any of its components - Severe lactose intolerance - Current drug or alcohol abuse or dependence - Clinically significant illness requiring systemic treatment or hospitalization - Chronic disability or serious illness that may affect body composition - Received an investigational drug other than NucleomaxX or uridine for lipoatrophy within 30 days prior to study entry - Certain abnormal laboratory values - Pregnancy or breastfeeding | |
| 21 | NCT00169221 | terminated | toxicity in an independent study imex. the trial was subsequently terminated (54 pts instead of 140) despite safety analyses showing no excess of toxicity | 0 | phase 2 | ['head and neck cancer'] | ["['C76.0', 'C47.0', 'C49.0', 'C77.0', 'D17.0', 'D21.0', 'D36.11']"] | ['iressa (gefitinib)'] | ['COC1=C(OCCCN2CCOCC2)C=C2C(NC3=CC(Cl)=C(F)C=C3)=NC=NC2=C1'] | Inclusion Criteria: - Patients with upper aerodigestive tract carcinomas (all sites included) having surgical resection and eligible for post-operative radiation + cisplatin. - Patient having a tumoral biopsy (0.5 - 1 cm3) stored in liquid nitrogen at time of surgical resection (patients with small tumors located in larynx for instance will not be included) - Patients receiving post-operative radiation (>=60 Gy on tumor bed and/or cervical area), associated with cisplatin, 6 weeks after surgery at the latest. Exclusion Criteria: - previous history of cancer (except skin basal cell carcinoma) |
| 22 | NCT00096434 | completed | 0 | phase 2 | ['male breast cancer', 'recurrent breast cancer', 'stage iv breast cancer'] | ["['C50.021', 'C50.022', 'C50.029', 'C50.121', 'C50.122', 'C50.129', 'C50.621']", "['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']", "['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']"] | ['sorafenib tosylate'] | ['CNC(=O)C1=NC=CC(OC2=CC=C(NC(=O)NC3=CC(=C(Cl)C=C3)C(F)(F)F)C=C2)=C1'] | Inclusion Criteria: - Histologically or cytologically confirmed breast cancer - Clinical evidence of metastatic disease - Measurable disease - HER2-positive or -negative disease - If HER2 gene amplified or strongly positive for HER2 by immunohistochemistry, patient must have had prior treatment containing trastuzumab (Herceptin®) unless contraindicated - Previously treated with anthracycline- and/or taxane-containing regimen in the neoadjuvant, adjuvant, or metastatic setting - Candidate for first- or second-line chemotherapy for metastatic disease - Core block or tumor slides of the primary or metastatic tumor available - No known brain metastases - Hormone receptor status: - Not specified - Male or female - Performance status - ECOG 0-1 - At least 3 months - WBC ≥ 3,000/mm^3 - Absolute neutrophil count ≥ 1,500/mm^3 - Platelet count ≥ 100,000/mm^3 - Hemoglobin ≥ 8.5 g/dL - No evidence of bleeding diathesis - Bilirubin ≤ 1.5 times upper limit of normal (ULN) - AST ≤ 3 times ULN - Alkaline phosphatase ≤ 3 times ULN - PT normal - PTT normal - INR normal - Creatinine ≤ 1.5 times ULN - Calcium normal - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia - No uncontrolled hypertension - No gastrointestinal tract disease that would preclude taking oral medication - No active peptic ulcer disease - Not pregnant or nursing - Fertile patients must use effective contraception - No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer - No history of allergic reaction attributed to compounds of similar chemical or biological composition to sorafenib or other study agents - No ongoing or active infection - No psychiatric illness or social situation that would preclude study participation - No other uncontrolled illness - See Disease Characteristics - More than 4 weeks since prior immunotherapy - No concurrent anticancer immunotherapy - No concurrent bevacizumab - See Disease Characteristics - More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered - No more than 1 prior chemotherapy regimen for metastatic disease - No concurrent anticancer chemotherapy - Prior hormonal therapy in the neoadjuvant, adjuvant, or metastatic setting is allowed - No concurrent anticancer hormonal therapy - No prior radiotherapy to ≥ 25% of the bone marrow - More than 4 weeks since prior radiotherapy - More than 4 weeks since prior major surgery - No prior surgical procedure that would affect gastrointestinal absorption - No other concurrent drugs that target vascular endothelial growth factor (VEGF) or VEGF receptors - No concurrent antiretroviral therapy for HIV-positive patients - No other concurrent investigational agents - No other concurrent anticancer therapy - No concurrent cytochrome P450 enzyme-inducing antiepileptic drugs, including any of the following: - Phenytoin - Carbamazepine - Phenobarbital - No concurrent rifampin - No concurrent Hypericum perforatum (St. John's wort) - No concurrent therapeutic anticoagulation - Concurrent prophylactic anticoagulation (i.e., low-dose warfarin) for venous or arterial devices is allowed | |
| 23 | NCT00087087 | completed | 1 | phase 2 | ['ovarian cancer', 'primary peritoneal cavity cancer'] | ["['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']", "['C30.0', 'Z12.81', 'D14.0', 'C14.8', 'D37.09', 'Z86.003', 'Z85.818']"] | ['pemetrexed disodium'] | ['[H][C@@](CCC(O)=O)(NC(=O)C1=CC=C(CCC2=CNC3=C2C(O)=NC(=N)N3)C=C1)C(O)=O'] | DISEASE CHARACTERISTICS: - Histologically confirmed ovarian epithelial or primary peritoneal cancer - Recurrent or persistent disease - Measurable disease - At least 1 unidimensionally measurable target lesion ≥ 20 mm by conventional techniques (e.g., palpation, plain x-ray, CT scan, or MRI) OR ≥ 10 mm by spiral CT scan - Tumors within a previously irradiated field are considered non-target lesions - Must have received 1 prior platinum-based (carboplatin, cisplatin, or another organoplatinum compound) chemotherapy regimen for primary disease - Initial treatment may have included high-dose therapy, consolidation, or extended therapy administered after surgical or non-surgical assessment - Patients who had not received prior paclitaxel may have received a second regimen that included paclitaxel - Platinum-resistant or refractory disease - Treatment-free interval < 6 months after prior platinum-based therapy OR progressed during platinum-based therapy - Not eligible for a higher priority GOG protocol (i.e., any active phase III GOG protocol for the same patient population) PATIENT CHARACTERISTICS: Age - Any age Performance status - GOG 0-2 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count ≥ 1,500/mm^3 - Platelet count ≥ 100,000/mm^3 - Hemoglobin ≥ 9 g/dL Hepatic - Bilirubin ≤ 1.5 times upper limit of normal (ULN) - Alkaline phosphatase ≤ 3 times ULN* - AST and ALT ≤ 3 times ULN* NOTE: * ≤ 5 times ULN if due to hepatic metastases Renal - Creatinine clearance ≥ 45 mL/min Other - No other malignancy within the past 5 years except nonmelanoma skin cancer - No neuropathy (sensory or motor) > grade 1 - No active infection requiring antibiotics - Not pregnant - Negative pregnancy test - Fertile patients must use effective contraception during and for at least 3 months after study treatment PRIOR CONCURRENT THERAPY: Biologic therapy - One prior noncytotoxic (biologic or cytostatic) regimen allowed for management of recurrent or refractory disease, including, but not limited to, the following: - Monoclonal antibodies - Cytokines - Small-molecule inhibitors of signal transduction - At least 3 weeks since prior biologic or immunologic therapy - At least 24 hours since prior growth factors - No concurrent routine colony-stimulating factors Chemotherapy - See Disease Characteristics - Recovered from prior chemotherapy - No prior cytotoxic chemotherapy for recurrent or persistent disease, including retreatment with initial chemotherapy regimens - No prior pemetrexed disodium Endocrine therapy - At least 1 week since prior hormonal therapy for the malignant tumor - Concurrent hormone replacement therapy allowed Radiotherapy - See Disease Characteristics - No prior radiotherapy to > 25% of bone marrow - At least 2 weeks since prior radiotherapy and recovered Surgery - Recovered from prior surgery Other - No prior cancer treatment that would preclude study participation - No non-steroidal anti-inflammatory drugs (NSAIDs) for 2-5 days before, during, and for 1-2 days after study drug administration - Concurrent low-dose (≤ 325 mg/day) aspirin allowed - At least 3 weeks since other prior therapy for the malignant tumor | |
| 24 | NCT01273896 | completed | 0 | phase 2 | ['breast cancer'] | ["['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']"] | ['sta-9090'] | ['CC(C)C1=CC(C2=NN=C(O)N2C2=CC=C3N(C)C=CC3=C2)=C(O)C=C1O'] | Inclusion Criteria: - Male and Female patients must be at least 18 years of age - Pathologically confirmed diagnosis of breast cancer - Metastatic or advanced stage breast cancer - Prior treatment with at least one and no more than three lines of biologic and/or chemotherapy for metastatic breast cancer (excluding hormonal therapy) - Patients with HER2+ disease must have received prior treatment with Trastuzumab - Patients with ER and/or PR+ disease must have received prior treatment with hormonal therapy - Off cytotoxic chemotherapy or biologic therapy (excluding Hormonal therapy) ≥ 3 weeks - Measurable disease by RECIST 1.1 - Central nervous system metastases are permitted if treated and radiographically and clinically stable for at least 4 weeks prior to first dose of STA-9090 - Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 - Life expectancy of at least 3 months - Adequate hematologic function as defined by: - Absolute neutrophil count ≥1,500 cells/μL - Platelets ≥100,000/μL - Hemoglobin ≥ 9.0g/dL - Adequate hepatic function as defined by: - Serum bilirubin ≤ 1.5 X upper limit of normal (ULN); - Adequate renal function as defined by a serum creatinine ≤ 1.5 x ULN - AST, ALT, and alkaline phosphatase ≤ 3 × ULN except for: - Patients with hepatic metastases: ALT and AST ≤ 5 × ULN - Patients with hepatic and/or bone metastases: alkaline phosphatase ≤ 5 × ULN - Patients with Gilbert's disease: serum bilirubin < 5 mg/dL - Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures - Female subjects of childbearing potential and males must agree to use adequate contraception (e.g., hormonal or barrier method of birth control; abstinence) for the duration of study treatment - Female subjects of childbearing age must have a negative serum pregnancy test at study entry. Exclusion Criteria: - Surgery, radiotherapy, or lesion ablative procedure to the only area of measurable disease - Major surgery within 4 weeks prior to first dose of STA-9090 - Poor peripheral venous access for study drug administration. Study drug administration via indwelling catheters allowed only if the catheter is made of silicone material. - History of severe (grade 3 or 4) allergic or hypersensitivity reactions to excipients (e.g., Polyethylene glycol [PEG] 300 and Polysorbate 80) - Baseline QTc > 470 msec - Ventricular ejection fraction (EF) <50% at baseline - Treatment with chronic immunosuppressants (e.g., cyclosporine following transplantation) - Women who are pregnant or lactating - Uncontrolled intercurrent illness including, but not limited to, human immunodeficiency virus (HIV)-positive subjects receiving combination antiretroviral therapy, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, ventricular arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements - Other medications, or severe acute/chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results in the judgment of the investigator - Seizure disorder or requirement for seizure medication - Prior treatment with an HSP90 inhibitor - persistent adverse events of prior therapies that are > 1 grade 1 in severity - history of or current coronary artery disease, myocardial infarction, angina pectoris, angioplasty or coronary bypass surgery - history of or current uncontrolled dysrhythmias, or requirement for antiarrhythmic medications, or Grade 2 or greater left bundle branch block - New York Heart Association class II/III/IV congestive heart failure with a history of dyspnea, orthopnea, or edema that requires current treatment with angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, beta blockers or diuretics | |
| 25 | NCT01134510 | completed | 1 | phase 1/phase 2 | ['kidney transplantation'] | ["['N26.2', 'Q63.0', 'Q63.2', 'Z52.4', 'I75.81', 'N19', 'N20.0']"] | ['c1 esterase inhibitor', 'placebos'] | ['COCCC1=CC=C(OCC(O)CNC(C)C)C=C1'] | Inclusion Criteria: - End-stage renal disease. - No known contraindications for therapy with Immune Globuillin Intravenous 10%/Rituximab or C1 INH. - Age 18-65 years at the time of screening. - Panel Reactive Antibody [PRA] > 50% demonstrated on 3 consecutive samples, Patient highly-HLA (Human Leukocyte Antigen) sensitized and a candidate for Living Donor/Deceased Donor transplantation after desensitization at Cedars Sinai Medical Center. - At transplant, patient must have Donor Specific Antibody /Cross match + non-HLA (Human Leukocyte Antigen) identical donor. Subject/Parent/Guardian must be able to understand and provide informed consent. Exclusion Criteria: - Lactating or pregnant females. - Women of child-bearing age who are not willing or able to practice Food and Drug Administration [FDA]-approved forms of contraception. - HIV-positive subjects. - Subjects who test positive for Hepatitis B Virus infection [positive Hepatitis B Virus surface Antigen, Hepatitis B Virus core Antigen, or Hepatitis B Virus e Antigen/DNA] or Hepatitis C Virus infection [positive Anti-Hepatitis C Virus (EIA) and confirmatory Hepatitis C Virus Recombinant ImmunoBlot Assay (RIBA)]. - Subjects with active Tuberculosis. - Subjects with selective Immunoglobulin A deficiency, those who have known anti-Immunoglobulin A antibodies, and those with a history of anaphylaxis or severe systemic responses to any part of the clinical trial material. - Subjects who have received or for whom multiple organ transplants are planned. - Recent recipients of any licensed or investigational live attenuated vaccine(s) within two months of the screening visit (including but not limited to any of the following: - Adenovirus [Adenovirus vaccine live oral type 7] Varicella [Varivax] Hepatitis A [VAQTA] Rotavirus [Rotashield] Yellow fever [Y-F-Vax] Measles and mumps [Measles and mumps virus vaccine live] Measles, mumps, and rubella vaccine [M-M-R-II] Sabin oral polio vaccine Rabies vaccines [IMOVAX Rabies I.D., RabAvert]) - A significantly abnormal general serum screening lab result defined as a White Blood Cell < .0 X 103/ml, a Hemoglobin < 8.0 g/dL, a platelet count < 100 X 103/ml, , an Serum Glutamic Oxaloacetic Transaminase [SGOT] > 5X upper limit of normal, and an Serum Glutamic Pyruvic Transaminase [SGPT] >5X upper limit of normal range. - Individuals deemed unable to comply with the protocol. - Subjects with active Cytomegalovirus or Epstein Barr Virus infection as defined by Cytomegalovirus-specific serology (Immunoglobulin G or Immunoglobulin M) and confirmed by quantitative Polymerase Chain Reaction with or without a compatible illness. - Subjects with a known history of previous myocardial infarction within one year of screening. - Subjects with a history of clinically significant thrombotic episodes, and subjects with active peripheral vascular disease. - Use of investigational agents within 4 weeks of participation. - Know allergy/sensitivity to C1 INH infusions | |
| 26 | NCT00073034 | terminated | 0 | phase 2 | ['diabetes mellitus', 'diabetic neuropathy, painful'] | ["['P70.2', 'O24.92', 'Z83.3', 'E10.65', 'E10.9', 'E11.65', 'E11.9']", "['G58.0', 'G61.1', 'A52.15', 'G60.3', 'G61.82', 'H46.2', 'H46.3']"] | ['eaa-090'] | ['OP(O)(=O)CCN1CCCNC2=C1C(=O)C2=O'] | Inclusion Criteria: - Women of childbearing potential must have a negative serum pregnancy test result at screening - Diabetes mellitus (type I or II) that is controlled by oral or parenteral hypoglycemic agents or diet - Diagnosis of painful diabetic distal symmetric sensory/motor polyneuropathy Exclusion Criteria: - Pregnancy, lactation, or plans to become pregnant during the study - Depo-Provera or oral contraceptives that have been taken for less than 1 month before study day 1 if not using another medically accepted form of birth control - History of multiple drug allergies that may put the subject at greater risk during study participation in the opinion of the investigator | |
| 27 | NCT01246960 | completed | 0 | phase 2 | ['stomach cancer', 'esophageal cancer'] | ["['D13.1', 'C16.9', 'C16.1', 'C16.2', 'D37.1', 'C16.8', 'C16.5']", "['K22.2', 'K22.81', 'Q39.4', 'P78.83', 'I85.00', 'I85.01', 'I85.10']"] | ['placebo', 'oxaliplatin', 'leucovorin', '5-fluorouracil'] | ['CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O', '[H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1', '[H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1', 'FC1=CNC(=O)NC1=O'] | Inclusion Criteria: - Histologic or cytologic confirmation of adenocarcinoma of the esophagus, gastroesophageal junction (GEJ), or stomach - Metastatic or locally advanced, unresectable disease at time of study entry - Provided signed informed consent and is amenable to compliance with protocol schedules and testing - Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1 at study entry - Adequate renal, hematological, and hepatic function - Measurable or non-measurable disease at the time of study entry - Resolution to Grade less than or equal to 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.0, of all clinically significant toxic effects of prior locoregional therapy, surgery, or other anticancer therapy, except where otherwise mentioned in the eligibility criteria - Eligible participants of reproductive potential (both sexes) must agree to use adequate contraceptive methods (hormonal or barrier methods) during the study period and at least 12 weeks after the last dose of study therapy - Life expectancy of greater than or equal to 3 months - Willingness to provide blood and tissue samples for research purposes. Submission of tumor specimen is mandatory for participation in this study, if a histologic, paraffin-embedded specimen exists (either from a surgical resection or biopsy); submission of paraffin block or a minimum of 8 unstained slides is required if sufficient sample. NOTE: If insufficient additional tissue exists (that is, all tissue has been utilized for prior diagnostic purposes), participation in the study is allowable without the requirement for an additional biopsy; this situation must be discussed with the study principal investigator and/or the ImClone medical monitor or designee. Exclusion Criteria: - The participant has received prior first-line systemic therapy for advanced/unresectable and/or metastatic disease (prior adjuvant or neo-adjuvant therapy is permitted) - Previous or concurrent malignancy except for basal or squamous cell skin cancer and/or in situ carcinoma of the cervix, or other solid tumors treated curatively and without evidence of recurrence for at least 3 years prior to study entry - Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the participant ineligible for entry into this study - The participant is receiving chronic therapy with nonsteroidal anti-inflammatory agents (NSAIDs; for example, indomethacin, ibuprofen, naproxen, or similar agents) or other antiplatelet agents (for example, clopidogrel, ticlopidine, dipyridamole, anagrelide). Aspirin use at doses up to 325 milligrams per day (mg/day) is permitted. - The participant has significant third-space fluid retention (for example, ascites or pleural effusion), and is not amenable for required repeated drainage - The participant is pregnant or breastfeeding - Uncontrolled intercurrent illness including, but not limited to, active or uncontrolled clinically serious infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled thromboembolic, or hemorrhagic disorder, psychiatric illness/social situations, or other co-morbid systemic illnesses, or other severe concurrent disease - Immunocompromised participants including participants known to be human immunodeficiency virus (HIV) positive. - Progressive disease less than or equal to 12 months of completing platinum or 5-FU treatment, including capecitabine, if given previously in the perioperative (adjuvant or neoadjuvant) setting - Current or recent (within 28 days prior to randomization) treatment with an investigational drug that has not received regulatory approval for any indication at the time of study entry, or participation in another interventional clinical trial. Participants participating in surveys or observational studies are eligible to participate in this study. - Are currently enrolled in, or discontinued within the last 28 days from, a clinical trial involving ramucirumab drug product (DP), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study - Received prior therapy with an antiangiogenic agent (including but not limited to bevacizumab, sunitinib, or sorafenib) - Major surgical procedure or significant traumatic injury less than 28 days prior to randomization, or anticipation of need for elective or planned major surgical procedure during the course of the study. Subcutaneous venous access device placement within 7 days prior to randomization - Clinically significant peripheral neuropathy at the time of registration - Known central nervous system metastases that are symptomatic or untreated - New York Heart Association (NYHA) classification III-IV congestive heart failure - Greater than normal risk of bleeding or coagulopathy in the absence of therapeutic anticoagulation; Grade 3/4 gastrointestinal bleeding within 3 months prior to registration; active bleeding (that is, within 14 days prior to first dose of study therapy); or pathological condition present that carries a high risk of bleeding (for example, tumor involving major vessels or known varices) - Participant has experienced any arterial thromboembolic events, including but not limited to myocardial infarction, stroke, transient ischemic attack (TIA), cerebrovascular accident, or unstable angina, less than or equal to 6 months prior to registration - Clinically significant vascular disease (for example, aortic aneurysm, aortic dissection) for which more than minimal intervention is being administered or planned - History of hypertensive crisis or hypertensive encephalopathy or current poorly-controlled hypertension despite standard medical management - History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess less than 6 months prior to registration - Known hypersensitivity to any of the treatment components of modified FOLFOX6 (mFOLFOX6) (oxaliplatin, 5-FU, and leucovorin) or ramucirumab DP | |
| 28 | NCT01484080 | completed | 0 | phase 1/phase 2 | ['breast cancer'] | ["['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']"] | ['bibf + paclitaxel', 'paclitaxel'] | ['[H][C@]12[C@H](OC(=O)C3=CC=CC=C3)[C@]3(O)C[C@H](OC(=O)[C@H](O)[C@@H](NC(=O)C4=CC=CC=C4)C4=CC=CC=C4)C(C)=C([C@@H](OC(C)=O)C(=O)[C@]1(C)[C@@H](O)C[C@H]1OC[C@@]21OC(C)=O)C3(C)C', '[H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\\C=C(C)\\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\\C=C\\C=C\\C=C(C)\\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC'] | Inclusion Criteria: 1. Signed Informed Consent Form 2. Patients ≥18 year-old 3. Histological diagnosis of localized breast cancer with primary tumour over 2 cm on its longest diameter (measured by mammography and MRI). Any nodal status is allowed when it is an operable tumour at diagnosis. Multicentricity is allowed. 4. HER 2 negative (Inmunohistochemistry - or + over +++; FISH CISH (-); equivalent to HER2/CEP17 copies under 2: HER2 result ++/+++ needs FISH/CISH confirmation. 5. Measurable disease with a primary lesion >2 cm. by RECIST v1.1 criteria 6. ECOG 0-1 7. Adequate hematologic, renal and hepatic function, defined by the following laboratory results obtained within 14 days prior to randomization/registration: - Absolute granulocyte count >1.5 x 109/L - Absolute platelet count >100 x 109/L - Hemogobin >10 g/dL - Serum creatinine >1.5 x UNL or a calculated creatinine clearance >50 ml/min - Serum bilirubin <1.25 UNL - AST/ALT <1.5 times UL 8. Premenopausal women must be under effective birth control (non-hormone) and continue its use for the duration of the study and even 6 months later. 9. For female with childbearing potential, a negative pregnancy test within the prior 7 days to the study enrolment 10. Life expectancy >6 months Exclusion Criteria: 1. Metastatic or non-surgical breast cancer (including inflammatory). 2. Locally breast cancer with primary lesion under 2 cm. In case of multicentricity, it will not be admitted in the study unless any lesion would be over this length. 3. Previous or concurrent treatment of any kind for breast cancer: hormonal agents, conventional cytotoxic drugs, radiation therapy, targeted drugs, bisphosphonates, monoclonal antibodies or surgery. Chemoprevention with tamoxifen or raloxifene is allowed as far as the treatment was interrupted upon diagnosis and at least 4 weeks prior to inclusion. Same criteria for post-menopausal hormonal replacement therapy. Hormonal contraceptives should be discontinued. 4. HER-2 positive breast cancer defined as over-expression in Immunochemistry of HER-2 3+ or 2+ with positive FISH/CISH 5. Male patients. 6. Pregnancy, lactation or breastfeeding. 7. Active malignancy at any other side (including contra-lateral synchronous breast cancer) besides non-melanoma skin cancer or ductal/lobular of the breast or cervix in situ carcinoma, colon in situ carcinoma accurately treated as well as any other tumour diagnosis >5 years prior to registration without any sign of progression at present time. 8. Concurrent serious medical conditions such as myocardial infarction within 6 months prior to entry, congestive heart failure, unstable angina, active cardiomyopathy, unstable ventricular arrhythmia, uncontrolled hypertension (under NYHA criteria), uncontrolled psychotic disorders, serious active infections, active peptic ulcer disease, psychiatric illness, HIV infection, active hepatitis, COPD or any other medical conditions that might be aggravated by treatment or limit compliance. 9. Inability to take oral medication 10. History of malabsorption syndrome 11. Proven allergy to paclitaxel or BIBF 1120. 12. Grade ≥2 peripheral neuropathy. 13. Major surgery within 4 weeks of registration (breast cancer surgery regardless of timing is an exclusion criteria). 14. Inability to comply with the study and follow-up procedures. 15. Anticoagulation therapy (except low-dose heparin and / or wash out with heparin as needed to maintain a permanent intravenous device) or antiplatelet therapy (except for treatment with low doses of aspirin <325 mg per day. 16. History of hemorrhagic or thromboembolic event clinically significant in the last 6 months. 17. Known hereditary predisposition to bleeding or thrombosis | |
| 29 | NCT00041067 | completed | 0 | phase 2 | ['breast cancer'] | ["['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']"] | ['docetaxel', 'vinorelbine'] | ['[H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1', '[H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC'] | DISEASE CHARACTERISTICS: - Histologically confirmed stage IV breast cancer - Metastasis to the ipsilateral supraclavicular lymph nodes allowed - HER2-positive by fluorescence in situ hybridization (FISH) or immunohistochemistry 3+ staining confirmed in the adjuvant or metastatic setting - No effusions or ascites as only sites of disease - No primary or metastatic brain or central nervous system tumor - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age: - 18 and over Sex: - Female Menopausal status: - Not specified Performance status: - Zubrod 0-2 Life expectancy: - Not specified Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin normal - aspartate aminotransferase or Alanine aminotranferease no greater than 1.5 times upper limit of normal (ULN) - Alkaline phosphatase no greater than 2.5 times ULN Renal: - Not specified Cardiovascular: - left ventricular ejection fraction normal by multigated radionuclide angiography or echocardiogram (patients who have received prior anthracycline therapy) - No clinical evidence or history of cardiomyopathy Other: - No pre-existing grade 2 or greater motor or sensory peripheral neuropathy except abnormalities due to cancer - No prior severe hypersensitivity reaction to docetaxel or other drugs formulated with Polysorbate 80 - No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other adequately treated stage I or II cancer currently in complete remission - No known sensitivity to E. coli-derived proteins - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - At least 6 months since prior chemotherapy - Prior anthracycline as adjuvant therapy allowed - No prior cumulative dose of doxorubicin more than 360 mg/m^2 - No prior cumulative dose of epirubicin more than 720 mg/m^2 - No more than 1 prior adjuvant or neoadjuvant chemotherapy regimen for primary disease - No prior docetaxel - No prior vinorelbine - Prior paclitaxel allowed Endocrine therapy: - Prior hormonal therapy as adjuvant therapy or for metastatic breast cancer allowed - No concurrent hormonal therapy Radiotherapy: - At least 3 weeks since prior radiotherapy Surgery: - At least 2 weeks since prior surgery and recovered | |
| 30 | NCT01472939 | completed | 0 | phase 2 | ['gastroesophageal reflux disease'] | ["['K21.9', 'K21.00', 'K21.01']"] | ['ssp-002358 (0.1 mg) + ppi', 'ssp-002358 (0.5 mg) + ppi', 'ssp-002358 (2.0 mg) + ppi', 'placebo + ppi'] | ['CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: 1. Written Informed Consent Form signed voluntarily before the first study-related activity. 2. Aged between 18 and 70 years, inclusive. 3. Subjects with a history of the cardinal symptoms of GERD (both heartburn and regurgitation) prior to PPI therapy. 4. Subjects with symptoms of GERD for at least 6 months prior to the Screening Visit. 5. Subjects who have persistent symptoms of regurgitation for 3 or more days over the past week with or without heartburn while on PPI. 6. Subjects have at least some improvement to the symptom of heartburn while on PPI therapy. 7. Subjects on PPI therapy for at least 8 weeks prior to the Screening Visit of which the last 4 weeks are on a stable labeled dose for any GERD indication according to the country label, where a change of PPI therapy would not impact the symptoms (twice-daily dosing of PPI is not allowed in the last 4 weeks) Exclusion Criteria: 1. Subjects who show no response to heartburn while on PPI therapy. 2. Subjects with dyspepsia symptoms that are more predominant than their GERD symptoms (heartburn and/or regurgitation). 3. Subjects with prior endoscopic anti-reflux procedure or major GI surgery or subjects with major GI disorders. 4. Presence of severe and clinically uncontrolled cardiovascular, liver, lung or neurologic disease, cancer or AIDS. 5. Alarm symptoms suggestive of malignancies or organic disease. | |
| 31 | NCT00118105 | withdrawn | budget constraints | 0 | phase 2 | ['colorectal cancer', 'metastatic cancer'] | ["['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']", "['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']"] | ['capecitabine', 'oxaliplatin'] | ['[H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1', '[H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1'] | DISEASE CHARACTERISTICS: - Diagnosis of hepatic metastases secondary to colorectal cancer by percutaneous hepatic biopsy - Resectable hepatic metastases by any of the following: - Minor resection (i.e., less than a hemihepatectomy) - Major resection (i.e., hemihepatectomy or extended hepatectomy) - Bilobar resection (including atypical resection) - Synchronous primary tumor and hepatic metastases allowed - Radiologic evidence of hepatic metastases by multiphasic contrast-enhanced spiral CT scan - Resectable primary colorectal cancer that is in place allowed - Measurable disease - No evidence of extrahepatic metastases by chest x-ray or CT scan of the chest PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Zubrod 0-1 Life expectancy - Not specified Hematopoietic - Hemoglobin ≥ 9.0 g/dL - WBC ≥ 3,000/mm^3 - Platelet count ≥ 100,000/mm^3 - Absolute neutrophil count ≥ 1,500/mm^3 Hepatic - Bilirubin ≤ 2 times upper limit of normal (ULN) - SGOT or SGPT ≤ 2.5 times ULN Renal - Creatinine clearance ≥ 60 mL/min - Urine protein/creatinine ratio < 1 OR - Urine protein < 1 g by 24-hour urine collection Cardiovascular - No uncontrolled hypertension (i.e., blood pressure > 150/90 mm Hg) - History of hypertension allowed provided it is well controlled on a stable regimen of anti-hypertensive therapy - No arterial thromboembolic event within the past 12 months, including any of the following: - Transient ischemic attack - Cerebrovascular accident - Unstable angina - Myocardial infarction - No peripheral vascular disease ≥ grade 2 Other - Not pregnant or nursing - Fertile patients must use effective contraception - No pre-existing peripheral neuropathy ≥ grade 2 - No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - More than 6 months since prior adjuvant chemotherapy for the primary tumor - No prior systemic chemotherapy for metastatic disease - No prior hepatic artery infusion chemotherapy for metastatic disease Endocrine therapy - Not specified Radiotherapy - No prior radiotherapy for metastatic disease Surgery - More than 7 days since prior colonoscopy or fine needle aspiration - More than 28 days since prior major invasive surgery or open biopsy Other - At least 4 weeks since prior and no concurrent sorivudine or brivudine - No prior radiofrequency ablation for metastatic disease - No prior cryotherapy for metastatic disease - No other prior ablative techniques for metastatic disease - No concurrent cimetidine - Concurrent ranitidine or other drug from a different antiulcer class allowed - No concurrent oral anticoagulation for treatment of thrombosis - Concurrent warfarin (1 mg) to maintain patency of central venous catheter allowed |
| 32 | NCT01505881 | terminated | 0 | phase 2 | ['thromboembolism', 'heart valve prosthesis'] | ["['O88.22', 'O88.23', 'O88.211', 'O88.212', 'O88.213', 'O88.219']"] | ['dabigatran etexilate low dose', 'warfarin 5mg', 'dabigatran etexilate intermediate dose', 'warfarin 1mg', 'dabigatran etexilate high dose', 'warfarin 3mg'] | ['CCCCCCOC(=O)\\N=C(\\N)C1=CC=C(NCC2=NC3=C(C=CC(=C3)C(=O)N(CCC(=O)OCC)C3=NC=CC=C3)N2C)C=C1', 'CC(=O)CC(C1=CC=CC=C1)C1=C(O)C2=C(OC1=O)C=CC=C2', 'CCCCCCOC(=O)\\N=C(\\N)C1=CC=C(NCC2=NC3=C(C=CC(=C3)C(=O)N(CCC(=O)OCC)C3=NC=CC=C3)N2C)C=C1', 'CC(=O)CC(C1=CC=CC=C1)C1=C(O)C2=C(OC1=O)C=CC=C2', 'CCCCCCOC(=O)\\N=C(\\N)C1=CC=C(NCC2=NC3=C(C=CC(=C3)C(=O)N(CCC(=O)OCC)C3=NC=CC=C3)N2C)C=C1', 'CC(=O)CC(C1=CC=CC=C1)C1=C(O)C2=C(OC1=O)C=CC=C2'] | Inclusion criteria: 1. Completed study 1160.113 per protocol 2. Continuing need for anticoagulation Exclusion criteria: 1. uncontrolled hypertension 2. severe renal impairment 3. active liver disease 4. increased risk of bleeding | |
| 33 | NCT02898012 | completed | 0 | phase 2 | ['glioblastoma multiforme', 'primary brain tumor'] | ["['L51.0', 'L51.8', 'L51.9']"] | ['temozolomide', 'bevacizumab'] | ['CSCC[C@H](N)C(O)=O', '[H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1'] | Inclusion Criteria: - Supratentorial Glioblastoma diagnosed by biopsy. - Patients aged ≥ 70 years - KPS >30 and < 70 - Life expectancy > or = 8 weeks - Patients were enrolled at least 14 days after stereotactic biopsy and 28 days after surgical biopsy. - CT or brain MRI was performed within 4 weeks before treatment to rule out haemorrhage. - Included to health social security system - Medical assessment previous to inclusion - Informed consent form Exclusion Criteria: - Previous treatment with Surgical resection, RT or chemotherapy to the tumor. - Hemoglobin level < 9 g% - Absolute neutrophil count < 1500 - Platelet count < 100.000 - ASAT or ALAT levels more than 3 times the upper limit of normal. - Bilirubin levels more than 2 times the upper limit of normal - Creatinin more than 1.5 times the upper limit of normal - Untreated high blood pressure >150/100 mmHg - Congestive cardiac failure - Proteinuria > 1 gr/24h - INR > 1.5 the upper limit of normal - Recent symptomatic haemorrhage - History of abnormal wound healing - Gastrointestinal fistula - Haemoptysis > grade 2 (NCI-CTC) - Intracranial abscess - Coagulation disorder - Active infection requiring intravenous antibiotics - Vascular disease (including myocardial infarction, unstable angina, cerebrovascular disease, peripheral arterial or aortic disease) in the previous 6 months - Malignancy diagnosed in the previous 5 years (except basocellular skin cancer and in situ cervix cancer) - Allergy to dacarbazine, Bevacizumab, Temozolomide or their excipients, recombinant human monoclonal antibodies, or ovarian cells of Chinese hamsters. | |
| 34 | NCT01059825 | completed | 1 | phase 2 | ['diabetes mellitus, type 2'] | ["['E11.65', 'E11.9', 'E11.21', 'E11.36', 'E11.41', 'E11.42', 'E11.44']"] | ['placebo to ertugliflozin', 'ertugliflozin 1 mg', 'ertugliflozin 5 mg', 'ertugliflozin 25 mg', 'sitagliptin 100 mg', 'placebo to sitagliptin', 'metformin'] | ['CCOC1=CC=C(CC2=CC(=CC=C2Cl)[C@]23OC[C@](CO)(O2)[C@@H](O)[C@H](O)[C@H]3O)C=C1', 'CCOC1=CC=C(CC2=CC(=CC=C2Cl)[C@]23OC[C@](CO)(O2)[C@@H](O)[C@H](O)[C@H]3O)C=C1', 'CCOC1=CC=C(CC2=CC(=CC=C2Cl)[C@]23OC[C@](CO)(O2)[C@@H](O)[C@H](O)[C@H]3O)C=C1', 'CCOC1=CC=C(CC2=CC(=CC=C2Cl)[C@]23OC[C@](CO)(O2)[C@@H](O)[C@H](O)[C@H]3O)C=C1', 'N[C@@H](CC(=O)N1CCN2C(C1)=NN=C2C(F)(F)F)CC1=CC(F)=C(F)C=C1F', 'N[C@@H](CC(=O)N1CCN2C(C1)=NN=C2C(F)(F)F)CC1=CC(F)=C(F)C=C1F', 'CSCC[C@H](N)C(O)=O'] | Inclusion Criteria: - Participants with type 2 diabetes on stable doses of background medicines for management of the diabetes; aged 18-70 years; body mass index between 23-45 kg/m^2 Exclusion Criteria: - Participants with type 1 diabetes, heart attack or stroke in last 6-months, uncontrolled blood pressure, significant kidney disease | |
| 35 | NCT00219908 | terminated | 1 | phase 2 | ['relapsing-remitting multiple sclerosis'] | ["['G35', 'G93.81', 'K74.1', 'Q85.1', 'G12.21', 'G12.23', 'M34.0']"] | ['mitoxantrone'] | ['OCCNCCNC1=CC=C(NCCNCCO)C2=C1C(=O)C1=C(C(O)=CC=C1O)C2=O'] | Inclusion Criteria: - age : 18-45 years, - Clinical disease satisfying the Poser criteria (Amdmt n°4) - relapsing-remitting disease (Amdmt N°4) - at least 2 exacerbations within the preceding 12 months, having left sequelae, - MRI activity at inclusion expressed by at least one gadolinium-enhanced lesion (cranial MRI with 0.1mmol/kg gadolinium), - a significant disability at inclusion: EDSS score between 2.5 and 5.5 (Amdt N° 4) - written informed consent Exclusion Criteria: - pregnancy and breast-feeding - use of an insufficiency effective contraceptive method, - general immunosuppressive therapy using cyclophosphamide, mitoxantrone,or total lymphoid irradiation - treatment with azathioprine during the 3 months preceding the study - clinical relapse or intensive corticosteroid treatment within the 30 days preceding inclusion, - associated disease (psychiatric disorder, depressive statenot controlled by appropriate drug therapy, history of heart disease at inclusion examination | |
| 36 | NCT00578370 | completed | 1 | phase 1/phase 2 | ['psoriasis'] | ["['L40.0', 'L40.4', 'L40.8', 'L40.9', 'L40.1', 'L40.50']"] | ['ciclosporin 0.5% (formulation 01b)', 'ciclosporin 1.5% (formulation 02b)', '0.1% betamethasone', '0.005% calcipotriol', 'formulation 00b'] | ['CC[C@@H]1NC(=O)[C@H]([C@H](O)[C@H](C)C\\C=C\\C)N(C)C(=O)[C@H](C(C)C)N(C)C(=O)[C@H](CC(C)C)N(C)C(=O)[C@H](CC(C)C)N(C)C(=O)[C@@H](C)NC(=O)[C@H](C)NC(=O)[C@H](CC(C)C)N(C)C(=O)[C@@H](NC(=O)[C@H](CC(C)C)N(C)C(=O)CN(C)C1=O)C(C)C', 'CC[C@@H]1NC(=O)[C@H]([C@H](O)[C@H](C)C\\C=C\\C)N(C)C(=O)[C@H](C(C)C)N(C)C(=O)[C@H](CC(C)C)N(C)C(=O)[C@H](CC(C)C)N(C)C(=O)[C@@H](C)NC(=O)[C@H](C)NC(=O)[C@H](CC(C)C)N(C)C(=O)[C@@H](NC(=O)[C@H](CC(C)C)N(C)C(=O)CN(C)C1=O)C(C)C', '[H][C@@]12C[C@H](C)[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])CCC2=CC(=O)C=C[C@]12C', 'O[C@H](\\C=C\\[C@@H](C)[C@@]1([H])CC[C@@]2([H])\\C(CCC[C@]12C)=C\\C=C1\\C[C@@H](O)C[C@H](O)C1=C)C1CC1'] | Inclusion Criteria: - Subjects with chronic plaque type psoriasis - Sexually active females of childbearing potential should either be surgically sterile (hysterectomy or tubal ligation), or should use a highly effective medically accepted contraceptive regimen Exclusion Criteria: - Local treatment with antipsoriatics (except for salicylic acid in vaseline) in the 4 weeks preceding and during the study (corticosteroids 8 weeks) - Systemic treatment with antipsoriatics or therapy with PUVA, selected ultraviolet photo therapy in the three months preceding and during the study - Treatment with systemic or locally acting medications which might counter or influence the study aim - Previous therapy with methotrexate over many years - Therapy with nephrotoxic medication - Therapy with digoxin, colchicin and statins - Medications which might influence the potassium metabolism - Subjects with known dysfunction of the calcium metabolism - Subjects with increased uric acid or potassium serum levels - Erythrodermic psoriasis, psoriasis punctata and pustular psoriasis or extended chronic stationary forms of psoriasis - Subjects with acute virus infection - Subjects with acne, anogenital pruritus, rosacea, perioral dermatitis, specific skin problems (skin tuberculosis, luetic skin diseases), vaccination reactions, skin infections caused by bacteria or viruses - Symptoms of a clinically significant illness that may influence the outcome of the study in the four weeks before and during the study | |
| 37 | NCT00693472 | terminated | 0 | phase 2 | ['akathisia, drug-induced', 'antipsychotic agents', 'movement disorders'] | ["['G47.61', 'G25.70', 'G25.9', 'H51.9', 'F98.4', 'G25.79', 'G25.89']"] | ['preladenant', 'placebo', 'anticholinergic agents or propanolol', 'haloperidol'] | ['COCCOC1=CC=C(C=C1)N1CCN(CCN2N=CC3=C2N=C(N)N2N=C(N=C32)C2=CC=CO2)CC1', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O', 'O=C(O[C@H]1CN2CCC1CC2)N1CCC2=CC=CC=C2[C@@H]1C1=CC=CC=C1', 'OC1(CCN(CCCC(=O)C2=CC=C(F)C=C2)CC1)C1=CC=C(Cl)C=C1'] | Inclusion Criteria: - Participants or guardian must be willing to give written informed consent. - Part 1 Only: Participants with acute (not drug related) psychoses with a Positive and Negative Symptom Scale for Schizophrenia (PANSS) score of at least 60: schizophrenia, schizo-affective, schizo-manic, and acute mania with a history of previous treatment with neuroleptics. - Part 1 Only: Participants initiating haloperidol for the treatment of an acute psychotic episode at a dose of at least 7.5 mg per day. - Part 2 Only: Inpatient participants who have developed akathisia as a result of haloperidol at >=5 mg per day for the treatment of acute psychosis. The enrollment of participants receiving other neuroleptics is allowed only after consultation and agreement by the sponsor. - Participants of either sex and of any race between the ages of 18 and 65 years, inclusive. - Participant's clinical laboratory tests (complete blood count [CBC], blood chemistry, and urinalysis) must be within normal limits or clinically acceptable to the investigator/sponsor. Participant's liver function test results (ie, aspartate aminotransferase [AST], alanine aminotransferase [ALT]) must not be elevated above the normal limits at Screening and on Day -1/1. - Participants must be free of any clinically significant disease other than psychosis that would interfere with the study evaluations. - Screening electrocardiogram (ECG) must be clinically acceptable to the investigator. - Female of childbearing potential must: - Have used a medically accepted method of contraception for 1 month (or abstained from sexual intercourse) prior to the screening period. An acceptable method of contraception includes one of the following: - condom (male or female) used with spermicide, - diaphragm or cervical cap used with spermicide and condom, - stable oral/transdermal/injectable hormonal contraceptive regimen without breakthrough uterine bleeding for 2 months prior to Screening visit and a condom used with spermicide, - intrauterine device (inserted at least 2 months prior to Screening visit) used with spermicide. Note: Vasectomy of the partner is not considered sufficient contraception and one of the 4 bulleted methods listed above must be used. - Agree to use one of the accepted methods of contraception (listed above) during the trial (including the screening period prior to receiving trial medication), and for 1 month after stopping the trial medication. - Participants enrolled in the placebo arm of Part 1 and who developed akathisia may be eligible for Part 2 in the standard of care arm. Exclusion Criteria: - Participants who have a positive screen for drugs with a high potential for abuse. Participants that screen positive for cannabis are permitted. - Participants who have previously received this compound. - Participants who are currently participating in another clinical study or have participated in a clinical study within 30 days (except participants enrolled in the Part 1 of the P05145 study). - Participants who are part of the study staff personnel or family members of the study staff personnel. - Participants with severe/uncontrolled hypertension will be excluded. Participants with hypertension well controlled on a stable dose of standard antihypertensive medication (excluding beta-blockers) will be eligible. - Participants with history of coronary artery disease including myocardial infarction (MI), or cerebrovascular disease (stroke, transient ischemic attack [TIA]), or peripheral arterial disease. - Participants with congestive heart failure or participants with ECGs consistent with ischemic heart disease, sick sinus syndrome or significant Q waves. - Participants who are found to be at immediate risk of suicide. - Female participants pregnant or nursing. - Participants treated by Clozapine will be excluded. A washout period of 6 months prior to dosing will be acceptable for study entry. | |
| 38 | NCT00025584 | completed | 0 | phase 2 | ['recurrent breast cancer', 'stage iv breast cancer'] | ["['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']", "['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']"] | ['bortezomib'] | ['ClCCN(CCCl)P1(=O)NCCCO1'] | Inclusion Criteria: - Histologically or cytologically confirmed invasive breast cancer - Clinical and/or radiological evidence of stage IV disease - Relapsed or resistant disease within 6-12 months after completion of prior chemotherapy with doxorubicin or epirubicin and/or paclitaxel or docetaxel foradvanced disease or in the adjuvant setting - At least 1 unidimensionally measurable lesion - At least 20 mm by conventional techniques - At least 10 mm by spiral CT scan - No bone metastases as only measurable site - Pleural or peritoneal effusions not acceptable as measurable disease - No known brain metastases - Hormone receptor status: - Estrogen receptor-negative - Estrogen receptor-positive - Female - Performance status - ECOG 0-2 - Performance status - Karnofsky 60-100% - More than 12 weeks - WBC at least 3,000/mm^3 - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Bilirubin normal - AST or ALT no greater than 2.5 times upper limit of normal - Creatinine normal - Creatinine clearance at least 60 mL/min - No acute ischemia or significant conduction abnormality by EKG - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia - LVEF greater than 50% - No uncontrolled concurrent illness - No psychiatric illness or social situation that would preclude study - No ongoing or active infection - No prior allergic reaction(s) to compounds of similar chemical or biologic composition to PS-341 - No other malignancy within the past 5 years except carcinoma in situ of the cervix or basal cell skin cancer - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective barrier-method contraception - See Chemotherapy - See Disease Characteristics - No more than 1 prior chemotherapy regimen for metastatic disease - High-dose regimen or bone marrow transplantation considered 1 prior regimen - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered - Prior hormonal therapy for metastatic disease or in adjuvant setting allowed - Prior localized radiotherapy allowed if it does not influence the signal evaluable lesion - At least 4 weeks since prior radiotherapy and recovered - At least 2 weeks since prior minor surgery and recovered - At least 4 weeks since prior major surgery and recovered - No other concurrent investigational agent - No other concurrent investigational or commercial agents or therapies to treat this malignancy | |
| 39 | NCT00070499 | active, not recruiting | 1 | phase 2 | ['chronic myelogenous leukemia, bcr-abl1 positive'] | ["['C95.91', 'C95.92', 'Z80.6', 'Z85.6', 'C90.11', 'C90.12', 'C91.01']"] | ['dasatinib', 'imatinib mesylate'] | ['CC1=NC(NC2=NC=C(S2)C(=O)NC2=C(C)C=CC=C2Cl)=CC(=N1)N1CCN(CCO)CC1', 'CN1CCN(CC2=CC=C(C=C2)C(=O)NC2=CC(NC3=NC=CC(=N3)C3=CN=CC=C3)=C(C)C=C2)CC1'] | Inclusion Criteria: - Patients must have CML in chronic phase based on bone marrow aspiration and biopsy and peripheral blood counts obtained within 28 days before registration - Patients must be registered on this study within 180 days after the date of first being diagnosed with CML, based on a cytogenetic or molecular analysis of peripheral blood or bone marrow, demonstrating the presence of the Philadelphia chromosome or variants of the (9;22) translocation or testing positive for Bcr-Abl by real time-polymerase chain reaction (RT-PCR); patients may have secondary chromosomal abnormalities in addition to the Philadelphia chromosome and remain eligible - Patients must have Zubrod performance status 0-2 - Patients must not have received prior treatment for CML with the exception of hydroxyurea and/or anagrelide - Patients must not have received any prior chemotherapy regimen for peripheral blood stem cell mobilization; (prior collection of unmobilized peripheral blood stem cells is permitted) - Serum bilirubin =< 2.0 x the institutional upper limit of the normal (IULN) - Serum glutamic oxaloacetic transaminase (SGOT)/aspartate aminotransferase (AST) or serum glutamate pyruvate transaminase (SGPT)/alanine transaminase (ALT) =< 2.0 x the IULN - Patients (Southwestern Oncology Group [SWOG] institutions only) must be registered on SWOG-9007, "Cytogenetic Studies in Leukemia Patients;" collection of the pretreatment bone marrow specimen must be completed within 28 days prior to registration; the pretreatment bone marrow specimen must be submitted to an approved Southwest Oncology Group Cytogenetics Laboratory for cytogenetic analysis as described, and an aliquot of the bone marrow (or peripheral blood if the marrow aspiration is a dry tap) must be submitted for fluorescent in situ hybridization (FISH) analysis; note that protocol SWOG-9007 also requires submission of bone marrow specimens at the time of progression to the accelerated or blastic phase of CML or the loss of complete hematologic response and every six months while the patient is on this study - Patients (SWOG institutions only) must be registered on S9910, "Leukemia Centralized Reference Laboratories and Tissue Repositories, Ancillary;" specimens of peripheral blood and bone marrow must be submitted to the Southwest Oncology Group Lymphoid Leukemia and CML Centralized Laboratory in Seattle, Washington; collection of pretreatment blood and marrow specimens must be completed within 28 days prior to registration; note that this study also requires submission of peripheral blood and bone marrow specimens at various times after entry into the study - Patients must not have undergone major surgery within 28 days before registration, and must have fully recovered from any other prior major surgery - Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method - No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, cervical carcinoma in situ, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for five years - Patients must have an electrocardiogram (ECG) within 42 days prior to registration, and must not have any of the following cardiac symptoms prior to entry on study: - Uncontrolled angina, congestive heart failure or myocardial infarction (MI) within 6 months of study entry - Diagnosed or suspected congenital long QT syndrome - Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes) - Prolonged corrected QT (QTc) interval on pre-entry electrocardiogram (> 450 msec) - Uncontrolled hypertension - Patients must not have a history of significant bleeding disorder unrelated to cancer, including: - Congenital bleeding disorders (e.g., von Willebrand's disease) - Acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies) - All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines - At the time of patient registration, the treating institution's name and identification (ID) number must be provided to the Data Operations Center in Seattle in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the data base | |
| 40 | NCT01065454 | active, not recruiting | 1 | phase 2 | ['hypertension, pulmonary', 'ventricular dysfunction, left'] | ["['I27.0', 'I27.20', 'I27.21', 'I27.24', 'I27.29', 'P29.30', 'I27.22']", "['I47.2', 'I49.01', 'I49.02', 'I49.3', 'Q21.0', 'I47.0', 'I50.1']"] | ['riociguat (adempas, bay63-2521)', 'riociguat (adempas, bay63-2521)', 'riociguat (adempas, bay63-2521)', 'placebo'] | ['COC(=O)N(C)C1=C(N)N=C(N=C1N)C1=NN(CC2=C(F)C=CC=C2)C2=C1C=CC=N2', 'COC(=O)N(C)C1=C(N)N=C(N=C1N)C1=NN(CC2=C(F)C=CC=C2)C2=C1C=CC=N2', 'COC(=O)N(C)C1=C(N)N=C(N=C1N)C1=NN(CC2=C(F)C=CC=C2)C2=C1C=CC=N2', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Male and female patients with symptomatic pulmonary hypertension due to left ventricular systolic dysfunction despite optimized heart failure therapy Exclusion Criteria: - Types of pulmonary hypertension other than group 2.1 of Dana Point Classification | |
| 41 | NCT01234402 | completed | 0 | phase 2 | ['breast cancer'] | ["['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']"] | ['capecitabine'] | ['[H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1'] | Inclusion Criteria: - The participant has histologically or cytologically confirmed breast cancer which at the time of study entry is either Stage III disease not amenable to curative therapy or Stage IV disease - Has measurable or nonmeasurable disease - Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 - Has received prior anthracycline therapy - Has received prior taxane therapy - Participants with human epidermal growth factor receptor-2 (HER2) positive disease must have progressed on or following trastuzumab - Participants with hormone receptor-positive disease must have progressed on or following hormone therapy - Has received ≤ 3 prior chemotherapy regimens in any setting (a regimen is defined as any agent[s] that has been administered for more than 1 cycle; sequential neoadjuvant/adjuvant treatment is considered 1 regimen) - Has completed any prior radiotherapy ≥ 4 weeks prior to randomization - Has completed any prior hormonal therapy ≥ 2 weeks prior to randomization - Has adverse events (AEs) that have resolved to Grade ≤ 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v 4.0) from all clinically significant toxic effects of prior chemotherapy, surgery, radiotherapy,or hormonal therapy - Has adequate hematologic, coagulation, hepatic and renal function - Does not have: - cirrhosis at a level of Child-Pugh B (or worse) or - cirrhosis (any degree) and a history of hepatic encephalopathy or ascites resulting from cirrhosis and requiring ongoing treatment with diuretics and/or paracentesis - Has urinary protein is ≤ 1+ on dipstick or routine urinalysis; if urine protein ≥ 2+, a 24-hour urine collection must demonstrate < 1000 mg of protein in 24 hours to allow participation in the study - Agrees to use adequate contraception during the study period and for 12 weeks after the last dose of study medication Exclusion Criteria: - Has a concurrent active malignancy other than adequately treated nonmelanomatous skin cancer, curatively treated cervical carcinoma in situ, or other noninvasive carcinoma or in situ neoplasm. A participant with previous history of malignancy is eligible, provided that there has been a disease-free interval for > 3 years - Has a known sensitivity to capecitabine, any of its components, or other drugs formulated with polysorbate 80 - Has a known sensitivity to 5-fluorouracil (5-FU) - Has a known dihydropyrimidine dehydrogenase deficiency - Has received prior capecitabine treatment for advanced breast cancer - Has received investigational therapy within 2 weeks prior to randomization - Has received bevacizumab within 4 weeks prior to randomization - Has received more than 1 prior antiangiogenic agent for breast cancer - Has a known sensitivity to agents of similar biologic composition as ramucirumab DP or Icrucumab (IMC-18F1), or other agents that specifically target vascular endothelial growth factor (VEGF) - Has an acute/subacute bowel obstruction or history of chronic diarrhea requiring ongoing medical intervention - Has a history of uncontrolled hereditary or acquired bleeding or thrombotic disorders - Has experienced a Grade ≥ 3 bleeding event within 3 months prior to randomization - Is receiving prophylactic or therapeutic anticoagulation with warfarin or any other oral anticoagulant - Has an uncontrolled intercurrent illness, including, but not limited to uncontrolled hypertension, symptomatic anemia, symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, psychiatric illness/social situations, or any other serious uncontrolled medical disorder in the opinion of the investigator - Has experienced any arterial thrombotic or thromboembolic events, including, but not limited to myocardial infarction, transient ischemic attack, or cerebrovascular accident within 6 months prior to randomization - Has brain metastases, uncontrolled spinal cord compression, or leptomeningeal disease - Has an ongoing or active infection requiring parenteral antibiotic, antifungal, or antiviral therapy - Has received a prior allogeneic organ or tissue transplantation - Has undergone major surgery within 4 weeks prior to randomization, or subcutaneous venous access device placement within 7 days prior to randomization - Has had a serious nonhealing wound, ulcer, or bone fracture within 4 weeks prior to randomization - Has known HIV or AIDS infection - Has an elective or planned major surgery to be performed during the course of the trial - Participant is pregnant or lactating | |
| 42 | NCT01596062 | completed | 0 | phase 2 | ['renal transplantation'] | ["['N25.0', 'Q61.4', 'N23', 'N26.9', 'P96.0', 'Q60.0', 'Q60.1']"] | ['simulect®', 'neoral®', 'certican®', 'myfortic®', 'corticosteroids'] | ['CC[C@@H]1NC(=O)[C@H]([C@H](O)[C@H](C)C\\C=C\\C)N(C)C(=O)[C@H](C(C)C)N(C)C(=O)[C@H](CC(C)C)N(C)C(=O)[C@H](CC(C)C)N(C)C(=O)[C@@H](C)NC(=O)[C@H](C)NC(=O)[C@H](CC(C)C)N(C)C(=O)[C@@H](NC(=O)[C@H](CC(C)C)N(C)C(=O)CN(C)C1=O)C(C)C', '[H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\\C=C(C)\\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\\C=C\\C=C\\C=C(C)\\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC', 'COC1=C(C\\C=C(/C)CCC(O)=O)C(O)=C2C(=O)OCC2=C1C', '[H][C@@]12C[C@@H](C)[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])CCC2=CC(=O)C=C[C@]12C'] | Inclusion Criteria: - Patients receiving a primary renal graft from a deceased or living, related or unrelated donor and who require basiliximab induction therapy - Cold ischemia time < 30 hours Exclusion (Non inclusion) criteria: - Patients undergoing multi-organ transplantation, including both kidneys, or who have previously undergone organ transplantation, including renal transplantation - Patients receiving a graft from a non-heart-beating donor - A-B-O incompatible graft or positive T cell crossmatch - Patients receiving a graft from an expanded criteria donor according to the UNOS definition (donor older than 60 years or donor aged between 50 and 60 years and presence of at least 2 of the following factors: hypertension, serum creatinine concentration ≥ 132 µmol/mL, cardiovascular cause of death) - Positive anti-HLA antibodies (Luminex) prior to transplantation - Patients whose original renal disease was primary focal and segmental hyalinosis or was related to atypical hemolytic uremic syndrome - EBV-negative patients receiving a graft from an EBV-positive donor (EBV D+R-) Other protocol-defined inclusion/exclusion criteria may apply. | |
| 43 | NCT01261494 | completed | 1 | phase 2 | ['type ii diabetes mellitus'] | ["['E23.2', 'N25.1', 'P70.2', 'O24.92', 'Z83.3', 'Z86.32', 'E10.65']"] | ['gft505 80mg', 'placebo'] | ['CSC1=CC=C(C=C1)C(=O)\\C=C\\C1=CC(C)=C(OC(C)(C)C(O)=O)C(C)=C1', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Male or post-menopausal female (defined as >12 months since last menstrual period) or surgical menopause. If hormonal replacement therapy, it should be stable at least for 6 months prior to screening. - Body Mass Index ≥27 and ≤45 kg/m². - Drug-Naive patients with type 2 diabetes mellitus (non insulin dependent diabetes). Patients should not be treated by insulin or other diabetes medication for the last 3 months prior to screening. Patients treated for less than 4 weeks with insulin may be included in the study. - HbA1c ≥ 7.0% and <9.5%. - Antibody glutamate decarboxylase acid (Anti-GAD) negative for patients aged less than 40 years. Exclusion Criteria: - Type I Diabetes Mellitus. - Blood Pressure > 160 / 95 mmHg. - Lipid-lowering drugs such as fibrates. - Fasting Plasma Glucose (FPG) ≥ 240 mg/dL. - Triglycerides (TG) > 400 mg/dL. | |
| 44 | NCT00427466 | completed | 1 | phase 2 | ['sarcoma'] | ["['C96.A', 'C46.9', 'C96.22', 'C46.0', 'C46.2', 'C92.31', 'C92.32']"] | ['pemetrexed'] | ['[H][N]([H])([H])[Pt](Cl)(Cl)[N]([H])([H])[H]'] | Inclusion Criteria: - Histologically confirmed metastasized or locally inoperable soft tissue sarcoma - Progression or relapse after previous cytostatic treatment with adriamycin and/or an ifosfamide containing chemotherapeutic substance - Two-dimensionally measurable/evaluable tumor parameters (according to WHO-criteria) - Previous radiotherapy is acceptable as long as the irradiated area does not include the only measurable lesion - Patient compliance and geographic proximity, which ensure the possibility of adequate Follow-up - Life expectancy of more than 3 months - ECOG <= 2 - Age at least 18 years - Adequate bone marrow function at the initiation of therapy - Adequate kidney function - Patient consent - Patient ability to consent Exclusion Criteria: - Previous or concurrent irradiation of the indicator lesion - Other concomitant tumor therapy - Severe impairment in hepatic function - Active Infection - Previous treatment with Pemetrexed - Second tumor within the past 5 years (excepting basal cell carcinoma, adequately treated carcinoma in situ of the uterine cervix, of the bladder urothelium or colon polyps including pTis and pTin) - Severely symptomatic cardiovascular and cerebrovascular disease - HIV, active Hepatitis B or C - Dementia, Cerebral stroke with cognitive deficits - Kidney function <= 79 ml/min (calculated according to MDRD): Inability to interrupt treatment with NSAIDs/ASS/Cox-2 Inhibitors 2 days prior to and following administration of Pemetrexed. If a patient is taking an NSAID or salicylate with a long half-life it should not be taken five days prior to, on the day of or two days after application of Pemetrexed. Low dose acetyl salicylic acid administration is permitted (e.g. 100 mg/die.) There are no restrictions with kidney function greater than 80 ml/min. - Inability or unwillingness to take folic acid, vitamin B12 or dexamethasone - Pleural or pericardial exudate, ascites without a drain (3rd Space) - Time Interval from the last course of chemotherapy < 4 weeks - Symptomatic CNS-Metastases - Gravidity or Lactation - Women of reproductive age without reliable contraception if not the following applies: Must be surgically sterile, postmenopausal, or compliant with a medically approved contraceptive regimen during and for 3 months after treatment - Positive serum or urine pregnancy test - Participation in another trial at the same time | |
| 45 | NCT01309659 | terminated | lack of enrollment | 0 | phase 2 | ['anemia', 'unexplained anemia (uae)'] | ["['D53.2', 'D64.9', 'D46.4', 'D53.0', 'D53.9', 'D61.3', 'D61.9']"] | ['iron sucrose', 'iron sucrose'] | ['O.O.O.[OH-].[O--].[O--].[O--].[O--].[O--].[O--].[O--].[O--].[Na+].[Na+].[Fe+3].[Fe+3].[Fe+3].[Fe+3].[Fe+3].OC[C@H]1O[C@@](CO)(O[C@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O)[C@@H](O)[C@@H]1O', 'O.O.O.[OH-].[O--].[O--].[O--].[O--].[O--].[O--].[O--].[O--].[Na+].[Na+].[Fe+3].[Fe+3].[Fe+3].[Fe+3].[Fe+3].OC[C@H]1O[C@@](CO)(O[C@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O)[C@@H](O)[C@@H]1O'] | Inclusion Criteria: - Age ≥ 65 years old - Hemoglobin concentration ≥ 9.0 g/dL and < 11.5 g/dL (women) or < 12.7 g/dL (men) - Unexplained anemia - Serum ferritin level ≥ 20 and ≤ 200 ng/mL - Able to walk without the use of a walker, motorized device or the assistance of another person. - Able to understand and willing to provide written informed consent in the absence of dementia - Must be able to understand and speak in English Exclusion Criteria: - Red blood cell transfusions within the past 3 months - Use of erythropoiesis stimulating agents (ESA) in the past 3 months - Intravenous Iron Infusions within the past 3 months - Distance on baseline 6MWT (6 minute walk test) above the median for age and sex - History of unstable angina or myocardial infarction in the past 3 months - History of stroke or TIA (transient ischemic attack) the past 3 months - Uncontrolled hypertension (diastolic blood pressure > 100 mm Hg or systolic blood pressure > 160 mm Hg on 2 separate occasions) - Positive fecal occult blood test within the screening period - Elevated AST (aspartate aminotransferase) or ALT (alanine aminotransferase) ≥ 2x upper limit of normal - Documented anaphylactic reaction to iron sucrose infusion in the past - Subjects initiated on oral iron supplementation within the last 6 weeks, or those initiated on oral iron within the last 3 months who have had at least a one gram/dL improvement in Hb since starting oral iron supplementation |
| 46 | NCT00606593 | completed | 1 | phase 2 | ['chronic primary insomnia'] | ["['F51.01', 'F51.02', 'F51.03', 'F51.04', 'G47.00', 'G47.09', 'A81.83']"] | ['act-078573 oral capsules at 25 and 100 mg and matching placebo', 'act-078573 and matching placebo', 'act-078573 and matching placebo', 'act-078573 and matching placebo', 'act-078573 and matching placebo', 'act-078573 and matching placebo', 'act-078573 and matching placebo', 'act-078573 and matching placebo', 'act-078573 and matching placebo', 'act-078573 and matching placebo'] | ['CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O', 'CNC(=O)[C@H](N1CCC2=CC(OC)=C(OC)C=C2[C@@H]1CCC1=CC=C(C=C1)C(F)(F)F)C1=CC=CC=C1', 'CNC(=O)[C@H](N1CCC2=CC(OC)=C(OC)C=C2[C@@H]1CCC1=CC=C(C=C1)C(F)(F)F)C1=CC=CC=C1', 'CNC(=O)[C@H](N1CCC2=CC(OC)=C(OC)C=C2[C@@H]1CCC1=CC=C(C=C1)C(F)(F)F)C1=CC=CC=C1', 'CNC(=O)[C@H](N1CCC2=CC(OC)=C(OC)C=C2[C@@H]1CCC1=CC=C(C=C1)C(F)(F)F)C1=CC=CC=C1', 'CNC(=O)[C@H](N1CCC2=CC(OC)=C(OC)C=C2[C@@H]1CCC1=CC=C(C=C1)C(F)(F)F)C1=CC=CC=C1', 'CNC(=O)[C@H](N1CCC2=CC(OC)=C(OC)C=C2[C@@H]1CCC1=CC=C(C=C1)C(F)(F)F)C1=CC=CC=C1', 'CNC(=O)[C@H](N1CCC2=CC(OC)=C(OC)C=C2[C@@H]1CCC1=CC=C(C=C1)C(F)(F)F)C1=CC=CC=C1', 'CNC(=O)[C@H](N1CCC2=CC(OC)=C(OC)C=C2[C@@H]1CCC1=CC=C(C=C1)C(F)(F)F)C1=CC=CC=C1', 'CNC(=O)[C@H](N1CCC2=CC(OC)=C(OC)C=C2[C@@H]1CCC1=CC=C(C=C1)C(F)(F)F)C1=CC=CC=C1'] | Inclusion Criteria: - Elderly subjects (> 64 years) with a diagnosis of primary insomnia. Exclusion Criteria: - History of any sleep disorder, or any Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) axis I disorder other than primary insomnia. - Sleep apnea, or restless legs syndrome. - Daytime napping of more than 1 hour per day. - Important caffeine consumption, heavy tobacco use, alcohol or drug abuse within 2 years prior to the screening visit. - Unwillingness to refrain from drugs, over-the-counter or herbal medication having an effect on sleep or behavior. | |
| 47 | NCT00089921 | completed | 0 | phase 2 | ['arthritis, rheumatoid'] | ["['M06.9', 'M05.9', 'M06.08', 'M06.00', 'M06.011', 'M06.012', 'M06.019']"] | ['scio-469', 'scio-469', 'placebo', 'scio-469'] | ['[H][C@]1(C)CN(C(=O)C2=C(Cl)C=C3N(C)C=C(C(=O)C(=O)N(C)C)C3=C2)[C@]([H])(C)CN1CC1=CC=C(F)C=C1', '[H][C@]1(C)CN(C(=O)C2=C(Cl)C=C3N(C)C=C(C(=O)C(=O)N(C)C)C3=C2)[C@]([H])(C)CN1CC1=CC=C(F)C=C1', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O', '[H][C@]1(C)CN(C(=O)C2=C(Cl)C=C3N(C)C=C(C(=O)C(=O)N(C)C)C3=C2)[C@]([H])(C)CN1CC1=CC=C(F)C=C1'] | Inclusion Criteria: - Patients having active rheumatoid arthritis who are not receiving medications known as hepatotoxic disease-modifying anti-rheumatic drugs (DMARDs) - Patients taking hydroxychloroquine (Plaquenil) must be on a stable or consistent dose prior to entering study Exclusion Criteria: - Patients using Enbrel, Remicade, Kineret, Humira, or an experimental biologic agent within the past 3 months - Lab tests revealed elevated liver enzymes within the past 6 months - Medical history of Tuberculosis, cancer, multiple sclerosis, neuropathy or encephalopathy - HIV positive - Abnormal electrocardiogram - Chronic or acute infection | |
| 48 | NCT00489476 | completed | 1 | phase 2 | ['migraine'] | ["['G43.B1', 'G43.D1', 'G43.B0', 'G43.D0', 'G43.A1', 'G43.411', 'G43.419']"] | ['staccato loxapine', 'staccato placebo'] | ['CN1CCN(CC1)C1=NC2=CC=CC=C2OC2=C1C=C(Cl)C=C2', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: 1. Male and female patients between the ages of 18 to 65 years, inclusive. 2. Patients who have migraine headache with or without aura (diagnosis according to International Headache Society guidelines) for at least 6 months. 3. Patients who have a history of migraine and have had at least 3 migraine attacks in the last 3 month period (but not more than 8 migraine attacks in the last month). 4. Patients who have been pain free for at least 48 hours since the end of their last migraine attack. 5. Patients who have not taken any acute migraine or pain medication within 48 hours prior to dosing (including OTC products). 6. Patients who have a pain rating of Moderate or Severe (on a None-Mild- Moderate-Severe Scale) prior to dosing. 7. Patients who speak, read, and understand English and are willing and able to provide written informed consent on an IRB approved form prior to the initiation of any study procedures. 8. Patients who are willing and able to comply with the study schedule and requirements, are willing and able to travel to the Clinical Research Unit (CRU) for treatment and stay at the CRU for approximately a 4-6 hour period, and agree to return to the clinic within 5 working days of use of the investigational treatment. 9. Patients who are in good general health prior to study participation as determined by a detailed medical history, physical examination, 12-lead ECG, blood chemistry profile, hematology, urinalysis, and in the opinion of the Principal Investigator. 10. Female participants (if of child-bearing potential and sexually active) and male participants (if sexually active with a partner of child-bearing potential) who agree to use a medically acceptable and effective birth control method throughout the study and for one week following the end of the study. Medically acceptable methods of contraception that may be used by the participant and/or his/her partner include abstinence, birth control pills or patches, diaphragm with spermicide, intrauterine device (IUD), condom with foam or spermicide, vaginal spermicidal suppository, surgical sterilization, and progestin implant or injection. Prohibited methods include: the rhythm method, withdrawal, condoms alone, or diaphragm alone. Exclusion Criteria: 1. Patients who are currently taking antipsychotics, tricyclic antidepressants, valproate, barbiturates, benzodiazepines, or lithium must be excluded. 2. Patients with a history of contraindications to anticholinergics (bowel obstruction, urinary retention, acute glaucoma) must be excluded. 3. Patients with a history of allergy or intolerance to dibenzoxazepines (loxapine and amoxapine) must be excluded. 4. Patients with a history of extra-pyramidal disorders, movement disorders including Parkinson's disease, and patients with a history of neuroleptic malignant syndrome must be excluded. 5. Female patients who have a positive pregnancy test at screening or during randomization visit, or are breastfeeding must be excluded. 6. Patients who have a history within the past year of drug or alcohol dependence or abuse as defined by DSM-4 must be excluded. 7. Patients who have a history of syncope, unstable angina, myocardial infarction (within 6 months), congestive heart failure, transient ischemic attack, or pheochromocytoma must be excluded. 8. Patients who have a history of a major neurological disorder other than migraine (seizure disorder, subarachnoid bleeding, stroke, brain tumor) must be excluded. 9. Patients who have any other disease(s), by history, physical examination, or laboratory abnormalities (ALT or AST > 2-fold the upper limit of normal, Bilirubin > 1.5 mg/dL, or creatinine > 1.8 mg/dL) or that in the investigator's opinion, would present undue risk to the patient or may confound the interpretation of study results must be excluded. 10. Patients who have a history of asthma or chronic obstructive lung disease should be excluded. 11. Patients who have received an investigational drug within 30 days prior to the Screening Visit must be excluded. 12. Patients who are considered by the investigator, for any reason, to be an unsuitable candidate for receiving loxapine, or unable to use the inhalation device, must be excluded. | |
| 49 | NCT00311662 | completed | 1 | phase 2 | ['migraine without aura', 'migraine with aura'] | ["['G43.111', 'G43.011', 'G43.119', 'G43.101', 'G43.001', 'G43.109', 'G43.711']"] | ['tonabersat', 'placebo'] | ['CC(=O)C1=CC=C2OC(C)(C)[C@@H](O)[C@@H](NC(=O)C3=CC=C(F)C(Cl)=C3)C2=C1', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - An established history of migraine of at least one year, with or without aura, meeting the diagnostic criteria of the International Classification of Headache Disorders, and experience between four and 14 migraine headache days per month; headache days should be experienced within at least two and no more than six migraine attacks per month. - Women of child bearing potential must be using a reliable form of contraception (defined in the protocol) for at least three months prior to enrolment with contraception maintained for at least 7 days after the last dose of study medication and they must have a negative pregnancy test at screening with no intention of becoming pregnant during the study period. Exclusion Criteria: - Patients with a diagnosis of migraine according to the diagnostic criteria of the International Classification of Headache Disorders at age 50 years or more. - Experience frequent non-migraine headache - Patients with pure menstrual migraine defined as patients in whom migraine attacks occur exclusively on Day 1 +/- 2 (i.e. Days -2 to +3) of menstruation in at least two out of three menstrual cycles and at no other times of the cycle. - Patients with other significant central nervous system disorders in the opinion of the investigator. - Failure to respond to more than two adequately dosed (i.e. recommended total daily dose and of sufficient duration) migraine prophylactic medications. - Overuse of acute migraine treatments defined as more than 14 medication days per month with analgesics and opioids and nine medication days per month of ergots or triptans. - Prophylactic treatment within two months prior to entry to the trial. - Patients taking any of the following medications: beta-blockers (during the last two months), tricyclic antidepressants (during the last two months), antiepileptic drugs (during the last two months), calcium channel blockers (during the last two months), monoamine oxidase inhibitors (during the last two months), daily oral NSAIDs, daily paracetamol, high dose magnesium supplements (600 mg/day), daily multivitamin preparations containing more than 10 mg riboflavin, daily use of oral corticosteroids and daily herbal preparations (e.g. feverfew, butterwort and St John's Wort). Parenteral administration of Botulinum toxin is also excluded. Patients taking other medications used as prophylaxis for migraine including methysergide, anti spasticity agents (e.g. tizanidine) and the new generation antipsychotics (e.g. olanzapine) currently or within the previous two months should also be excluded. - Patients who, in the opinion of the investigator, have significant cerebrovascular disease, e.g. transient ischaemic attacks, stroke. - Patients who, in the opinion of the investigator, have clinically significant cardiovascular disease. - Patients suffering from a current clinical diagnosis of major depressive disorder or schizophrenia. - Patients with renal dysfunction, defined as a serum creatinine of greater than 125% of the upper limit of normal for their age group. - Patients with hepatic dysfunction defined as a liver function test (aspartate aminotransferase [AST], alanine aminotransferase [ALT], alkaline phosphatase, bilirubin) of greater than twice the upper limit of normal for their age group. - Patients with known alcohol or other substance abuse. - Failure to complete the diary card during the baseline period. - Participation in another clinical trial in the previous four weeks. - Any women who is pregnant, lactating or not using medically acceptable contraception. | |
| 50 | NCT00326625 | completed | 0 | phase 2 | ['amyotrophic lateral sclerosis'] | ["['G12.21']"] | ['40 mg glatiramer acetate', 'placebo'] | ['CC(O)=O', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: 1. Diagnosis of definite or probable ALS in accordance with the El-Escorial criteria. 2. Subject has experienced his/her first ALS symptoms within 3 years prior to the screening visit. 3. Slow VC test equal or greater than 70% of the predicted value. 4. The sum of the 3 respiratory items on the ALSFRS-R must total at least 10 points. 5. Stable dose of riluzole for at least 8 weeks prior to screening. 6. Age - 18-70 (inclusive). Exclusion Criteria: 1. The use of invasive or non-invasive ventilation. 2. Subject having undergone gastrostomy. 3. Subject with any clinically significant or unstable medical condition. 4. Subjects participating in any other clinical trial (within 12 weeks prior to screening and thereafter). 5. Additional criteria per protocol. | |
| 51 | NCT01055821 | completed | 1 | phase 2 | ['chronic hepatitis c infection'] | ["['B00.81', 'B25.1', 'B26.81', 'B58.1', 'K75.4', 'A51.45', 'B17.2']"] | ['pegylated interferon and ribavirin'] | ['NC(=O)C1=NN(C=N1)[C@@H]1O[C@H](CO)[C@@H](O)[C@H]1O'] | Inclusion Criteria: - Chronically infected patients with Hepatitis C virus Genotype 1 (1a or 1b) with detectable viremia (HCV RNA in blood) for more than 6 months and naïve to treatment; - Patients must have compensated liver disease, with no history of ascites, jaundice, hepatic encephalopathy or bleeding from esophageal or gastric varices requiring beta-blockers; - No histological evidence of hepatic cirrhosis (including compensated cirrhosis) based on a liver biopsy taken within 24 months prior to baseline; or on a FibroScan® performed within 6 months prior to treatment which indicates the absence of liver cirrhosis, i.e., stage < F4 (METAVIR); in case of no available results, a liver biopsy will be performed prior to treatment; - All laboratory parameters must be grade 0 or 1 (as per CTCAE criteria) except for alanine amino-transferase (ALT), aspartate amino-transferase (AST), gamma glutamyl transferase (GGT) and alkaline phosphatase (ALP) for which a grade 2 will be allowed if stated non clinically significant; - No co-infection with Human Immunodeficiency Virus (HIV) or hepatitis B virus (HBsAg positive); - No intravenous (IV) drug or alcohol abuse; - Serum thyroid stimulating hormone (TSH) levels within normal ranges, regardless of treatment with L-thyroxin; - Normal electrocardiogram (ECG); - Normal retinal examination (eye fundus) within last 12 months for diabetic patients or patients suffering from high blood pressure; - Negative pregnancy test in women of childbearing potential (a woman who is two years post-menopausal or surgically sterile is not considered to be of childbearing potential); - Female patients and female partners of male patients (if childbearing potency) must agree to use two effective methods of birth control during the study and for 6 months after the end of treatment. One of the methods needs to be a 'barrier' method (condom or diaphragm); Exclusion Criteria: - Prior treatment for hepatitis C; - Malignancy within the last 5 years; except for patients with history of squamous cell skin cancer or basal cell skin cancer who will be enrolled, unless patients have a history of skin cancer at the vaccination site; - Diagnosed or suspected hepatocellular carcinoma; - History of psychiatric conditions including, but not limited to, psychosis, suicidal ideations, or major depression. Patients with mild to moderate depression in the past and no prior history of suicidal gestures or attempts may be enrolled if, in the Investigator's opinion, they are suitable for treatment; - Serious, concomitant medical disorder, including active systemic infection and proven or suspected immunosuppressive disorder; - History of immunodeficiency or autoimmune disease including autoimmune hepatitis, allogenic transplant, or pre-existing autoimmune or antibody-mediated disease including, but not limited to: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, or autoimmune thrombocytopenia; - Administration of any vaccine or immunoglobulin within 30 days before the first dose of TG4040 /SOC; - Significant cardiovascular disease (e.g., New York Heart Association [NYHA] class 3 congestive heart failure; myocardial infarction within the past 6 months; unstable angina; coronary angioplasty within the past 6 months; or uncontrolled arterial or ventricular cardiac arrhythmias); - Systemic corticosteroid therapy or other immunosuppressive/immunomodulating drugs (e.g. Cyclosporine) within 2 months prior to first TG4040/SOC administration; corticosteroid nasal sprays, inhaled steroids for asthma and/or topical steroids are allowed; - Any known allergy to interferon (IFN), RBV and/or their excipients; - Any medical contraindications to IFN and/or RBV; - Any known allergy to eggs; - Women who are breastfeeding; | |
| 52 | NCT00489359 | completed | 1 | phase 1/phase 2 | ['ovarian cancer', 'primary peritoneal cancer'] | ["['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']", "['K65.1', 'K66.0', 'N99.4', 'N73.6', 'R88.0', 'Z49.32', 'Z49.02']"] | ['pemetrexed - phase 1', 'carboplatin - phase 1', 'pemetrexed - phase 2', 'carboplatin - phase 2'] | ['[H][C@@](CCC(O)=O)(NC(=O)C1=CC=C(CCC2=CNC3=C2C(O)=NC(=N)N3)C=C1)C(O)=O', 'N[C@@H](CCCNC(N)=N)C(O)=O', '[H][C@@](CCC(O)=O)(NC(=O)C1=CC=C(CCC2=CNC3=C2C(O)=NC(=N)N3)C=C1)C(O)=O', 'N[C@@H](CCCNC(N)=N)C(O)=O'] | Inclusion Criteria: - Diagnosis of ovarian or primary peritoneal cancer confirmed by pathology - Patients must have recurrent ovarian cancer which is sensitive to platinum therapy - Prior radiation therapy is allowed Measurable disease as defined by the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines, or non-measurable but cancer antigen 125 (CA-125) greater than or equal to 2X upper limit. Exclusion Criteria: - More than 2 lines of therapy for ovarian or primary peritoneal cancer. - Pregnant or breast feeding. - Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry. | |
| 53 | NCT00678015 | terminated | per protocol - interim analysis showed no significant psa declines among the first 12 patients after 3 cycles of treatment | 0 | phase 2 | ['prostate cancer'] | ["['C61', 'D29.1', 'D40.0', 'Z15.03', 'Z80.42', 'Z85.46', 'Z12.5']"] | ['nordihydroguaiaretic acid (ndga)'] | ['C[C@@H](CC1=CC(O)=C(O)C=C1)[C@H](C)CC1=CC(O)=C(O)C=C1'] | Inclusion Criteria: - Rising prostate-specific antigen (PSA) value after local therapy with a PSA doubling time (PSADT) between 6 and 24 months (four or more readings at least two weeks apart within the last six months) - Prior definitive therapy for prostate cancer consisting of one of the following: 1. External beam radiotherapy with or without hormone therapy 2. Brachytherapy with or without pelvic external beam radiation or hormone therapy 3. Radical prostatectomy with or without adjuvant or salvage radiation therapy - PSA > 1 ng/ml, which has risen serially on two determinations at least one week apart - Progressive disease by "Phoenix" consensus definition for patients who have undergone primary radiation therapy (PSA nadir + 2 ng/mL) - No metastatic disease - Prior adjuvant or neoadjuvant androgen deprivation is permitted, provided: 1. > 6 months since last day of effective androgen deprivation 2. Testosterone > 250 ng/dL 3. Patient is not on intermittent androgen deprivation - Karnofsky performance status (KPS) of > 70% - Liver Function Tests are within normal range - Glycated hemoglobin (HgA1c) < 6% - Patients must be four weeks from major surgery or radiotherapy to be eligible Exclusion Criteria: - Presence of another active malignancy other than prostate cancer, or treated squamous/basal cell carcinoma of the skin. Concomitant medical condition which would make it undesirable, in the physician's opinion, for the patient to participate in the protocol or would jeopardize compliance with the protocol requirements - Diabetes mellitus, unless diet-controlled - Must be off saw palmetto, pomegranate juice, finasteride, or any herbal agent intended to lower PSA for > 4 weeks. Baseline PSADT calculation must occur off of these agents - Patients may not have evidence of local-only recurrence of prostate cancer - No history of liver disease, including Hepatitis B or C, alcoholic liver disease, or autoimmune liver disease. A prior history of Hepatitis A is allowed provided that baseline liver function tests are within normal limits - Patients with castration resistant prostate cancer are ineligible (prostate cancer which has progressed on androgen deprivation therapy with a Luteinizing hormone-releasing hormone (LHRH)-agonist or orchiectomy) |
| 54 | NCT00603382 | completed | 1 | phase 2 | ['asthma'] | ["['J45.998', 'J82.83', 'J45.909', 'J45.991', 'J45.20', 'J45.30', 'J45.40']"] | ['gw685698x', 'placebo'] | ['[H][C@@]12C[C@@H](C)[C@](OC(=O)C3=CC=CO3)(C(=O)SCF)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])C[C@H](F)C2=CC(=O)C=C[C@]12C', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: Subjects eligible for enrollment in the study must meet all of the following criteria: - Type of Subject: Outpatient - Age: 12 years of age or older at Visit 1. For sites in the following countries, subjects recruited will be ≥18 years of age: Bulgaria, Czech Republic, Germany, Greece, Lithuania, New Zealand, Russian Federation, Turkey and any other countries where local regulations or the regulatory status of study medication permit enrollment of adults only. - Gender: Male or Eligible Female - To be eligible for entry into the study, females of childbearing potential must commit to consistent and correct use of an acceptable method of birth control, as defined by the following: - Male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for that female subject - Implants of levonorgestrel - Injectable progestogen - Oral contraceptive (either combined estrogen/progestin or progestin only) - Any intrauterine device (IUD) with a documented failure rate of less than 1% per year. - Females of childbearing potential who are not sexually active must commit to complete abstinence from intercourse throughout the clinical trial and for a period after the trial to account for elimination of the drug (minimum of six days). - Double barrier method - spermicide plus a mechanical barrier (e.g., spermicide plus a male condom or a spermicide and female diaphragm). - NB: For German sites, female subjects must use a method of birth control other than the double barrier method. - The contraceptive transdermal patch, Ortho Evra (if the subject is less than 198 pounds) - Female subjects should not be enrolled if they are pregnant, lactating or plan to become pregnant during the time of study participation. A serum pregnancy test is required of all females. This test will be performed at the initial screening visit (Visit 1) and Visit 8. In addition, a urine pregnancy test will be performed on the evening of the double-blind treatment visit, prior to randomization (Visit 3) and at Visits 4 through 7. - Asthma Diagnosis: Asthma as defined by the National Institutes of Health [National Institutes of Health, 2007]. - Severity of Disease: A best FEV1 of 40%-85% of the predicted normal value during the morning Visit 1 screening period or a best FEV1 of 40%-90% of the predicted normal value during the evening Visit 1 screening period. - Reversibility of Disease: Demonstrated a ≥ 12% and ≥200mL reversibility of FEV1 within approximately 30-minutes following 4 inhalations of albuterol/salbutamol inhalation aerosol (spacers are permitted for reversibility testing if required) or one nebulized albuterol/salbutamol solution at the screening period. Re-screening of subjects during the Visit 1 screening period: If a subject does not meet the inclusion criteria based upon FEV1 percent predicted and/or reversibility, the subject may return to the site once within 4 days and repeat the lung function tests. - Current Anti-Asthma Therapy: Subjects must have been using a non-corticosteroid controller or short acting beta2-agonist bronchodilators alone (with no inhaled corticosteroids use for at least 6 weeks) for ≥ 3 months preceding Visit 1. - Short- Acting Beta2-Agonists: All subjects must be able to replace their current short-acting beta2-agonists with albuterol/salbutamol inhalation aerosol at Visit 1 for use as needed for the duration of the study. The use of spacer devices with metered dose inhaler (MDI) or nebulized albuterol/salbutamol will not be allowed during the study with the exception of their use during reversibility testing at Visit 1. Subjects must be able to withhold all inhaled short-acting beta sympathomimetic bronchodilators for at least 6 hours prior to all study visits. - Informed Consent: All subjects must be able and willing to give written informed consent to take part in the study. - Compliance: Subjects must be able to comply with completion of the Daily Diary (includes paper medical conditions diary). - French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category. Inclusion Criteria for Randomization At the end of the run-in period, a subject will be eligible to enter the treatment period of the study if he/she meets the following criteria at Visit 3: - Evening pre-dose percent predicted FEV1 of between 40% and 90% of their predicted normal. - Any combination of the daily asthma symptom scores (day-time plus night-time) of ≥1 or albuterol/salbutamol use on at least 4 of the last 7 consecutive days of the run-in period (immediately preceding Visit 3). Exclusion Criteria: - History of Life-threatening asthma: Defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest or hypoxic seizures. - Respiratory Infection: Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear that is not resolved within 4 weeks before Visit 1 and led to a change in asthma management, or in the opinion of the Investigator is expected to affect the subjects asthma status or the subjects ability to participate in the study. - Asthma Exacerbation: Any asthma exacerbation requiring oral corticosteroids within 3 months of Visit 1. A subject must not have had any hospitalization for asthma within 6 months prior to Visit 1. - Concurrent Diseases/Abnormalities: Historical or current evidence of clinically significant uncontrolled disease including, but not limited to: cardiovascular disease, hepatic disease, renal disease, hematological disease, neurological disease, or pulmonary disease (including, but not confined to chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis, bronchopulmonary dysplasia, and chronic obstructive pulmonary disease). Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study. The list of additional excluded conditions/diseases includes, but is not limited to the following: congestive heart failure, clinically significant coronary heart disease, stroke within 3 months of Visit 1, poorly controlled peptic ulcer, immunologic compromise, tuberculosis (current or untreated), Addison's disease, uncontrolled thyroid disorder, known aortic aneurysm, clinically significant cardiac arrhythmia, uncontrolled hypertension1, hematological, hepatic, or renal disease, current malignancy2, cushings disease, uncontrolled diabetes mellitus, recent history of drug or alcohol abuse. - systolic blood pressure ≥160, or diastolic blood pressure >100 - history of malignancy is acceptable only if subject has been in remission for one year prior to Visit 1 (remission = no current evidence of malignancy and no treatment for the malignancy in the 12 months prior to Visit 1) - Patients with a history of tuberculosis who have received an approved prophylactic treatment regimen or an approved active treatment regimen and who have had no evidence of active disease for a minimum of 2 years may be enrolled [American Thoracic Society, 2003; American Thoracic Society, 2005]" - Oropharyngeal Examination: A subject will not be eligible for the run-in if he/she has clinical visual evidence of oral candidiasis at Visit 1. - Investigational Medications: A subject must not have participated in a study or used any investigational drug within 30 days prior to Visit 1. - Drug Allergy: Any adverse reaction including immediate or delayed hypersensitivity to any beta2-agonist, sympathomimetic drug, or any intranasal, inhaled, or systemic corticosteroid therapy. Known or suspected sensitivity to the constituents of the novel dry powder inhaler or DISKUS/ACCUHALER (i.e., lactose or magnesium stearate). - Milk Protein Allergy: History of severe milk protein allergy. - Immunosuppressive Medications: A subject must not be using, or require use, of immunosuppressive medications during the study. NOTE: Immunotherapy for the treatment of allergies is allowed during the study provided that the treatment was initiated prior to Visit 1 and the subject is maintained on a stable regimen throughout the study period. - Attendance: A subject will not be eligible if he/she or his/her parent or legal guardian has any infirmity, disability, or geographical location which seems likely (in the opinion of the Investigator) to impair compliance with any aspect of this study protocol or scheduled visits to the study center and non-compliant with study medication or procedures (e.g. completion of daily diary). Neurological or psychiatric disease or history of drug or alcohol abuse which in the opinion of the investigator could interfere with the subject's proper completion of the protocol requirements excludes study participation. - Tobacco Use : Current smoker or a smoking history of 10 pack years or more (e.g. 20 cigarettes/day for 10 years). A subject may not have used tobacco products within the past one year (i.e., cigarettes, cigars, or pipe tobacco). - Affiliation with Investigator's Site: A subject will not be eligible for this study if he/she is an immediate family member of the participating Investigator, sub-Investigator, study coordinator, or employee of the participating Investigator. - Corticosteroid Use: Administration of systemic, oral or depot corticosteroids within 12 weeks of Visit 1. Administration of inhaled corticosteroids within 6 weeks of Visit 1. - Potent Cytochrome P450 3A4 (CYP3A4) inhibitors: Patients who are receiving potent CYP3A4 inhibitors within 4 weeks of Visit 1 (e.g., ritonavir, ketoconazole, itraconazole). Exclusion Criteria for Randomization At the end of the run-in period, a subject will not be eligible to enter the treatment period of the study if they meet any of the following criteria. - Clinical Laboratory Abnormalities: Clinically significant abnormal laboratory tests during Visit 1 which are still abnormal upon repeat analysis and are not believed to be due to disease(s) present. Each Investigator will use his/her own discretion in determining the clinical significance of the abnormality. When in doubt, GlaxoSmithKline, or designee, should be notified so that a joint decision can be made. - Changes in asthma medication (excluding albuterol/salbutamol inhalation aerosol provided at Visit 1). - Occurrence of an culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear during the run-in period that led to a change in asthma management, or in the opinion of the Investigator is expected to affect the subject's asthma status or the subject's ability to participate in the study. - Asthma exacerbation, defined as any worsening of asthma requiring any treatment other than rescue albuterol/salbutamol or regular inhaled corticosteroid use. This includes requiring the use of systemic corticosteroids and / or emergency room visit or hospitalization or a change in subject's regular inhaled corticosteroid dose. - A subject will not be eligible for randomization if he/she has an abnormal visual oropharyngeal exam at the randomization Visit 3 (visual clinical evidence of oral candidiasis). - Non-compliance with completion of the Daily Diary, defined as: - Completion of AM and PM symptom scores on less than 4 days out of the last 7 days immediately preceding Visit 3. - Completion of AM and PM rescue use on less than 4 days out of the last 7 days immediately preceding Visit 3. - Completion of AM and PM PEF measurements on less than 4 days out of the last 7 days immediately preceding Visit 3. - Recording run-in asthma medication use on less than 4 days out of the last 7 days immediately preceding Visit 3. | |
| 55 | NCT01145404 | terminated | changes of soc for third line therapy resulting in poor recruitment | 0 | phase 2 | ['gastroesophageal cancer'] | ["['K22.6', 'K21.9', 'K21.00', 'K21.01']"] | ['lapatinib', 'lapatinib plus capecitabine'] | ['CN(C1=CC2=NN(C)C(C)=C2C=C1)C1=CC=NC(NC2=CC=C(C)C(=C2)S(N)(=O)=O)=N1', 'CCCCCOC(=O)NC1=NC(=O)N(C=C1F)[C@@H]1O[C@H](C)[C@@H](O)[C@H]1O'] | Inclusion Criteria: - Histologically confirmed adenocarcinoma of the stomach, including adenocarcinoma of the gastroesophageal junction and esophagus - Metastatic disease - Measurable disease (according to RECIST criteria) - At least one prior chemotherapy for metastatic disease with progression during or no later than 6 months after last administration of chemotherapy. Chemotherapy must have contained a platinum compound (cisplatin or oxaliplatin) - Her2 overexpression measured by FISH (amplification or increased gene copy number). Immunohistochemistry (ICH) 3+ can be included in case of an uncertain FISH test. - Patient willing to allow for biomarker analyses on his tumor tissue. - Written informed consent given prior to any protocol specific procedures according to the local regulatory requirements - Age >= 18 years - Eastern Cooperative Oncology Group Performance Status (ECOG-PS) <= 2 - Life expectancy > 3 months - Adequate hematological, hepatic and renal function defined by: Hematology: Neutrophils >1.5x109/L; Platelets >100x109/L; Hemoglobin >8g/dL Hepatic function: Total bilirubin <=1.5xULN; ASAT (SGOT) and ALAT (SGPT) <= 2.5xULN; Alkaline phosphatase <5xULN. Renal function: The calculated creatinine clearance should be .60 mL/min - Eligibility of patients receiving medications or substances known to affect, or with the potential to affect the activity or pharmacokinetics of lapatinib will be determined following review of their use by the local Principal Investigator. A list of medications and substances known or with the potential to interact with CYP450 isoenzymes is provided in: Cytochrome P-450 Enzymes and Drug metabolism. In: Lacy CF, Armstrong LL, Goldman MP, Lance LL eds. Drug Information Handbook 8TH ed. Hudson, OH; LexiComp Inc. 2000: 1364-1371 - Able to swallow and retain oral medication - Negative pregnancy test (urine or serum) within 28 days prior to randomization for all women of childbearing potential (has to be verified within 7 days prior to randomization and during the study according the judgement of the investigator) - Willingness to perform double-barrier contraception during study and 6 months after end of treatment - Ability to understand and the willingness to sign a written informed consent document - Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. Exclusion Criteria: - Previous non curatively treated malignant disease other than the current gastroesophageal cancer with a disease-free survival of less than 5 years - History of significant neurological or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent - History of active Hepatitis B or C or history of an HIV infection - Active uncontrolled infection - Treatment within any other clinical trial parallel to the treatment phase of the current study within 30 days prior to randomisation. - Concurrent treatment with any other anti-cancer drug. Presence of other medication that may interfere with study treatment or the action of the investigational product or confuse the assessment of study results - History of allergic reactions attributed to compounds of similar chemical or biologic composition to lapatinib or to any excipients - History of allergic reactions attributed to compounds of similar chemical composition to capecitabine, fluorouracil or to any excipients - Known DPD deficiency - Concomitant requirement for medication classified as CYP3A4 inducers or inhibitors - Current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment) - Active cardiac disease, defined as: - History of uncontrolled or symptomatic angina - History of arrhythmias requiring medications, or clinically significant, with the exception of asymptomatic atrial fibrillation requiring anticoagulation - Myocardial infarction < 6 months from randomization - Uncontrolled or symptomatic congestive heart failure (> New York Heart Association score 2) - Ejection fraction below the institutional normal limit - Any other cardiac condition, which in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient - Pregnancy and lactation - History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product |
| 56 | NCT01160419 | unknown status | 1 | phase 2 | ['gastric cancer'] | ["['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']"] | ['docetaxel 50 mg/m2, 1-hour-infusion, day 1', 'oxaliplatin 85 mg/m², 2-hour-infusion, day 1', 'folinic acid 200 mg/m², 1-2-hour-infusion, day 1', '5-fu 2600 mg/m², 24-hour-infusion, day 1'] | ['[H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1', '[H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1'] | Inclusion Criteria: - Histologically Confirmed Adenocarcinoma of the Gastroesophageal Junction (AEG I-III) or Gastric Adenocarcinoma (every T, N+ or T3/T4, Nx, M0) - Written Informed Consent - Age ≥ 18 Years - Expected operability - ECOG ≤ 2 - Exclusion of Peritoneal Metastasis - Adequate Hematological, Renal, Cardiac and Hepatic Function - Effective Contraception Exclusion Criteria: - Prior Chemotherapy or Radiotherapy of the Adenocarcinoma of the Gastroesophageal Junction (AEG I-III) or Gastric Adenocarcinoma - Not Histologically Confirmed Primary Tumor - Distant Metastasis, Local Relapse - Known Hypersensitivity for 5-Fluorouracil, Leucovorin, Oxaliplatin or Docetaxel - Known Dihydropyrimidin-Dehydrogenase (DPD) - Deficiency - Peripheral Polyneuropathy ≥ Grade II (NCI-CTCAE, Version 3.0) - Myocardial Infarction in the last 3 Months, Cardiac Insufficiency Grade II-IV (NYHA) - Severe Comorbidity or Acute Infections - Pregnancy or Breast Feeding - Insufficient Contraception - Participation in another Clinical Trial (Simultaneously or 30 Days Prior to Enrollment) - Malignancy <5 years (except: Carcinoma In Situ of the Cervix Uteri or Adequately Treated Basalioma of the Skin) - Lack of Legal Capacity | |
| 57 | NCT00439634 | terminated | following a pre-specified interim analysis and data monitoring committee recommendation due to insufficient level of efficacy | 0 | phase 2 | ['schizophrenia'] | ["['F20.0', 'F20.1', 'F20.2', 'F20.3', 'F20.5', 'F20.89', 'F20.9']"] | ['ave1625', 'placebo'] | ['CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Outpatients with diagnosis of schizophrenia (diagnosed ≤ 35 years of age). - Current treatment consisting exclusively of olanzapine, risperidone/paliperidone, quetiapine or aripiprazole monotherapy for at least 2 months. Exclusion Criteria: - Inpatient hospitalization within past 3 months. - Residence at the current address < 3 months due to any instability in the disease. - Presence of depressive symptoms. - Past history of clinically significant violent behavior. - Substance dependence or abuse. - Pregnant or breast-feeding women or women not protected by effective contraceptive method of birth control. The investigator will evaluate whether there are other reasons why a patient may not participate. |
| 58 | NCT00115193 | completed | 0 | phase 2 | ["non-hodgkin's lymphoma"] | ["['S33.110S', 'S33.111S', 'S33.120S', 'S33.121S', 'S33.130S', 'S33.131S', 'S33.140S']"] | ['pegfilgrastim', 'pegfilgrastim'] | ['CN1[C@H]2CC[C@@H]1C[C@@H](C2)OC(=O)[C@H](CO)C1=CC=CC=C1', 'CN1[C@H]2CC[C@@H]1C[C@@H](C2)OC(=O)[C@H](CO)C1=CC=CC=C1'] | Inclusion Criteria: - Histologically proven mantle cell lymphoma or histologically proven diffuse large B-cell non-Hodgkin's lymphoma (NHL) according to the REAL classification - Measurable and/or evaluable disease - Previously untreated patients Exclusion Criteria: - Burkitt's or B-lymphoblastic lymphoma - Central nervous system (CNS) involvement - Active infection requiring treatment with systemic anti-infectives within 72 hours of chemotherapy - Prior malignancy within the last 5 years - T-cell lymphoma or history of indolent lymphoma - Prior bone marrow or stem cell transplantation - Known sensitivity to E. coli derived drug products | |
| 59 | NCT01259193 | unknown status | 1 | phase 2 | ['hepatocellular carcinoma'] | ["['C22.0', 'C4A.9', 'C7B.1', 'C4A.0', 'C4A.31', 'C4A.51', 'C4A.8']"] | ['sorafenib and zoledronic acid'] | ['CNC(=O)C1=NC=CC(OC2=CC=C(NC(=O)NC3=CC(=C(Cl)C=C3)C(F)(F)F)C=C2)=C1'] | Inclusion Criteria: - Age ≥ 18 years - Hepatocellular carcinoma confirmed with pathology or identified with radiological images with typical features - patient with unresectable primary hepatocellular carcinoma - Child-Pugh Class A or B, score ≤ 7 - ECOG score 0-2 - Expected survival time not less than 12 weeks - At least one tumor nodule with one uni-dimension of ≥ 1 cm - Peripheral platelet of or more than 50×10(9)/L - Peripheral hemoglobin of or more than 85g/L - Peripheral albumen of or more than 28g/L - Total bilirubin ≤3.0mg/dl - ALT and AST ≤ 5.0 x the upper limit of normal - Serum amylase ≤ 1.5x the upper limit of normal - Serum creatinine ≤ 1.5x upper limit of normal - PT-INR<2.3 or PT prolong no more than 4s of normal Exclusion Criteria: - Congestive heart failure > NYHA class 2 - History of active coronary disease( except myocardial infarction more than 6 months ago) - Receive anti-arrhythmia treatment(except β-receptor blocker,calcium channel blocker and digoxin) - uncontrollable hypertension - Active clinically serious infections (> 2 NCI-CTC Version 3.0) - History of HIV infection - Inclined to hemorrhage or active hemorrhage with 1 month - Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in this study - Pregnant or breast-feeding.Women of childbearing potential must have a negative pregnancy test performed within 7 days prior to enrolling in this portion of the study - Known or suspected allergy to any agent given in association with this trial - Concomitant anti-cancer therapy (except immunotherapy and Chinese traditional treatment) - Surgical operation within 4 weeks prior to enrolling in this portion of the study | |
| 60 | NCT01093222 | completed | 0 | phase 2 | ['extrahepatic bile duct adenocarcinoma', 'gallbladder adenocarcinoma', 'gallbladder adenocarcinoma with squamous metaplasia', 'hilar cholangiocarcinoma', 'recurrent extrahepatic bile duct carcinoma', 'recurrent gallbladder carcinoma', 'undifferentiated gallbladder carcinoma', 'unresectable extrahepatic bile duct carcinoma', 'unresectable gallbladder carcinoma'] | ["['C22.0', 'C22.1', 'C4A.9', 'C7B.1', 'D09.9', 'C4A.0', 'C4A.31']", "['C22.0', 'C22.1', 'C4A.9', 'C7B.1', 'D09.9', 'C4A.0', 'C4A.31']", "['C22.0', 'C22.1', 'C4A.9', 'C7B.1', 'D09.9', 'C4A.0', 'C4A.31']", "['C22.0', 'C22.1', 'C4A.9', 'C7B.1', 'D09.9', 'C4A.0', 'C4A.31']", "['C22.0', 'C22.1', 'C4A.9', 'C7B.1', 'D09.9', 'C4A.0', 'C4A.31']"] | ['erlotinib hydrochloride', 'sorafenib tosylate'] | ['COCCOC1=CC2=C(C=C1OCCOC)C(NC1=CC(=CC=C1)C#C)=NC=N2', 'CNC(=O)C1=NC=CC(OC2=CC=C(NC(=O)NC3=CC(=C(Cl)C=C3)C(F)(F)F)C=C2)=C1'] | Inclusion Criteria: - Cytologically or pathologically confirmed gallbladder carcinoma or cholangiocarcinoma - No ampullary carcinoma - Locally advanced unresectable or distant metastatic disease - Measurable disease - Patients with biliary obstruction must have decompression of the biliary tree by ERCP and stenting or percutaneous drainage - No prior systemic treatment for metastatic or unresectable locally advanced disease - No known brain metastases - Zubrod performance status of 0-1 - Leukocyte count ≥ 3,000/mm^3 - ANC ≥ 1,000/mm^3 - Platelet count ≥100,000/mm^3 - Total serum bilirubin ≤ 1.5 times upper limit of normal (ULN) - For patient who had decompression of the biliary tree within the past 14 days, stability of the bilirubin level needs to be confirmed with two measurements within 5 to 7 days of each other - Serum albumin ≥ 2.5 g/dL - AST and ALT ≤ 2.5 times ULN (≤ 5 times ULN for liver metastases) - Creatinine clearance ≥ 60 mL/min - Not pregnant or nursing - Fertile patients must agree to use effective contraception - No active biliary sepsis - No bleeding diathesis - No uncontrolled or clinically significant cardiovascular disease, including any of the following: - Myocardial infarction within the past 6 months - Uncontrolled angina within the past 6 months - NYHA class II-IV congestive heart failure - Grade 3 cardiac valve dysfunction - Cardiac arrhythmia not controlled by medication - History of stroke or transient ischemic attack within the past 6 months - History of arterial thrombotic event of any type in the past 6 months - No uncontrolled hypertension, as evidenced by systolic BP ≥ 150 mm Hg or diastolic BP ≥ 100 mm Hg, within the past 28 days - Must be able to swallow and tolerate oral medications - No gastrointestinal tract disease or prior abdominal surgery that results in an inability to absorb oral medication - No other prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free within the past 3 years - No concurrent grapefruit or its juice - At least 6 months since 1 adjuvant or neoadjuvant regimen of chemotherapy, hormonal therapy, immunotherapy, radiotherapy (to < 25% of bone marrow only), or chemoradiotherapy before documented recurrence or metastatic disease - No prior treatment with any antiangiogenic agent or any EGFR inhibitors for any reason - Concurrent multiple anti-hypertensive medications allowed - No plans to receive concurrent chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or any other therapy, including herbal or alternative medications for treatment of cancer | |
| 61 | NCT00458601 | completed | 1 | phase 2 | ['malignant glioma'] | ["['R18.0', 'C17.3', 'G21.0', 'J91.0', 'C05.2', 'C10.0', 'C16.0']"] | ['cdx-110 with gm-csf', 'temozolomide'] | ['CSCC[C@H](N)C(O)=O'] | Inclusion Criteria: - Newly diagnosed de novo GBM with documented EGFRvIII expression in tumor tissue. - Gross total resection followed by conventional chemoradiation therapy without progression of disease. Exclusion Criteria: - Presence of diffuse leptomeningeal disease or gliomatosis cerebri. - Systemic corticosteroid therapy > 2 mg of dexamethasone or equivalent (as defined by the investigator) per day at study enrollment. - Patients who have undergone stereotactic radiosurgery prior to or following surgical resection, or the placement of Gliadel® Wafers. - Known allergy or hypersensitivity to KLH, GM-CSF or yeast derived products, or a history of anaphylactic reactions to shellfish proteins. | |
| 62 | NCT00702585 | completed | 0 | phase 2 | ['infertility'] | ["['N46.8', 'N46.9', 'N97.9', 'N97.0', 'N97.1', 'N97.2', 'N97.8']"] | ['org 36286', 'placebo'] | ['CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Wish to conceive; - Oligomenorrhea (cycle length >=41 days) or amenorrhea (no menstrual cycle for >6 months); - Body Mass Index (BMI) >=18 and <=32 kg/m^2; - Serum FSH levels within normal limits (1-10 IU/L); - Normal serum prolactin and thyroid stimulating hormone (TSH) levels; - Progestagen induced withdrawal bleeding or spontaneous menstrual bleeding; Exclusion Criteria: - Tumours of the ovary, breast, uterus, pituitary or hypothalamus; - Pregnancy or lactation; - Undiagnosed vaginal bleeding; - Ovarian cysts or enlarged ovaries not related to polycystic ovarian disease (PCOD); - Any ovarian and/or abdominal abnormality interfering with ultrasound examination; - Malformations of the sexual organs incompatible with pregnancy; - Clomiphene resistance with documented anovulation (treated with 150 mg clomiphene for five days and no ovulation); - Treatment with metformin, gonadotropins, or GnRH analogs within 90 days prior to the start of Org 36286 treatment; - Treatment with clomiphene citrate within 42 days prior to the start of Org 36286 treatment; - Alcohol or drug abuse within the 12 months preceding signing of informed consent; - Any clinically relevant abnormal laboratory value; - Hypersensitivity to any of the substances in Org 36286; - Hypersensitivity to Orgalutran® or any of its components; - Use of any investigational drugs during 90 days before screening or previous participation in this trial. | |
| 63 | NCT01026428 | completed | 1 | phase 1/phase 2 | ["idiopathic parkinson's disease"] | ["['G20']"] | ['safinamide + levodopa'] | ['C[C@H](NCC1=CC=C(OCC2=CC(F)=CC=C2)C=C1)C(N)=O'] | Inclusion Criteria: 1. Gender: male or female 2. Age: 30 years 3. Body Mass Index (BMI): 18 - 32 kg/m2 4. Diagnosed with idiopathic Parkinson's disease, with Hoehn and Yahr (H&Y) of I-III 5. Levodopa-responsive patients treated with a stable dose of levodopa/carbidopa 6. Electrocardiogram recording (12 leads) normal or with abnormalities which are not hazardous to the patient according to the opinion of the investigator. 7. Negative beta-HCG test and not lactating (females). Women who are of childbearing potential must be using acceptable methods of contraception and should be informed of the potential risks associated with becoming pregnant while enrolled within a clinical research study. Accepted forms of contraception are: i.e. intrauterine device and a barrier method, combined oral contraceptives and a barrier method, or double-barrier method throughout the study. Female volunteers who are post -menopausal or surgically sterile may be enrolled 8. Ability to maintain an accurate and complete dosing diary, with the help of a caregiver, recording doses of levodopa and study medication taken at home All parameters will be determined within three weeks prior to first dosing. Subjects must have given written informed consent before any study-related activities are carried out Exclusion Criteria: To be eligible for inclusion in this study the subjects must not meet any of the following criteria: 1. Co-administration of other drugs causing dopamine release (e.g. reserpine) or affecting levodopa metabolism (e.g COMT inhibitors except AADC inhibitors) or any other medication clinically contraindicated with MAO B inhibitors or with levodopa/carbidopa Note: Use of Selective serotonin reuptake inhibitors [SSRI] and selective noradrenalin reuptake inhibitors [SNRI] will be permitted, provided the dose is kept as low as possible and remains stable throughout the trial. 2. Co-administration of other MAO inhibitors (e.g. selegiline, rasagiline) 3. The patient is in a late stage of Parkinson's disease, and is experiencing severe, disabling peak-dose or biphasic dyskinesia and/or unpredictable or widely swinging fluctuations in their symptoms 4. Any indication of forms of Parkinsonism, other than idiopathic Parkinson's disease. 5. Treatment with any agent known to inhibit or induce drug-metabolizing enzymes (e.g., barbiturates, St John's Wort etc.) within 4 weeks prior study treatment 6. Concomitant oral iron treatment 7. History of hypersensitivity or contraindications to MAO-B inhibitors or levodopa 8. Clinically relevant allergies (especially hypersensitivity toward any medicinal drugs) 9. Significant hepatic impairment 10. Significant renal impairment 11. Diseases or surgeries of the gastrointestinal tract which could influence the gastrointestinal absorption and/or motility 12. Diagnosis of Human Immunodeficiency Virus (HIV), or acute Hepatitis B or C 13. Clinically relevant disease which in the investigator's opinion would exclude the subject from the study, such as significant cardiovascular and lung diseases, narrow-angle glaucoma or endocrinological diseases such as hyperthyroidism or pheochromocytoma 14. A neoplastic disorder, which is either currently active or has been in remission for less than one year. 15. Active psychiatric disease (e.g, schizophrenia, psychotic depression) 16. History of melanoma or current cancer disease and undiagnosed, but melanoma suspicious skin lesion 17. Signs for dementia which could interfere with the compliance to the study as judged by the investigator 18. Ophthalmologic history including any of the following conditions: albino subjects, family history of hereditary retinal disease, progressive and/or severe diminution of visual acuity (i.e., 20/70), retinitis pigmentosa, retinal pigmentation due to any cause, any active retinopathy or ocular inflammation (uveitis), or diabetic retinopathy. 19. Consumption of important quantities of coffee or tea corresponding to more than 600 mg caffeine/day, or tobacco smoking (more than 10 cigarettes per day) 20. Diet considerably deviating from normal nutritional patterns (e.g. vegan; diets with very high protein content [Atkins]) 21. Participation in another clinical study within 30 days prior to the planned first drug administration 22. Alcohol and drug abuse (during the past three years) 23. Transfusion of blood or plasma derivatives within 3 month prior to the planned first drug administration 24. Blood donation within 90 days before the start of the clinical study 25. Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such. | |
| 64 | NCT00570765 | completed | 1 | phase 2 | ['liver cirrhosis, biliary'] | ["['Z52.6', 'K71.8', 'K71.7', 'A06.4', 'C22.0', 'C22.3', 'K70.0']"] | ['placebo', 'obeticholic acid (oca)'] | ['CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O', '[H][C@@](C)(CCC(O)=O)[C@@]1([H])CC[C@@]2([H])[C@]3([H])[C@]([H])(O)[C@]([H])(CC)[C@]4([H])C[C@]([H])(O)CC[C@]4(C)[C@@]3([H])CC[C@]12C'] | Inclusion Criteria: - Female participants must be postmenopausal, surgically sterile, or if premenopausal, be prepared to use 1 effective method of contraception with all sexual partners during the study and for 14 days after the end of dosing. - Male participants must be prepared to use 1 effective method of contraception with all sexual partners during the study during the study unless they had a prior vasectomy. - Proven or likely PBC, as demonstrated by the participant presenting with at least 2 of the following 3 diagnostic factors: - History of increased alkaline phosphatase (ALP) levels for at least 6 months; - Positive antimitochondrial antibody titer (>1:40 titer on immunofluorescence or M2 positive by enzyme-linked immunosorbent assay) or PBC-specific antinuclear antibodies (antinuclear dot and nuclear rim positive); - Liver biopsy consistent with PBC - Screening ALP level between 1.5 and 10 × upper limit of normal (ULN). Exclusion Criteria: - Administration of the following drugs at any time during the 3 months prior to screening for the study: ursodeoxycholic acid, colchicine, methotrexate, azathioprine, or systemic corticosteroids. - Screening conjugated (direct) bilirubin >2 × ULN. - Screening alanine aminotransferase or aspartate aminotransferase >5 × ULN. - Screening serum creatinine >133 micromoles/liter (1.5 mg/deciliter). History or presence of hepatic decompensation (for example, variceal bleeds, encephalopathy, or poorly controlled ascites). - History or presence of other concomitant liver diseases including hepatitis due to hepatitis B or C virus infection, primary sclerosing cholangitis, alcoholic liver disease, definite autoimmune liver disease or biopsy proven nonalcoholic steatohepatitis. - Pregnancy. | |
| 65 | NCT01393158 | completed | 1 | phase 2 | ['atopic dermatitis'] | ["['L20.89', 'L20.9']"] | ['apremilast'] | ['[H][C@](CS(C)(=O)=O)(N1C(=O)C2=C(C1=O)C(=CC=C2)N=C(C)O)C1=CC(OCC)=C(OC)C=C1'] | Inclusion Criteria: - Disease severity of Moderate, Severe, or Very Severe by Investigator Global Assessment. - Disease severity must be greater than or equal to 6 on the Rajka-Langeland Severity Scoring system corresponding to moderate-severe disease. - Baseline EASI score must be greater than or equal to 11. A previous validation study for the EASI scoring system revealed patients with moderate to very severe disease had mean EASI scores ranging from 11-30. - Candidate for, or previously on systemic therapy, including cyclosporine, methotrexate, or other immunosuppressant and treatment with ultraviolet light. Specifically, subjects are considered candidates for systemic therapy when their disease is not adequately controlled using topical therapies or side-effects prevent the further safe use of topical therapies. - Subjects must meet the washout requirements Exclusion Criteria: - History of active mycobacterial infection with any species (including Mycobacterium tuberculosis) within 3 years prior to screening visit. Subjects with Mycobacterium tuberculosis infection more than 3 years prior to screening visit are allowed if successful treatment was completed at least 3 years prior to randomization and is documented and available for verification. - At least 3 major bacterial infections resulting in hospitalization and/or requiring intravenous antibiotic treatment within the past 2 years. - Clinically significant abnormality on the chest X-ray (CXR) at screening. Chest X-rays performed within 3 months prior to start of study drug are acceptable. - Use of any investigational medication within 4 weeks prior to start of study drug or 5 pharmacokinetic/pharmacodynamic half-lives (whichever is longer). - Any clinically significant abnormality on 12-lead ECG (electrocardiogram) at screening. - History of congenital or acquired immunodeficiency (e.g., Common Variable Immunodeficiency [CVID]). - Hepatitis B surface antigen positive or Hepatitis B core antibody positive at screening. - History of Human Immunodeficiency Virus (HIV) infection. - Antibodies to Hepatitis C at screening. - History of squamous cell carcinoma of the skin and thin melanoma. - Systemic corticosteroid-dependent asthma. - Active infection of any type at the time of enrollment. | |
| 66 | NCT00073957 | completed | 1 | phase 2 | ['lymphoma'] | ["['S33.110S', 'S33.111S', 'S33.120S', 'S33.121S', 'S33.130S', 'S33.131S', 'S33.140S']"] | ['cytarabine', 'liposomal cytarabine'] | ['ClCCN(CCCl)P1(=O)NCCCO1', '[H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)C=C[C@]12C'] | DISEASE CHARACTERISTICS: - Histologically confirmed diffuse large B-cell non-Hodgkin's lymphoma, including any of the following: - B-cell diffuse large cell variant - Immunoblastic - Mediastinal (thymic) large cell - T-cell/histiocyte-rich - Anaplastic large B-cell - Intravascular large B-cell - Lymphomatoid granulomatosis - Relapsed or refractory disease after at least 1 prior chemotherapy regimen and requires further treatment - Relapsed disease, defined as the following: - Appearance of any new lesion OR increase of at least 50% in the size of a previously involved site - 50% increase in greatest diameter of any previously identified node greater than 1 cm in the short axis OR in the sum of the perpendicular diameter (SPD) of more than 1 node - Progressive disease, defined as the following: - 50% increase from nadir in the SPD of any previously identified abnormal node - Appearance of any new lesion during or at the end of therapy - CD20-positive disease by immunohistochemistry - Bidimensionally measurable disease - At least 1 lesion at least 2.0 cm by CT scan - Less than 25% bone marrow involvement by lymphoma - No transformed lymphoma from indolent to aggressive - No HIV- or AIDS-related lymphoma - No hypocellular bone marrow - No marked reduction in bone marrow precursors of 1 or more cell lines (e.g., granulocytic, megakaryocytic, or erythroid) - No CNS lymphoma - Ineligible for myeloablative therapy OR refused transplantation - Ineligible for any other open yttrium Y 90 ibritumomab tiuxetan investigational protocols PATIENT CHARACTERISTICS: Age - 18 and over Performance status - WHO 0-2 Life expectancy - At least 3 months Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Lymphocyte count no greater than 5,000/mm^3 (for patients with small lymphocytic lymphoma) - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin no greater than 2.0 mg/dL Renal - Creatinine no greater than 2.0 mg/dL Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 1 year after study participation - No concurrent serious nonmalignant disease or infection that would preclude study participation - No human antimurine antibody reactivity PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics - No prior autologous bone marrow transplantation - No prior peripheral blood stem cell rescue - No prior failed stem cell collection - Prior rituximab within the past 90 days allowed provided patient has fludeoxyglucose-avid disease that is also indium In 111 ibritumomab tiuxetan-avid disease in at least 1 lesion - More than 2 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF) Chemotherapy - See Disease Characteristics Endocrine therapy - Not specified Radiotherapy - No prior radioimmunotherapy - No prior external beam radiotherapy (involved field or regional) to more than 25% of active bone marrow Surgery - More than 4 weeks since prior major surgery (except diagnostic surgery) Other - Recovered from all prior therapy - More than 4 weeks since prior therapy for lymphoma - More than 8 weeks since prior phase II investigational drugs - No other concurrent antineoplastic therapy | |
| 67 | NCT00284154 | completed | 1 | phase 2 | ['carcinoma, small cell', 'lung cancer'] | ["['C78.00', 'C78.01', 'C78.02', 'D14.30', 'D14.31', 'D14.32', 'C34.2']"] | ['vinflunine'] | ['CC[C@@]12C=CCN3CC[C@@]4([C@H]13)[C@@H](N(C)C1=CC(OC)=C(C=C41)[C@]1(C[C@@H]3C[C@H](C[N@@](C3)CC3=C1NC1=CC=CC=C31)C(C)(F)F)C(=O)OC)[C@](O)([C@@H]2OC(C)=O)C(=O)OC'] | Inclusion Criteria: - Small cell lung cancer with progression after one previous chemotherapy or chemotherapy/radiation therapy regimen - Measurable or evaluable disease - Able to perform activities of daily living with minimal assistance - Adequate hematological, liver, and kidney function - Must give written informed consent prior to entry Exclusion Criteria: - CNS involvement - Serious active infection or underlying medical condition - Significant history of uncontrolled cardiac disease | |
| 68 | NCT00630786 | completed | 1 | phase 1/phase 2 | ['colon cancer', 'colorectal cancer', 'rectal cancer', 'metastatic colorectal cancer', 'oncology'] | ["['C18.2', 'C18.4', 'C18.6', 'C18.7', 'C18.9', 'D12.2', 'D12.3']", "['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']", "['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']", "['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']"] | ['panitumumab', 'conatumumab'] | ['NC1=NC(=O)N(C=C1)[C@@H]1O[C@H](CO)[C@@H](O)C1(F)F'] | Inclusion Criteria: - Histologically or cytologically confirmed metastatic adenocarcinoma of the colon or rectum - Radiographically documented disease progression per modified Response Evaluation Criteria in Solid Tumors (RECIST) during or following treatment with fluoropyrimidine, irinotecan, and/or oxaliplatin chemotherapy for Metastatic Colorectal Cancer. Progressive disease must be documented during or ≤ 6 months after the last dose of the most recent chemotherapy regimen prior to enrollment. - At least 1 uni-dimensionally measurable lesion measuring ≥ 20 mm in one dimension per modified RECIST. Lesion must not be chosen from a previously irradiated field, unless there has been documented disease progression in that field after irradiation and prior to enrollment. All sites of disease must be evaluated. - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Available archived paraffin-embedded tumor tissue from the primary tumor or metastasis for submission to the central laboratory - Man or woman ≥ 18 years of age at the time of enrollment - Hematologic function within the following limits: - Absolute neutrophil count (ANC) > 1.0 x 10^9 cells/L - Platelets ≥ 100 x 10^9/L - Renal function within the following limits: - Creatinine < 2.0 mg/dL - Hepatic function within the following limits: - Aspartate aminotransferase (AST) ≤ 2.5 x upper limit of normal (ULN) (≤ 5 x ULN if liver metastases) - Alanine aminotransferase (ALT) ≤ 2.5 x ULN (≤ 5 x ULN if liver metastases) - Bilirubin ≤ 2 x ULN - Metabolic function within the following limits: - Amylase ≤ 2 x ULN - Lipase ≤ 2 x ULN - Magnesium ≥ lower limit of normal - Negative pregnancy test ≤ 72 hours before enrollment (for woman of childbearing potential only) - Must have received 1, 2, or 3 prior chemotherapy regimens for Metastatic Colorectal Cancer - Competent to comprehend, sign, and date the independent ethics committee/institutional review board (IEC/IRB) approved written informed consent Exclusion Criteria: - History of other primary cancer, unless: - Curatively resected non-melanomatous skin cancer - Curatively treated cervical carcinoma in situ - Other primary solid tumor curatively treated with no known active disease present and no treatment administered for ≥ 5 years before enrollment - Prior treatment with anti-epidermal growth factor receptor (EGFr) inhibitors (eg, cetuximab, erlotinib, gefitinib), unless treatment was received in the adjuvant setting ≥ 6 months before enrollment - Use of systemic chemotherapy and radiotherapy ≤ 30 days before enrollment - Use of prior anti-tumor therapies with a short serum half-life (less than 1 week) including prior experimental agents or approved anti-tumor small molecules ≤ 30 days before enrollment - Use of anti-tumor therapies with a longer serum half-life (eg, bevacizumab) including prior experimental or approved protein/antibodies ≤ 42 days before enrollment - Any investigational agent or therapy ≤ 30 days before enrollment - Known allergy or hypersensitivity to any component of panitumumab and/or AMG 655 - History of or known presence of central nervous system (CNS) metastases - History of interstitial lung disease (eg, pneumonitis, pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest computerized tomography (CT) scan - Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrollment - Active inflammatory bowel disease or other active bowel disease causing chronic diarrhea (defined as ≥ Common Terminology Criteria for Adverse Events [CTCAE] grade 2 [CTCAE version 3.0]) - Known positive test for human immunodeficiency virus (HIV) infection, hepatitis C virus, acute or chronic hepatitis B infection - Any co-morbid disease or condition that could increase the risk of toxicity (eg, significant ascites, significant pleural effusion) - Any uncontrolled concurrent illness (eg, infection, bleeding) or history of any medical condition that may interfere with the interpretation of the study results - Major surgical procedure (requiring general anesthesia) ≤ 28 days or minor surgical procedure (excluding central venous catheter placement) ≤ 14 days before enrollment. Patients must have recovered from surgery related toxicities. - Other investigational procedures are excluded - Patient is currently pregnant or breast feeding - Man or woman of childbearing potential who is not willing to use adequate contraceptive precautions during treatment and for 6 months (for women) or 1 month (for men) after the last investigational product administration. Adequate contraceptive precautions includes double barrier contraceptive methods (eg, diaphragm and condom) or abstinence. - Previously enrolled into this study - Patient unwilling or unable to comply with study requirements | |
| 69 | NCT00068289 | completed | 0 | phase 2 | ['lung cancer'] | ["['C78.00', 'C78.01', 'C78.02', 'D14.30', 'D14.31', 'D14.32', 'C34.2']"] | ['bortezomib'] | ['ClCCN(CCCl)P1(=O)NCCCO1'] | DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed extensive stage small cell lung cancer - Diagnosis by sputum cytology allowed provided it is confirmed by an independent pathologic review - Clinical evidence of recurrent or refractory disease does not require a confirmatory biopsy - Measurable disease by plain radiographs, CT scan, or MRI - Prior radiotherapy to measurable disease allowed provided there is evidence of disease progression by CT scan OR there is measurable disease outside of the radiotherapy field - Must have received a prior platinum-based chemotherapy regimen and meet criteria for 1 of the following: - Platinum-sensitive disease, defined as an initial response with subsequent progression more than 90 days after last platinum treatment (temporarily closed to accrual as of 8/1/04) - Platinum-refractory disease, defined as no response to or progression during platinum treatment or subsequent progression no more than 90 days after last platinum treatment (temporarily closed to accrual as of 6/1/04) - Brain and/or leptomeningeal metastases are allowed provided all of the following are true: - Asymptomatic on neurological exam - No concurrent corticosteroids for symptom control - No concurrent enzyme-inducing anticonvulsants (e.g., phenytoin or phenobarbital) PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Zubrod 0-1 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Not specified Renal - Creatinine no greater than upper limit of normal OR - Creatinine clearance at least 60 mL/min Other - Not pregnant or nursing - Fertile patients must use effective contraception - No symptomatic sensory neuropathy greater than grade 1 - No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or any other adequately treated stage I or II cancer currently in complete remission PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - See Disease Characteristics - At least 3 weeks since prior chemotherapy Endocrine therapy - See Disease Characteristics Radiotherapy - See Disease Characteristics - At least 3 weeks since prior radiotherapy - No concurrent radiotherapy to measurable lesions Surgery - At least 14 days since prior thoracic or other major surgery and recovered - Must have disease outside of the prior surgical resection area OR new lesion must be present | |
| 70 | NCT00102895 | terminated | see detailed description | 0 | phase 2 | ['breast neoplasms', 'neoplasm metastasis'] | ["['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']", "['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']"] | ['cp-724,714'] | ['COCC(=O)NC\\C=C\\C1=CC=C2N=CN=C(NC3=CC=C(OC4=CC=C(C)N=C4)C(C)=C3)C2=C1'] | Inclusion Criteria: - Signed written and voluntary informed consent - Histologically or cytologically confirmed breast cancer - Stage IV (metastatic) breast cancer - Biopsy (fresh or archival) of primary breast cancer or metastatic site demonstrating HER2 gene amplification as determined in study-specified central laboratory by fluorescence in situ hybridization (FISH) - Prior treatment and progressive disease with at least 1 but not more than 2 cytotoxic chemotherapy regimen(s) for metastatic disease - Those for whom the use of an investigational HER2 inhibitor is appropriate because they do not have access to approved HER2 inhibitors (e.g., Herceptin®) or for whom treatment with currently available HER2 inhibitors is inappropriate - Limited visceral disease burden (i.e., <30% involvement of any organ) and limited disease-related symptoms (i.e., well controlled with supportive care measures) - Presence of at least one measurable target lesion [i.e., malignant tumor mass that can be accurately measured in at least 1 dimension of >=2 cm with conventional radiographic techniques or magnetic resonance imaging, or >=1 cm with spiral CT scan as per RECIST], excluding previously irradiated lesions, bone metastasis or pleural effusion as sole manifestations of disease. If the measurable disease is restricted to a solitary lesion, its neoplastic nature must be confirmed by cytology/histology - Eastern Cooperative Oncology Group (ECOG) performance status 0 1 - Patient available for treatment, monitoring, and follow-up. Willing and able to comply with scheduled visits, therapy plan, laboratory tests and blood sampling for pharmacokinetic (PK) analyses - Recovery to baseline or NCI CTCAE Version 3.0 Grade 1 toxicity from all acute effects related to prior treatment, except alopecia - Adequate Bone Marrow Function, including: a. Absolute neutrophil count (ANC) >=1500 cells/mm3; b. Platelets >=100,000 cells/mm3 - Adequate Renal Function, including: a. Estimated creatinine clearance >=60 mL/min; b. SrCr <1.5 x ULN - Adequate Liver Function, including: a. Bilirubin <=ULN (upper limit of normal); b. AST (SGOT) <=2.5 x ULN; c. ALT (SGPT) <=2.5 x ULN - Adequate Cardiac Function, including: a. 12-Lead electrocardiogram (ECG) with normal tracing or non clinically significant changes that do not require medical intervention; b. QTc interval <=450 msec and without history of Torsades des Pointes or other symptomatic QTc abnormality; c. Left ventricular ejection fraction (LVEF) >= institutional lower limit of normal and 45% as measured by echocardiogram or multi gated radionuclide angiography (MUGA) within 4 weeks prior to start of study treatment - >= 18 years old - Female Exclusion Criteria: - Women of child-bearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and up to 4 weeks after study - Women who are pregnant or breastfeeding - Women with a positive pregnancy test on enrollment or within 72 hours prior to study drug administration - Prior treatment with trastuzumab (Herceptin®) or other HER2-targeting agents [e.g., lapatinib (GW572016), pertuzumab (Omnitarg™; rhuMab 2C4), CI 1033, EKB 569, CP 724,714] - Cumulative dose >450 mg/m2 of doxorubicin or doxorubicin equivalents - Prior high-dose chemotherapy requiring hematopoetic stem cell transplantation within 12 months of study treatment start - Radiotherapy, investigational chemotherapy, biologic therapy within 4 weeks of study treatment start - Previous (within the last 5 years) or current malignancies arising from sites other than breast, except for adequately treated basal cell or squamous cell skin cancer or in situ carcinoma of the cervix uteri - Known or clinically suspected brain metastasis or leptomeningeal disease (no screening CT scan required) requiring therapy. Patients with asymptomatic previously treated CNS metastases that no longer require therapy or corticosteroids/anticonvulsants for at least 4 weeks prior to start of study treatment are eligible - Any clinically significant gastrointestinal abnormalities, which may impair intake, transit or absorption of the study drug, such as the inability to take oral medication in tablet form, prior complete/partial gastrectomy or intestinal resection, or a requirement for H2 antagonists or proton pump inhibitors - Any mental disorder that would limit the understanding or rendering of informed consent and/or compromise compliance with the requirements of this protocol - Uncontrolled or significant cardiovascular disease, including: a. Myocardial infarction within 12 months; b. Uncontrolled angina within 6 months; c. Congestive heart failure within 6 months or left ventricular ejection fraction below local institutional lower limit of normal or below 45%; d. Diagnosed or suspected congenital long QT syndrome; e. Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or torsade de pointes); f. Prolonged QTc interval on pre-entry electrocardiogram (>450 msec); g. Any history of second or third degree heart block (may be eligible if currently have a pacemaker); h. Heart rate <50/minute on pre-entry electrocardiogram; i. Uncontrolled hypertension - History of drug-induced hyperbilirubinemia - Concurrent treatment with approved or investigational chemotherapy, hormonal therapy, immunotherapy, or radiotherapy (hormone replacement therapy is permitted) - Concurrent treatment with H2 antagonists and/or proton pump inhibitors. However, H2 antagonists can be used for the treatment of an unexpected hypersensitivity reaction during the study period. Antacids are allowed but only up to 2 hours before and 2 hours after study drug administration - Concurrent treatment or treatment within 4 weeks of first dose with potent and/or irreversible CYP3A4 inhibitors including: ketoconazole, itraconazole, troleandomycin, clarithromycin, erythromycin, ritonavir, indinavir, nelfinavir, saquinavir, nefazodone, mibefradil, amiodarone and grapefruit juice - Concurrent treatment or treatment within 4 weeks of first dose with potent inducers of CYP3A4 including: rifampin, rifabutin, rifamycins, phenytoin, barbiturates, carbamazepine, glucocorticoids, modafinil, phenobarbital, troglitazone, pioglitazone, efavirenz, nevirapine, dexamethasone, and St. John's wort - Prisoners or patients who are compulsorily detained or involuntarily incarcerated (e.g., for treatment of infectious disease, psychiatric illness, etc.) |
| 71 | NCT00079261 | completed | 0 | phase 2 | ['lymphoma', 'small intestine cancer'] | ["['S33.110S', 'S33.111S', 'S33.120S', 'S33.121S', 'S33.130S', 'S33.131S', 'S33.140S']", "['C17.9', 'C78.4', 'D37.2', 'C17.8', 'D13.30', 'D13.39', 'Z12.13']"] | ['chop regimen', 'cyclophosphamide', 'doxorubicin hydrochloride', 'gemcitabine hydrochloride', 'prednisone', 'vincristine sulfate'] | ['CCO', 'ClCCN(CCCl)P1(=O)NCCCO1', 'COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O', 'NC1=NC(=O)N(C=C1)[C@@H]1O[C@H](CO)[C@@H](O)C1(F)F', '[H][C@@]12CC=C(C3=CC=CN=C3)[C@@]1(C)CC[C@@]1([H])[C@@]2([H])CC=C2C[C@@H](O)CC[C@]12C', 'CC[C@]1(O)C[C@@H]2CN(C1)CCC1=C(NC3=CC=CC=C13)[C@@](C2)(C(=O)OC)C1=C(OC)C=C2N(C=O)[C@@H]3[C@]4(CCN5CC=C[C@](CC)([C@@H]45)[C@@H](OC(C)=O)[C@]3(O)C(=O)OC)C2=C1'] | DISEASE CHARACTERISTICS: - Histologically confirmed aggressive non-Hodgkin's lymphoma (NHL) of 1 of the following WHO subtypes: - Diffuse large B large cell lymphoma (including all clinical and morphologic variants) - Grade 3 follicular lymphoma - Extranodal T/NK cell lymphoma, nasal type - Enteropathy-type T cell lymphoma - Hepato-splenic T cell lymphoma - Peripheral T cell lymphoma, unspecified - Angioimmunoblastic lymphoma - Anaplastic large cell lymphoma, systemic type - Stage II-IV disease - At least 1 site of measurable disease (e.g., lymph node or lymph node mass) - The following subtypes are not allowed: - Mantle cell lymphoma - Burkitt's lymphoma - Precursor B or T cell lymphoma - Primary cutaneous B or T cell lymphoma - No CNS involvement by lymphoma PATIENT CHARACTERISTICS: Age - 18 to 70 Performance status - Not specified Life expectancy - Not specified Hematopoietic - WBC > 3,000/mm^3 - Neutrophil count > 1,000/mm^3 - Platelet count > 100,000/mm^3 Hepatic - Bilirubin < 2.5 times normal (unless due to lymphoma) - ALT and AST < 2.5 times normal (unless due to lymphoma) Renal - Creatinine < 2.0 mg/dL Cardiovascular - No severe cardiac disease that would preclude study participation or limit life expectancy Pulmonary - FEV_1 and DLCO ≥ 75% of predicted (unless due to lymphoma) - No severe pulmonary disease that would preclude study participation or limit life expectancy Other - Not pregnant or nursing - Fertile patients must use effective contraception - HIV negative - No other prior or concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix - No severe neurologic or metabolic disease that would preclude study participation or limit life expectancy - No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent monoclonal antibodies Chemotherapy - No other concurrent chemotherapy Endocrine therapy - Not specified Radiotherapy - No prior radiotherapy - No concurrent radiotherapy Surgery - Not specified Other - No prior cytotoxic agents - No prior treatment for NHL - No other concurrent anticancer therapy - No other concurrent investigational drugs | |
| 72 | NCT00405938 | completed | 1 | phase 2 | ['breast cancer', 'breast neoplasms'] | ["['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']", "['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']"] | ['bevacizumab', 'anastrozole', 'fulvestrant'] | ['[H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1', 'CC(C)(C#N)C1=CC(=CC(CN2C=NC=N2)=C1)C(C)(C)C#N', '[H][C@@]12CC[C@H](O)[C@@]1(C)CC[C@]1([H])C3=CC=C(O)C=C3C[C@@H](CCCCCCCCCS(=O)CCCC(F)(F)C(F)(F)F)[C@@]21[H]'] | Inclusion Criteria: - Postmenopausal breast cancer (adenocarcinoma) estrogen (ER)and/or progesterone (PR) receptor positive that is locally advanced or locally recurrent and not able to be surgically removed OR with measurable and/or disease that is able to be assessed including isolated bone metastasis - Female patients 18 years or older - Documentation of ER+ and/or PR+ - No prior chemotherapy or hormone therapy for metastatic breast cancer or inoperable breast cancer that is locally recurrent or locally advanced - Measurable or evaluable disease - Radiation therapy to painful bone lesions or impending fractures is allowed as long as there is measurable or evaluable disease outside the radiated area. - Must have adequate bone marrow, renal and liver function - Patients receiving prior treatment with an anthracycline based chemotherapy must have a normal left ventricle ejection fraction Exclusion Criteria: - No metastatic disease to the Central Nervous System - No history of myocardial infarction (MI), stroke or transient ischemic attacks in the last 6 months - No symptoms of peripheral vascular disease - No history of abdominal fistula, gastrointestinal perforation or intrabdominal abscess in the past 6 months - No known hypersensitivity to phosphate, trehalose or polysorbate - No serious non-healing wound, ulcer or bone fracture - No uncontrolled high blood pressure or history of hypertensive crisis - No New York Hear Association class II congestive heart failure - No extensive cancer involvement of the liver or lungs - No history of significant psychiatric disorders - No significant vascular disease There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have. You can then decide if you wish to participate. | |
| 73 | NCT00112437 | completed | 1 | phase 2 | ['osteoporosis'] | ["['M81.6', 'Z82.62', 'Z13.820', 'M81.8', 'Z87.310', 'M81.0', 'M80.80XS']"] | ['odanacatib', 'odanacatib', 'odanacatib', 'odanacatib', 'placebo'] | ['CC(C)(F)C[C@H](N[C@@H](C1=CC=C(C=C1)C1=CC=C(C=C1)S(C)(=O)=O)C(F)(F)F)C(=O)NC1(CC1)C#N', 'CC(C)(F)C[C@H](N[C@@H](C1=CC=C(C=C1)C1=CC=C(C=C1)S(C)(=O)=O)C(F)(F)F)C(=O)NC1(CC1)C#N', 'CC(C)(F)C[C@H](N[C@@H](C1=CC=C(C=C1)C1=CC=C(C=C1)S(C)(=O)=O)C(F)(F)F)C(=O)NC1(CC1)C#N', 'CC(C)(F)C[C@H](N[C@@H](C1=CC=C(C=C1)C1=CC=C(C=C1)S(C)(=O)=O)C(F)(F)F)C(=O)NC1(CC1)C#N', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Postmenopausal for 5 or more years, defined as no menses for at least 5 years OR at least 5 years status post bilateral oophorectomy - Bone mineral density T-score at the hip or spine of -2.0 or less - Spinal anatomy suitable for dual-energy x-ray absorptiometry (DXA). At the lumbar spine, there is no evidence of vertebral fracture in at least 3 vertebrae in the L1 to L4 region on baseline spine films. (Significant scoliosis, bony trauma, degenerative joint disease, and sequelae of orthopedic procedures that result in anatomy that is unsuitable for accurate bone densitometry must be absent from the lumbar spine.) - At least one hip must be evaluable by DXA (e.g., contain no hardware from orthopedic procedures) - In a state of general health allowing for successful completion of the trial - Agreement to not use any medications to treat osteoporosis during the study Exclusion Criteria: - History of prior osteoporotic fracture (unless declined treatment with or was ineligible for osteoporosis therapy) - Past treatment with osteoporosis medications, steroids, hormone replacement, as well as various other medications that affect bone may be exclusionary. (Different exclusion criteria apply to each bone active drug. For example, any prior use of intravenous (IV) bisphosphonates is not permitted. By contrast, prior use of hormone replacement for several years is permitted if it has not occurred within the past 6 months. Please ask the study doctor for details) - Significant clinical or laboratory abnormalities at the screening visit for the study that, in the opinion of the investigator, could complicate interpretation of the study results or pose additional risk to the patient (for example, patients who are non-ambulatory should be excluded for this reason) | |
| 74 | NCT01375049 | completed | 1 | phase 2 | ['cystic fibrosis'] | ["['E84.9', 'Z14.1', 'E84.0', 'E84.11', 'E84.8', 'E84.19', 'P09.4']"] | ['aztreonam for inhalation solution (azli)'] | ['C[C@H]1[C@H](NC(=O)C(=N/OC(C)(C)C(=O)O)\\C2=CSC([NH3+])=N2)C(=O)N1S([O-])(=O)=O'] | Inclusion Criteria: - Males or females age 3 months to less than 18 years - Diagnosis of CF as determined by the 1997 CF Consensus Conference criteria: - Documented sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis test OR - Abnormal nasal transepithelial potential difference test OR - Two well-characterized, disease-causing genetic mutations in the CF transmembrane conductance regulator (CFTR) gene AND - One or more clinical features consistent with CF - Documented new onset of positive lower respiratory tract culture (e.g., throat swab, sputum, or BAL) for PA within 30 days of study entry (prior to screening visit) defined as either first lifetime documented PA-positive culture OR PA recovered after at least a 2 year history of PA-negative respiratory cultures (at least 2 cultures per year) - Forced expiratory volume in 1 second (FEV1) ≥ 80% predicted at screening visit (subjects ≥ 6 years of age) - Clinically stable with no evidence of significant respiratory symptoms or, if obtained for clinical evaluation, no chest radiograph findings at screening that would have required administration of IV antipseudomonal antibiotics, oxygen supplementation, or hospitalization. - All sexually active females who were of childbearing potential must agree to use a highly effective method of contraception during heterosexual intercourse throughout the study. Females utilizing hormonal contraceptives as a birth control method must have used the same method for at least 3 months prior to study drug dosing. - Males must agree to use barrier contraception (condom with spermicide) during heterosexual intercourse from screening through to study completion and for 90 days from the last dose of study investigational medicinal product - Participants and/or parent/guardian must be able to give written informed consent prior to any study related procedure Exclusion Criteria: - Use of IV or inhaled antipseudomonal antibiotics within 2 years of study entry (screening visit) - Use of oral antipseudomonal antibiotics within 30 days of study entry (screening visit) - History of sputum or throat swab culture yielding Burkholderia spp. within 2 years prior to screening visit - History of local or systemic hypersensitivity to monobactam antibiotics - History of intolerance to inhaled short acting beta 2 agonists - History of lung transplantation - History of AZLI (or Cayston®) administration - Administration of any investigational drug or device within 28 days prior to screening visit or within 6 half-lives of the investigational drug (whichever is longer) - Current use of oral corticosteroids in doses exceeding the equivalent of 10 mg prednisone per day or 20 mg prednisone every other day - Current requirement for daily continuous oxygen supplementation or requirement of more than 2 L/minute at night - Hospitalization for pulmonary-related illness within 28 days prior to screening visit - Changes in or initiation of chronic azithromycin treatment within 28 days prior to screening visit - Changes in antimicrobial, bronchodilator (BD), corticosteroid, dornase alfa, or hypertonic saline medications within 7 days prior to screening visit; for participants on a stable regimen of hypertonic saline (28 days on/28 days off), beginning or ending a cycle of hypertonic saline is allowed - Changes in physiotherapy technique or schedule within 7 days prior to screening visit - Abnormal renal or hepatic function results at most recent test within the previous 12 months, defined as: - Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 5 times upper limit of normal (ULN), or - Serum creatinine > 2 times ULN for age - Pregnant or lactating females; a negative urine pregnancy test is required for all females of childbearing potential (unless surgically sterile), and confirmatory serum pregnancy test in the event of an initial positive urine test result - Any serious or active medical or psychiatric illness (including drug or alcohol abuse), which in the opinion of the investigator, would interfere with treatment, assessment, or compliance with the protocol - Presence of a condition or abnormality that would compromise the patient's safety or the quality of study data, in the opinion of the investigator | |
| 75 | NCT00259857 | completed | 1 | phase 2 | ['osteoporosis'] | ["['M81.6', 'Z82.62', 'Z13.820', 'M81.8', 'Z87.310', 'M81.0', 'M80.80XS']"] | ['alendronate'] | ['COC1=CC2=C(C=C1)C=C(C=C2)[C@H](C)C(O)=O'] | Eligibility Criteria: - 5-15 yrs of age - Weighing 20 kg and more - History of multiple fractures - Tanner stage II or less - Osteoporosis by DXA. Inclusion Criteria: - Male and female children with a history of one or more atraumatic fractures, or evidence of one or more compression fractures on radiographs of the spine (reduction of >20 percent). - Bone Mineral Density (BMD) determined by DXA sacn to confirm osteoporosis at a Z score greater than 2 SD (standard deviations) below the normal mean for age (Z score < -2 SD). - Parental consent (and patient assent after age 12 years) to participate in the study. - Sexual development at: Tanner stage II or less (Prepubertal stage). - Weight = 20 kg and more. Exclusion Criteria: - History of severe gastritis or reflux. - Abnormalities of the esophagus that delay emptying, such as strictures or achalasia - Marked kyphoscoliosis or the inability to sit or stand for at least 30 minutes - Hypersensitivity to bisphosphonates - Uncorrected hypocalcemia - History of gastric or duodenal ulcers - Renal dysfunction as indicated by serum Cr >1.5 mg/dl. - Liver dysfunction as indicated by serum SGPT > 2 times the upper limit for age or serum total bilirubin > 2.0 mg/dl. - Diagnosis of osteogenesis imperfecta, a family history of osteogenesis imperfecta, blue sclerae or deafness. - Diagnosis of active rickets or osteomalacia or serum bone alkaline phosphatase 2 times greater than normal for age. - Pregnancy - Anorexia Nervosa | |
| 76 | NCT01103050 | completed | 1 | phase 2 | ['allergic rhinitis'] | ["['J30.89', 'J30.9', 'J30.2', 'J30.1', 'J30.5', 'J30.81']"] | ['qav680 + cetirizine placebo', 'qav680 + cetirizine', 'cetirizine + qav680 placebo', 'qav680 placebo + cetirizine placebo'] | ['OC(=O)COCCN1CCN(CC1)C(C1=CC=CC=C1)C1=CC=C(Cl)C=C1', 'OC(=O)COCCN1CCN(CC1)C(C1=CC=CC=C1)C1=CC=C(Cl)C=C1', 'OC(=O)COCCN1CCN(CC1)C(C1=CC=CC=C1)C1=CC=C(Cl)C=C1', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Patients with clinical history of intermittent allergic rhinitis with seasonal onset and offset of nasal allergy symptoms during each of the last two ragweed allergy seasons - positive skin prick test to ragweed allergen within twelve months of screening Exclusion criteria: - Use of any medication used to treat allergy (administered via any route), such as: pseudoephedrine, antihistamines, ipratropium bromide, cromoglycates, corticosteroids, immunotherapy or other antiinflammatory or immunosuppressive agents, or any other medication administered via the nasal or ocular routes) - Within the last three years a recurrent history of acute or chronic bronchospastic disease including moderate-severe asthma or chronic obstructive pulmonary disease - Nasal conditions such as nasal septal perforations,nasal polyps, sinus disease, chronic nasal obstruction Other protocol-defined inclusion/exclusion criteria may apply | |
| 77 | NCT00304135 | completed | 0 | phase 2/phase 3 | ['extrahepatic bile duct cancer', 'gallbladder cancer', 'liver cancer'] | ["['C24.0', 'D13.5']", "['C23', 'D37.6']", "['D13.4', 'Z85.05', 'C22.8', 'C78.7', 'C22.9', 'D37.6']"] | ['cisplatin', 'gemcitabine hydrochloride', 'oxaliplatin'] | ['[H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC', 'NC1=NC(=O)N(C=C1)[C@@H]1O[C@H](CO)[C@@H](O)C1(F)F', '[H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1'] | DISEASE CHARACTERISTICS: - Diagnosis of cancer of the biliary tract by 1 of the following methods: - Histologic confirmation - Stenosis of the biliary tract by MRI, CT scan, or ECHO - Unresectable disease - Amenable to radiotherapy - No visceral metastases by imaging - Hepatic adenopathies that can be included in a radiation field allowed - No known ampulla of Vater or pancreatic cancer involving the biliary tract PATIENT CHARACTERISTICS: - WHO performance status 0-2 - Creatinine < 1.5 mg/dL - Absolute neutrophil count ≥ 1,500/mm^3 - Platelet count ≥ 75,000/mm^3 - Prothrombin time > 70% - Bilirubin ≤ 2.9 mg/dL (after hepatic draining, if needed) - No unstable angina - No symptomatic cardiac insufficiency - No other comorbidity that would preclude study therapy - No other prior malignancy except basal cell skin cancer or carcinoma in situ of the cervix - No prior hydatid cyst or alveolar echinococciasis - Not pregnant or nursing PRIOR CONCURRENT THERAPY: - No recent biliary surgery - No hepatic intra-arterial chemotherapy - No prior anticancer therapy | |
| 78 | NCT00494442 | completed | 1 | phase 2 | ['ovarian neoplasm'] | ["['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']"] | ['ku-0059436 (azd2281)(parp inhibitor)', 'ku-0059436 (azd2281)(parp inhibitor)'] | ['OC1=NN=C(CC2=CC(C(=O)N3CCN(CC3)C(=O)C3CC3)=C(F)C=C2)C2=CC=CC=C12', 'OC1=NN=C(CC2=CC(C(=O)N3CCN(CC3)C(=O)C3CC3)=C(F)C=C2)C2=CC=CC=C12'] | Inclusion Criteria: - Advanced ovarian cancer with positive BRCA1 or BRCA2 status - Failed at least one prior chemotherapy - In investigators opinion, no curative standard therapy exists - Measurable disease Exclusion Criteria: - Brain metastases - Less than 28 days since last treatment used to treat the disease - Considered a poor medical risk due to a serious uncontrolled disorder | |
| 79 | NCT00429793 | completed | 0 | phase 2 | ['fallopian tube cancer', 'primary peritoneal cavity cancer', 'recurrent ovarian epithelial cancer'] | ["['C57.00', 'C57.01', 'C57.02']", "['C30.0', 'Z12.81', 'D14.0', 'C14.8', 'D37.09', 'Z86.003', 'Z85.818']", "['H18.523', 'H18.521', 'H18.522', 'H18.529']"] | ['temsirolimus'] | ['CN1N=NC2=C(N=CN2C1=O)C(N)=O'] | Inclusion Criteria: - Histologically confirmed ovarian epithelial, fallopian tube or primary peritoneal cavity cancer - Recurrent or refractory - Prior treatment with ≥ 1 platinum-based chemotherapeutic regimen for management of primary disease (containing carboplatin, cisplatin, or another organoplatinum compound) required - Initial treatment may have included any of the following: - High-dose therapy - Intraperitoneal therapy - Consolidation therapy - Noncytotoxic agents - Extended therapy administered after surgical or nonsurgical assessment - Patients must meet ≥ 1 of the following criteria: - Treatment-free interval after platinum therapy of < 12 months for patients who received only 1 platinum-based regimen - Progressed during platinum-based therapy - Refractory disease after a platinum-based regimen - Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan - Must have ≥ 1 target lesion - Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained ≥ 90 days after completion of radiotherapy - Not eligible for a higher priority GOG protocol, if one exists - GOG performance status (PS) 0-2 for patients who have receive one prior regimen OR GOG PS 0-1 for patients who have received 2-3 prior regimens - Absolute neutrophil count ≥ 1,500/mm³ - Platelet count ≥ 100,000/mm³ - Creatinine ≤ 1.5 times upper limit normal (ULN) - Bilirubin ≤ 1.5 times ULN - AST ≤ 2.5 times ULN - Alkaline phosphatase ≤ 2.5 times ULN - No neuropathy (sensory and motor) > grade 2 - Fasting cholesterol < 350 mg/dL - Fasting triglycerides < 400 mg/dL - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No active infection requiring antibiotics (with the exception of uncomplicated UTI) - No other invasive malignancies within the past 5 years, except for non-melanoma skin cancer, breast cancer, or head and neck cancer - See Disease Characteristics - Recovered from prior surgery, radiotherapy, or chemotherapy - At least 1 week since prior hormonal therapy directed at the malignant tumor - At least 3 years since prior radiotherapy for localized cancer of the breast, head and neck, or skin - Patient must remain free of recurrent or metastatic disease - At least 3 years since prior adjuvant chemotherapy for localized breast cancer - Patient must remain free of recurrent or metastatic disease - At least 3 weeks since other prior therapy directed at the malignant tumor, including immunologic agents - No prior temsirolimus - No prior cancer treatment that would preclude study therapy - No prior radiotherapy to > 25% of marrow-bearing areas - No prior radiotherapy to any portion of the abdominal cavity or pelvis, except for the treatment of ovarian cancer - No prior non-cytotoxic therapy for management of recurrent or persistent ovarian disease, except for therapy that was part of the primary treatment regimen - Two additional cytotoxic regimens (defined as any agent that targets the genetic and/or mitotic apparatus of dividing cells, resulting in dose-limiting toxicity to the bone marrow and/or gastrointestinal mucosa) for management of recurrent or persistent ovarian disease allowed - Concurrent low molecular weight heparin allowed provided PT/INR ≤ 1.5 - Concurrent hormone replacement therapy allowed - No concurrent amifostine or other protective reagents - No concurrent prophylactic filgrastim (G-CSF) | |
| 80 | NCT00541008 | completed | 1 | phase 2 | ['kidney cancer'] | ["['D17.71', 'D30.00', 'D30.01', 'D30.02', 'D41.00', 'D41.01', 'D41.02']"] | ['sunitinib malate'] | ['CCN(CC)CCNC(=O)C1=C(C)NC(\\C=C2/C(=O)NC3=C2C=C(F)C=C3)=C1C'] | DISEASE CHARACTERISTICS: Inclusion criteria: - Diagnosis of papillary renal cell carcinoma - Locally advanced or metastatic disease - Type I or type II disease - Progressive disease - Measurable disease defined by RECIST criteria as at least 1 lesion at least 2 cm in length by conventional CT scan techniques or at least 1 cm by spiral CT scan - No brain metastases including treated and nonprogressive metastases PATIENT CHARACTERISTICS: Inclusion criteria: - ECOG performance status 0-1 - Life expectancy ≥ 3 months - Absolute neutrophil count ≥ 1,500/mm³ - Platelet count ≥ 100,000/mm³ - Hemoglobin ≥ 8 g/dL - Total bilirubin ≤ 3 mg/dL - AST and ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present) - Serum creatinine < 1.5 times ULN - INR ≤ 1.7 or PT ≤ 6 seconds over ULN - Not pregnant or nursing - Fertile patients must use effective contraception - Patients must be affiliated to a Social Security System - Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures Exclusion criteria: - NCI CTC grade 3 hemorrhage within 4 weeks prior to start of study treatment - Diagnosis of any second malignancy within the past 3 years except for basal cell carcinoma, squamous cell skin cancer, or in situ carcinoma of the cervix that has been adequately treated with no evidence of recurrent disease within the past 12 months - Spinal cord compression, carcinomatous meningitis, or leptomeningeal disease - Any of the following within the past 12 months prior to study drug administration: - Severe/unstable angina - Myocardial infarction - Coronary artery bypass graft - Symptomatic congestive heart failure - Cerebrovascular accident including transient ischemic attack - Pulmonary embolism - Any of the following conditions: - Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥ 2 - Atrial fibrillation of any grade - Prolongation of the QTc interval to > 450 msec for males or > 470 msec for females - Hypertension that cannot be controlled by medications - Inability to swallow oral medications or presence of active inflammatory bowel disease, partial or complete bowel obstruction, or chronic diarrhea - Known HIV or AIDS infection - Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration - Psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and the follow-up schedule - Patients deprived of liberty or placed under the authority of a tutor PRIOR CONCURRENT THERAPY: - Recovered from all toxic effects of any prior local treatment to CTCAE version 3.0 grade ≤ 1 - At least 4 weeks since prior radiotherapy - At least 1 week since prior radiotherapy to < 10% of the whole body allowed provided side effects are < grade 2 and there is at least one site for evaluation - More than 2 weeks since prior and no concurrent anticoagulant agents or therapeutic doses of warfarin - Low-dose warfarin (up to 2 mg/day) for deep vein thrombosis prophylaxis allowed - Low molecular weight heparin allowed - No prior specific medical systemic therapy (i.e., first-line therapy) - No prior sunitinib malate - No prior investigational agents - No concurrent treatment on another therapeutic clinical trial | |
| 81 | NCT00215748 | terminated | slow accrual | 0 | phase 2 | ['breast cancer', 'lung cancer'] | ["['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']", "['C78.00', 'C78.01', 'C78.02', 'D14.30', 'D14.31', 'D14.32', 'C34.2']"] | ['dexamethasone'] | ['C[C@@H](O[C@H]1OCCN(CC2=NNC(=O)N2)[C@H]1C1=CC=C(F)C=C1)C1=CC(=CC(=C1)C(F)(F)F)C(F)(F)F'] | Inclusion Criteria: - age ≥ 65 years; - breast or lung cancer patients to receive docetaxel therapy as per protocol; - corticosteroid administration, other than what is prescribed in this protocol, is not permitted during study participation, except topical administration and for adverse events; - performance status ECOG 0-2; - peripheral neuropathy ≤ 1; - adequate kidney and liver functions - signed study-specific informed consent Exclusion Criteria: - Patients who have received an investigational drug within 4 weeks of registration; - Prior or concurrent malignancies (other than surgically treated carcinoma in situ; - Serious medical or psychiatric illness which would prevent informed consent; - Life expectancy < 3 months; - Active uncontrolled bacterial, viral, or fungal infection until these conditions are corrected or controlled. |
| 82 | NCT00616629 | completed | 1 | phase 2 | ['atrial flutter'] | ["['I48.3', 'I48.4', 'I48.92']"] | ['azd1305'] | ['CC(C)(C)OC(=O)NCCN1C[C@H]2CN(CCOC3=CC=C(C=C3F)C#N)C[C@@H](C1)O2'] | Inclusion Criteria: - Patients with atrial flutter (with a ventricular rate of <100 beats/minute at enrolment), scheduled for curative catheter ablation - Sinus rhythm at randomisation Exclusion Criteria: - QTc (Fridericia, QTcF ) >450 ms measured in sinus rhythm at randomisation, - Serum potassium below 3.8 or above 5.0 mmol/L or plasma potassium below 3.6 or above 5.0 mmol/L - QRS duration >120 ms at randomisation | |
| 83 | NCT01037907 | terminated | lack of efficacy | 0 | phase 2 | ['relapsing remitting multiple sclerosis'] | ["['M94.1', 'A68.9', 'A68.0', 'A68.1', 'M35.6']"] | ['pleneva tm bgc20-0134', 'placebo'] | ['CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Diagnosis of relapsing MS according to the revised 2005 McDonald criteria - Has shown disease activity defined by 1 or more MS attack within the last year which has been documented in prior medical notes and or the presence of active lesions on historical scans being either (based on radiology report or investigator review of MRI): - Gd-enhancing on any scan obtained in the last year, or - new T2 lesions between two scans both obtained within the last year - A minimum total of 9 T2 lesions reported on a recent MRI obtained within 1 month prior to the screening visit - Baseline EDSS score 0 - 5.5 - Has refused to be treated with approved disease modifying therapies available for MS, for any reason and once the investigator has fully informed the patient about the related benefits and potential adverse events associated with such treatments. Also, patients for whom such treatments have proved to be intolerable Exclusion Criteria: - Has experienced an MS relapse or received systemic corticosteroids or adrenocorticotropic hormone (ACTH) in the previous 1 month - Has a secondary progressive (SPMS), progressive relapsing (PRMS), or primary progressive MS (PPMS). - Has received any of the following agents to treat MS (approved or unapproved): - Within the previous 3 months: interferon beta, glatiramer acetate, intravenous immunoglobulin or plasmapheresis - Within the previous 12 months: natalizumab, daclizumab, cytapheresis, azathioprine, cladribine, cyclophosphamide, methotrexate, mitoxantrone, mycophenolate, pixantrone, sirolimus, tacrolimus, or other agents typically used to prevent transplant rejection or as cancer chemotherapy, excluding hormonal treatments - Ever having received: stem cell or bone marrow transplant, total lymphoid irradiation, vaccine therapy for MS, or monoclonal antibodies whose effects may be longer than 1 year (such as alemtuzumab or rituximab) - Within the previous 3 months: any other agents given for the non-symptomatic treatment of MS which are not included above, including over-the-counter, herbal and nutritional supplements. However, if the agent is being taken primarily to treat another medical condition, then it is allowed as long as the dose is unchanged within the previous 3 months and is unlikely to change before week 24. |
| 84 | NCT01253564 | completed | 1 | phase 2 | ['malignant melanoma'] | ["['C43.0', 'C43.31', 'C43.51', 'C43.9', 'C43.4', 'C43.52', 'C43.10']"] | ['ro5185426'] | ['CCCS(=O)(=O)NC1=C(F)C(C(=O)C2=CNC3=NC=C(C=C23)C2=CC=C(Cl)C=C2)=C(F)C=C1'] | Inclusion Criteria: - Adult patients, >/= 18 years of age - Metastatic melanoma (Stage IV, American Joint Committee on Cancer) with BRAF mutation (cobas 4800 BRAF V600 Mutation Test) - Brain metastases for which surgical resection is not a treatment option - Patients must have failed at least one previous treatment for brain metastases - Requiring corticosteroids for symptom control - Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Exclusion Criteria: - Increasing corticosteroid dose during the 7 days prior to study entry - Previous malignancy within the past 2 years, except for basal or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix - Concurrent administration of any anticancer therapies other than those administered in the study - Clinically significant cardiovascular disease or event within the 6 months prior to first dose of study drug | |
| 85 | NCT01196871 | completed | 1 | phase 2 | ['fabry disease'] | ["['E75.21']"] | ['migalastat hcl'] | ['OC[C@H]1NC[C@H](O)[C@@H](O)[C@H]1O'] | Inclusion Criteria: - Male diagnosed with Fabry disease and between 18 and 65 years of age, inclusive - Body mass index between 18-35 kg per meter squared - Had initiated treatment with agalsidase at least 1 month prior to screening, and had received at least 2 infusions before screening - Had stable dose level, dosing regimen, and form of agalsidase for at least 1 month before screening - Had an estimated creatinine clearance greater than or equal to 50 milliliters (mL)/minute at screening - Agreed to use medically accepted methods of contraception during the study and for 30 days after study completion - Were willing and able to provide written informed consent Exclusion Criteria: - Had a documented transient ischemic attack, ischemic stroke, unstable angina, or myocardial infarction within the 3 months before screening - Had clinically significant unstable cardiac disease (for example, cardiac disease requiring active management, such as symptomatic arrhythmia, unstable angina, or New York Heart Association class III or IV congestive heart failure) - History of allergy or sensitivity to study drug (including excipients) or other iminosugars (such as miglustat, miglitol) - Required a concomitant medication prohibited by the protocol: Glyset® (miglitol), or Zavesca® (miglustat) - Any investigational/experimental drug or device within 30 days of screening, except for use of investigational enzyme replacement therapy for Fabry disease - Had any intercurrent illness or condition that might have precluded the participant from fulfilling the protocol requirements or suggested to the investigator that the potential participant might have had an unacceptable risk by participating in this study | |
| 86 | NCT01263886 | completed | 0 | phase 2 | ['non-small cell lung cancer'] | ["['C78.00', 'C78.01', 'C78.02', 'D14.30', 'D14.31', 'D14.32', 'C34.2']"] | ['ombrabulin (ave8062)', 'placebo'] | ['COC1=CC=C(\\C=C/C2=CC(OC)=C(OC)C(OC)=C2)C=C1NC(=O)[C@@H](N)CO', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion criteria: - Histologically proven squamous metastatic non-small cell lung cancer (stage IV, according to Tumor Nodes Metastasis (TNM) classification seventh edition) - Patients with measurable disease, Response Evaluation Criteria In Solid Tumors (RECIST) criteria (version 1.1) - Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 Exclusion criteria: - Prior chemotherapy, immunotherapy or targeted therapy for lung cancer disease (including adjuvant/neoadjuvant therapy) - History of brain metastases, uncontrolled spinal cord compression, or carcinomatous meningitis - History of another neoplasm. Adequately treated basal cell or squamous skin cancer, or in situ cervical cancer, or any other cancer from which the patient has been disease-free for >5 years are allowed - Participation in another clinical trial and any concurrent treatment with any investigational drug within 30 days prior to randomization - Acquired immunodeficiency syndrome (AIDS-related illness) or known human immunodeficiency virus (HIV) disease requiring antiretroviral treatment - Any severe acute or chronic medical condition, which could impair the ability of the patient to participate in the study or interfere with interpretation of study results - Pregnant or breast-feeding woman. Positive serum or urine pregnancy test prior to randomization - Patient with reproductive potential (Male/Female) who do not agree to use accepted and effective method of contraception during the study treatment period and for at least 3 months after the completion of the study treatment. The definition of "effective method of contraception" will be based on the investigator's judgment - Inadequate organ function - Pre-existing peripheral neuropathy > grade 1 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) V.4.03 - Pre-existing hearing impairment > grade 2 - Known hypersensitivity due to taxanes and /or polysorbate 80 or any other compound of the study drug combination - Other serious illness or medical conditions such as (but not restricted): Active infection, Superior vena cava syndrome, Pericardial effusion requiring intervention (drainage) - Documented medical history of myocardial infarction, documented angina pectoris, arrhythmia especially severe conduction disorder such as second or third-degree atrioventricular block, stroke, or history of arterial or venous thromboembolism within the past 6 months still requiring anticoagulants. - Uncontrolled hypertension within 3 months prior to study treatment or patient with organ damage related to hypertension. - Patient with Left Ventricular Ejection Fraction (LVEF) value lower than institution inferior normal limit, evaluated by echocardiography or angiocardiography - 12-lead Electrocardiogram (ECG): Infarction Q-wave, ST segment depression or elevation ≥1 mm in at least 2 contiguous leads - History of gross hemoptysis (i.e. 1/2 teaspoon of red blood or more per episode) within the past 1 month. - Has non-squamous NSCLC(adenocarcinoma/large cell or other) The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. | |
| 87 | NCT00421733 | completed | 1 | phase 2 | ['diabetic nephropathy', 'chronic kidney disease'] | ["['E10.21', 'E11.21', 'E13.21', 'E08.21', 'E09.21']", "['I12.9', 'N18.9', 'I12.0', 'D63.1', 'N18.1', 'N18.5', 'I13.0']"] | ['zemplar (paricalcitol ) capsules', 'zemplar (paricalcitol) capsules', 'placebo'] | ['[H][C@@]1(CC[C@@]2([H])\\C(CCC[C@]12C)=C\\C=C1C[C@@H](O)C[C@H](O)C1)[C@H](C)\\C=C\\[C@H](C)C(C)(C)O', '[H][C@@]1(CC[C@@]2([H])\\C(CCC[C@]12C)=C\\C=C1C[C@@H](O)C[C@H](O)C1)[C@H](C)\\C=C\\[C@H](C)C(C)(C)O', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Male or female participant >= 20 years old. - Participant has Type 2 Diabetes Mellitus and has been treated with at least one anti-hyperglycemic medication within the 12 months prior to the Screening Phase - Participant has been receiving a stable dose (i.e., same type and regimen) of ACEi and/or ARB for at least three months prior to the Screening Phase. However, participant may have switched to different brands but at equivalent doses during the three months prior to the Screening Phase. - Participant is not expected to begin dialysis for at least 6 months. - If female, participant is not breast feeding or is not pregnant. - For entry into the Treatment Phase, the participant must satisfy the following criteria based on the Screening laboratory values: - Estimated glomerular filtration rate (GFR) between 15-90 mL/min/1.73m2 by simplified Modification in Diet in Renal Disease (MDRD) formula - Urinary albumin to creatinine ratio (UACR) between 100 and 3000 mg/g as determined by the mean of the three first morning void urine specimens obtained within one week of each other - Corrected serum calcium level <= 9.8 mg/dL - intact parathyroid hormone (iPTH) value between 35-500 pg/mL - Glycosylated hemoglobin A1c (HbA1c) <= 12% - Serum albumin > 3.0 g/dL - Negative urine pregnancy test for female participants Exclusion Criteria: - Participant has previously been on prescription-based vitamin D therapy within the six months prior to the Screening Phase. - Participant has a history of an allergic reaction or significant sensitivity to paricalcitol or to drugs similar to the study drug. - Participant has primary glomerulonephritis or secondary nephritis in addition to diabetic nephropathy. - Participant has had acute renal failure within 12 weeks of the Screening Phase, defined as an acute rise (of >= 0.5 mg/dL) in serum creatinine to > 4 mg/dL. - Participant has chronic gastrointestinal disease. - Participant has secondary hypertension. - Participant has poorly controlled hypertension. - Participant has a history of kidney stones. - Participant has a history of drug or alcohol abuse within six months prior to the Screening Phase. - Participant has evidence of poor compliance with diet or medication. - Participant has received any investigational drug within 30 days prior to study drug administration. - Participant is taking calcitonin, bisphosphonates, cinacalcet, glucocorticoids (except topical glucocorticoids), or other drugs that may affect calcium, or bone metabolism, other than calcium containing phosphate binder or female participants on stable (same dose and product for three months) estrogen and/or progestin therapy. - For any reason, participant is considered by the Investigator to be an unsuitable candidate to receive paricalcitol capsules or is put at risk by study procedures. - Participant is known to be human immunodeficiency virus (HIV) positive. - Participant has used known inhibitors or inducers of cytochrome P450 3A (CYP3A) within two weeks prior to study drug administration. | |
| 88 | NCT00595985 | terminated | low response rate, no evidence of pfs or os improved. | 0 | phase 2 | ['gastric cancer'] | ["['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']"] | ['sorafenib'] | ['CNC(=O)C1=NC=CC(OC2=CC=C(NC(=O)NC3=CC(=C(Cl)C=C3)C(F)(F)F)C=C2)=C1'] | Inclusion Criteria: - Histologically confirmed advanced or metastatic adenocarcinoma of the stomach - ECOG performance scale ≤ 2 - At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan) - Adequate hepatic, renal, heart, and hematologic functions: - platelets>80 × 109/L - neutrophil>2.0 × 109/L - serum creatinine ≤ 1.5mg/dl - total bilirubin within upper limit of normal(ULN) - serum transaminase ≤ 2.5 × the ULN Exclusion Criteria: - Pregnant or lactating women - Concurrent cancer - History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix - Neuropathy, brain, or leptomeningeal involvement - Uncontrolled significant comorbid conditions and previous radiotherapy |
| 89 | NCT01009515 | terminated | low accrual; target accrual not met | 0 | phase 2 | ['melanoma'] | ["['C43.0', 'C43.31', 'D03.9', 'C43.51', 'C43.9', 'D03.0', 'C43.4']"] | ['paclitaxel, carboplatin, temozolomide'] | ['CN1N=NC2=C(N=CN2C1=O)C(N)=O'] | Inclusion Criteria: - All patients with biopsy proven advanced melanoma are eligible if there is measurable disease. - Patients must have a life expectancy of at least 12 weeks. - Prior surgery, immunotherapy, minimal chemotherapy (1 drug for less than 4 months), or radiotherapy for primary tumor is acceptable but must be completed at least 4 weeks from study entry, and patient should have completely recovered from such procedures. - Patients must have a Zubrod performance status of 0-2. - Patients must sign an informed consent. - Patients should have adequate bone marrow function defined by an absolute peripheral granulocyte count of ≥ 1500 cells/mm3, hemoglobin > 8 g/dl, platelet count ≥ 100 000/mm3. - Patients should have a normal hepatic function with a total bilirubin < 1.5 the upper limit of normal (ULN) and serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic-pyruvic transaminase (SGPT) < 2 times the upper limit of normal (ULN),and adequate renal function as defined by a serum creatinine ≤ 1.5 times the ULN. - Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and at least for 3 months. - Patients with brain metastases are eligible if they have been appropriately treated, are asymptomatic Exclusion Criteria: - Pregnant women or nursing mothers are not eligible. - Patients must not receive any other concurrent chemotherapy or radiation during this trial. - Patients with severe medical problems that would interfere with the therapy are not eligible. |
| 90 | NCT01120275 | terminated | administratively complete. | 0 | phase 2 | ['acral lentiginous malignant melanoma', 'lentigo maligna malignant melanoma', 'nodular malignant melanoma', 'recurrent melanoma', 'solar radiation-related skin melanoma', 'stage iv melanoma', 'superficial spreading malignant melanoma'] | ["['G47.13', 'J01.41', 'K11.22', 'K12.0', 'N96', 'F33.8', 'G03.2']", "['C43.0', 'C43.31', 'D03.9', 'C43.51', 'C43.9', 'D03.0', 'C43.4']"] | ['gamma-secretase/notch signalling pathway inhibitor ro4929097'] | ['CC(C)(C(=O)NCC(F)(F)C(F)(F)F)C(=O)N[C@H]1C2=CC=CC=C2C2=CC=CC=C2NC1=O'] | Inclusion Criteria: - Patients must have histologically confirmed melanoma of cutaneous or unknown origin (ocular primary and mucosal primary excluded); patients must have Stage IV disease - All patients must undergo a computed tomography (CT) or magnetic resonance imaging (MRI) of the brain within 42 days prior to registration that is negative for brain metastases; patients with a history of brain metastases are ineligible - Patients must have measurable disease; all measurable lesions must be assessed (by physical examination, CT, or MRI scan) within 28 days prior to registration; tests to assess non-measurable disease must be performed within 42 days prior to registration; all disease must be assessed and documented on the Baseline Tumor Assessment Form (Response Evaluation Criteria In Solid Tumors [RECIST] 1.1); the CT from a combined positron emission tomography (PET)/CT must not be used to document measurable disease unless it is of diagnostic quality - Sites must offer all patients participation in translational medicine studies and banking of paraffin embedded tissue and whole blood - Patients must not have received any prior systemic therapy for Stage IV disease except for noncytotoxic biologic agents (e.g., vaccines, cytokines, cell therapies that do not require cytotoxic agents); patients may have received prior treatment with up to two prior biological therapies - no cytotoxics or kinase inhibitors - for advanced disease - Patients may have had prior adjuvant immunotherapy with biological response modifiers (examples include but are not limited to interferon, vaccines, GM-CSF, and CTLA-4 blocking antibodies); prior adjuvant immunotherapy must have been completed at least 28 days prior to registration - Adjuvant therapy containing cytotoxic agents is allowed if completed >= 180 days prior to registration - Patients may have received prior radiation therapy; any side effects the patients had due to prior radiation therapy must have resolved to =< Grade 1 prior to registration; prior radiation therapy must have completed at least 28 days prior to registration - Patients must have Zubrod performance status of 0-1 - Leukocytes >= 3,000/mcL - Absolute neutrophil count (ANC) >= 1,500/mcL - Platelets >= 100,000/mcL - Hemoglobin >= 9 g/dL - Total bilirubin =< institutional upper limit of normal (IULN) - Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =< 2.5 x IULN - Serum creatinine =< IULN OR measured or calculated creatinine clearance >= 60 mL/min - Patients must have the following serum electrolytes within the institutional ranges of normal: potassium, sodium, magnesium, phosphorous, chloride and calcium (corrected for serum albumin); these tests must be performed within 28 days prior to registration; patient must not require parenteral replacement therapy - Patients must not have a history of allergic reaction attributed to compounds of similar chemical or biologic composition to RO4929097 - Patients must be able to swallow tablets - Patients must not have malabsorption syndrome or other condition that would interfere with intestinal absorption of the agent - Patients taking medications with narrow therapeutic indices that are metabolized by cytochrome P450 (CYP450), including warfarin sodium (Coumadin), are ineligible - Patients must not be taking strong inducers or strong inhibitors of CYP3A4 at the time of registration - Patients must not be known to be serologically positive for Hepatitis A, B, or C, or have a history of liver disease, other forms of hepatitis, or cirrhosis - Patients must have an ECG within 28 days prior to registration. Patients must not have a QTcF > 450 msec (males) or QTcF > 470 msec (females) - Patients must not have symptomatic congestive heart failure or unstable angina pectoris - Patients with a history of torsades de pointes or any significant cardiac arrhythmia (except asymptomatic unifocal ventricular premature beats or supraventricular tachycardia easily controlled with oral medications) are excluded; any patient requiring or expected to require antiarrhythmics or other therapy known to prolong QTc is also excluded - No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years - Women of childbearing potential must have a negative pregnancy test within 14 days prior to registration (the type of pregnancy test used is at the discretion of the registering institution); female patients of childbearing potential include the following: - Patients with regular menses - Patients, after menarche with amenorrhea, irregular cycles, or using a contraceptive method that precludes withdrawal bleeding - Women who have had tubal ligation - Women must not be nursing due to possible harm to a nursing infant from the treatment regimen - All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines - At the time of patient registration, the treating institution's name and ID number must be provided to the Data Operations Center in Seattle in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the data base |
| 91 | NCT00066248 | completed | 1 | phase 2 | ['brain tumor', 'central nervous system tumors', 'cachexia', 'leukemia', 'lymphoma', 'myelodysplastic syndromes', 'myelodysplastic/myeloproliferative diseases', 'unspecified childhood solid tumor, protocol specific'] | ["['C71.7', 'C71.9', 'C79.31', 'D33.0', 'D33.1', 'D33.2', 'D49.6']", "['C72.9', 'D33.9', 'D43.9', 'D33.7', 'D43.8']", "['R64']", "['C95.91', 'C95.92', 'Z80.6', 'Z85.6', 'C90.11', 'C90.12', 'C91.01']", "['S33.110S', 'S33.111S', 'S33.120S', 'S33.121S', 'S33.130S', 'S33.131S', 'S33.140S']", "['D46.9', 'D46.C', 'D46.Z']", "['H01.009', 'H02.209', 'H02.009', 'H02.109', 'H04.209', 'H05.409', 'H10.509']"] | ['cyproheptadine hydrochloride', 'megestrol acetate'] | ['CN1CCC(CC1)=C1C2=CC=CC=C2C=CC2=CC=CC=C12', '[H][C@@]12CC[C@](OC(C)=O)(C(C)=O)[C@@]1(C)CC[C@@]1([H])[C@@]2([H])C=C(C)C2=CC(=O)CC[C@]12C'] | INCLUSION CRITERIA: - Any cachectic patient with weight loss presumed secondary to cancer or cancer related therapy is eligible. Cachexia is defined as having one or more of the following: - documented history of weight loss > 5% - drop in growth rate two or more percentile ranks on standard growth charts, - weight for height less than the tenth percentile. - Patients with newly diagnosed or relapsed cancer of any type, including brain tumors. - Patients who are receiving active or palliative therapy are eligible. - If patients have completed treatment for cancer (surgery, chemotherapy, radiotherapy) within 8 weeks of study registration, they are also eligible. - Patients must be ≥ 2 years and < 21 years of age at the time of admission to this study. - Patients must have a predicted life expectancy of at least eight weeks. EXCLUSION CRITERIA: - Patients who are currently taking or who have taken Periactin and/or Megace during the past three weeks are not eligible. - Patients receiving corticosteroid or monoamine oxidase (MAO) inhibitor therapy. (Intermittent steroid use is permitted IF you anticipate it will not be administered for more than 7 days in a 4 week period. Calculate anticipated intermittent steroid use in 4-week intervals through the 8-week period during which study agent may be administered (4 weeks for Periactin and potentially 4 weeks for Megace. - Patients who have received parenteral nutrition or tube feedings within 1 week of starting this protocol or patients who are expected to require parenteral nutrition or tube feedings during the 4-week course of this study. - Patients taking dronabinol (Marinol) or other appetite-stimulating medications during the past three weeks or patients expected to be prescribed appetite-stimulating medications during the 4-week course of this study. - Patients with hormone sensitive tumors specifically meningiomas, breast cancer, ovarian cancer, and endometrial carcinoma.31, 32 - Children with neurofibromatosis, type I or II, are at risk for the development of meningiomas and are thus excluded from this study.32 - Children with glaucoma, chronic persistent asthma, or gastrointestinal (GI) or genitourinary (GU) obstruction. - Patients with recurrent and/or persistent hypertension, defined as blood pressure values >20% above normal. - Patients with thromboembolic disease, congestive heart failure, or peripheral edema. - Patients who are pregnant. | |
| 92 | NCT00242866 | completed | 0 | phase 2 | ['migraine disorders'] | ["['G43.B1', 'G43.D1', 'G43.B0', 'G43.D0', 'G43.A1', 'G43.411', 'G43.419']"] | ['gw274150'] | ['CC(=N)NCCSCC[C@H](N)C(O)=O'] | Inclusion Criteria: - Suffering from migraine with or without aura. - Migraine for at least one year, and the age of onset was prior to 50 years. - Consistent migraine headache over time and has had at least 3 migraine headache attacks but less than 15 days with headache (migraine or non-migraine) per month in each of the three months prior to the Screening Visit and maintains this requirement during the baseline period. - Able to distinguish migraine headache attacks as discreet attacks from other headaches (i.e. tension-type headaches). - No clinically significant abnormality identified on the medical or laboratory evaluation. A subject with a clinical abnormality or laboratory parameters outside the reference range may be included only if the doctor considers that the finding will not introduce additional risk factors and will not interfere with the study procedures. - Written informed consent prior to entry into the study. - Females who are: a) non-childbearing potential or, b) of child-bearing potential, has a negative pregnancy test at screen, and is taken adequate contraceptive measures. Exclusion Criteria: - As a result of the medical interview, physical examination or screening investigations, that the doctor considers the subject unfit for the study. - Headache for 15 days per month or greater in any of the three months (90 days) preceding the Screening Visit. - History of alcohol, substance or drug abuse within the last year. - Taken a migraine prophylactic medication within 1 month of the Screening Visit. - Uses an opiate as first line acute treatment for migraine attacks. - History of ergotamine, triptan, opioid, or combination medication intake on greater than/equal 10 days per month on a regular basis for greater than/equal 3 months. - History of simple analgesic intake on greater than/equal 15 days per month for greater than/equal 3 months. - Failed two or more adequate treatments of migraine prophylaxis, where failure is defined as a lack of efficacy with a treatment duration of at least 8 weeks or withdrawal of treatment due to treatment intolerance. - Uncontrolled hypertension at the Screening Visit, defined as systolic blood pressure >140mmHg or diastolic blood pressure >90mmHg. - Taking cyclosporine and/or aminoglycosides. - Evidence of renal impairment - calculated creatinine clearance <60ml/min or clinically relevant finding on urinalysis. - History of drug or other allergy which, in the opinion of the doctor, makes the subject unsuitable for participation in the study. - Concurrently participating in another clinical study or investigational drug trial or has participated within the previous 3 months or is planning to participate in another drug or device study at any time during this study (screening through follow-up) or has had previous exposure to GW274150 in Part 1 of the study. - Felt to be at risk of non-compliance (for taking study medication or for completing the electronic diary (e-diary)), in the doctor's opinion. - Pregnant or nursing women. - History of, or risk factors for, HIV, Hepatitis B and Hepatitis C. - Past or present disease, which as judged by the doctor, may affect the outcome of this study. These diseases include, but are not limited to history of liver or renal disease in the 6 months prior to screening. - Clinically significant abnormalities in safety laboratory analysis at the Screening Visit, particularly any abnormal liver or pancreatic function test at the Screening Visit. - Not covered by social security. | |
| 93 | NCT00141037 | completed | 1 | phase 1/phase 2 | ['kidney diseases', 'kidney transplantation', 'kidney transplant', 'renal transplantation', 'renal transplant'] | ["['I12.9', 'N18.9', 'Q61.9', 'I12.0', 'D63.1', 'N18.1', 'N18.5']", "['N26.2', 'Q63.0', 'Q63.2', 'Z52.4', 'I75.81', 'N19', 'N20.0']", "['T86.11', 'T86.12', 'T86.13', 'Z94.0', 'T86.10', 'T86.19', 'Z48.22']", "['N25.0', 'Q61.4', 'N23', 'N26.9', 'P96.0', 'Q60.0', 'Q60.1']", "['N25.0', 'Q61.4', 'N23', 'N26.9', 'P96.0', 'Q60.0', 'Q60.1']"] | ['daclizumab', 'mycophenolate mofetil (mmf)', 'prednisone', 'tacrolimus', 'ganciclovir', 'valganciclovir', 'trimethoprim and sulfamethoxazole'] | ['COC(=O)\\C=C\\C(O)=O', '[H][C@@]12CC=C(C3=CC=CN=C3)[C@@]1(C)CC[C@@]1([H])[C@@]2([H])CC=C2C[C@@H](O)CC[C@]12C', 'COC1=CC2=C(C(OC)=C1OC)C1=CC=C(OC)C(=O)C=C1C(CC2)NC(C)=O', 'NC1=NC2=C(N=CN2COC(CO)CO)C(=O)N1', 'CC(C)[C@H](N)C(=O)OCC(CO)OCN1C=NC2=C1NC(N)=NC2=O', 'CC1=CC(NS(=O)(=O)C2=CC=C(N)C=C2)=NO1'] | Inclusion Criteria: - Primary recipient of a kidney transplant - Meets site-specific transplant criteria - Panel Reactive Antibody (PRA) of 20% or less - Willing to use acceptable forms of contraception - Parent or guardian willing to provide informed consent, if applicable Exclusion Criteria: - Previous treatment with steroids within 6 months prior to transplantation - Received en-bloc kidney or other kidney that does not meet protocol-specified requirements - Received an organ from an human leukocyte antigen (HLA) identical donor or a non-heart-beating donor - Received a solid organ other than a kidney - Received a bone marrow or hematopoietic stem cell transplant - Received a repeat kidney transplant - Currently receiving an investigational pharmacologic or biologic agent - Human Immunodeficiency virus (HIV) infected or infected with another immunodeficiency virus - Hypersensitivity to murine products or the study drugs or their formulations - Inability to measure height accurately - Pregnant or breastfeeding | |
| 94 | NCT00509769 | completed | 1 | phase 2 | ['metastatic breast cancer'] | ["['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']"] | ['trastuzumab emtansine [kadcyla]'] | ['[H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1'] | Inclusion Criteria: - Signed informed consent form. - Human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC); tissue (slides or blocks) available for HER2 confirmation. - History of progression on HER2-directed therapy for the treatment of HER2-positive breast cancer. - At least 1, and no more than 3, chemotherapy regimens for MBC. - Granulocyte count ≥ 1500/μL, platelet count ≥ 100,000/μL, and hemoglobin ≥ 9 g/dL. - Serum bilirubin ≤ 1.5 mg/dL, aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase ≤ 2.5x the upper limit of normal (ULN). - Serum creatinine ≤ 1.5 mg/dL or creatinine clearance ≥ 60 mL/min. - Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. Exclusion Criteria: - Any chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or biological therapy for the treatment of breast cancer within 2 weeks of the first study treatment. - Prior cumulative doxorubicin dose > 360 mg/m^2 or the equivalent. - History of significant cardiac disease, unstable angina, congestive heart failure (CHF), myocardial infarction, or ventricular arrythmia requiring medication. | |
| 95 | NCT00549770 | completed | 1 | phase 2 | ['hypertension'] | ["['I15.0', 'I97.3', 'K76.6', 'P29.2', 'G93.2', 'H40.053', 'I10']"] | ['lcz696', 'valsartan', 'ahu377', 'placebo'] | ['CCCCC(=O)N(CC1=CC=C(C=C1)C1=CC=CC=C1C1=NNN=N1)[C@@H](C(C)C)C(O)=O', 'CCCCC(=O)N(CC1=CC=C(C=C1)C1=CC=CC=C1C1=NNN=N1)[C@@H](C(C)C)C(O)=O', '[H][C@@](CC1=CC=C(C=C1)C1=CC=CC=C1)(C[C@@]([H])(C)C(=O)OCC)NC(=O)CCC(O)=O', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Male or females from 18 up to and including 75 years - Patients with mild-to-moderate uncomplicated essential hypertension, untreated or currently taking antihypertensive therapy (monotherapy or combination therapy of 2 drugs; therapy with a fixed dose combination of two active substances represents 2 drugs) - Untreated patients must have had an office msDBP≥ 95 mmHg at the randomization visit (Visit 3) and the 2 preceding visits (Visits 1 and 2). - Treated patients must have had an office msDBP≥ 90 mmHG after washout (Visit 2), and a msDBP> 95 mmHg at baseline (Visit 3); Exclusion Criteria: - Severe hypertension (msSBP ≥180 mmHg and/or msDBP ≥110 mmHg) - History of angioedema, drug-related or otherwise, as reported by the patient - Type 1 or Type 2 diabetes mellitus (according to the ADA criteria) - History or evidence of a secondary form of hypertension, such as renal parenchymal hypertension, renovascular hypertension, coarctation of the aorta, primary hyperaldosteronism, Cushing's disease, drug-induced hypertension, unilateral or bilateral renal artery stenosis, pheochromocytoma, polycystic kidney disease, etc. - History of angina pectoris, myocardial infarction, coronary bypass surgery, ischemic heart disease, surgical or percutaneous arterial intervention of any kind (coronary, carotid or peripheral intervention), stroke, TIA (transient ischemic attack), carotid artery stenosis, aortic aneurysm or peripheral arterial disease | |
| 96 | NCT00402116 | completed | 1 | phase 1/phase 2 | ['glioblastoma', 'glioblastoma multiforme', 'gliosarcoma'] | ["['L51.0', 'L51.8', 'L51.9']"] | ['enzastaurin', 'temozolomide'] | ['CN1C=C(C2=CC=CC=C12)C1=C(C(=O)NC1=O)C1=CN(C2CCN(CC3=CC=CC=N3)CC2)C2=CC=CC=C12', 'CSCC[C@H](N)C(O)=O'] | Inclusion Criteria: - Patients must have a histologically confirmed diagnosis of intracranial glioblastoma multiforme (GBM) or gliosarcoma (GS). - Biopsy or resection must have been performed no more than 5 weeks prior to treatment. - An MRI or CT scan must be obtained within 14 days prior to treatment. - Patients must not have received prior drug therapy for brain tumors. - Patients must have adequate organ function demonstrated by lab tests within 14 days prior to treatment. Exclusion Criteria: - Patients will be excluded if unable to swallow tablets. - Patients will be excluded if unable to discontinue use of enzyme inducing antiepileptic drugs or have been off of these agents less than 2 weeks prior to treatment (i.e. phenytoin (Dilantin®), carbamazepine, etc.). - Patients will be excluded if have active infection. - Patients will be excluded if have a significant medical illness that, in the investigator's opinion, cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy. - Patients will be excluded if they have concurrent therapy with an anticoagulant. If the patient requires anticoagulant therapy after starting treatment, the patient may remain on study but should be monitored carefully. | |
| 97 | NCT00727207 | terminated | lack of participations (8 of 25) | 0 | phase 2 | ['lymphoma'] | ["['S33.110S', 'S33.111S', 'S33.120S', 'S33.121S', 'S33.130S', 'S33.131S', 'S33.140S']"] | ['everolimus'] | ['[H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\\C=C(C)\\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\\C=C\\C=C\\C=C(C)\\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC'] | DISEASE CHARACTERISTICS: - Diagnosis of mantle cell lymphoma - Stable disease after first- or second-line chemotherapy - No uncontrolled cerebral or leptomeningeal disease PATIENT CHARACTERISTICS: - WHO performance status 0-2 - Life expectancy ≥ 3 months - Age ≥ 60 years or patients ≥ 40 and < 60 years who are not suitable for high-dose chemotherapy followed by autologous stem cell transplantation or allogeneic stem cell transplantation - ANC ≥ 1,500/mm^3 - Platelet count ≥ 100,000/mm^3 - Hemoglobin > 9 g/dL - Serum creatinine ≤ 1.5 times upper limit of normal (ULN) - SGPT and SGOT ≤ 3 times ULN - Bilirubin ≤ 1.5 times ULN - No other malignancies within the past 3 years except treated cervical carcinoma or basal cell cancer - No other serious or non-controlled illnesses (e.g., diabetes mellitus, uncontrolled hypertension, serious infections, serious malnutrition, unstable angina pectoris, weak heart, myocardial infarction within the past 6 months, chronic liver illness, active ulceration in the gastrointestinal tract, psychiatric illness) - No known HIV infection - No gastrointestinal disturbances that could influence the absorption of everolimus and cause short-intestine syndrome (e.g., atrophic gastritis) - No coagulation or bleeding diatheses - Not pregnant or nursing - Fertile patients must use effective contraception - Patients must have complied with their previous drug prescription PRIOR CONCURRENT THERAPY: - See Disease Characteristics - See Patient Characteristics - Recovered from all prior therapy - At least 2 weeks since prior surgery, radiotherapy, or systemic antitumor therapy - More than 4 weeks since prior experimental medication - No chronic therapy with systemic steroids or other immunosuppressants except rituximab - No prior organ transplantation - No therapy with vitamin K antagonist, except low-dose coumarin - No prior mTOR inhibitors |
| 98 | NCT00445198 | completed | 1 | phase 1/phase 2 | ['small cell lung cancer', 'small cell lung carcinoma'] | ["['C78.00', 'C78.01', 'C78.02', 'D14.30', 'D14.31', 'D14.32', 'C34.2']", "['D02.20', 'D02.21', 'D02.22']"] | ['abt-263'] | ['[H][C@@](CCN1CCOCC1)(CSC1=CC=CC=C1)NC1=C(C=C(C=C1)S(=O)(=O)NC(=O)C1=CC=C(C=C1)N1CCN(CC2=C(CCC(C)(C)C2)C2=CC=C(Cl)C=C2)CC1)S(=O)(=O)C(F)(F)F'] | Inclusion Criteria: - The subject must be >=18 years of age.(Phase 1 & 2a) - Histologically and/or cytologically documented diagnosis of small cell lung cancer (North America & UK) or other non-hematological malignancy (North America only).(Phase 1 only) - Histologically and/or cytologically documented diagnosis of SCLC.(Phase 2a) - At least one prior chemotherapy treatment regimen(s) and their disease is refractory or experienced progressive disease following the treatment.(Phase 1) - Extensive-stage SCLC & is chemotherapy naïve(US only) has experienced progressive disease following at least one chemotherapy regimen or their disease is refractory.(Phase 2a) - Brain metastases with clinically controlled neurologic symptoms, defined as surgical excision and/or radiation therapy followed by 21 days of stable neurologic function & no evidence of CNS disease progression as determined by CT or MRI within 21 days prior to the first dose of study drug. - ECOG performance score <= 2(Ph 1) <=1(Phase 2a) - Must be receiving a stable dose of Selective Serotonin Reuptake Inhibitor (SSRI) anti-depressants 21 days prior to 1st dose of study drug. - Adequate bone marrow, renal & hepatic function per local lab reference range at Screening as follows: - Bone marrow: Absolute Neutrophil count (ANC)>=1000/µL - Platelets>= 100,000/mm3 - Hemoglobin>=9.0g/dL - Renal function: Serum creatinine<= 2.0mg/dL or calculated creatinine clearance>=50mL/min - Hepatic function&enzymes: AST and ALT<=3.0 x the upper normal limit(ULN) of institution's normal range - Bilirubin<=1.5xULN. If Gilbert's Syndrome may have Bilirubin> 1.5 x ULN - Coagulation: aPTT and PT<=1.2 x the upper limit of normal - Should have archived diagnostic tissue available for assessment of Bcl-2 family protein expression.(Phase 2a) - All female subjects not surgically sterile or postmenopausal(for at least 1 year)and non-vasectomized male subject must practice at least one method of birth control. Exclusion Criteria: - Underlying or predisposing condition of bleeding or currently exhibits signs of bleeding. - Recent history of non-chemotherapy induced thrombocytopenia associated bleeding within 1 year prior to first dose of study drug. - Active peptic ulcer disease or other potentially hemorrhagic esophagitis/gastritis. - The subject has active immune thrombocytopenic purpura (ITP),active autoimmune hemolytic anemia (AIHA), or a history of being refractory to platelet transfusions (within 1 year prior to the first dose of study drug). - Currently receiving or requires anticoagulation therapy or any drug or herbal supplements that affect platelet function, with exception of low-dose anticoagulation medications that are used to maintain the patency of a central intravenous catheter. - Received any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal (with the exception of hormones for hypothyroidism or estrogen replacement therapy (ERT), anti estrogen analogs, agonists required to suppress serum testosterone levels), or any investigational therapy within 14 days prior to the first dose of study drug, or has not recovered to less than a grade 2 adverse effect(s) of the previous therapy. - Received a biologic (G-CSF, GM-CSF or erythropoietin) within 28 days prior to the first dose of study drug. - Steroid therapy for anti-neoplastic intent within seven days prior to the first dose of study drug. - Has consumed grapefruit or grapefruit products within 3 days prior to the first dose of study drug. - Significant history of cardiovascular disease, renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, or hepatic disease that in the opinion of the investigator would adversely affect his/her participating in this study. - Positive for HIV - A history of other active malignancies within the past 3 years prior to screening, with the exception of: - Adequately treated in situ carcinoma of the cervix uteri - Basal or squamous cell carcinoma of the skin - Previous malignancy confined and surgically resected with curative intent - Evidence of other clinically significant uncontrolled condition(s) including, but not limited to: - Active systemic fungal infection - Diagnosis of fever and neutropenia within 1 week prior to study drug administration. | |
| 99 | NCT01601808 | unknown status | 0 | phase 2 | ['pancreatic cancer'] | ["['C25.3']"] | ['placebo', 'caprelsa (vandetanib)'] | ['CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O', 'COC1=C(OCC2CCN(C)CC2)C=C2N=CN=C(NC3=C(F)C=C(Br)C=C3)C2=C1'] | Inclusion Criteria: - Age ≥ 18 years. - Histologically or cytologically proven pancreatic ductal adenocarcinoma or undifferentiated carcinoma of the pancreas. - Locally advanced or metastatic disease precluding curative surgical resection or definitive locally directed therapies such as chemo radiation. Patients who have relapsed following previously resected Pancreatic Cancer can be included. - Contrast enhanced computerised tomography (CT) scan of the thorax, abdomen and pelvis within 28 days prior to commencing treatment. - Unidimensionally measurable disease as shown by CT scan, in accordance with RECIST guidelines (version 1.1) - ECOG performance status 0, 1 or 2 where the investigator feels that treatment with combination chemotherapy. - Platelets ≥100 x 109/l; WBC ≥ 3 x 109/l; neutrophils ≥ 1.5 x 109/l at entry. - Documented Life expectancy > 3 months. - Informed written consent Exclusion Criteria: - Laboratory results: - Serum bilirubin ≥ 1.5x the upper limit of reference range (ULRR). - Haemoglobin < 10G/dl - Creatinine clearance < 30 mL/minute (calculated by Cockcroft-Gault formula)**. Patients with a creatinine clearance of ≥30mL/minute and <50mL/minute should begin vandetanib on a reduced dose of 200mg. - Potassium, ≤4.0 mmol/L despite supplementation; or > 5.5 mmol/L - Magnesium below the normal range despite supplementation, or > 1.23 mmol/L - Serum calcium is > 2.9 mmol/L. In cases where serum calcium is below the normal range this can be substituted with the value for calcium adjusted for albumin, if this is below the normal range despite supplementation patients should be excluded. - Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or alkaline phosphatase (ALP) >2.5 x ULRR or > 5x ULRR if judged by the investigator to be related to liver metastases. - Medical or psychiatric conditions compromising informed consent. - Intracerebral metastases or meningeal carcinomatosis. - Major surgery within 4 weeks or incompletely healed surgical incision before starting study therapy. - Evidence of severe or uncontrolled systemic disease or any concurrent condition - Clinically significant cardiovascular eventclassification of heart disease ≥2 within 3 months before entry; or presence of cardiac disease that, in the opinion of the Investigator, increases the risk of ventricular arrhythmia. - History of arrhythmia which is symptomatic or requires treatment (CTCAE grade 3) or asymptomatic sustained ventricular tachycardia. Atrial fibrillation, controlled on medication is not excluded. - QTc prolongation with other medications that required discontinuation of that medication. - Congenital long QT syndrome or 1st degree relative with unexplained sudden death under 40 years of age. - Presence of left bundle branch block (LBBB). - QTc with Bazett's correction that is un-measurable or ≥ 480 msec on screening ECG. Patients who are receiving a drug that has a risk of inducing Torsades-de-Pointes are excluded if QTc is ≥ 460 msec. - Any concurrent medication with a known risk of inducing Torsades-de-Pointes, that in the investigator's opinion cannot be discontinued, are allowed. - Concomitant medications that are potent inducers. - Hypertension not controlled by medical therapy. - Currently active diarrhoea. - Malabsorption syndrome. - Pregnancy or breast feeding. - Previous chemotherapy for locally advanced and metastatic disease. Adjuvant chemotherapy for resected pancreatic cancer will be permitted provided that chemotherapy was completed > 12 months previously. - Radiotherapy within the last 4 weeks prior to start of study treatment. - Concurrent malignancies or invasive cancers diagnosed within past 5 years. - Chemotherapy directed at tumour apart from that described in this protocol. - All men or women of reproductive potential, unless using at least two contraceptive precautions, one of which must be a condom. | |
| 100 | NCT01018017 | completed | 0 | phase 2 | ['diabetes mellitus, type 2'] | ["['E11.65', 'E11.9', 'E11.21', 'E11.36', 'E11.41', 'E11.42', 'E11.44']"] | ['placebo', 'srt2104'] | ['CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O', 'CC1=C(SC(=N1)C1=CC=CN=C1)C(=O)NC1=CC=CC=C1C1=CN2C(CN3CCOCC3)=CSC2=N1'] | Inclusion Criteria: - Able and willing to provide written informed consent to participate in the study - Ambulatory male and female subjects (of any race) with T2D within the age range of 18-65 years (inclusive) at the time of screening - All female subjects must be of non-childbearing potential. All male subjects must agree with their partners to use double-barrier birth control or abstinence while participating in the study and for 12 weeks following the last dose of investigational product. For the purposes of this study, non-childbearing is defined as: - Amenorrheic for at least 12 consecutive months; menopausal status in amenorrheic females will be confirmed by demonstrating levels of follicle stimulating hormone (FSH) >40-138 mIU/mL and estradiol < 30 pg/mL at entry. In the event a subject's menopause status has been clearly established (for example, the subject indicates she has been amenorrheic for 10 years), but FSH and/or estradiol levels are not consistent with a post-menopausal condition, determination of subject eligibility will be at the discretion of the principal investigator with agreement of the independent medical monitor - At least 6 weeks post-surgical bilateral oophorectomy (with or without hysterectomy) or post tubal ligation - The subject must be on stable metformin monotherapy for a minimum of 3 months prior to the Screening visit. - HbA1c of 6.5%-9.5% (inclusive) - Body Mass Index (BMI) of 22-38 kg/m^2 (inclusive) - Resting supine blood pressure (BP) < 160/90 mmHg - Have a normal 12-lead electrocardiogram (ECG) or one with changes considered to be clinically insignificant on medical review and QTc intervals as defined below: - QTcB must be <450 msec for males and <470 msec for females (based on single or average QTc value of triplicate ECGs obtained over a brief period) - QTcB must be <480 msec in subjects with Bundle Branch Block - Comprehension of the nature and purpose of the study and able to comply with the protocol requirements - Able to communicate in person and by telephone in a manner that allows all protocol procedures to be carried out safely and reliably in the opinion of the investigative site staff Exclusion Criteria: - Any major illness in the 3 months prior to study entry or any significant ongoing chronic medical illness not related to diabetes (e.g., recent myocardial infarction, unstable angina, stroke, or transient ischemic attack) which in the opinion of the principal investigator or medical monitor could risk subject safety or interpretation of the results - Renal or liver impairment, defined as: - Serum creatinine level of ≥ 1.4 mg/dL for females and ≥ 1.5 mg/dL for males - AST and ALT ≥ 2xULN - alkaline phosphatase and bilirubin > 1.5xULN (an isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin is <35%) - A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of Screening - A positive test for HIV antibody - History of or current gastrointestinal diseases influencing drug absorption as judged by the investigator - Significant history of alcoholism or drug/chemical abuse, or a positive result of the urine drug/alcohol screen at the Screening Visit, or consuming more than 28 units of alcohol per week (one unit of alcohol equals about 250 mL of beer or lager, one glass of wine, or 20 mL spirits) - Participation in any clinical trial within 3 months prior to the first dose of investigational product in the current study - History of difficulty in donating blood or accessibility of veins in left or right arm - Donation or loss of blood (more than 500 mL) within 3 months prior to receiving the first dose of investigational product - Use of any prescription drug therapy, with the exception of any prescription medication administered at a stable dose for at least 6 weeks prior to Screening, provided the medication is not contraindicated by the metformin label (see Appendix A for Glucophage® Summary of Product Characteristics) - Use of any anti-diabetic therapy other than metformin, within 3 months of the first dose of investigational product - Use of any dietary or herbal supplements within 3 weeks prior to the first dose of investigational product - History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates their participation - Active neoplastic disease or history of neoplastic disease within 5 years of study entry (except for basal cell carcinoma of the skin or carcinoma in situ) - Increased risk of thrombosis, e.g., subjects with a history of deep leg vein thrombosis or family history of deep leg vein thrombosis, as judged by the investigator |