Downloads: 1
| # | nctid | status | why_stop | label | phase | diseases | icdcodes | drugs | smiless | criteria |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT00232479 | completed | 1 | phase 2 | ['breast cancer'] | ["['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']"] | ['trastuzumab, docetaxel and carboplatin in dose dense regimen'] | ['[H][N]([H])([H])[Pt]1(OC(=O)C2(CCC2)C(=O)O1)[N]([H])([H])[H]'] | Inclusion Criteria: - HER-2 overexpressing breast cancer - Clinical stage 2-3B - Normal ejection fraction Exclusion Criteria: - Metastatic disease - Low ejection fraction | |
| 2 | NCT01107938 | unknown status | 1 | phase 2 | ['gastroesophageal reflux disease'] | ["['K21.9', 'K21.00', 'K21.01']"] | ['10 mg ilaprazole', '15 mg ilaprazole', '40 mg esomeprazole'] | ['COC1=C(C)C(C[S+]([O-])C2=NC3=CC(=CC=C3N2)N2C=CC=C2)=NC=C1', 'COC1=C(C)C(C[S+]([O-])C2=NC3=CC(=CC=C3N2)N2C=CC=C2)=NC=C1', 'COC1=CC2=C(NC(=N2)[S@@](=O)CC2=NC=C(C)C(OC)=C2C)C=C1'] | Inclusion Criteria: - Consenting patients will be eligible for enrollment if they: - are 18-70 years of age, - have at least one of the two symptoms, heartburn and reflux, - have photographically documented erosive esophagitis confirmed by esophagogastroduodenoscopy(EGD), and graded according to the Los Angeles (LA) Classification (A-D), within 5 days before randomization to treatment. Female patients are required to be nonpregnant, nonlactating, postmenopausal, surgically sterilized, or using a medically acceptable form of birth control, as determined by the investigator. Women of child- bearing potential will receive a pregnancy test. Exclusion Criteria: - Patients will be ineligible if they: - have cancerous or peptic ulcers, Zollinger-Ellison syndrome, varices of esophagus or fundus of stomach - have a known history of gastric acid suppression operation, esophageal operation or peptic operation other than simple closure of perforation, - have severe complications, severe other diseases of digestive tract such as Crohn's disease and ulcerative colitis, and severe other systemic diseases, - have taken proton pump inhibitors within the 5 days or for more than three consecutive days within the two weeks immediately preceding start of study drug, - participated in a clinical trial with an investigational drug or device within the past three months, - have hypersensitivity or idiosyncratic reaction to ilaprazole, esomeprazole or any other benzimidazole, - have alcoholic intemperance, drug addiction or any other improper habits. | |
| 3 | NCT00310076 | completed | 0 | phase 2 | ['carcinoma of the appendix', 'colorectal cancer'] | ["['C22.0', 'C22.1', 'C4A.9', 'C7B.1', 'D09.9', 'C4A.0', 'C4A.31']", "['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']"] | ['thalidomide'] | ['CC(C)NCC(O)COC1=CC=CC2=C1C=CC=C2'] | DISEASE CHARACTERISTICS: - Pathologically confirmed peritoneal carcinomatosis or adenomucinosis secondary to colorectal or appendiceal cancer - Underwent cytoreductive surgery and intraperitoneal hyperthermic chemotherapy (IPHC) within the past 12 weeks - Patients with residual disease or no evidence of disease after IPHC are eligible - No extra-abdominal disease or parenchymal liver metastases PATIENT CHARACTERISTICS: - ECOG performance status 0-3 - Free of infection or postoperative complications - Hemoglobin > 8.0 g/dL - Absolute neutrophil count > 1,000/mm³ - Platelet count > 100,000/mm³ - PTT or PT < 1.5 times normal (except in patients who are receiving therapeutic anticoagulant therapy for non-related medical conditions, such as atrial fibrillation) - Bilirubin < 1.5 mg/dL OR direct bilirubin ≤ 1.0 mg/dL (for patients with Gilbert's syndrome) - AST/ALT ≤ 2.5 times normal - Serum creatinine < 2.0 mg/dL - No peripheral neuropathy > grade 1, except localized neuropathy due to a mechanical cause or trauma - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use 2 effective methods of contraception for 4 months prior to, during, and for 4 months after treatment with thalidomide - No history of hepatic cirrhosis - No history of severe hypothyroidism - No history of medical problem such as severe congestive heart failure or active ischemic heart disease - No other malignancy within the past 5 years except nonmelanoma skin cancer - No known history of deep vein thrombosis or pulmonary embolus PRIOR CONCURRENT THERAPY: - More than 4 weeks since prior chemotherapy, biologic therapy, or radiotherapy (except for IPHC) - No other concurrent systemic therapy - No concurrent high level sedatives - No concurrent sedating "recreational" drugs or alcohol | |
| 4 | NCT01401517 | completed | 1 | phase 2 | ['peripheral arterial disease'] | ["['A18.2', 'H11.043', 'H11.053', 'H18.463', 'H35.40', 'H81.393', 'I73.9']"] | ['sodium nitrite'] | ['[O-]N=O'] | Inclusion Criteria: - The subject is between and including 35 and 85 years of age. - Subjects must be either male or females post-menopausal, sterilized or using suitable birth control. Suitable birth control must be total abstinence, male partner sterilization or double barrier method paired with using oral contraception, injectable progestogen, implants of levonorgestrel, estrogenic vaginal ring, percutaneous contraceptive patches, or intrauterine device (IUD). - History of Peripheral Arterial Disease (PAD) confirmed by medical chart or an ankle brachial pressure index at rest ≤0.90. - If receiving medical standard treatment for cardiac risk factors, subject must have been on a stable treatment for at least 1 month prior to Screening. Treatments must have not changed significantly in the last month and are not expected to change over the duration of the study. - If subjects experience claudication symptoms, subjects must have stable lower extremity symptoms for at least 1 month prior to Screening. - Ability to provide written informed consent and willingness as documented by a signed informed consent form. Exclusion Criteria: - Non-atherosclerotic PAD. - Lower extremity surgical or percutaneous revascularization, evidence of graft failure or other peripheral vascular surgical procedure within last 6 months prior to Screening. - Anticipated lower extremity revascularization within the treatment period. - Myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack within 3 months prior to Screening. - Poorly controlled diabetes (HgA1c > 10.0). - Poorly controlled hypertension (systolic blood pressure (SBP) ≥ 160 mmHg or diastolic blood pressure (DBP) ≥ 100 mmHg) despite therapy. - Systolic blood pressure ≤100 mmHg on current medical regimen. - Hypersensitivity to sodium nitrite or related compounds. - Renal insufficiency documented as eGFR < 30 mL/minute/1.73 m2. - Pregnant or nursing women. - Life expectancy < 6 months. - A chronic illness that may increase the risks associated with this study in the opinion of the investigator. - Active malignancy requiring active anti-neoplastic therapy that will, in the opinion of the investigator, interfere with study treatment or participation. - Active infection. - NYHA CHF Class III or IV. - Recent hospitalization (< 30 days) for acute coronary syndrome, myocardial infarction, congestive heart failure or stroke. - Recent (< 30 days) coronary revascularization. - Previously treated with angiogenic factors or stem cell therapy within 1 year prior to Screening. - Involvement in another PAD clinical trial within past 1 month prior to Screening. - Exposed tendon, muscle or bone or a diagnosis of critical leg ischemia. - Previous amputation within 3 months prior to Screening or planned amputation that would limit walking (e.g. small toe is allowed). - The subject's ability to perform the 6 minute walk test is limited by symptoms other than claudication. - Current diagnosis of alcohol or other substance abuse. - History of methemoglobinemia, [met-Hb > 15%]. - Inability to speak English (due to need to administer standardized English-language questionnaire). - Evidence of anemia. - History of chronic hemolytic condition, including sickle cell disease. - Chronic use of anti-migraine medication such as Imitrex or sumatriptan. - Have a positive screen for glucose-6-phosphate dehydrogenase deficiency at screening. - Subjects who regularly take the following medications: Allopurinol, PDE-5 inhibitors, sedative tricyclic antidepressants, antihistamines, meperidine and related central nervous system depressants, and nitrates. | |
| 5 | NCT01576380 | completed | 0 | phase 2 | ['adenocarcinoma, scirrhous', 'linitis plastica', 'stomach neoplasms', 'stomach diseases', 'neoplasms by site', 'neoplasms'] | ["['D13.1', 'C16.9', 'C16.1', 'C16.2', 'D37.1', 'C16.8', 'C16.5']", "['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']"] | ['tki258'] | ['CN1CCN(CC1)C1=CC=C2N=C(NC2=C1)C1=C(N)C2=C(NC1=O)C=CC=C2F'] | Inclusion Criteria: - Diagnosis of advanced/metastatic scirrhous gastric carcinoma - Evidence of diffusely infiltrating gastric lesions and/or at least one measurable extra-gastric lesion - Patients previously treated with one or two systemic lines - Documented radiological confirmation of disease progression - ECOG performance status of 0 to 2 - Male and female patients aged 20 years or greater - Adequate liver, renal, and hematologic function Exclusion Criteria: - Patients who received prior treatment with an FGFR inhibitor - Patients with known brain metastases or who have signs/symptoms attributable to brain metastases and have not been assessed with radiologic imaging to rule out the presence of brain metastases - Patients with another primary malignancy within 3 years prior to starting study treatment Other protocol-defined inclusion/exclusion criteria may apply | |
| 6 | NCT01382719 | completed | 1 | phase 2 | ['female sexual arousal disorder', 'hypoactive sexual desire disorder'] | ["['F52.22']", "['F52.0']"] | ['bremelanotide'] | ['CCCC[C@H](NC(C)=O)C(=O)N[C@H]1CC(=O)NCCCC[C@H](NC(=O)[C@H](CC2=CNC3=CC=CC=C23)NC(=O)[C@H](CCCNC(N)=N)NC(=O)[C@@H](CC2=CC=CC=C2)NC(=O)[C@H](CC2=CN=CN2)NC1=O)C(O)=O'] | Inclusion Criteria: Female, at least 21 years of age, and premenopausal Previously experienced sexual arousal during sexual activity and/or normal level of desire in the past for least 2 years. Willing to engage in sexual activities Currently in stable relationship with a partner(male or female)for at least 6 months. If subject has a male sexual partner, has recorded a score of "not impotent" or "minimally impotent" on Single-question Assessment of ED. For at least 6 months before Screening, has met diagnostic criteria for FSAD, HSDD, or mixed FSAD/HSDD Has a negative serum pregnancy test (hCG) at Screening and, if subject's partner is male, has used a medically acceptable form of contraception for the 3 months before Screening (Visit 1), and is willing to continue for the duration of the trial and 1 month following the last dose of trial drug. Has a normal pelvic examination. At Screening or documented within 12 months before Screening, has:normal Pap test results with or without history of positive HPV, dysplasia, or ASCUS that has resolved or been treated;Pap test results positive for ASCUS and negative for HPV;Pap test results positive for HPV AND no ASCUS or dysplasia on Pap or condyloma present upon examination. At Screening and Visit 2, meets all necessary questionnaire scores. Exclusion Criteria: Medical condition that is unstable or uncontrolled despite current therapy. History of unresolved sexual trauma or abuse. Pregnant or nursing. Lifelong anorgasmia, vaginismus, sexual pain disorder, sexual aversion disorder, or persistent sexual arousal disorder. Female sexual dysfunction caused by untreated endocrine disease. Has or has had any of the following: hepatitis C, other infectious hepatitis, infectious blood disorders such as HIV; myocardial infarction;stroke. Has or has had any of the following within 12 months before Screening:chronic dyspareunia not attributable to vaginal dryness; pelvic inflammatory disease; chronic or complicated UTI, or an active STD other than herpes and condyloma; cervical dysplasia, including LGSIL and HGSIL and/or ASCUS with HPV; significant cervicitis as manifested by mucopurulent discharge from the cervix. Has had any of the following within 6 months before Screening:≥ 2 outbreaks of genital herpes; occurrence/recurrence of clinically significant condyloma;clinically unstable angina or clinically unstable arrhythmia;significant CNS diseases;AST or ALT concentrations > 3 times the ULN;serum creatinine > 2.5 mg/dL;any other clinically significant abnormal laboratory result. Has used prohibited medications within the 3 months before Screening: Has currently active moderate to severe vaginitis or a clinically significant vaginal infection. Has one or more significant gynecologic conditions . Is taking or has received treatment for psychosis, bipolar disorder, depression, and/or alcohol/substance abuse within 6 months before Screening. Is currently receiving psychotherapy for the treatment of FSAD and/or HSDD. Has any of the following: Uncontrolled hypertension;Systolic BP of ≥ 140 mm Hg at Screening;Diastolic BP of ≥ 90 mm Hg at Screening; Treatment for hypertension that has changed in the 3 months before Screening. Had a hysterectomy with bilateral oophorectomy. Had a hysterectomy without bilateral oophorectomy AND meets several other criteria. Is taking contraceptives that have affected the menstrual cycle or caused amenorrhea AND did not have a normal menstrual cycle before starting the contraceptive medication. | |
| 7 | NCT00640146 | completed | 1 | phase 2 | ['opioid-induced constipation'] | ["['F11.14', 'F11.181', 'F11.182', 'F11.188', 'F11.19', 'F11.24', 'F11.281']"] | ['methylnaltrexone bromide', 'placebo'] | ['C[N@+]1(CC2CC2)CC[C@]23[C@H]4OC5=C(O)C=CC(C[C@@H]1[C@]2(O)CCC4=O)=C35', '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 participants greater than or equal to (>=) 18 years of age. 2. Participants must have undergone an orthopedic procedure (that is, total knee or hip replacement, spinal fusion, or reduction of fracture(s) with or without surgical fixation post trauma). 3. Participants must be receiving opioid analgesics (a mu agonist only-not to include agents with mixed mechanisms of action such as tramadol or buprenorphine) after the procedures and be expected to require daily opioid analgesics for at least 7 days post randomization. 4. Participants must be acutely constipated following their orthopedic procedure. 5. Participants must receive all doses of study drug in either hospitals or rehabilitation facilities. 6. Participants must sign an informed consent form. 7. Females of childbearing potential must have a negative pregnancy test and use appropriate birth control throughout the study. 8. Body weight within range of 40 kilograms (kg) - 150 kg (88 - 330 pounds [lbs]). Exclusion Criteria: 1. Participants with known hypersensitivity to methylnaltrexone, naltrexone, or naloxone. 2. Participants who received any investigational new drug (experimental) in the previous 30 days. 3. Participants who have received a laxative (for example, lactulose) or an enema within 48 hours prior to the first dose. 4. Participants with constipation not attributed to post procedure opioids. 5. Participants with a history of alcohol or prescription or non-prescription drug abuse within the past 2 years. 6. Female participants who are pregnant or lactating. 7. Participants with a known history of chronic active hepatitis B or hepatitis C virus or human immunodeficiency virus (HIV) infection. | |
| 8 | NCT00350207 | completed | 1 | phase 2 | ['asthma'] | ["['J45.998', 'J82.83', 'J45.909', 'J45.991', 'J45.20', 'J45.30', 'J45.40']"] | ['tiotropium bromide', 'placebo', 'salmeterol xinafoate'] | ['[H][C@]12O[C@@]1([H])[C@]1([H])C[C@@]([H])(C[C@@]2([H])[N+]1(C)C)OC(=O)C(O)(C1=CC=CS1)C1=CC=CS1', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O', 'OCC1=C(O)C=CC(=C1)C(O)CNCCCCCCOCCCCC1=CC=CC=C1'] | Inclusion_Criteria: 1. Patients homozygous for arginine at the 16th amino acid position of the beta2 adrenergic receptor (B16 Arg/Arg) 2. All patients must sign and date an Informed Consent Form for the study prior to participation in the trial 3. Male or female outpatients with at least 18 years of age, but not older than 65 years 4. Patients must have a documented history of asthma 5. Patients must be current non-smokers or ex-smokers with a cigarette smoking history of <10 pack-years 6. Patients must be on a maintenance treatment with inhaled corticosteroids with a total daily dose of 400 - 1000 mcg budesonide or equivalent Exclusion_Criteria: 1. Patients with a significant disease other than asthma 2. Patients with a recent history (i.e., six months or less) of myocardial infarction 3. Patients who have been hospitalized for heart failure (New York Heart Association class III or IV) within the past year 4. Patients with any unstable or life threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year 5. Patients with malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years. Patients with treated basal cell carcinoma are allowed. 6. Patients with a diagnosis of chronic obstructive pulmonary disease (COPD) 7. Patients with a history of life threatening pulmonary obstruction, or a history of cystic fibrosis or clinically evident bronchiectasis 8. Patients with known active tuberculosis 9. Patients who have undergone thoracotomy with pulmonary resection. 10. Patients who have completed a pulmonary rehabilitation program in the six weeks prior to visit 1 or patients who are currently in a pulmonary rehabilitation program that will not be maintained throughout the duration of the study. | |
| 9 | NCT01267266 | terminated | per protocol, study was terminated due to low rate of randomized patients. | 0 | phase 2 | ['hormone-resistant prostate cancer', 'recurrent prostate cancer', 'stage iv prostate cancer'] | ["['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']"] | ['saracatinib'] | ['CN1CCN(CCOC2=CC3=C(C(NC4=C(Cl)C=CC5=C4OCO5)=NC=N3)C(OC3CCOCC3)=C2)CC1'] | Inclusion Criteria: - Histologically or cytologically confirmed prostate cancer with progressive disease; progressive disease may be defined as either - New clinical or radiographic metastases - Rising PSA: PSA must be greater than 1.0 ng/mL with at least 2 consecutive rises after completion of prior therapy; the PSA values documenting these rises should be separated by no less than 10 days; the baseline PSA value may be taken from the end of prior therapy - Previous treatment with docetaxel for disease progression following hormonal therapy (i.e., castrate-resistant disease) required - Treatment in the adjuvant or neoadjuvant setting will NOT be grounds for inclusion unless docetaxel has been used again in the setting of progressive CRPC - ECOG performance status 0-1 - ANC ≥ 1,500/mm³ - Hemoglobin > 9.0 g/dL - Platelet count > 100,000/mm³ - Total bilirubin < 2.0 x institutional ULN - AST/ALT < 5 x institutional ULN in the presence of bone/liver metastases - Serum creatinine (Cr) within ULN - Patients with Cr > ULN must have a Cr clearance of > 60 mL/min - Testosterone 50 ng/mL or lower if a patient is receiving an LHRH agonist - No testosterone testing is required for men who have undergone surgical orchiectomy - Fertile patients must agree to abstinence or some adequate form of contraception - No patients with any condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease) that impairs the ability to swallow AZD0530 tablets - No history of uncontrolled or unstable cardiac dysrhythmia - No resting ECG with measurable QTc interval of > 480 msec at 2 or more time points within a 24-hour period - No evidence of interstitial lung disease (bilateral, diffuse, parenchymal lung disease) - A high-resolution CT of the chest will be required during screening - No evidence of severe or uncontrolled systemic conditions (e.g., severe hepatic impairment) or current unstable or uncompensated respiratory or cardiac conditions which makes it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol - No patients with a known immunodeficiency syndrome - No patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to AZD0530 - No patients receiving any other investigational agents - Previous AZD0530 exposure is allowed provided that the patient did not show radiographic progression during treatment - Patients receiving non-steroidal anti-androgens (e.g., flutamide) or other hormonal treatment (such as ketoconazole, abiraterone, or TAK-700) must have stopped these drugs at least 28 days prior to enrollment for flutamide or ketoconazole, or at least 42 days prior to enrollment for bicalutamide or nilutamide, and the patients must have demonstrated progression of disease since the agents were suspended - Patients should be at least 2 weeks away from previous chemotherapy, surgery, or radiotherapy - No unresolved toxicity from previous treatments that are CTCAE grade 2 from previous anti-cancer therapy (except alopecia) - Patients who are currently on zoledronic acid (Zometa) or other bisphosphonate therapy are eligible provided that they have been on therapy at least 6 weeks prior to participation - Increases in bisphosphonate dosing will not be allowed (i.e., starting within 6 weeks or changing from every 3-month to every 1-month dosing) - Use of specifically prohibited CYP3A4-active agents or substances are not permitted during protocol treatment, and patients who must continue treatment with these agents are not eligible - 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 (unless otherwise specified) - No concurrent use of non-FDA approved medications |
| 10 | NCT00351715 | terminated | study stopped due to low accrual | 0 | phase 2 | ['cancer', 'pain'] | ["['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']", "['N50.82', 'R07.2', 'R07.82', 'R10.13', 'R10.33', 'R14.1', 'R52']"] | ['sublingual methadone'] | ['CCC(=O)C(CC(C)N(C)C)(C1=CC=CC=C1)C1=CC=CC=C1'] | Inclusion Criteria: - Pain due to cancer or its treatment; controlled baseline pain; - episodes of breakthrough pain every day that are "4/10" in severity or greater, ; - ast 10 minutes or longer, and - are responsive to short acting oral opioids such as morphine or hydromorphone; - are able to hole a volume of 1.0cc of water under the tongue for a 5-minute period; are able to provide written informed consent; - are able to fill out the study forms Exclusion Criteria: - Severe underlying respiratory disease such that an investigator is wary about the risk of respiratory failure from modest doses of opioid; - prior sensitivity to methadone; - currently are being administered methadone; - have breakthrough pain that in the opinion of the investigator is likely to change within the next seven days (recent or imminent radiation therapy to the main site of pain, - new chemotherapy or use of an injectable bisphosphonate likely to alter the pain, new use corticosteroids within the past week with a corresponding change in pain, or other interventions judged likely to alter pain); - are clinically unstable or have a life expectancy of less than one month making completion of the trial unlikely |
| 11 | NCT00240097 | completed | 1 | phase 2 | ['non-small cell lung cancer'] | ["['C78.00', 'C78.01', 'C78.02', 'D14.30', 'D14.31', 'D14.32', 'C34.2']"] | ['intervention a: irinotecan; oxaliplatin; neulasta', 'intervention b: etoposide; carboplatin; neulasta'] | ['[H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1', '[H][C@]12COC(=O)[C@]1([H])[C@H](C1=CC(OC)=C(O)C(OC)=C1)C1=CC3=C(OCO3)C=C1[C@H]2O[C@@H]1O[C@]2([H])CO[C@@H](C)O[C@@]2([H])[C@H](O)[C@H]1O'] | Inclusion Criteria: 1. Histologic or cytologic diagnosis of SCLC. 2. Measurable or assessable tumor parameters. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2. 4. Age between 18 and 79 years (in the State of Alabama > 18). 5. Adequate bone marrow, liver and renal function, defined as: - Absolute neutrophil count (ANC) ≥ 1500/µL - Platelet count ≥ 100,000/µL - SGOT/SGPT ≤ 2.5 x upper limit of normal or ≤ 5 x upper limit of normal when liver metastases are present. - Total bilirubin value ≤ 1.5 x upper limit of normal. - Serum creatinine value ≤ 1.5 x upper limit of normal. 6. Fully recovered from any previous surgery (at least 4 weeks since major surgery) 7. Must have recovered from prior radiation therapy (at least 3 weeks) 8. All participants must agree to practice approved methods of birth control (if applicable). A negative pregnancy test must be documented during the screening period for women of childbearing potential. 9. Must provide written informed consent and authorization to use and disclose health information (HIPAA). For Part I 10. Extensive-stage SCLC as defined as disease not confined to one hemithorax, including ipsilateral pleural effusion or pericardial effusion. 11. No prior chemotherapy. For Part II 12. Patients with either refractory disease, or who have relapsed 1st line therapy. No prior chemotherapy with Oxaliplatin or irinotecan. 13. Demonstrated tumor progression at the time of study entry. Exclusion Criteria: 1. Concurrent cancer chemotherapy, biologic therapy or radiotherapy. 2. Administration of any investigational drug within 28 days prior to administration of the current therapy. 3. Symptomatic brain metastases; those patients should be treated first with either whole brain radiation therapy or radiosurgery. 4. Concurrent serious infection. 5. Concomitant severe or uncontrolled underlying medical disease unrelated to the tumor, which is likely to compromise patient safety and affect the outcome of the study. 6. History of other malignancy (except non-melanoma skin cancer or carcinoma in situ of the cervix), unless in complete remission and off all therapy for a minimum of 2 years. 7. Neuropathy at baseline ≥ Grade 2. 8. Any evidence or history of hypersensitivity or other contraindications for the drugs used in this trial. 9. History of chronic diarrhea; or diarrhea (excess of 2-3 stools/day above normal frequency) in the past 2 weeks. 10. History of a positive serology for human immunodeficiency virus (HIV). 11. Psychiatric disorder that prevents patients from providing informed consent or following protocol instructions. 12. Pregnant or lactating women. | |
| 12 | NCT00098540 | completed | 0 | phase 2 | ['recurrent non-small cell lung cancer', 'stage iiib non-small cell lung cancer', 'stage iv non-small cell lung cancer'] | ["['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']", "['C78.00', 'C78.01', 'C78.02', 'D14.30', 'D14.31', 'D14.32', 'C34.2']"] | ['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 non-small cell lung cancer (NSCLC), meeting 1 of the following stage criteria: - Stage IIIB with pleural effusion - Stage IV - Measurable disease - At least 1 lesion ≥ 2.0 cm by conventional techniques OR ≥ 1.0 cm by spiral CT scan - The following are not considered measurable disease: - Bone lesions - Leptomeningeal disease - Ascites - Pleural/pericardial effusion - Inflammatory breast disease - Lymphangitis cutis/pulmonis - Abdominal masses not confirmed and followed by imaging techniques - Cystic lesions - No known brain metastases, even if treated and stable - Performance status - ECOG 0-2 - At least 12 weeks - Absolute neutrophil count ≥ 1,500/mm^3 - Platelet count ≥ 100,000/mm^3 - Hemoglobin ≥ 10 g/dL - No bleeding diathesis - Bilirubin ≤ 2 times upper limit of normal (ULN) - AST ≤ 3 times ULN (5 times ULN if hepatic metastasis present) - Creatinine ≤ 1.5 times ULN - No uncontrolled hypertension - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No known HIV positivity - HIV negative - Able to swallow tablets - No uncontrolled infection - No other severe underlying disease that would preclude study participation - No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or adequately treated noninvasive carcinomas - No prior immunotherapy, biologic therapy, or gene therapy - No concurrent prophylactic colony-stimulating factors - At least 4 weeks since prior low-dose weekly chemotherapy as a radiosensitizer - No other prior chemotherapy for NSCLC - No concurrent chemotherapy - See Chemotherapy - At least 4 weeks since prior radiotherapy - No prior radiotherapy to ≥ 30% of bone marrow - No concurrent radiotherapy - Concurrent palliative radiotherapy to nontarget lesions (e.g., painful pre-existing bony metastasis) allowed - Prior adjuvant therapy allowed provided recurrent disease occurred > 6 months after completion of adjuvant therapy - No prior systemic therapy for NSCLC, including all novel targeted agents (e.g., gefitinib or erlotinib) - No concurrent therapeutic anticoagulation - Prophylactic anticoagulation (e.g., low-dose warfarin) for venous and arterial devices allowed provided PT, INR, and PTT requirements are met - No other concurrent anticancer agents or therapies - No other concurrent investigational agents or therapies | |
| 13 | NCT00492206 | completed | 0 | phase 2 | ['non small cell lung cancer (nsclc)'] | ["['C78.00', 'C78.01', 'C78.02', 'D14.30', 'D14.31', 'D14.32', 'C34.2']"] | ['cetuximab'] | ['[H][C@]12SCC(COC(C)=O)=C(N1C(=O)[C@H]2NC(=O)C(=N/OC)\\C1=CSC(N)=N1)C(O)=O'] | Inclusion Criteria: - Patients must have histologically or cytologically confirmed diagnosis of non-small cell lung cancer - Patients must have surgically unresectable stage IIIA disease or stage IIIB disease without malignant pleural/pericardial effusion - Patients must have measurable disease as per the RECIST criteria, 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. See section 9.2 for the evaluation of measurable disease. - Age >18 years. Lung cancer is extremely rare in children. - ECOG performance status 0-1 (Karnofsky >70%; see Appendix A). - If available, tumor tissue should be submitted for EGFR status by IHC and correlative studies. - Patients must have normal organ and marrow function as defined below: - leukocytes >3,000/μL - absolute neutrophil count >1,500/μL - platelets >100,000/μL - total bilirubin within normal institutional limits - AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal - creatinine within normal institutional limits OR - creatinine clearance >60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal - The effects of cetuximab on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because EGFR inhibitors, chemotherapeutic agents and radiation therapy, as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. - Patients must either be not of child bearing potential or have a negative pregnancy test within 7 days of treatment. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal. - Willingness to sign an approved informed consent. Exclusion Criteria: - Patients should not have received prior chest radiation therapy. - Patients with a history of pulmonary fibrosis are excluded from study. - Patients may not be receiving any other investigational agents. - History of allergic reactions attributed to compounds of similar chemical or biologic composition to carboplatin, paclitaxel, cetuximab or other agents used in the study. - History of any cancer other than NSCLC (except non-melanoma skin cancer or carcinoma in situ of the cervix) within the last five years. - Prior therapy with known specific inhibitors of the EGFR. - History of severe allergic reaction to prior therapy with monoclonal antibodies - Peripheral neuropathy of more than grade 1 in severity - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, significant history of uncontrolled cardiac disease ie. uncontrolled hypertension, unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure,and cardiomyopathy with decreased ejection fraction, or psychiatric illness/social situations that would limit compliance with study requirements. - Pregnant women are excluded from this study because carboplatin, paclitaxel, cetuximab and radiation therapy have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with the above agents, breastfeeding should be discontinued if the mother is treated with the agents used in this study. These potential risks may also apply to other agents used in this study. - Patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy. Therefore, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with carboplatin, paclitaxel and cetuximab or other agents administered during the study. Appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated. - Active hepatitis. - History of pulmonary fibrosis. | |
| 14 | NCT00467077 | terminated | protocol was closed due to slow accrual. | 0 | phase 2 | ['kidney cancer'] | ["['D17.71', 'D30.00', 'D30.01', 'D30.02', 'D41.00', 'D41.01', 'D41.02']"] | ['gefitinib'] | ['COC1=C(OCCCN2CCOCC2)C=C2C(NC3=CC(Cl)=C(F)C=C3)=NC=NC2=C1'] | DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed renal cell carcinoma - Metastatic or advanced/unresectable disease - Measurable or nonmeasurable disease as defined by RECIST criteria - No uncontrolled brain metastases - Patients with adequately treated brain metastases who are not taking anticonvulsants and corticosteroids may be eligible PATIENT CHARACTERISTICS: - Karnofsky performance status 60-100% - Life expectancy ≥ 12 weeks - WBC ≥ 3,500/mm³ - Platelet count ≥ 100,000/mm³ - Absolute granulocyte count ≥ 1,500/mm³ - Creatinine ≤ 2.0 mg/dL OR creatinine clearance ≥ 50 mL/min - Bilirubin ≤ 1.5 mg/dL - AST ≤ 2 times upper limit of normal (ULN) - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No other malignancy within the past 5 years except adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or adequately treated stage I or II cancer from which the patient is currently in complete remission - No known severe hypersensitivity to gefitinib or its excipients - No incomplete healing from previous oncologic or other major surgery - No unresolved chronic toxicity > grade 2 from previous anticancer therapy (except alopecia and anemia) - No evidence of clinically active interstitial lung disease - Patients with chronic stable radiographic changes who are asymptomatic are eligible - No evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease) - No other significant clinical disorder or laboratory finding that would preclude study participation PRIOR CONCURRENT THERAPY: - More than 30 days since prior nonapproved or investigational drugs - More than 6 weeks since prior aldesleukin or interferon and recovered - At least 3 weeks since prior radiotherapy - No prior gefitinib - Prior chemotherapy or biological therapy allowed - Prior or concurrent bisphosphonate therapy for bone metastases allowed - No concurrent phenytoin, carbamazepine, rifampin, barbiturates, phenobarbital, or Hypericum perforatum (St. John's wort) - No other concurrent agents specifically designed to inhibit the epidermal growth factor receptor (EGFR) - No concurrent radiotherapy to measurable lesions |
| 15 | NCT00544362 | completed | 0 | phase 1/phase 2 | ['esophageal cancer'] | ["['K22.2', 'K22.81', 'Q39.4', 'P78.83', 'I85.00', 'I85.01', 'I85.10']"] | ['cisplatin', 'fluorouracil'] | ['[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', '[H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1'] | DISEASE CHARACTERISTICS: Inclusion criteria: - Histologically confirmed epidermoid or glandular carcinoma of the thoracic esophagus - Invasive disease - Only Siewert type I gastroesophageal carcinoma allowed - Resectable disease - T1N+, T2N0, T2N+, T3N0, or T3N+ (stage II or III) - No visceral metastases or mediastinal extensions compromising resectability Exclusion criteria: - Inoperable disease - Invasion of the tracheo-bronchial tree - Recurring esophageal paralysis - Esopho-tracheal fistula - Cervical esophageal carcinoma (< 19 cm above the dental arches) - Multifocal esophageal carcinoma - Superficial esophageal carcinoma (T1N0) - Esophageal carcinoma in the lymph nodes that cannot be included in the radiotherapy field or cannot be completely surgically resected - Proven metastatic disease PATIENT CHARACTERISTICS: Inclusion criteria: - WHO performance status 0-1 - Weight loss < 15% - Absolute neutrophil count ≥ 1,500/mm3 - Platelet count ≥ 100,000/mm3 - Creatinine ≤ 1.25 times upper limit of normal - PTT ≥ 80% - Albumin ≥ 35 g/L - FEV1 > 1 L - Not pregnant or nursing - Fertile patients of must use effective contraception Exclusion criteria: - Known liver cirrhosis - Renal insufficiency - Respiratory insufficiency (i.e., severe dyspnea at rest or oxygen dependence) - Progressive coronary insufficiency - Myocardial infarction in the past 6 months - Legally incapacitated - Impossible to receive study therapy due to geographical, social, or psychological reasons - Noncompliant within constraints of the study - Hematologic malignancy or other cancer except carcinoma in situ of the uterine cervix, treated nonmelanoma skin cancer, or intramucous disease treated within the past 3 years PRIOR CONCURRENT THERAPY: Exclusion criteria: - Prior anticancer chemotherapy or radiotherapy - Treatment with endoprosthesis - Surgery (esophagectomy) planned without thoracotomy | |
| 16 | NCT00109135 | completed | 0 | phase 2 | ['smoking'] | ["['O99.334', 'O99.335', 'Y93.G2', 'O99.330', 'O99.331', 'O99.332', 'O99.333']"] | ['taranabant'] | ['C[C@H](NC(=O)C(C)(C)OC1=CC=C(C=N1)C(F)(F)F)[C@@H](CC1=CC=C(Cl)C=C1)C1=CC=CC(=C1)C#N'] | Inclusion Criteria: - Smoking greater than/equal to 10 cigarettes/day for at least 1 year - Laboratory tests that meet the criteria of the study - In overall good health as determined by the investigator Exclusion Criteria: - Psychiatric diagnoses - Certain cancers - Patients who use nicotine replacement therapy - Patients on a diet regimen | |
| 17 | NCT01809262 | completed | 1 | phase 2 | ['pulmonary disease, chronic obstructive'] | ["['J44.9', 'J44.1', 'J44.0']"] | ['single dose of 5 mcg', 'single dose of placebo', 'single dose of 40 mcg', 'single dose of 20 mcg', 'single dose of 2 mcg', 'single dose of 10 mcg'] | ['COC1=CC=C(CC(C)(C)NC[C@H](O)C2=C3OCC(=O)NC3=CC(O)=C2)C=C1', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O', 'COC1=CC=C(CC(C)(C)NC[C@H](O)C2=C3OCC(=O)NC3=CC(O)=C2)C=C1', 'COC1=CC=C(CC(C)(C)NC[C@H](O)C2=C3OCC(=O)NC3=CC(O)=C2)C=C1', 'COC1=CC=C(CC(C)(C)NC[C@H](O)C2=C3OCC(=O)NC3=CC(O)=C2)C=C1', 'COC1=CC=C(CC(C)(C)NC[C@H](O)C2=C3OCC(=O)NC3=CC(O)=C2)C=C1'] | Inclusion criteria: 1. Diagnosis of chronic obstructive pulmonary disease 2. Smoking history of more than 10-pack years Exclusion criteria: 1. History of asthma, allergic rhinitis, myocardial infarction or unstable of life-threatening cardiac arrhythmias 2. Marked baseline prolongation of QT/QTc interval | |
| 18 | NCT00262210 | completed | 0 | phase 2 | ["non-hodgkin's lymphoma"] | ["['S33.110S', 'S33.111S', 'S33.120S', 'S33.121S', 'S33.130S', 'S33.131S', 'S33.140S']"] | ['cyclophosphamide epirubicin etoposide prednisolone'] | ['ClCCN(CCCl)P1(=O)NCCCO1'] | - Inclusion Criteria: 1. Histologically proven NHL, and for which intensive chemotherapy is considered treatment-of-choice. 2. HBsAg-positive. 3. No previous chemotherapy and radiotherapy. 4. No concurrent radiotherapy. AGC ≧ 2,000/mm3, Platelet ≧ 100,000/mm3 of peripheral blood. 5. Total bilirubin ≦ 2.5 mg/dl. Alanine aminotransferase (SGPT) < 200 I.U/L 6. Serum creatinine ≦1.5 mg/dl Blood urea nitrogen (BUN) ≦ 25 mg/dl 7. Objectively measurable or evaluable disease 8. Signed informed consent - Exclusion Criteria: 1. Age > 75 years, or Age < 15 years 2. Pregnant or breast-feeding women. 3. Patients with history of brain metastasis or CNS involvement. 4. Child's class B or C in patients with liver cirrhosis. 5. Impaired cardiac function with NYHA (New York Heart Association) classification ≧ GrII. 6. Concurrent glucocorticoids use (for other reasons). The conventional use of glucocorticoids for antiemetic purpose is also not allowed. | |
| 19 | NCT00721409 | completed | 1 | phase 2 | ['breast cancer'] | ["['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']"] | ['pd 0332991', 'letrozole', 'letrozole'] | ['CC(=O)C1=C(C)C2=CN=C(NC3=NC=C(C=C3)N3CCNCC3)N=C2N(C2CCCC2)C1=O', 'N#CC1=CC=C(C=C1)C(N1C=NC=N1)C1=CC=C(C=C1)C#N', 'N#CC1=CC=C(C=C1)C(N1C=NC=N1)C1=CC=C(C=C1)C#N'] | Inclusion Criteria: - Inoperable estrogen receptor positive and HER2 negative breast cancer. - Postmenopausal status. - Tumor tissue (archived acceptable) available for biomarker studies. For Phase 2 Part 2 - CCND1 amplification and/or loss of p16 as determined by the central laboratory. - Acceptable bone marrow, liver and kidney function. Exclusion Criteria: - Prior or concomitant treatment for advanced breast cancer. - Other major cancer in the past 3 years. - Important cardiovascular events in the past 6 months. | |
| 20 | NCT00191347 | completed | 0 | phase 2 | ['breast cancer'] | ["['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']"] | ['pemetrexed', 'gemcitabine'] | ['[H][N]([H])([H])[Pt](Cl)(Cl)[N]([H])([H])[H]', '[H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1'] | INCLUSION: 1. Have a performance status of 0 to 2 on the ECOG performance status schedule. 2. Patients may have had up to one prior systemic chemotherapy for metastatic disease is allowed. Prior adjuvant therapy is allowed if it has been more than one year since the end of therapy. 3. Patients must have measurable disease as defined by RECIST criteria (Therasse et al. 2000): 4. Have adequate organ function including the following EXCLUSION: 1. Have serious concomitant systemic disorders (eg, active infection) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study. | |
| 21 | NCT01078662 | active, not recruiting | 1 | phase 2 | ['ovarian', 'breast', 'prostate', 'pancreatic', 'advanced tumours'] | ["['Q50.32', 'E28.2', 'E28.8', 'E28.9', 'Q50.1', 'E28.39', 'E89.40']"] | ['olaparib'] | ['OC1=NN=C(CC2=CC(C(=O)N3CCN(CC3)C(=O)C3CC3)=C(F)C=C2)C2=CC=CC=C12'] | Inclusion Criteria: - Confirmed documented deleterious or suspected deleterious BRCA mutation. (The presence of a loss-of-function germline mutation in the BRCA1 and/or BRCA2 gene must be confirmed prior to consent according to local practice). - Confirmed malignant solid tumours for which no standard treatment exists - At least one lesion (measurable and/or non measurable) at baseline that can be accurately assessed by CT/MRI and is suitable for repeated assessment at follow up visits Exclusion Criteria: - Any previous treatment with a PARP inhibitor, including olaparib - Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication - Patients receiving any systematic chemotherapy, radiotherapy (except for palliative reasons) within 2 weeks from the last dose prior to study treatment (or a longer period depending on the defined characteristics of the agents used) | |
| 22 | NCT01607853 | completed | 1 | phase 2 | ['psoriasis vulgaris'] | ["['L40.0']"] | ['daivobet® gel applied then removed after 10 minutes (+/- 2 minutes)', 'daivobet® gel applied then removed after 20 minutes (+/- 2 minutes)', 'daivobet® gel applied for 24 hours (+/- 2 hours)', 'daivobet® gel vehicle applied for 24 hours (+/- 2 hours)'] | ['CC1=CC(O)=CC(C)=C1Cl'] | Inclusion Criteria: 1. Following verbal and written information about the trial, the subject has to provide signed and dated informed consent before any study related activities are carried out. 2. Age 18 years or above. 3. Either sex. 4. All skin types. 5. Subjects with a diagnosis of psoriasis vulgaris with lesions located on arms, legs and/or trunk. The lesions must have a total size suitable for application of 4 different products. 6. Subjects with, in the opinion of the investigator, stable psoriasis based on Total Plaque Score evaluated at screening visit and at visit 2 (baseline). 7. Subjects with psoriasis lesions (plaques) assessed by a Total Clinical Score (sum of scores of erythema, scaling and infiltration) of 4 to 9 inclusive, but each individual item ≥ 1. 8. Subjects willing and able to follow all the study procedures and complete the whole study. 9. Subjects affiliated to a social security system. 10. Female subjects of childbearing potential using a reliable method of contraception for at least 1 month before the study start and during the course of the study (e.g., oral contraceptive pill, intrauterine device, contraceptive patches, implantable contraception, condoms) or females of non-childbearing potential (i.e. postmenopausal (absence of menstrual bleeding for 2 years), hysterectomy, bilateral ovariectomy or tubal section/ligation). 11. Female with a negative urine pregnancy test (at screening visit). Exclusion Criteria: 1. Females who are pregnant, of child-bearing potential and who wish to become pregnant during the study, or who are breast feeding. 2. Systemic treatment with biological therapies (marketed or not marketed) with a possible effect on psoriasis vulgaris within 4 weeks (etanercept), 2 months (adalimumab, alefacept, infliximab), 4 months (ustekinumab) or 4 weeks/5 half-lives (which-ever is longer) for experimental biological products prior to randomisation and during the study. 3. Systemic treatments with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, immunosuppressants) within the 4- week period prior to randomisation and during the study. 4. Use of phototherapy within the following time periods prior to randomisation and during the study: - PUVA or Grenz ray therapy (4 weeks), - UVB (2 weeks). 5. Subjects using one of the following topical drugs within 4 weeks prior to randomisation and during the study: - Potent or very potent (WHO group III-IV) corticosteroids. 6. Subjects using one of the following topical drugs for the treatment of psoriasis within 2 weeks prior to randomisation and during the study: - WHO group I-II corticosteroids (except if used for treatment of scalp and/or facial psoriasis), - Topical retinoids, - Vitamin D analogues, - Topical immunomodulators (e.g. calcineurin inhibitors), - Anthracen derivatives, - Tar, - Salicylic acid. 7. Subjects using emollients on the target plaques within one week before randomisation and during the study. 8. Initiation of, or expected changes in concomitant medication that may affect psoriasis vulgaris (e.g., beta blockers, anti-malaria drugs, lithium and ACE inhibitors) within 2 weeks prior to randomisation and during the study. 9. Subjects with current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis. 10. Subjects with known/suspected disorders of calcium metabolism associated with hypercalcemia within the last 10 years, based on medical history. 11. Subjects with any of the following conditions present on the test area: viral (e.g. herpes or varicella) lesions of the skin, fungal and bacterial skin infections, parasitic infections and atrophic skin. 12. Subjects with skin manifestations in relation to syphilis or tuberculosis, rosacea, perioral dermatitis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, icthyosis, acne rosacea, ulcers and wounds within the plaque test areas. 13. History of any severe disease or serious current condition (based on subject interview and/or results of screening physical examination) which, in the opinion of the investigator, would put the subject at risk by participating in the study or would interfere significantly with the evaluation of study results or the study course (e.g. cancer, severe cardiopathy, severe renal insufficiency, severe hepatic insufficiency). 14. Subjects who have received treatment with any non-marketed drug substance (i.e., an agent which has not yet been made available for clinical use following registration) within the 4 week period prior to randomisation or longer, if the class of the substance requires a longer washout as defined above (e.g., biological treatments). 15. Subjects with current participation in any other interventional clinical trial, based on interview of the subject. 16. Subjects with known or suspected hypersensitivity to component(s) of the investigational products. 17. Subjects with any concomitant medical or dermatological disorder(s) which might preclude accurate evaluation of the psoriasis. 18. Subjects foreseeing an intensive solar exposure during the study (UV radiation, etc.) or having been exposed within two weeks preceding the screening visit. 19. Subjects impossible to contact in case of emergency. 20. Subjects who are known or, in the opinion of the investigator, are unlikely to comply with the Clinical Study Protocol (e.g. alcoholism, drug dependency or psychotic state). 21. Subjects who are in an exclusion period in the National Biomedical Research Register of the French Ministry of Health at randomisation. 22. Subjects under guardianship, hospitalized in a public or private institution, for a reason other than the research or subject deprived of freedom. 23. Subjects previously randomised in this trial. | |
| 23 | NCT01569516 | unknown status | 1 | phase 2 | ["alzheimer's disease"] | ["['G30.8', 'G30.9', 'G30.0', 'G30.1']"] | ['octohydroaminoacridine succinate tablets', 'octohydroaminoacridine succinate tablets', 'octohydroaminoacridine succinate tablets', 'placebo'] | ['CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: 1. Clinical diagnosis of probable AD based on DSM-IV and the NINCDS-ADRDA criteria. 2. Male/female patient aged between 50 and 85. 3. mild to moderate probable AD ：Middle school or above: 11 ≤MMSE ≤ 25, elementary school: 8 ≤ MMSE ≤ 20, illiteracy: 5 ≤ MMSE ≤ 16. 4. CT or MRI scan excluding another structural brain disease in one year. 5. Neurologic examination no significant abnormalities. 6. Hachinski Ischemic Score < 4；Hamilton Depression Scale ≤10. Able to complete the test procedure, audio-visual and physical ability to act to complete the neuropsychological measure. 7. Stable chaperone, more than 2 hours a day together with the patient or accumulated fewer than 14 hours per week. 8. Informed consent of the patient (or legal representative) and of the caregiver agreeing to take part in the study. Exclusion Criteria: 1. Proven or clinically suspected other type of dementia such as vascular dementia, Lewy body dementia, Parkinson's disease, frontotemporal dementia, g - Jakob disease (spastic pseudo-sclerosis), normal pressure hydrocephalus etc. 2. Sudden onset of early dementia or with gait disorders, seizures and behavioral changes. 3. Clinical manifestations of focal neurological signs (hemiparesis, sensory loss, visual field defect) or early extrapyramidal tract signs. 4. History of cerebrovascular disease and stroke. 5. Serious lack of folic acid and VitB12, syphilis antibody positive or thyroid dysfunction. 6. Mechanical intestinal obstruction patient ,Resting pulse less than 60,Severe liver or renal disease. 7. Patients with mechanical intestinal obstruction. 8. History of bone marrow transplantation.Mental illness, such as severe depression. 9. Cognitive damage caused by alcohol or drug abuse. Disable to correctly evaluate the cognitive function. 10. Critical condition, disable to make the exact evaluation of the efficacy and safety of new drug. 11. Use of any agent for the treatment of dementia within 4 weeks of randomization. 12. Be sensitive to ACHEI. 13. Be sensitive to two or more foods/drugs. 14. Use of another investigational agent within one months of screening. | |
| 24 | NCT01206101 | terminated | the decision to close the nn2211-3619 trial was based on the very low recruitment rate as well as challenges relating to trial execution and study completion. | 0 | phase 2 | ['diabetes', 'diabetes mellitus, type 1'] | ["['E23.2', 'N25.1', 'P70.2', 'O24.92', 'Z83.3', 'Z86.32', 'E10.65']", "['E10.65', 'E10.9', 'E10.21', 'E10.36', 'E10.41', 'E10.42', 'E10.44']"] | ['liraglutide', 'placebo'] | ['CN(C)C(=N)NC(N)=N', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Type 1 diabetes mellitus for at least 5 years - Candidate for islet cell transplantation based upon local accepted practice and guidelines - Reduced awareness of hypoglycaemia Exclusion Criteria: - Treatment with any anti-diabetic medication other than insulin including insulin pump within 4 weeks of trial start - Any previous organ transplantation - A history of acute idiopathic or chronic pancreatitis - Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC) |
| 25 | NCT00503386 | completed | 1 | phase 2 | ['nausea', 'vomiting', 'chemotherapy'] | ["['R11.0', 'R11.11', 'R11.2']", "['R11.10', 'R11.12', 'R11.14', 'R11.11', 'K91.0', 'O21.2', 'O21.8']", "['D61.810', 'Z51.11', 'D64.81', 'D70.1', 'Z92.21', 'P04.11', 'T80.810S']"] | ['palonosetron', 'granisetron'] | ['[H][C@]12CCCC3=C1C(=CC=C3)C(=O)N(C2)[C@@H]1CN2CCC1CC2', 'CN1N=C(C(=O)N[C@@H]2C[C@@H]3CCC[C@H](C2)N3C)C2=C1C=CC=C2'] | Inclusion Criteria: - Male or female, age ≥ 18 yrs and <70 yrs with histologically or cytologically confirmed - Malignant disease - Naive or nonnaive to chemotherapy, with a Karnofsky score of ≥ 60 - Scheduled to receive two courses of moderately emetogenic chemotherapy or cisplatin 60 ~ 80 mg/m2 on study Day 1 - Use of reliable contraceptive measures (for females of childbearing potential) and negative pregnancy test at baseline visit - Patients with hepatic, renal, or cardiovascular impairment eligible at the investigator's discretion - Patients experiencing, at maximum, mild nausea after previous chemotherapy eligible at the investigator's discretion - Predicted life expectancy of ≥ 3 months - Provision of written informed consent. Exclusion Criteria: - Inability to understand or cooperate with study procedures - Receipt of investigational drugs ≤ 30 days before study entry - Receipt of other investigational drugs during the course of this study - Seizure disorder or any condition requiring anticonvulsants, sedatives - CNS malignancy or metastasis - Ongoing emesis due to obstruction of digestive tract - Emesis, retching, or Grade 2 or 3 nausea 24 hrs before chemotherapy - Moderate or severe nausea and vomiting after any previous chemotherapy - Scheduled receipt of any chemotherapeutic agent with an emetogenicity level >3 during study Days 2-5 - Scheduled receipt of radiotherapy of the upper abdomen or cranium on study Days 2-5 - Scheduled to receive any other drug with potential antiemetic efficacy within 24 h of study initiation and throughout day 5 - Contraindications to 5-HT3 receptor antagonists - Contraindications to chemotherapy | |
| 26 | NCT01004159 | terminated | former pi left institute | 1 | phase 2 | ['colorectal cancer'] | ["['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']"] | ['cetuximab with irinotecan'] | ['[H][C@]12SCC(COC(C)=O)=C(N1C(=O)[C@H]2NC(=O)C(=N/OC)\\C1=CSC(N)=N1)C(O)=O'] | Inclusion Criteria: - Histologically confirmed colon cancer that is metastatic or unresectable - Progressed on cetuximab plus irinotecan based combination prior to enrolling on this study - Patient must have tumor tissue tested for KRAS mutation and should be confirmed to carry a wild type - ECOG less than or equal to 1 - Must have adequate organ and marrow function - Ability to understand and the willingness to sign a written informed consent document. - Presence of measurable disease defined as a lesion ≥ 2 cm by CT (or 1 cm by spiral CT). All sites of disease should be evaluated ≤ 3 weeks before treatment initiation - Patients should have failed or been deemed intolerant to other standard chemotherapy treatments such as oxaliplatin and fluoropyrimidines Exclusion Criteria: - Patients may not be receiving any other investigational agents that are not included in this study. Prior investigational anticancer agents wil not be allowed within 4 weeks prior to study treatment. Herbal medicine and vitamins wil not be considered as contraindications for enrollment on study. - Patients with known brain metastases are not eligible unless brain metastases are treated and stable on radiographic follow-up and without significant symptomatology - History of other invasive cancers with current evidence of disease - Patients should be off chemotherapy or other targeted therapies for at least 3 weeks before study treatment. Mitomycin C treatment should be at least 6 weeks before study treatment - History of allergic reactions to irinotecan - Prior severe infusion reaction to cetuximab - History of allergic reaction to tetracycline or doxycycline - Need for prior dose reduction on cetuximab secondary to grade 3 skin toxicity - Active skin toxicity of grade 2 or higher at the time of study enrollment - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. - Pregnant women are excluded from this study because the chemotherapeutic agents proposed are category D agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with chemotherapy, breastfeeding should be discontinued if the mother is treated on this study. - Grade 2 or higher hypomagnesemia at baseline evaluation |
| 27 | NCT00351195 | terminated | did not meet the criteria for continuation to second stage | 0 | phase 2 | ['hepatocellular carcinoma'] | ["['C22.0', 'C4A.9', 'C7B.1', 'C4A.0', 'C4A.31', 'C4A.51', 'C4A.8']"] | ['etoposide', 'oxaliplatin', 'capecitabine'] | ['OCCOCCN1CCN(CC1)C(C1=CC=CC=C1)C1=CC=C(Cl)C=C1', '[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 verified intra- or extrahepatic inoperable hepatocellular carcinoma or hyperdense liver lesion at computed tomography and concurrent elevated alpha-feto-protein > 400 ng/ml - PS 0-2 - Age 18-75 - Life expectancy > 12 weeks - Normal bone marrow function (neutrophiles > 1,5 x 109/l and platelets > 100 x 109/l) - Bilirubin < 2 x UNL - Transaminases < 3 x UNL - Normal renal function, Cr-EDTA clearance > 50 ml/min - No chemotherapy, radiotherapy or immunotherapy 4 weeks prior to inclusion - No uncontrolled, severe concurrent medical disease - Fertile women must have a negative pregnancy test - Fertile women must use adequate contraceptives during and 3 months after trial exposure - Signed informed consent Exclusion Criteria: - Chemotherapy, radiotherapy or immunotherapy 4 weeks prior to inclusion - Experimental therapy < 8 weeks prior to inclusion - Known DPD-deficiency - Known neuropathy - Uncontrolled, severe concurrent medical disease - Prior malignancy during the last 5 years, except for non-melanoma skin cancer and carcinoma in situ cervix uteri. |
| 28 | NCT01343745 | completed | 1 | phase 2 | ['mild persistent asthma'] | ["['J45.30', 'J45.31', 'J45.32']"] | ['bdp/formoterol', 'bdp/formoterol', 'placebo'] | ['COC1=CC=C(CC(C)NCC(O)C2=CC(NC=O)=C(O)C=C2)C=C1', 'COC1=CC=C(CC(C)NCC(O)C2=CC(NC=O)=C(O)C=C2)C=C1', '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 18-50 years of age, who have signed an informed consent form. 2. Clinical evidence of asthma 3. Steroid naïve asthmatic patients 4. FEV1 at Screening Visit is >70 % of the predicted value and at least 2.0 L. 5. Body Mass Index between 18 and 35. 6. Sensitivity to AMP at Screening Visit. 7. FENO levels >25 ppb at the Screening Visit Exclusion Criteria: 1. Having received an investigational product within 2 months of Screening Visit. 2. Inability to comply with study procedures or with study treatment intake. 3. Any significant lung disease which is considered by the investigator to be clinically significant. 4. Patients who suffer from Chronic Obstructive Pulmonary Disease (COPD) 5. Previous or current smokers who have a smoking history greater than 5 pack years. 6. Patients with any uncontrolled disease that might, in the judgment of the investigator, place the patients at undue risk or potentially compromise the results or interpretation of the study. 7. Patients with QTc >450msec at the Screening Visit. 8. Patients with serum potassium <3.5 mEq/L or >6 mEq/L. 9. Intolerance/hypersensitivity or any contra-indication to treatment with beta2-agonists and/or inhaled corticosteroids. 10. Patients who have a history of alcohol or substance abuse that in the opinion of the Investigator may be of clinical significance. 11. Patients who have undergone major surgery in the previous 3 months. 12. Patients who have had an exacerbation of asthma, requiring treatment with oral steroids during the last month prior to Screening Visit. 13. Patients treated with slow-release corticosteroids 2 months prior to Screening Visit. 14. Patients currently treated with anti-IgE Antibodies. 15. Patients who have had a respiratory tract infection within 4-weeks prior to Screening Visit. 16. Females not willing to use effective contraceptive measures such as oral contraceptive or intra-uterine device (IUD). 17. Females who are pregnant, lactating or planning to become pregnant | |
| 29 | NCT01136499 | completed | 0 | phase 2 | ['soft tissue sarcoma'] | ["['C46.1']"] | ['lbh589 (panobinostat®)'] | ['[H]\\C(=C(\\[H])C1=CC=C(CNCCC2=C(C)NC3=CC=CC=C23)C=C1)C(O)=NO'] | INCLUSION CRITERIA - Age ≥ 18 years. - Histologically proven advanced metastatic or unresectable soft tissue sarcoma, excluding osteosarcoma. - Prior treatment with a doxorubicin containing regimen whether in the adjuvant setting or for metastatic/advanced disease. If doxorubicin was given as adjuvant therapy patient may be included if relapse occurs within a year of adjuvant therapy. If relapse occurs more than one year after the completion of adjuvant therapy, the patient must have received one prior regimen for metastatic disease. Patient may have received one or more previous line of therapy. Patients with sex cord tumors may be included after prior treatment with a platinum containing regimen (pretreatment with a doxorubicin containing regimen is not required for this patients subgroup). - Patient has at least one site of measurable nodal disease at baseline ≥ 2.0 cm in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by CT scan (MRI is allowed only if CT scan can not be performed). - ECOG performance status (PS) ≤ 2. - Adequate haematological, liver and renal function: - Absolute Neutrophil Count (ANC) ≥ 1.5 G/L, - Hemoglobin ≥ 9 g/dL, - Platelets ≥ 100 G/L, - Total calcium (corrected for serum albumin) ≥ lower limit of normal (LLN) or correctable with supplements, - Magnesium ≥ LLN or correctable with supplements, - Potassium ≥ LLN or correctable with supplements, - Phosphorus ≥ LLN or correctable with supplements, - Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN) (or ≤ 5.0 x ULN if liver metastasis are present), - Serum bilirubin ≤ 1.5 x ULN, - Serum creatinine ≤ 1.5 x ULN, - If the serum creatinine is ≥ 1.5 x ULN, then a 24-hour creatinine clearance must be conducted and the result must be ≥ 50 mL/min. - Clinical euthyroidy (patients are permitted to receive thyroid hormone supplements to treat underlying hypothyroidism). - Ability to swallow capsules or tablets. - Life expectancy ≥ 12 weeks. - Mandatory affiliation with health security insurance. - Signed written informed consent. EXCLUSION CRITERIA - Prior treatment with any HDAC or HSP90 inhibitor drug. - Unresolved toxicities (≥ Grade 1) from prior therapy that would, in the opinion of the investigator, compromise patient safety. - Any of the following concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study: - Impaired cardiac function or clinically significant cardiac diseases, including any one of the following: - Left ventricular systolic function (LVEF) determined by MUGA scan or echocardiogram < center normal value, - Complete left bundle branch block, - Obligate use of a cardiac pacemaker, - Congenital long QT syndrome, - History or presence of ventricular tachyarrhythmia, - Presence of unstable atrial fibrillation (ventricular response > 100bpm), - Clinically significant resting bradycardia (< 50 bpm), - Mean corrected QT interval (QTcF - n ≥ 3) ≥ 450 msec on screening ECG, - Right bundle branch block + left anterior hemiblock (bifasicular block), - Angina pectoris ≤ 3 months prior to starting study drug, - Acute myocardial infarction (MI) ≤ 3 months prior to starting study drug, - History or presence of acute coronary syndrome, - Other clinically significant heart disease (e.g.: Congestive heart failure (CHF), uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen), - Impaired gastrointestinal (GI) function or GI disease that may significantly alter the absorption of LBH589 (e.g.: ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or extensive small bowel resection), - Other concurrent severe and/or uncontrolled medical conditions (e.g.: uncontrolled diabetes, active or uncontrolled infection, chronic obstructive or chronic restrictive pulmonary disease) that could cause unacceptable safety risks or compromise compliance with the protocol. - Current treatment with any of the medications listed in appendix 04, if the treatment cannot be discontinued or switched to a different medication prior to starting study drug. The medications listed in appendix 04 have a relative risk of prolonging the QT interval, or inducing Torsades de Pointes, or inhibit CYP3A4/5. - Major surgery ≤ 2 weeks prior starting study drug or who have not recovered from side effects of such therapy. - History of brain metastases. - Absence of at least one metastatic lesion greater than or equal to 2cm on pretreatment CT scan or other radiographic imaging as defined in RECIST criteria (appendix 02). - Systemic treatment with any anti-cancer drug, including any investigational drug that is administered on an intermittent schedule if the last dose has not been administered ≥ 4 weeks ago, or if the patient has not recovered from any ongoing toxicity prior to study enrolment. - Systemic treatment with any anti-cancer drug, including investigational drug that is administered on a chronic dosing schedule (e.g.: daily dosing, every-other-day dosing, MWF weekly) if ≤ 5 half-lives elapsed since the last dose, or if the patient has not recovered from any ongoing toxicity prior to study enrolment. - Women who are pregnant or breast feeding. - Women of childbearing potential (WCBP) are excluded unless they have a negative serum pregnancy test ≤ 48 hours prior starting study treatment. All sexually active WCBP and male patients are excluded unless they agree to use adequate contraceptive methods (injectable or implantable hormonal contraceptive, tubal ligation, intra-uterine device, barrier contraceptive with spermacide, or vasectomized partner) throughout the study. Since the potential of LBH589 to induce CYP3A4 is unknown, patients who are using oral contraceptives should use another effective method of contraception. - Current immunosuppressive syndrome. - History of another malignancy that is currently clinically significant or currently requires active intervention. - Refusal or inability to comply with the protocol or follow the instructions given to them by the clinic staff. | |
| 30 | NCT01003379 | completed | 1 | phase 2 | ['cognitive dysfunction', 'schizophrenia'] | ["['F20.0', 'F20.1', 'F20.2', 'F20.3', 'F20.5', 'F20.89', 'F20.9']"] | ['tc-5619', 'placebo'] | ['[H][C@@]1(CC2=CC=CN=C2)N2CCC(CC2)[C@@]1([H])NC(=O)C1=CC2=C(O1)C=CC=C2', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Diagnosis of schizophrenia, per DSM-IV TR criteria, as aided by the MINI International Neuropsychiatric Interview (MINI) - Controlled schizophrenia, on same dose of quetiapine or risperidone for no less than 2 months prior to screening - Age 18 - 60, male or female - Stable schizophrenia as documented by lack of psychiatric hospitalization for 2 months prior to Screening - Clinical history of stable psychotic symptoms for 1 month prior to Screening - Stable positive symptoms of schizophrenia for 4 weeks prior to Day 1, as shown by score ≤ 4 on PANSS for items related to delusion, hallucination, conceptual disorganization, and unusual thought content, at Screening and at Day 1 - Calgary Depression Scale for Schizophrenia score < 6 - Outpatient with stable housing, and presence of an informant who sees the subject at least 4 times weekly - Able to understand and sign informed consent Exclusion Criteria: - Diagnosis of schizoaffective or schizophreniform disorders 1 year prior to Screening - Patients at significant risk of suicide or of danger to themselves or others - Antipsychotics other than quetiapine or risperidone, or a change in dosing of these within 2 months of Screening - Treatment with mood stabilizers, antidepressants, or anxiolytics (short-acting hypnotics permitted) - Treatment within 1 month using cognition-affecting agents other than the above, as listed in Appendix 3 (e.g. CNS stimulants) - Use of other prohibited concomitant medications - Other concomitant medications that have been changed within 1 month prior to Screening - History within past 6 months of alcohol or illicit drug abuse - Use of smoking cessation therapy within 1 month prior to Screening - Tobacco users with no detectable urine cotinine level; and tobacco non-users with a detectable urine cotinine level - Unable to comply with study procedures in opinion of investigator, including CogState battery - History of significant other major or unstable neurological, metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, or urological disorder - Myocardial infarction - Seizure disorder - Type 1 diabetes mellitus (DM); type 2 DM that requires medication (diet-controlled allowed, with HbA1C < 7.3) - Electroconvulsive therapy within 2 months prior to Screening - Uncontrolled hypothyroidism, vitamin B12 or folic acid deficiency - Current TB or known systemic infection (HBV, HCV, HIV) - Clinically significant finding on physical exam that could be a safety issue in the study - ALT or AST levels > 2.5 times the upper limits of the laboratory reference range - Clinically significant lab or ECG abnormality that could be a safety issue in the study, including QTcF > 450msec (males) or QtcF > 480msec (females) - Women of child-bearing potential and men unwilling or unable to use accepted methods of birth control - Women with a positive pregnancy test, or who are lactating - Participation in another clinical trial in last 3 months prior to Screening - Involvement in planning or conduct of the study by site staff | |
| 31 | NCT00504270 | completed | 1 | phase 2 | ['psoriasis'] | ["['L40.0', 'L40.4', 'L40.8', 'L40.9', 'L40.1', 'L40.50']"] | ['placebo', 'rg3421 120mg', 'rg3421 20mg'] | ['CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - adult patients, 18-70 years of age; - medically stable, moderate to severe chronic plaque psoriasis. Exclusion Criteria: - any skin condition which may interfere with evaluation of the effect of study medication on plaque lesions; - confounding or concomitant condition or treatment. | |
| 32 | NCT00474916 | completed | 1 | phase 2 | ['neuropathic pain'] | ["['E85.1', 'E85.0', 'N31.0', 'N31.1', 'N31.2', 'E10.610', 'E11.610']"] | ['krn5500', 'placebo'] | ['CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - 18 years or older - Diagnosis of advanced or recurrent cancer - No options for curative chemotherapy, but palliative chemotherapy allowed under certain conditions - Refractory neuropathic pain rated 4 or greater on 0-10 scale and failure to respond to 2 commonly used treatments - If taking opioids for pain, stable regimen over past week before enrolling - Karnofsky performance status of 40 or more - Females must be sterile or post-menopausal Exclusion Criteria: - Radiation to site of neuropathic pain for past 4 weeks - Major surgery within past 2 weeks - Liver function and other key labs outside normal parameters - ECG showing significant abnormality - Myocardial Infarction (heart attack) within past 6 months - History of interstitial lung disease - History of severe allergic reaction to drugs containing polysorbate 80 - Other investigational drug within 2 weeks or 5 half-lives (whichever is longer | |
| 33 | NCT00563706 | completed | 0 | phase 2 | ['schizophrenia'] | ["['F20.0', 'F20.1', 'F20.2', 'F20.3', 'F20.5', 'F20.89', 'F20.9']"] | ['vabicaserin', 'risperidone'] | ['C1C[C@H]2CN3CCNCC4=C3C(=CC=C4)[C@H]2C1', 'OCCOCCN1CCN(CC1)C1=NC2=CC=CC=C2SC2=CC=CC=C12'] | Inclusion Criteria: - Generally healthy, men and women, aged 18 to 65. - Hospitalization because of an acute exacerbation of schizophrenia with a diagnosis of schizophrenia established greater than 1 year. - Ability to remain hospitalized for the duration of the screening period and for 4 weeks of double-blind treatment. Exclusion Criteria: - Current Axis I primary psychiatric diagnosis other than schizophrenia (DSM-IV-TR criteria). - Current diagnosis or history of substance abuse or dependence (DSM-IV-TR criteria), including alcohol (except for nicotine), within 3 months before baseline (day -1). - Subjects taking high or chronic doses of benzodiazepine at the screening evaluation who, in the investigator's judgment, would be likely to have severe withdrawal symptoms upon discontinuation. | |
| 34 | NCT00621049 | completed | 1 | phase 2 | ['non-small cell lung cancer'] | ["['C78.00', 'C78.01', 'C78.02', 'D14.30', 'D14.31', 'D14.32', 'C34.2']"] | ['docetaxel/carboplatin/bevacizumab/erlotinib', 'docetaxel/carboplatin'] | ['[H][N]([H])([H])[Pt]1(OC(=O)C2(CCC2)C(=O)O1)[N]([H])([H])[H]', '[H][N]([H])([H])[Pt]1(OC(=O)C2(CCC2)C(=O)O1)[N]([H])([H])[H]'] | Inclusion Criteria: 1. Patients must have histologically-confirmed non-small cell lung cancer (adenocarcinoma, squamous, large cell and undifferentiated). Mixed small cell and non-small histologies are excluded. 2. Patients with completely resected (R0) stage IB, II, and select III NSCLC. The following stages are eligible: IB T2 N0 IIA T1 N1 IIB T2 N1 IIB T3 N0 IIIA T3 N1 - Bronchioalveolar carcinoma that presents as a single, solitary discrete nodule or mass may be included - Patients determined to have N2 disease, that was not apparent radiologically preoperatively (and completely resected) can be included. 3. Complete surgical resection defined as the appropriate pulmonary parenchymal resection including lobectomy, bilobectomy, sleeve lobectomy, and pneumonectomy with histologically confirmed negative bronchial margins. Patients treated by segmentectomy or wedge resection are not eligible for this study. Additionally all patients must have had either a mediastinal node dissection or at least, sampling of 2 mediastinal nodal stations (levels 4,7,and 9 for right-sided tumors, and levels 5,6,7, and 9 for left-sided tumors are suggested.) 4. No evidence of metastatic disease 5. ANC >= 1500, platelets >= 100,000 and hemoglobin >= 10.0. 6. Total bilirubin <= ULN. AST and ALT and alkaline phosphatase must be WNL 7. Serum creatinine <= 1.5mg/dl (If greater than 1.5, the creatinine clearance, calculated according to the Cockroft-Gault formula, must be >= 50ml/min). 8. Patients may have had no previous chemotherapy, radiation therapy, angiogenesis inhibitor, or tyrosine kinase inhibitor for non-small cell lung cancer. 9. Patients must be able to understand the nature of this study and give written informed consent. 10. Age >= 18 years 11. Ability to start treatment between 8 and 12 weeks following surgery. 12. Ability to take oral medication. Exclusion Criteria: 1. Patients with preoperative radiologic evidence of N2 disease by either PET or CT scan (i.e. radiological evidence of metastasis to ipsilateral mediastinal and subcarinal nodes) that is confirmed as N2 disease histologically are excluded. - PLEASE SEE EXCEPTION in section 3.1.2 of protocol 2. Mixed small cell and non-small cell histologies 3. Pulmonary carcinoid tumors 4. Positive bronchial margins 5. History of prior malignancy within 5 years with the exception of skin cancer or cervical carcinoma in situ. 6. Women who are pregnant (positive pregnancy test) or breast-feeding. Subjects of childbearing potential or with partners of childbearing potential (women and men) must use effective birth control measures during treatment. 7. Treatment with a non-approved or investigational drug within 30 days before day 1 of trial treatment. 8. Patients with seizures not controlled with standard medical therapy. 9. Patients with active infection requiring parenteral antibiotics 10. Patients who have had major surgical procedure, open biopsy, or significant traumatic injury within 8 weeks of beginning study treatment or anticipation of need for major surgical procedure during the course of the study 11. Fine needle aspiration, core biopsy or other minor surgical procedure (excluding placement of a vascular access device) within 7 days of beginning study treatment. 12. Patients receiving thrombolytic therapy within 10 days of starting study treatment are also ineligible. Patients may receive prophylactic anticoagulation therapy, 1 mg coumadin daily for port clot prophylaxis. 13. Patients with proteinuria at screening as demonstrated by either: - Urine protein creatinine (UPC) ratio >= 1.0 at screening OR - Urine dipstick for proteinuria >= 2+ (patients discovered to have >= 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate >= 1 g of protein in 24hours to be eligible). 14. Patients with serious nonhealing wound, ulcer, or bone fracture. 15. Patients with evidence of bleeding diathesis or coagulopathy. 16. Patients with history of hemoptysis defined as bright red blood of ½ teaspoon or more per episode) within 8 weeks prior to study treatment. 17. History of myocardial infarction or unstable angina within 6 months of beginning study treatment. 18. Inadequately controlled hypertension (defined as systolic blood pressure > 150 and /or diastolic blood pressure > 100 mmHg on antihypertensive medications). 19. New York Heart Association (NYHA) grade II or greater CHF. 20. Serious cardiac arrhythmia requiring medication. 21. Symptomatic peripheral vascular disease. 22. History of stroke or transient ischemic attack within 6 months prior to beginning bevacizumab. 23. Any prior history of hypertensive crisis or hypertensive encephalopathy. 24. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to beginning study treatment. 25. ECOG Performance status > 1. 26. Peripheral neuropathy> grade 1. 27. Known hypersensitivity to any component of study drugs including platinum or to drugs formulated with polysorbate 80. 28. Impaired oral absorption. 29. Inability to comply with study and/or follow-up procedures. | |
| 35 | NCT00325351 | completed | 1 | phase 2 | ['ovarian neoplasms'] | ["['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']"] | ['sagopilone (zk 219477) + carboplatin'] | ['C[C@H]1CCC[C@@]2(C)O[C@H]2C[C@H](OC(=O)C[C@H](O)C(C)(C)C(=O)[C@H](CC=C)[C@H]1O)C1=CC=C2SC(C)=NC2=C1'] | Inclusion Criteria:- Must have evidence of ovarian cancer measurable by computed tomography (CT) scan or by CA125 blood levels- No radiation therapy in last 4 weeks- No chemotherapy in last 24 weeks - No immunotherapy in last 4 weeks- Good response after previous treatment with carboplatin or cisplatin and then the ovarian cancer got worse again after at least 6 months- Additional criteria determined at screening visit Exclusion Criteria:- Having had more than one treatment regimen with carboplatin or cisplatin- Prior treatment with other epothilones (e.g. ixabepilone)- Use of any investigational drug in the last 4 weeks- Previous radiation to the whole pelvis- Symptomatic brain tumors requiring radiation to the brain - Active infection- Pregnant or breast feeding- Additional criteria determined at screening visit | |
| 36 | NCT00712062 | withdrawn | lack of accrual | 0 | phase 2 | ['primary central nervous system lymphoma'] | ["['S33.110S', 'S33.111S', 'S33.120S', 'S33.121S', 'S33.130S', 'S33.131S', 'S33.140S']"] | ['pemetrexed'] | ['[H][N]([H])([H])[Pt](Cl)(Cl)[N]([H])([H])[H]'] | Inclusion Criteria: - Histological confirmation of Primary Central Nervous System Lymphoma - Male or female > 18 years of age or older - Negative pregnancy test (if of childbearing potential) - Any number of previous recurrences will be allowed - Karnofsky Performance Status > 60 - Hematocrit > 30,000 - Platelet > 100,000 - Absolute Neutrophil Count > 1,500 - Bilirubin < 1.5 x upper limits of normal - Transaminases (ALT and AST) < 1.5 x upper limits of normal - Creatinine < 1.5 x upper limits of normal - Creatinine Clearance > 45 mL/min - Adequate medical health to participate in this study - Adequate documentation of menopause (natural/surgical) or patient commitment to routine use of reliable birth control (barrier/hormonal) - Ability to read and understand the patient informed consent form - Ability and willingness to follow all requirements of the study including following all directions, taking medication as prescribed, and completion of all diaries and forms Exclusion Criteria: - Karnofsky Performance Status < 60 - Hematocrit < 30,000 - Platelet < 100,000 - Absolute Neutrophil Count < 1,500 - Bilirubin >1.5 x upper limits of normal - Transaminases (ALT & AST) > 1.5 x upper limits of normal - Creatinine > 1.5 x upper limits of normal - Creatinine Clearance < 45 mL/min - Inability to undergo gadolinium-contrasted MRIs, including severe claustrophobia or insufficient allergy prophylaxis |
| 37 | NCT01116895 | completed | 0 | phase 2 | ['psoriasis vulgaris'] | ["['L40.0']"] | ['leo 22811', 'placebo'] | ['CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Following verbal and written information about the trial the subject must provide signed and dated informed consent before any study related activity is carried out, including activities relating to the washout period. - Clinical diagnosis of psoriasis vulgaris, for at least 6 months prior to randomisation, and currently covering at least 10% of the body surface area (BSA) - Candidates for systemic anti-psoriatic treatment - Psoriasis Area and Severity Index (PASI) ≥10 - Disease severity of moderate, severe or very severe according to the Investigators' Global Assessment of disease severity (IGA) - Aged 18 years or above - Any race or ethnicity - Males, surgically sterile females (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) or post menopausal females (at least 1 year since last menses) - Attending hospital outpatient clinic or the private practice of a dermatologist Exclusion Criteria: - Systemic treatment with biological therapies whether marketed or not with a possible effect on psoriasis vulgaris within the following time periods prior to randomisation: - Etanercept - 4 weeks - Adalimumab, alefacept, infliximab - 2 months - Ustekinumab - 4 months - Systemic treatment with all other therapies (other than biologics) with a possible effect on psoriasis vulgaris (e.g.corticosteroids, retinoids, immunosuppressants, methotrexate, cyclosporin or fumaric acid) within 4 weeks prior to randomisation - PUVA therapy within 4 weeks prior to randomisation - UVB therapy within 2 weeks prior to randomisation - Any topical treatment (except for emollients/ medicated shampoo) within 2 weeks prior to randomisation - Initiation of, or changes to concomitant medication that could affect psoriasis vulgaris (e.g. beta-blockers, anti-malaria drugs, lithium) 2 weeks prior to randomisation and during the study - Current diagnosis with erythrodermic, exfoliative or pustular psoriasis - Other current skin conditions that may confound the evaluation of psoriasis vulgaris as judged by the Investigator - Generally in good health and does not have any clinically significant cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, haematologic, or gastrointestinal disease, immunologic insufficiency, or other major diseases or current condition which, in the opinion of the Investigator, would put the subject at risk by participating in the study - Current active tuberculosis or latent tuberculosis - Planned exposure to the sun during the study that may affect psoriasis vulgaris - Known malignancy or history of malignancy (other than cervical carcinoma in situ, basal cell or squamous cell carcinoma) within the 5 year period prior to randomisation - Live vaccination within the 4 weeks prior to randomisation - Males who do not agree to use adequate contraception during the study (including follow-up) to ensure their partner does not become pregnant - Known or suspected hypersensitivity to component(s) of the investigational product - Current participation in any other interventional trial - Treatment with any non-marketed drug substance (i.e. an agent which has not yet been made available for clinical use following registration) within 4 weeks or 5 half-lives (whichever is longer) prior to randomisation - Previously randomised in this study - Known or, in the opinion of the Investigator, is unlikely to comply with the Clinical Study Protocol (e.g., alcohol abuse, drug dependency or psychotic state). | |
| 38 | NCT00426127 | terminated | inadequate number of eligible patients | 0 | phase 2 | ['pancreatic cancer'] | ["['C25.3']"] | ['docetaxel', 'liposomal doxorubicin', 'enoxaparin'] | ['[H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1', '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][N]([H])([H])[Pt](Cl)(Cl)[N]([H])([H])[H]'] | Inclusion Criteria: - Histologically-confirmed pancreatic carcinoma, with at least one lesion measurable by CT scan with a longest diameter of > 10mm, (other than bone) that has either not been previously irradiated, or if previously irradiated, has demonstrated progression since the radiation therapy based on RECIST criteria. - Locally-advanced unresectable disease or be ineligible for neo-adjuvant therapy (Stage III disease, unresectable and medically unfit for neo-adjuvant treatment or decline chemo radiation treatment) or have metastatic disease. - 18 years of age or greater. Female patients with child-bearing potential must have a negative pregnancy test at screening. All patients of reproductive potential must agree to practice effective contraception in order to participate in this study for duration of treatment and for 3 months post. - WBC >3000 cells/mm3 with segments over 1800, hemoglobin >10 g/dl, platelets >150,000 cells/mm3, creatinine <1.5 mg/dl. - Hepatic function: Total Bilirubin </= ULN. AST and ALT and Alkaline Phosphatase must be within the range allowing for eligibility. In determining eligibility the more abnormal of the two values (AST or ALT) should be used. - ECOG performance status of </= 2 and an expected survival of at least 3 months. - Stable neurological status without clinical evidence of CNS metastases and/or stroke. Peripheral neuropathy must be </= Grade 1. Exclusion Criteria: - Chemotherapy or radiation therapy within the preceding 4 weeks. Patients must never have had docetaxel or liposomal or regular doxorubicin. - Spinal/epidural anesthesia and/or catheters for pain management - New York Heart Association (NYHA) class III or IV congestive heart failure - Evidence of duodenal erosion from the cancer. - Heparin or coumadin at the time of enrollment, with the exception of low dose coumadin (1 mg/day or less) administered prophylactically and/or heparin for maintenance of in-dwelling lines or ports. - Acute DVT or PE on initial evaluation - History of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 - Pregnant or breast feeding - Undergone a major surgical procedure, open biopsy, or major traumatic injury less than 4 weeks prior to study entry. Fine needle aspirations or venous access devices are allowed if placed > 7 days before study treatment begins. - Presence of active or suspected acute or chronic uncontrolled infection, including abscess or fistula - HIV positive - History of another malignancy within 5 years prior to study entry, except curatively treated basal cell skin cancer or cervical cancer in situ - Medical or psychiatric illness that would preclude study or informed consent and/or history of noncompliance to medical regimens or inability or unwillingness to return for all scheduled visits - Enoxaparin is contraindicated in patients with active major bleeding or who are at high risk for bleeding, in patients with thrombocytopenia associated with a positive in vitro test for anti-platelet antibody in the presence of enoxaparin sodium, or in patients with hypersensitivity to enoxaparin sodium. Patients with known hypersensitivity to heparin or pork products should not be treated with enoxaparin injection or any of its constituents. |
| 39 | NCT00323817 | completed | 0 | phase 2 | ['functional dyspepsia'] | ["['K30']"] | ['z-338'] | ['COC1=C(OC)C=C(C(=O)NC2=NC(=CS2)C(=O)NCCN(C(C)C)C(C)C)C(O)=C1'] | Inclusion Criteria: - Subjects presenting diagnosis of FD as defined by the Rome II - Subjects presenting postprandial fullness and/or Early satiety should be the most bothersome symptom Exclusion Criteria: - | |
| 40 | NCT00600067 | completed | 1 | phase 2 | ['diabetes'] | ["['E23.2', 'N25.1', 'P70.2', 'O24.92', 'Z83.3', 'Z86.32', 'E10.65']"] | ['phentermine/topiramate', 'placebo'] | ['CC(C)(N)CC1=CC=CC=C1', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Have completed the qualifying OB-202 trial - If females of child-bearing potential, subjects must be using adequate contraception - Provide written informed consent - Be willing and able to comply with scheduled study visits, treatment plan, lab tests and other study procedures Exclusion Criteria: - Subjects who have developed one or more morbidities during the OB-202 trial that would pose a safety concern | |
| 41 | NCT00490711 | completed | 0 | phase 2 | ['epithelial ovarian cancer'] | ["['H18.523', 'H18.521', 'H18.522', 'H18.529']"] | ['gemcitabine', 'carboplatin', 'paclitaxel'] | ['[H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1', 'N[C@@H](CCCNC(N)=N)C(O)=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'] | Inclusion Criteria: - Histologically verified epithelial ovarian cancer - FIGO stage III-IV - Patients with measurable disease. RECIST criteria with GCIG modifications will be used for response and for progression assessment. - Lesions serving as measurable disease must have the longest diameter of greater than or equal to 20 mm as measured with conventional techniques or greater than or equal to 10 mm with spiral CT scan. Lesions measured by physical examination must have a longest diameter of greater than or equal to 20 mm. Exclusion Criteria: - Ovarian tumors with low malignant potential (borderline tumors) - Non-epithelial ovarian or mixed epithelial. non epithelial tumors (e.g. mixed Mullerian tumors) - Time between definitive surgery and enrollment into the study is greater than 6 weeks - Patients who have received previous chemotherapy or radiotherapy | |
| 42 | NCT00625833 | terminated | study was terminated for futility following the planned interim analysis. | 0 | phase 2 | ['diabetic neuropathies'] | ["['G60.8']"] | ['placebo', '[s,s]-reboxetine'] | ['CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Male or female of any race at least 18 years of age - Diagnosis of painful, distal, symmetrical, sensory-motor polyneuropathy, which is due to diabetes, for at least 1 year - Patients at Visit 1 must have a score ≥40 mm on the Pain Visual Analogue Scale Exclusion Criteria: - Patients with significant hepatic impairment - Neurological disorders unrelated to diabetic neuropathy that may confuse the assessment of neuropathic pain - Any pain or other condition that may confound assessment or self-evaluation of the pain due to diabetic neuropathy - Amputations other than toes - A current or recent diagnosis (past 6 months) or episode of major depressive disorder and/or uncontrolled depression - History of transient ischemic attack or stroke - Myocardial infarction or unstable angina within the past three months |
| 43 | NCT00513656 | completed | 1 | phase 2 | ['cancer', 'pain', 'constipation'] | ["['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']", "['N50.82', 'R07.2', 'R07.82', 'R10.13', 'R10.33', 'R14.1', 'R52']", "['K59.00', 'K59.09', 'K59.01', 'K59.02', 'K59.03', 'K59.04', 'K58.1']"] | ['oxycodone', 'oxycodone/naloxone'] | ['CC(=O)OC1=CC=CC=C1C(O)=O', 'OC1=CC=C2C[C@H]3N(CC=C)CC[C@@]45[C@@H](OC1=C24)C(=O)CC[C@@]35O'] | Inclusion Criteria: 1. Male or female subjects at least 18 years or older with a diagnosis of cancer. 2. Females less than one year post-menopausal must have a negative urine pregnancy test recorded at the screening visit, be non-lactating, and willing to use adequate and highly effective method of contraception throughout the study. Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as sterilization, implants, injectables, combined oral contraceptives, some IUDs (hormonal), sexual abstinence or vasectomised partner. 3. Subjects who are receiving WHO step II or Step III analgesic medication who have constipation induced, or worsened by their opioid medication, as shown by 1. the subject's medical need of regular intake of laxatives to have at least 3 bowel evacuations per week, or having less than 3 bowel evacuations when not taking a laxative, respectively. 2. the subject's self-assessment that their constipation was induced or worsened by their current pre-study opioid medication. 4. Documented history of moderate to severe, chronic cancer pain that requires around-the-clock opioid therapy (starting dose at the beginning of the double-blind phase of oxycodone PR between 20 - 80 mg/day) and are likely to benefit from WHO step III opioid therapy for the duration of the study. Subjects must be willing to discontinue their current opioid analgesic routine. 5. Subjects are willing to discontinue pre-study laxative medication and take study specific laxative medication. 6. Subjects taking daily fibre supplementation or bulking agents are eligible if they can be maintained on a stable dose and regimen throughout the study, and in the investigators opinion are willing and able to maintain adequate hydration. 7. Subjects willing and able (e.g. mental and physical condition) to participate in all aspects of the study, including use of medication, completion of subjective evaluations, attending scheduled clinic visits, completing telephone contacts, and compliance with protocol requirements as evidenced by providing written, informed consent. 8. Subjects already taking non-opioid analgesics and all other concomitant medications (including those for the treatment of depression) are eligible to take part in the study. However, all concomitant medications that are considered necessary for the subject's welfare should be continued at a stable dose throughout the double-blind phase of the study and under the supervision of the investigator. Regarding cyclic chemotherapy please see exclusion criteria list. Exclusion Criteria: 1. Subjects that require a dose >80 mg/day oxycodone PR at the start of the double-blind phase. 2. Any history of hypersensitivity to oxycodone, naloxone, bisacodyl, related products, and other ingredients. 3. Subjects with any situation in which opioids are contra-indicated, severe respiratory depression with hypoxia and/or hypercapnia, severe chronic obstructive pulmonary disease, cor pulmonale, severe bronchial asthma, paralytic ileus. 4. Evidence of clinically significant cardiovascular, renal, hepatic or psychiatric disease, as determined by medical history, clinical laboratory tests, ECG results, and physical examination, that would place the subject at risk upon exposure to the study medication or that may confound the analysis and/or interpretation of the study results. 5. Abnormal aspartate aminotransferase (AST; SGOT), alanine aminotransferase (ALT; SGPT), or alkaline phosphatase levels (>3 times the upper limit of normal) or an abnormal total bilirubin and/or creatinine level(s) (greater than 1.5 times the upper limit of normal). 6. Subjects with known or suspected unstable brain metastases or spinal cord compression that may require changes in steroid treatment throughout the duration of the study. 7. Subjects with uncontrolled seizures. 8. Subjects with increased intracranial pressure. 9. In the investigator's opinion, subjects who are receiving hypnotics or other central nervous system (CNS) depressants that may pose a risk of additional CNS depression with opioid study medication. 10. Subjects with myxodema, not adequately treated hypothyroidism or Addisons disease. 11. Active alcohol or drug abuse and/or history of opioid abuse. 12. Subjects receiving opioid substitution therapy for opioid addiction (e.g. methadone or buprenorphine). 13. Subjects with evidence of clinically significant gastrointestinal disease (e.g. paralytic ileus, peritoneal carcinosis), significant structural abnormalities of the gastrointestinal tract (e.g. scarring, obstruction etc) either related or not related to the underlying cancer or disease progression. 14. Subjects who have a confirmed diagnosis of ongoing irritable bowel syndrome. 15. Subjects suffering from diarrhea and/or opioid withdrawal. 16. Surgery completed prior to the start of the Screening Period, or planned surgery during the study that would influence pain or bowel function during the study or preclude completion of the study. 17. Cyclic chemotherapy in the two weeks before the screening visit or planned during the core study that has shown in the past to influence bowel function. If subjects are having their first cycle of chemotherapy during the 2 weeks before the screening visit or during the double-blind phase of the study they should be excluded from the study. 18. Radiotherapy that, in the investigators opinion, would influence bowel function or pain during the double-blind phase of the study. 19. Subjects presently taking, or who have taken, naloxone 30 days prior to the start of the Screening Period. 20. Subjects who participated in a clinical research study involving a new chemical entity or an experimental drug within 30 days of study entry (defined as the start of the Screening Period). | |
| 44 | NCT00631488 | completed | 1 | phase 2 | ['diabetes mellitus, type 2'] | ["['E11.65', 'E11.9', 'E11.21', 'E11.36', 'E11.41', 'E11.42', 'E11.44']"] | ['mk-0893', 'sitagliptin', 'metformin', 'placebo for mk-0893', 'placebo for sitagliptin', 'placebo for metformin'] | ['COC1=CC2=CC=C(C=C2C=C1)C1=CC(=NN1[C@@H](C)C1=CC=C(C=C1)C(=O)NCCC(O)=O)C1=CC(Cl)=CC(Cl)=C1', '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', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Participants who have Type 2 Diabetes Mellitus, with suboptimal glucose control, while either not on AHA (antihyperglycemic agent) therapy or on monotherapy or on low-dose combination therapy Exclusion Criteria: - Participants have a history of Type 1 Diabetes Mellitus - Participants taking insulin or thiazolidinediones (TZDs: peroxisome proliferator-activated receptor [PPAR]-gamma agonists) - Participants who have a contraindication to metformin or sitagliptin | |
| 45 | NCT00418028 | completed | 0 | phase 2/phase 3 | ['metastatic 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 1. Patients diagnosed with metastatic breast cancer 2. Patients that either have received previous treatment with anthracyclines and/or taxanes or not (either as advance or in metastatic disease). 3. The patient is ambulatory with a functional ECOG < 2 status (see Appendix 2). 4. Patient presents, at least one lesion measurable according to RECIST criteria (see Appendix 3) 5. Patients with a life expectancy of at least 3 months. 6. Patients that agree to and are able to fulfill the requirements of the whole protocol through the whole study. Exclusion criteria: 1. Patients that have previously shown unexpected severe reactions to therapy with fluoropyrimidines or with a known sensitivity to 5-fluorouracile. 2. Patients previously treated with capecitabine. 3. Patients with organ transplants. 4. Other diseases or severe affections: 1. Patients with previous convulsions, central nervous system diseases or psychiatric diseases, including dementia, that the investigator might consider clinically significant and which adversely affect therapeutic compliance. 2. Patients with severe intellectual impairment, unable to carry out basic daily routines and established depression. 3. Clinical significant cardiac disease (e. g. . congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmia not fully controlled with medication) or myocardial infarction within the last 12 months. 4. Severe renal impairment (baseline creatinine clearance < 30 ml/min) 5. Patients with signs of metastasis in the CNS. Patients with a history of uncontrolled convulsions, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant precluding informed consent or interfering with compliance for oral drug intake should be excluded. 6. Patients with an active infection. 7. Patients with a history of other neoplasias during the previous five years, except for basal cell skin cancer or cervical cancer in situ, both cured. 8. Patients showing the following laboratory values: 1. Neutrophil count < 555 x 109/l 2. Platelet count< 100 x 109/l 3. Serum creatinine > 1,5 x upper normality limit 4. seric bilirubin > 2,0 x upper normality limit 5. ALAT, ASAT > 2,5 x upper normality limit or > 5 x upper normality limit in case of liver metastases 6. Alkaline phosphatase > 2,5 x upper normality limit > 5 x upper normality limit in case of liver metastases o > 10 x upper normality limit in case of bone metastases. 9. Patients under radiotherapy four weeks prior to the initiation of the study treatment, or under previous radiotherapy on the marker lesions be measured during the study (new marker lesions that appear in previously irradiated areas are accepted) or patients who are receiving programmed radiotherapy. 10. Patients under major surgery within 4 weeks prior to study treatment or who have not completely recovered from the effects of major surgery. 11. Patients who lack upper gastrointestinal tract physical integrity or with malabsorption syndrome. 12. Patients who have received more than two cycles of chemotherapy for the metastatic disease. 13. Patients Her2 + per FISH ó +++ Immunohistochemistry | |
| 46 | NCT01156311 | completed | 1 | phase 2 | ['relapsing-remitting multiple sclerosis', 'multiple sclerosis'] | ["['G35', 'G93.81', 'K74.1', 'Q85.1', 'G12.21', 'G12.23', 'M34.0']", "['G35', 'C81.18']"] | ['dimethyl fumarate'] | ['[H]\\C(=C(\\[H])C(=O)OC)C(=O)OC'] | Key Inclusion Criteria: - Must have a confirmed diagnosis of relapsing-remitting multiple sclerosis (RRMS) according to McDonald criteria #1-4 (Polman et al, 2005 [Appendix I]), and have a prior brain magnetic resonance imaging (MRI) demonstrating lesion (s) consistent with multiple sclerosis (MS) from any point in time. - Must have an Expanded Disability Status Scale (EDSS) between 0.0 and 5.0, inclusive. - Must be taking the same dose of a prescribed IFNβ (either Avonex, Betaseron, Rebif) or GA for at least 12 months consecutively at the time of enrollment and remain on this treatment for the duration of the study. Participants receiving Rebif must be prescribed 44 μg by subcutaneous injection three times per week. Key Exclusion Criteria: - Primary progressive, secondary progressive, or progressive relapsing MS (as defined by Polman et al. 2005). - Other chronic disease of the immune system, malignancies, acute urologic, or pulmonary disease. - Pregnant or nursing women. - Participation within 6 months prior to study enrollment in any other drug, biologic, or device study. NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply. | |
| 47 | NCT00718640 | terminated | study stopped due to lagging enrolment. | 0 | phase 2 | ['multiple myeloma'] | ["['C90.01', 'C90.02', 'C90.00']"] | ['dexamethasone', 'bortezomib'] | ['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', 'ClCCN(CCCl)P1(=O)NCCCO1'] | Inclusion Criteria: - Participants diagnosed with symptomatic multiple myeloma based on the International Myeloma Working Group (IMWG) criteria; greater than or equal to 10 percent plasma cells in the bone marrow (or tissue biopsy) detected, monoclonal protein in the serum or urine and the, presence of end-organ injury - Participants with measurable disease defined by at least 1 of the following 5 measurements: a) serum M-protein greater than or equal to 1 gram per deciliter (g/dl), b) Urine M Protein greater than or equal to 200 milligram per 24 hour, c) Serum free light chain (FLC) assay: Involved FLC level greater than 10 mg per dl (mg/dl) provided serum FLC ratio is abnormal, d) Bone marrow plasma cells greater than or equal to 30 percent - Participants who received at least 1 prior line of chemotherapy for multiple myeloma and, is refractory to or has relapsed after the last therapy - Participants with Karnofsky performance status greater than 60 or Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 - Participants with calculated or measured creatinine clearance of less than or equal to 30 mililiter per minute (ml/min). During the screening period, 2 measures of creatinine clearance at least 7 days apart must be obtained, and both must be less than 30 ml/min Exclusion Criteria: - Participants who had received bortezomib in previous clinical trial and best response was progressive disease or experienced one or more serious events - Participants who received nitorsoureas within 6 weeks, or 2 consecutive weeks of intense corticosteroids, or immunotherapy or antibody therapy within 4 weeks before enrolment - Participants with history of allergic reaction attributable to compounds containing boron or mannitol - Participants with peripheral neuropathy of Grade 2 or greater intensity at the time of signing informed consent form - Pregnant or breast-feeding female participants |
| 48 | NCT02005484 | terminated | study terminated due to slow patient recruitment. | 0 | phase 2 | ['gastric cancer'] | ["['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']"] | ['trastuzumab'] | ['[H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1'] | Inclusion Criteria: - adult patients 18-75 years of age; - metastatic or advanced gastric cancer; - disease progression under or after 1 prior platinum-based or 5-fluoropyrimidine-based chemotherapy for metastatic disease; - >=4 weeks from last platinum-based or fluoropyrimidine-based chemotherapy; - >=1 measurable lesion; - HER2 overexpression (IHC [2+] or [3+]). Exclusion Criteria: - concurrent chemotherapy or immunotherapy; - brain or meningeal metastases; - clinically significant cardiac disease, advanced pulmonary disease or severe dyspnoea; - co-existing malignancies or malignancies diagnosed within last 5 years, except basal cell cancer or cervical cancer in situ; - women who are pregnant or breastfeeding. |
| 49 | NCT01350258 | terminated | poor accrual | 0 | phase 1/phase 2 | ['hematologic malignancies', 'acute leukemia', 'myelodysplastic syndromes (mds) other than ra or rars subtypes', "hodgkin's lymphoma", "non-hodgkin's lymphoma", 'myeloma', 'chronic myelogenous (or myeloid) leukemia (cml) resistant to sti therapy'] | ["['E70.338', 'E70.339', 'P09.3', 'O28.0', 'P61.8', 'P61.9', 'T45.8X1A']", "['C91.01', 'C91.02', 'C92.01', 'C92.02', 'C92.41', 'C92.42', 'C92.51']", "['D46.Z', 'D46.9', 'C94.6', 'D46.C']", "['S33.110S', 'S33.111S', 'S33.120S', 'S33.121S', 'S33.130S', 'S33.131S', 'S33.140S']", "['S33.110S', 'S33.111S', 'S33.120S', 'S33.121S', 'S33.130S', 'S33.131S', 'S33.140S']", "['C90.01', 'C90.02', 'C90.00']", "['Z19.2', 'A41.02', 'A49.02', 'J15.212', 'Z86.14', 'Z22.322', 'B95.62']"] | ['fludarabine', 'thiotepa', 'melphalan'] | ['ClCCN(CCCl)P1(=O)NCCCO1', 'CN(C)CCOC(C)(C1=CC=CC=C1)C1=CC=CC=N1', 'N[C@@H](CC1=CC=C(C=C1)N(CCCl)CCCl)C(O)=O'] | Inclusion Criteria: 1. Any patient with a high-risk hematologic or oncologic diagnosis in which allogeneic HSCT is thought to be beneficial, and in whom front-line therapy has already been applied. High risk is defined as: - Acute leukemia in 3rd or greater CR or with persistent disease - Myelodysplastic syndrome (MDS) other than RA or RARS subtypes. - Hodgkin's or Non-Hodgkin's lymphoma in 3rd or greater remission or with persistent disease. - Myeloma in 3rd or greater remission or with less than PR to most recent therapy. - Chronic myelogenous (or myeloid) leukemia (CML) resistant to STI therapy 2. Patients must have a related donor who is at least a 4 antigen match at the HLA-A; B; C; DR loci. 3. Patients must adequate organ function: - LVEF of > or = 50% - DLCO > or = 50% of predicted corrected for hemoglobin - Adequate liver function as defined by a serum bilirubin < or = 1.8, AST or ALT < or = 2.5X upper limit of normal - GFR of > or = 60 mL/min/1.73m2 4. Performance status > or = 80% (TJU Karnofsky) for patients > or = 60 years old or > or = 70% for patients < 60. 5. HCT-CI Score < or = 4 points for patients > or = 60 years old or < or = 5 points for patients < 60. 6. Patients must be willing to use contraception if they have childbearing potential 7. Able to give informed consent Exclusion Criteria: 1. Performance status < 80% (TJU Karnofsky) for patients > or = 60 years old or < 70% for patients < 60. 2. HCT-CI Score > 4 points for patients > or = 60 years old or > 5 points for patients < 60. 3. HIV positive 4. Active involvement of the central nervous system with malignancy 5. Inability to obtain informed consent 6. Pregnancy 7. Patients with life expectancy of < 6 months for reasons other than their underlying hematologic/oncologic disorder 8. Patients who have received alemtuzumab within 8 weeks of the transplant admission, or who have recently received horse or rabbit ant-thymocyte globulin and have an ATG level of > or = 2 ugm/ml 9. Patients with evidence of another malignancy, exclusive of a skin cancer that requires only local treatment, should not be enrolled on this protocol Donor Selection All donors are selected and screened for their ability to provide adequate infection-free apheresis products for the patient in a manner that does not put the donor at risk for negative consequences. Donor selection will be in compliance with 21 CFR 1271 and TJU BMT Program SOP CP: P009.03. |
| 50 | NCT00562120 | completed | 1 | phase 2 | ['allergic rhinitis'] | ["['J30.89', 'J30.9', 'J30.2', 'J30.1', 'J30.5', 'J30.81']"] | ['placebo', 'allegra', 'allegra-d', 'pf-03654746'] | ['CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O', 'CC(C)(C(O)=O)C1=CC=C(C=C1)C(O)CCCN1CCC(CC1)C(O)(C1=CC=CC=C1)C1=CC=CC=C1', 'CC(C)(C(O)=O)C1=CC=C(C=C1)C(O)CCCN1CCC(CC1)C(O)(C1=CC=CC=C1)C1=CC=CC=C1', 'CCNC(=O)[C@H]1C[C@](F)(C1)C1=CC(F)=C(CN2CCCC2)C=C1'] | Inclusion Criteria: - Male or female subjects 19-55 years with allergic rhinitis requiring treatment within the previous 2 years. - Subjects that respond to a ragweed nasal allergen challenge at screening. Exclusion Criteria: - History of asthma or FEV1 < 80% predicted. - Significant concomitant disease or medications. - Symptoms of allergic rhinitis within 2 weeks prior to screening. | |
| 51 | NCT01038856 | terminated | the study was terminated by the sponsor | 0 | phase 2 | ['polycythemia vera'] | ["['D45']"] | ['erlotinib'] | ['COCCOC1=CC2=C(C=C1OCCOC)C(NC1=CC(=CC=C1)C#C)=NC=N2'] | Inclusion Criteria: - WHO 2008 diagnosis of Polycythemia Vera Hemoglobin > 18.5 g/dl for men (16.5 g/dl for women) and presence of JAK2V617F mutation and either bone marrow trilineage myeloproliferation or subnormal serum erythropoietin level Patients may be on active treatment (phlebotomy, aspirin) ECOG performance status 0,1,2,or 3 Adequate hepatic function, adequate renal function Exclusion Criteria: - Patient with active malignancy Patients with clinically significant cardiac disease within 1 year Opthalmologic or gastrointestinal abnormalities Concurrent cytoreductive therapy is not allowed |
| 52 | NCT01405924 | terminated | low enrollment | 1 | phase 2 | ['nausea', 'vomiting'] | ["['R11.0', 'R11.11', 'R11.2']", "['R11.10', 'R11.12', 'R11.14', 'R11.11', 'K91.0', 'O21.2', 'O21.8']"] | ['fosaprepitant dimeglumine', '5-ht3 ra', 'dexamethasone', 'rescue medication'] | ['[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: - Diagnosed with either breast or gynecological cancer - Receiving either AC-like or CT MEC - Experienced at least 1 episode of vomiting or retching during the first 5 days following Cycle 1 of chemotherapy that was thought to be due to chemotherapy. Received standard chemotherapy-induced nausea and vomiting (CINV) prophylaxis not containing aprepitant or fosaprepitant - No change in chemotherapy at Cycle 2 - No change in Cycle 1 antiemetic regimen at Cycle 2 - Eastern Cooperative Oncology Group (ECOG) status 0-1 Exclusion Criteria: - Requires increase in systemic corticosteroid therapy - Used benzodiazepines or opiates in the 48 hours prior to Cycle 2 chemotherapy - Received or will receive radiation therapy to the abdomen or pelvis in the week prior to Visit 1 or in Days 1-6 following chemotherapy - Vomited in the 24 hours prior to Treatment Day 1 - Pregnant or breast-feeding - Participating in a study with aprepitant or fosaprepitant or has taken an investigational drug in the last 4 weeks - Symptomatic central nervous system metastasis - History of other malignancies in the last 2 years |
| 53 | NCT01851408 | withdrawn | no progression of phase 1 trial to phase 2. | 0 | phase 2 | ['melanoma', 'recurrent melanoma', 'stage iii melanoma', 'stage iv melanoma'] | ["['C43.0', 'C43.31', 'D03.9', 'C43.51', 'C43.9', 'D03.0', 'C43.4']", "['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']", "['C43.0', 'C43.31', 'D03.9', 'C43.51', 'C43.9', 'D03.0', 'C43.4']"] | ['sorafenib tosylate', 'temsirolimus'] | ['CNC(=O)C1=NC=CC(OC2=CC=C(NC(=O)NC3=CC(=C(Cl)C=C3)C(F)(F)F)C=C2)=C1', 'CN1N=NC2=C(N=CN2C1=O)C(N)=O'] | Inclusion Criteria: - Histologically or cytologically confirmed melanoma, meeting 1 of the following criteria: recurrent or unresectable stage III disease, stage IV disease, non-choroidal origin. - Tumor must be accessible to biopsy unless appropriate tumor sample collection has occurred within the past 3 months and patient agrees to provide these samples for this study. - Eastern Cooperative Oncology Group (ECOG) performance status 0-1. - Bilirubin normal - Creatinine normal or creatinine clearance ≥ 60 mL/min - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 30 days after completion of study treatment. - No history of allergic reactions attributed to compounds of similar chemical or biological composition to sorafenib or temsirolimus. - No uncontrolled hypertension, defined as systolic blood pressure > 140 mm Hg on 2 separate days < 1 week prior to study entry OR diastolic pressure > 90 mm Hg on 2 separate days < 1 week prior to study entry. - No evidence of bleeding diathesis or coagulopathy. - No condition that would impair the ability to swallow pills (e.g., gastrointestinal tract disease resulting in an inability to take oral medication; requirement for IV alimentation; or active peptic ulcer disease). - No uncontrolled illness including, but not limited to, any of the following: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness or social situations that would limit study compliance. - No traumatic injury within the past 3 weeks. - No more than 1 prior systemic chemotherapy regimen for metastatic melanoma (Phase II). - No prior sorafenib, temsirolimus, or any other agents targeting raf, vascular endothelial growth factor (VEGF)/VEGF receptor, or mTOR (Phase II). - No prior surgical procedures affecting absorption. - At least 3 weeks since prior major surgery. - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) for melanoma and recovered. - At least 4 weeks since prior radiotherapy and recovered. - Prior biologic or immunotherapeutic regimens allowed. - Prior regional chemotherapy regimens (e.g., isolated limb perfusion) allowed but only 1 prior regional chemotherapy regimen allowed if all target lesions are within the prior regional treatment field. - No concurrent enzyme-inducing antiepileptic drugs including, but not limited to, any of the following: phenytoin, carbamazepine, phenobarbital, rifampin or Hypericum perforatum (St. John's wort). - No concurrent prophylactic hematopoietic colony-stimulating factors. - No other concurrent investigational agents. - No other concurrent anticancer agents or therapies for this cancer. - No concurrent full-dose anticoagulation (i.e., warfarin, IV heparin, or low-molecular weight heparin). - No concurrent grapefruit or grapefruit juice. - No concurrent combination antiretroviral therapy for HIV-positive patients. - Concurrent prophylactic anticoagulation therapy (e.g., low-dose warfarin) allowed provided prothrombin time (PT) international normalized ratio (INR) < 1.1 times upper limits of normal (ULN). - Unidimensionally measurable disease >= 20 mm by conventional techniques or >= 10 mm by spiral computed tomography (CT) scan (longest diameter to be recorded) and margins of visible cutaneous metastatic lesions should be clearly defined and measured in at least one dimension as >= 10 mm. - No known brain metastases unless the following criteria are met: no radiographical evidence of recurrences in the brain >= 3 months after complete resection of the brain metastases, asymptomatic brain metastases stable for >= 3 months since whole-brain radiation therapy and/or stereotactic radiosurgery and must not require steroid for brain metastases. - White Blood Count (WBC) >= 3,000/mm³ - Absolute neutrophil count >= 1,500/mm³ - Platelet count >= 100,000/mm³ - Serum cholesterol =< 350 mg/dL - Triglycerides =< 400 mg/dL - Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) =< 2.5 times upper limit of normal. - No peripheral neuropathy > grade 2. - At least 5 years since prior chemotherapy for other types of cancer. |
| 54 | NCT01592747 | completed | 0 | phase 2 | ['autistic disorder', 'autism', "asperger's disorder", 'asperger syndrome', 'autism spectrum disorders', 'pervasive developmental disorder - not otherwise specified (pdd-nos)'] | ["['F84.0']", "['Z13.41']", "['F84.5']", "['F84.5']", "['Z16.12']", "['K09.0', 'Q50.1', 'F84.8', 'F84.9', 'G70.2', 'M27.0', 'F81.89']"] | ['memantine hydrochloride (hcl)', 'memantine hydrochloride (hcl)', 'placebo capsules'] | ['CC12CC3CC(C)(C1)CC(N)(C3)C2', 'CC12CC3CC(C)(C1)CC(N)(C3)C2', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: 1. Completed at least 12 weeks of exposure to study drug in lead-in study MEM-MD-91 (NCT01592786) 2. Met responder criterion at two consecutive visits separated by at least two weeks in lead-in study MEM-MD-91 3. Provide written informed assent, when developmentally appropriate, to participate in the study before conduct of any study-specific procedures. The parent/guardian/LAR must provide written informed consent before the patient's participation in the study. A separate written informed consent for the caregiver must also be obtained before the conduct of any study specific procedures 4. Have a knowledgeable caregiver who is capable of providing reliable information about the patient's condition, attending all clinic visits with the patient, and overseeing the administration of study drug. Every effort should be made to maintain the same caregiver as used in the lead-in study throughout this study 5. Have normal results from the physical examination, laboratory tests, ECG, and vital signs at Visit 1 of this study (last visit of Study MEM-MD-91). Any abnormal findings must be deemed not clinically significant by the Investigator and documented 6. Be able to speak and understand English sufficiently (or their native language if this can be accommodated by the site), as well as have a caregiver and parent/guardian/LAR who is able to speak and understand English sufficiently (or their native language if this can be accommodated by the site), to comprehend the nature of the study and to allow for the completion of all study assessments 7. Have a family that is sufficiently organized and stable to guarantee adequate safety monitoring and continuous attendance to clinic visits for the duration of the study 8. Females who are 9 years and older or who have had onset of menses must have a negative urine pregnancy test at Visit 1 9. Age of 6 years to 12 years at the time of entry into lead in study MEM-MD-91 Exclusion Criteria: 1. Patients with a concurrent medical condition that might interfere with the conduct of the study, confound interpretation of the study results, or endanger the patient's well being 2. Significant risk of suicidality based on the Investigator's judgment, the Aberrant Behavior Checklist-Irritability subscale (ABC-I), or if appropriate, as indicated by a response of "yes" to questions 4 or 5 in the suicidal ideation section of the Children's C-SSRS (Columbia-Suicide Severity Rating Scale) or any suicidal behavior. 3. Patients with evidence or history of malignancy (other than excised basal cell carcinoma) or any significant hematologic, endocrine, cardiovascular (including any rhythm disorder), neurologic, respiratory, renal, hepatic, or gastrointestinal disease 4. Female patients of child-bearing potential who are not using or not willing to use a conventional method of contraception approved by the PI. Abstinence is an acceptable method of contraception 5. Patients requiring treatment with prohibited concomitant medications 6. Patients who, in the opinion of the Investigator, might not be suitable for the study 7. Employee or immediate relative of an employee of Forest Laboratories, Inc., any of its affiliates or partners, or the study center | |
| 55 | NCT01038037 | terminated | 1. very low enrollment rate. 2. recent studies question the effect of adding panitumumab in this category of patients. 3. too high toxicity rate | 0 | phase 2 | ['non small cell lung cancer'] | ["['C78.00', 'C78.01', 'C78.02', 'D14.30', 'D14.31', 'D14.32', 'C34.2']"] | ['carboplatin', 'vinorelbine', 'panitumumab'] | ['N[C@@H](CCCNC(N)=N)C(O)=O', '[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'] | Inclusion Criteria: - Histologically confirmed metastatic (stage IV) NSCLC - Measurable disease according to RECIST v.1.0 2009 - KRAS, BRAF and PI3K wild type in primary tumor or metastatic tissue. - Age ≥18 - PS < 2 - Adequate organ function Haematology: - Neutrophil count ≥1.5x10^9/L - Platelet count ≥100x10^9/L - Leucocyte count > 3,000/mm Hepatic function: - Total bilirubin ≤ 1.5 times the upper normal limit (UNL) - Serum transaminases ≤ 2.5xUNL in absence of liver metastases, or ≤ 5xUNL in presence of liver metastases Renal Function: - Creatinine clearance ≥ 50 mL/min and serum creatinine ≤ 1.5xUNL Metabolic function: - Magnesium ≥ lower limit of normal. - Calcium ≥ lower limit of normal. Consent to translational research studies Written informed consent Exclusion Criteria: - Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrollment/randomization, active severe infections or other concurrent disease. - Known CNS metastasis (pretreatment routine assessment not required) - Prior chemotherapy for metastatic disease - Indication for radiation therapy or prior radiotherapy within 30 days before treatment start. - Other malignant diseases within 5 years prior to inclusion in the study, except basal cell squamous carcinoma of the skin and cervical carcinoma-in-situ. - Other experimental therapy within 30 days prior to treatment initiation. - History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan. - Patients pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment. - Patients (male or female) not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment. |
| 56 | NCT00642811 | completed | 1 | phase 2 | ['stable coronary artery disease'] | ["['I25.84', 'I25.41', 'I25.42', 'Z98.61', 'Q24.5', 'T46.3X6S', 'I25.82']"] | ['ticagrelor', 'clopidogrel', 'aspirin'] | ['[H][C@@](N1CCC2=C(C1)C=CS2)(C(=O)OC)C1=CC=CC=C1Cl', 'N[C@@H](CCCNC(N)=N)C(O)=O', 'CC(=O)OC1=CC=CC=C1C(O)=O'] | Inclusion Criteria: - Patients with documented stable Coronary Artery Disease (CAD) (stable angina, previous MI history, previous history of revascularization) - Females of child bearing potential must have a negative pregnancy test prior to receiving study drug and be willing to use a hormonal contraceptive in addition to double barrier contraception Exclusion Criteria: - History of Acute Coronary Syndromes within 12 months of screening or need for revascularization (angioplasty or coronary artery bypass graft (CABG)) - Any acute or chronic unstable condition in the past 30 days - Have increased bleeding risk, eg, recent gastrointestinal bleed, uncontrolled high blood pressure, low platelet count, recent major trauma - History of intolerance or allergy to aspirin or clopidogrel | |
| 57 | NCT00539994 | completed | 1 | phase 2 | ['infections, bacterial'] | ["['A49.9', 'A04.9', 'A04.8', 'A49.8']"] | ['retapamulin', 'retapamulin', 'placebo'] | ['[H][C@]12CC[C@]([H])(C[C@]([H])(C1)SCC(=O)O[C@]1([H])C[C@@](C)(C=C)[C@@]([H])(O)[C@]([H])(C)[C@]34CCC(=O)[C@@]3([H])[C@@]1(C)[C@]([H])(C)CC4)N2C', '[H][C@]12CC[C@]([H])(C[C@]([H])(C1)SCC(=O)O[C@]1([H])C[C@@](C)(C=C)[C@@]([H])(O)[C@]([H])(C)[C@]34CCC(=O)[C@@]3([H])[C@@]1(C)[C@]([H])(C)CC4)N2C', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Male and female subjects between the ages of 18 and 65, inclusive. A female is eligible to enter and participate in this study if she is non-pregnant, nonlactating and if she is of: - non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including pre-menopausal females with documented (medical report verification) hysterectomy or double oophorectomy or documented tubal ligation or post-menopausal females defined as being amenorrheic for greater than one year and having follicle stimulating hormone (FSH) levels consistent with menopause. - child-bearing potential has a negative pregnancy test at screening. In addition, she must be willing to abstain from sexual intercourse or must use a nonhormone contraception such as an IUD or diaphragm with spermicide, in addition to having their male partner use condom/spermicide. This criterion must be followed from at least the commencement of her last normal period prior to the first dose of study medication or from screening (whichever is earlier) until completion of all follow-up procedures (33 days after the last dose of study medication). - Body weight ≥ 50 kg for men and ≥ 45 kg for women and a body mass index (BMI) between 18.5 - 33 kg/m2. - The subject is able to understand and comply with requirements, instructions and restrictions listed in the consent form. - Signed and dated written informed consent prior to admission to the study. Exclusion Criteria: - Negative nasal culture for S. aureus on the first screen visit. - Negative nasal cultures for S. aureus on second and third screen visits. - Concurrent treatment with antimicrobials for an infection. - MRSA decolonization attempt in the previous 6 months (prior treatment for a MRSA infection is not an exclusion criterion). - Inability to take medications nasally. - Nasal surgery in the previous 3 months. - Evidence of active rhinitis, sinusitis, or upper respiratory infection. - Within the judgment of the Principal Investigator and the Sponsor Medical Monitor, any clinically significant hematologic, endocrine, cardiovascular, hepatic, renal, gastrointestinal, and/or pulmonary disorder; any predisposing condition that might interfere with the absorption, distribution, metabolism, and/or excretion of drugs; or any clinically relevant abnormality identified on physical examination, 12-lead ECG, or clinical laboratories at screening. A single repeat for clinical laboratories or 12- lead ECG will be allowed to determine eligibility. - The subject's systolic BP is outside the range of 90-150mmHg, or diastolic BP is outside the range of 45-95mmHg or HR is outside the range of 50-100 bpm for female subjects or 40-100 bpm for male subjects. - Subjects who have a history of allergy to the study drug or drugs of this class, or a history of drug or other allergy that, in the opinion of the investigator, contraindicates participation in the trial. In addition, if heparin is used during PK sampling, subjects with a history of sensitivity to heparin or heparin-induced thrombocytopenia should not be enrolled. - The use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St. John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of Investigator and Sponsor the medication will not interfere with the study procedures or compromise subject safety. Use of nasal medications is strictly prohibited from 7 days prior to the first screening visit and then 7 days prior to the 2nd screening visit through the final follow-up visit. - Treatment with an investigational drug within 30 days or five half-lives (whichever is longer) preceding the first dose of study medication. - The subject has a history of alcohol or substance abuse or dependence within 12 months of the study: History of regular alcohol consumption averaging > 7 drinks/wk for women or > 14 drinks/wk for men. 1 drink is equivalent to 12g alcohol = 5 oz (150ml) of wine or 12oz (360ml) of beer or 1.5 oz (45ml) of 80 proof distilled spirits within six months of screening. - Positive for Human Immunodeficiency Virus (HIV) antibody, hepatitis B virus surface antigen or hepatitis C virus antibody at screening. - Donation of blood in excess of 500 mL within 56 days prior to dosing. Note: This does not include plasma donation. - The subject has a positive urine drug or alcohol screen. - The subject has a history of illicit drug abuse or is unwilling to refrain from the use of illicit drugs and adhere to other protocol-stated restrictions while participating in the study. | |
| 58 | NCT00758693 | withdrawn | funding was withdrawn due to insufficient accrual | 0 | phase 2 | ['chronic lymphocytic leukemia'] | ["['C91.11', 'C91.12', 'C91.10']"] | ['bendamustine', 'rituximab'] | ['ClCCN(CCCl)P1(=O)NCCCO1', 'ClCCN(CCCl)P1(=O)NCCCO1'] | Inclusion Criteria: - Patients must have histologically or cytologically confirmed chronic lymphocytic leukemia. - A minimum of any one of the following disease-related symptoms must be present: - Weight loss ≥10% within the previous 6 months. - Extreme fatigue (ie, ECOG PS 2; cannot work or unable to perform usual activities). - Fevers of greater than 100.5"F for ≥ 2 weeks without evidence of infection. - Night sweats without evidence of infection. or - Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia and/or thrombocytopenia or - Autoimmune anemia and/or thrombocytopenia poorly responsive to corticosteroid therapy or - Massive (ie, >6 cm below the left costal margin) or progressive splenomegaly or - Massive nodes or clusters (ie, > 10 cm in longest diameter) or progressive lymphadenopathy or - Progressive lymphocytosis with an increase of >50% over a 2-month period, or an anticipated doubling time of less than 6 months but - Marked hypogammaglobulinemia or the development of a monoclonal protein in the absence of any of the above criteria for active disease is not sufficient for protocol therapy - No prior therapy for CLL is allowed. Participants may have taken corticosteroids previously but must be ≥ 28 days from last dose prior to enrolment. - Age >65 years. - Life expectancy of greater than 1 year. - ECOG performance status better than or equal 2. - Patients must have normal organ and marrow function as defined below: - total bilirubin within normal institutional limits unless resulting from documented hemolysis - AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal - creatinine within normal institutional limits OR - creatinine clearance >60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal - Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: - Patients who have had previous chemotherapy or radiotherapy for the treatment of CLL. - Patients may not be receiving any other investigational agents. - Patients with known brain involvement should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. - History of allergic reactions attributed to compounds of similar chemical or biologic composition to bendamustine or rituximab. - 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 are ineligible because these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. - Patients with a known history of viral hepatitis, with the exception of Hepatitis A that has recovered. - Patients who require concomitant treatment with CYP1A2 inhibitors including: Cimetidine, Ciprofloxacin, Fluvoxamine, Ticlopidine. |
| 59 | NCT00367497 | terminated | the stopping rule was applied because of low response rates. | 0 | phase 2 | ['lymphoma, non-hodgkin'] | ["['S33.110S', 'S33.111S', 'S33.120S', 'S33.121S', 'S33.130S', 'S33.131S', 'S33.140S']"] | ['rituximab, etoposide, methylprednisolone, cytarabine, cisplatin'] | ['[H][N]([H])([H])[Pt](Cl)(Cl)[N]([H])([H])[H]'] | Inclusion Criteria: - Clinical diagnosis of aggressive non-Hodgkin's lymphoma - Refractory to the first line chemotherapy or relapsed - Expression of CD20 on lymphoma cells - Measurable lesions on imaging studies Exclusion Criteria: - Blood cell counts not reaching to 3,000/microliter for white blood cells, 7 g/dl for hemoglobin, and 50,000/microliter for platelets without transfusion at the time of registration - Circulating lymphoma cells equal to or more than 25,000/microliter - Hepatic dysfunction - Renal insufficiency - Cardiac dysfunction or arrhythmia - Sever infection (bacterial, viral) - CNS involvement - Other malignancies - Pregnancy or breast feeding |
| 60 | NCT00612677 | terminated | slow accrual - the 1 patient accrued did not go on treatment | 0 | phase 2 | ['lung cancer'] | ["['C78.00', 'C78.01', 'C78.02', 'D14.30', 'D14.31', 'D14.32', 'C34.2']"] | ['oxaliplatin', 'pemetrexed'] | ['[H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1', '[H][N]([H])([H])[Pt](Cl)(Cl)[N]([H])([H])[H]'] | Inclusion Criteria: - History of completely resected NSCLC and adjuvant/neoadjuvant chemotherapy with platinum-based regimen - Histologically/cytologically confirmed recurrence of NSCLC after curative therapy with surgery and adjuvant/neoadjuvant chemotherapy - Must have measurable disease according to RECIST criteria - ECOG Performance Score of 0-2 determined within 2 weeks prior to enrollment - Expected survival > 12 weeks - Adequate bone marrow function,as evidenced by: 1. Absolute neutrophil count (ANC) > 1,500/µL 2. Platelet count > 100,000/µL 3. Hemoglobin > 8 g/dL (determined within 2 weeks prior to enrollment) - Adequate renal function evidenced by: 1. serum creatinine < 1.5 mg/dL OR 2. calculated creatinine clearance >45 mL/min. - Adequate hepatic function evidenced by: 1. Serum total bilirubin < 1.5 mg/dL OR less than the upper limit of normal (ULN) 2. Alkaline phosphatase < 3X the ULN for the reference lab (< 5X the ULN for patients with known hepatic or bony metastases) 3. SGOT/SGPT < 3X the ULN for the reference lab (< 5X the ULN for patients with known hepatic metastases) - Must be recovered from both acute and late effects of any prior surgery, radiotherapy, other antineoplastic therapy - Signed informed written consent - Patients of childbearing potential and their partners must agree to use an effective form of contraception during the study and for 90 days following last dose of study medication Exclusion Criteria: - Patients amenable to a "curative intent" therapeutic approach (re-resection with or without preoperative or postoperative therapy or chemoradiotherapy without surgery are not eligible for this study). - An active infection or with fever > 101.00 F within 3 days of first scheduled day of protocol treatment - Active CNS metastases. Patients with stable CNS disease, who have undergone radiotherapy (or surgery ± radiotherapy) at least 4 weeks prior to planned first protocol treatment and who have been on stable or decreasing dose of corticosteroids for >2 weeks are eligible - Prior malignancy within the past 5 years except for curatively treated basal cell carcinoma of the skin, cervical intra-epithelial neoplasia, or localized prostate cancer with a current PSA of < 1.0 mg/dL on 2 successive evaluations, at least 3 months apart, with most recent evaluation no more than 4 weeks prior to entry. - Any diagnosis of NSCLC occurring after 5 years of curative therapy (surgery plus adjuvant chemotherapy) for original NSCLC will be considered a second primary rather than a recurrence and will render patient ineligible for this study. An exception will be if both tumors are considered the same after a direct pathologic comparison if both, sponsor and investigator agree. - Patients that at discretion of the PI have a second primary rather than metastasis are not eligible - Known hypersensitivity to any of the components of oxaliplatin or pemetrexed. - Patients receiving concurrent investigational therapy or who have received investigational therapy within 30 days of the first scheduled day of protocol treatment - Patients who received radiotherapy to more than 33% of their bone marrow or received any radiotherapy within 4 weeks of entry - Peripheral neuropathy ≥ Grade 2 - Patients pregnant or lactating - Any other medical condition, including mental illness or substance abuse, deemed likely to interfere with patient's ability to sign informed consent, cooperate and participate in the study, or interfere with interpretation of the results. - History of allogeneic transplant - Known history of HIV or Hepatitis B or C infection. Patients with Hepatitis B carrier status only are eligible. |
| 61 | NCT00713544 | completed | 0 | phase 2 | ['rheumatoid arthritis'] | ["['M06.9', 'M05.9', 'M06.08', 'M06.00', 'M06.011', 'M06.012', 'M06.019']"] | ['azd5672', 'etanercept', 'placebo', 'azd5672', 'azd5672', 'azd5672'] | ['CCN(C1CCN(CC[C@H](C2=CC=C(C=C2)S(C)(=O)=O)C2=CC(F)=CC(F)=C2)CC1)C(=O)CC1=CC=C(C=C1)S(C)(=O)=O', '[O-][N+](=O)OC[C@@H](O[N+]([O-])=O)[C@H](CO[N+]([O-])=O)O[N+]([O-])=O', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O', 'CCN(C1CCN(CC[C@H](C2=CC=C(C=C2)S(C)(=O)=O)C2=CC(F)=CC(F)=C2)CC1)C(=O)CC1=CC=C(C=C1)S(C)(=O)=O', 'CCN(C1CCN(CC[C@H](C2=CC=C(C=C2)S(C)(=O)=O)C2=CC(F)=CC(F)=C2)CC1)C(=O)CC1=CC=C(C=C1)S(C)(=O)=O', 'CCN(C1CCN(CC[C@H](C2=CC=C(C=C2)S(C)(=O)=O)C2=CC(F)=CC(F)=C2)CC1)C(=O)CC1=CC=C(C=C1)S(C)(=O)=O'] | Inclusion Criteria: - Diagnosis of RA with active disease defined as: ≥4 swollen joints and ≥6 tender/painful joints, and either have (blood tests) elevated erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP). - At least one of the following: documented history of positive rheumatoid factor (blood test), current presence of positive rheumatoid factor (blood test), baseline radiographic erosion, presence of serum anti-cyclic citrullinated peptide antibodies (bloo - Be receiving either: Oral (tablets) or subcutaneous (injection) methotrexate for at least 6 months prior to randomisation. Exclusion Criteria: - Any other inflammatory disease in addition to RA that may interfere with the study (e.g. polymyalgia rheumatica, giant cell arteritis, reactive arthritis, etc). - Current chronic pain disorders including fibromyalgia and chronic fatigue syndromes. | |
| 62 | NCT00504556 | completed | 0 | phase 2 | ['atrial fibrillation', 'thromboembolism'] | ["['I48.0', 'I48.21', 'I48.91', 'I48.11', 'I48.19', 'I48.20']", "['O88.22', 'O88.23', 'O88.211', 'O88.212', 'O88.213', 'O88.219']"] | ['edoxaban (du-176b)', 'edoxaban (du-176b)', 'edoxaban (du-176b)', 'edoxaban (du-176b)', 'warfarin'] | ['CN(C)C(=O)[C@H]1CC[C@H](NC(=O)C(=O)NC2=NC=C(Cl)C=C2)[C@@H](C1)NC(=O)C1=NC2=C(CN(C)CC2)S1', 'CN(C)C(=O)[C@H]1CC[C@H](NC(=O)C(=O)NC2=NC=C(Cl)C=C2)[C@@H](C1)NC(=O)C1=NC2=C(CN(C)CC2)S1', 'CN(C)C(=O)[C@H]1CC[C@H](NC(=O)C(=O)NC2=NC=C(Cl)C=C2)[C@@H](C1)NC(=O)C1=NC2=C(CN(C)CC2)S1', 'CN(C)C(=O)[C@H]1CC[C@H](NC(=O)C(=O)NC2=NC=C(Cl)C=C2)[C@@H](C1)NC(=O)C1=NC2=C(CN(C)CC2)S1', 'S1SSSSSSS1'] | Inclusion Criteria: 1. Male or female, 18 to 80 years old. 2. Able to provide written informed consent. 3. Persistent non-valvular AF supported by abnormal electrocardiogram (ECG) 4. A congestive heart failure, hypertension, age ≥ 75 years, diabetes, and prior stroke (CHADS2) index score of at least 2 Exclusion Criteria: 1. Subjects with mitral valve disease or previous valvular heart surgery 2. Known contraindication to any anticoagulant including vitamin K antagonists such as warfarin 3. Known or suspected hereditary or acquired bleeding or coagulation disorder | |
| 63 | NCT00089037 | completed | 0 | phase 1/phase 2 | ['chronic myeloproliferative disorders', 'graft versus host disease', 'leukemia', 'lymphoma', 'multiple myeloma and plasma cell neoplasm', 'myelodysplastic syndromes', 'myelodysplastic/myeloproliferative diseases'] | ["['D47.1']", "['D89.810', 'D89.811', 'D89.813', 'D89.812']", "['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']", "['C96.20', 'C96.29', 'D47.09']", "['D46.9', 'D46.C', 'D46.Z']"] | ['methotrexate', 'sirolimus', 'tacrolimus'] | ['CN(CC1=CN=C2N=C(N)N=C(N)C2=N1)C1=CC=C(C=C1)C(=O)N[C@@H](CCC(O)=O)C(O)=O', 'CC(=O)CC(C1=CC=CC=C1)C1=C(O)C2=C(OC1=O)C=CC=C2', 'COC1=CC2=C(C(OC)=C1OC)C1=CC=C(OC)C(=O)C=C1C(CC2)NC(C)=O'] | DISEASE CHARACTERISTICS: - Diagnosis of hematological malignancy - No chronic phase chronic myelogenous leukemia, de novo acute leukemia in first remission, or myelodysplastic syndromes with refractory anemia - Scheduled for hematopoietic stem cell transplantation from unrelated donors - Currently receiving conditioning regimen comprising cyclosporine and total body radiotherapy (1,200 to 1,350 cGy) or busulfan and cyclosporine - Donor must be typed to the highest level of resolution - One single non-serologic disparity for A, B, or C alleles allowed provided the disparity is within the third or fourth digit of the allele - No mismatch at DRB1 or DQB1 PATIENT CHARACTERISTICS: Age - Per primary treatment protocol Performance status - Not specified Life expectancy - Not specified Hematopoietic - Not specified Hepatic - SGOT and SGPT ≤ 2.0 times upper limit of normal - Bilirubin normal - Hepatitis B and C virus negative Renal - Creatinine clearance ≥ 70 mL/min Cardiovascular - No cardiac insufficiency requiring treatment - No coronary artery disease Pulmonary - No acute pulmonary infection by chest x-ray - No severe hypoxemia with pO_2 < 70 mm Hg AND DLCO < 70% of predicted - No mild hypoxemia with pO_2 < 80 mm Hg AND DLCO < 60% of predicted Other - Not pregnant or nursing - Negative pregnancy test - HIV negative - No active systemic infection - No known hypersensitivity to macrolide antibiotics (e.g., erythromycin, azithromycin, or clarithromycin) - No prior intolerance or unresponsiveness to sirolimus PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics - No concurrent T-cell depleted transplantations Chemotherapy - See Disease Characteristics Endocrine therapy - Not specified Radiotherapy - See Disease Characteristics Surgery - Not specified Other - No concurrent grapefruit juice - No concurrent voriconazole | |
| 64 | NCT00686803 | completed | 1 | phase 2 | ['hypertension'] | ["['I15.0', 'I97.3', 'K76.6', 'P29.2', 'G93.2', 'H40.053', 'I10']"] | ['pl3994', 'placebo'] | ['CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Subjects must have had a diagnosis of essential hypertension for at least 1 year, per subject verbal history - Subject must be on a stable dose of at least one, but not more than 3 antihypertensive medications for at least 3 months, per subject verbal history. - Subject must have a systolic blood pressure at screening between 100 and 150 mmHg, and diastolic blood pressure must not exceed 105 mmHg. Exclusion Criteria: - Subject weight greater than 100 kg or less than 50 kg. - Any significant medical condition or abnormal safety laboratory results which, in the judgement of the Investigator would place the subject at significant risk. | |
| 65 | NCT00539240 | completed | 0 | phase 2/phase 3 | ['gastroesophageal reflux disease'] | ["['K21.9', 'K21.00', 'K21.01']"] | ['rabeprazole 20mg, placebo dinner and bedtime', 'rabeprazole 20 mg two times, placebo at bedtime', 'rabeprazole 20mg,placebo dinner ,low dose tricyclic antidepressant'] | ['COCCCOC1=C(C)C(CS(=O)C2=NC3=CC=CC=C3N2)=NC=C1', 'COCCCOC1=C(C)C(CS(=O)C2=NC3=CC=CC=C3N2)=NC=C1', 'CNCCC=C1C2=CC=CC=C2CCC2=CC=CC=C12'] | Inclusion Criteria: - Currently being treated with a PPI, but continue to experience GERD symptoms (such as heartburn) at least 2 times per week. Exclusion Criteria: - Known allergy or intolerance to TCA - History of serious arrhythmia or use of anti-arrhythmics - History of seizures - Subjects with significant co-morbidity, e.g., cardiovascular, respiratory, urogenital, renal, gastrointestinal, hepatic, hematological, endocrine, neurologic or psychiatric - With evidence or history of drug abuse within the past 6 months - Erosive esophagitis, esophageal ulceration, peptic stricture, Barrett's esophagus or adenocarcinoma of the esophagus on endoscopy - History of esophagogastric surgery - Gastric or duodenal lesions (ulcer, tumor, etc.) - Women who are pregnant or of childbearing age who are not on contraception - Patients who are unwilling or unable to provide informed consent - Insulin dependent diabetes | |
| 66 | NCT00268437 | terminated | trial closed early because, during an interim analysis, the primary endpoint fell short. | 0 | phase 2 | ['esophageal cancer'] | ["['K22.2', 'K22.81', 'Q39.4', 'P78.83', 'I85.00', 'I85.01', 'I85.10']"] | ['carboplatin', 'pemetrexed'] | ['N[C@@H](CCCNC(N)=N)C(O)=O', '[H][N]([H])([H])[Pt](Cl)(Cl)[N]([H])([H])[H]'] | DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed squamous cell carcinoma or adenocarcinoma of the esophagus or gastroesophageal (GE) junction - No T1-2, N0, M0 disease - No palpable or biopsy-proven involvement of supraclavicular nodes or radiographically involved supraclavicular nodes (> 1.5 cm in greatest dimension) for lesions in mid-thoracic, distal thoracic, or GE junction + Supraclavicular node involvement allowed provided there are upper thoracic esophagus primary lesions - Patients with involvement of celiac nodes (stations 15-20) are eligible if the primary lesion is mid-thoracic, distal esophagus, or GE junction - No evidence of distant metastases - Tumor must be considered surgically resectable - Patients with T4, N0 tumors that are potentially resectable are eligible - No clinically relevant pleural or peritoneal effusion that is not amenable to drainage PATIENT CHARACTERISTICS: - Eastern Cooperative Oncology Group (ECOG) performance status 0-2 - Life expectancy ≥ 12 weeks - Absolute neutrophil count ≥1,500/mm^3 - Platelet count ≥100,000/mm^3 - Hemoglobin ≥10 g/dL - Bilirubin ≤ 1.5 times upper limit of normal (ULN) - AST ≤ 3 times ULN - Creatinine clearance ≥ 45 mL/min - No New York Heart Association class III or IV congestive heart failure - Pregnant or nursing women are ineligible - Negative pregnancy test - Fertile patients must use effective contraception - No uncontrolled infection - No other severe underlying disease that would preclude study entry - No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ - No prior sensitivity or allergic reaction to pemetrexed disodium or carboplatin - Able to swallow pills PRIOR CONCURRENT THERAPY: - No prior chemotherapy for esophageal cancer - No prior radiotherapy field that overlapped the anticipated fields of study radiotherapy - No prior radiotherapy to > 30% of the marrow cavity - Patients taking nonsteroidal anti-inflammatory drugs (NSAIDs) must be able to discontinue use 2 days prior, during, and 2 days after pemetrexed disodium administration (5 days prior for long-life NSAIDs) - Patients must not have been receiving cyclooxygenase-2 inhibitors at study entry and while receiving protocol therapy |
| 67 | NCT00126542 | completed | 0 | phase 2 | ['fallopian tube cancer', 'primary peritoneal cavity cancer', 'recurrent ovarian epithelial cancer', 'stage iv 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']", "['H18.523', 'H18.521', 'H18.522', 'H18.529']"] | ['erlotinib hydrochloride'] | ['COCCOC1=CC2=C(C=C1OCCOC)C(NC1=CC(=CC=C1)C#C)=NC=N2'] | Inclusion Criteria: - Histologically or cytologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer - Recurrent or metastatic disease - Measurable disease, defined as ≥ 1 unidimensionally measurable indicator lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan - Must have received a platinum-containing chemotherapy regimen for primary disease - Re-treatment with a platinum-based regimen required for patients who achieved a clinical complete response (CR) to primary therapy and then had a treatment-free interval > 12 months (i.e., platinum-sensitive) unless the patient developed a hypersensitivity to platinum - Patients with a treatment-free interval < 12 months do not require prior chemotherapy for recurrent disease - No evidence of CNS disease, including primary brain tumors or brain metastasis - Performance status - ECOG 0-2 - More than 3 months - WBC ≥ 3,000/mm^3 - Absolute neutrophil count ≥ 1,500/mm^3 - Platelet count ≥ 100,000/mm^3 - No history of bleeding diathesis - SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if due to liver metastasis) - Bilirubin normal - INR ≤ 1.5 (3 if receiving warfarin) - No history of esophageal varices - Creatinine ≤ 1.5 mg/dL - Creatinine clearance ≥ 60 mL/min - Urine protein < 1+ - Urine protein < 1,000 mg on 24-hour urine collection - Urine protein:creatinine ratio < 1.0 - No arterial thromboembolic event within the past 6 months, including any of the following: - Transient ischemic attack - Cerebrovascular accident - Unstable angina pectoris - Myocardial infarction - No clinically significant peripheral artery disease - No uncontrolled hypertension - No New York Heart Association grade II-IV congestive heart failure - No serious cardiac arrhythmia requiring medication - No peripheral vascular disease ≥ grade 2 - Not pregnant - No nursing during and for ≥ 3 months after study participation - Negative pregnancy test - Fertile patients must use effective contraception during and for ≥ 3 months after study participation - No history of allergic reaction attributed to compounds of similar chemical or biological composition to study drugs (e.g., Chinese hamster ovary cell products or recombinant humanized antibodies) - No serious or non-healing wound, ulcer, or bone fracture - No active infection requiring parenteral antibiotics - No other active malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix - No gastrointestinal tract disease resulting in an inability to take oral medication - No significant traumatic injury within the past 28 days - No known HIV positivity - No prior bevacizumab - See Disease Characteristics - No more than 2 prior cytotoxic chemotherapy regimens for recurrent or refractory disease (i.e., failed to achieve a clinical CR after primary therapy) - More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) - More than 4 weeks since prior radiotherapy - No prior radiotherapy to any indicator lesion unless disease has progressed since completion of radiotherapy - More than 4 weeks since prior major surgical procedure or open biopsy - More than 1 week since prior core biopsy - No prior surgery affecting absorption - No concurrent major surgery - Recovered from prior therapy - No prior vascular endothelial growth factor (VEGF) or an epidermal growth factor receptor (EGFR) directed therapy - No prior erlotinib - At least 30 days since prior investigational drugs - More than 1 month since prior thrombolytic agents - Concurrent warfarin allowed provided the following criteria are met: - Patient is on a therapeutic stable dose of warfarin - INR ≤ 3 - No active bleeding or pathological condition that would confer a high risk of bleeding (e.g., tumor invading adjacent organs or major blood vessels or varices that are likely to bleed) - No other concurrent investigational agents - No other concurrent anticancer therapy | |
| 68 | NCT01259050 | completed | 1 | phase 1/phase 2 | ['amyotrophic lateral sclerosis'] | ["['G12.21']"] | ['zinc and copper'] | ['Cl[Cu]Cl'] | Inclusion Criteria: 1. Age 18-85 2. Male or Female 3. Clinically definite or probable ALS by El Escorial criteria 4. ALS-FRS > 25 5. If on Riluzole they must be on a stable dose for at least 30 days prior to screening 6. Capable of providing informed consent and complying with trial procedures Exclusion Criteria: 1. Patients with FVC below 50% 2. History of liver disease 3. Severe renal failure 4. Creatinine greater than or equal to 1.5 mg/dL 5. History of intolerance to zinc or copper 6. Evidence of motor neuron disease for greater than 5 years 7. Any other co-morbid condition which would make completion of the trial unlikely 8. If female, pregnant or breast-feeding; or, if of childbearing age, an unwillingness to use birth control. 9. Any other trial medications. Non-trial medications are not cause for exclusion 10. Patient with history of significant anemia 11. Elevated levels of zinc at baseline 12. Patients with copper levels below normal at baseline | |
| 69 | NCT00119262 | completed | 1 | phase 2 | ['male breast cancer', 'stage ii breast cancer', 'stage iiia breast cancer', 'stage iiib 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']", "['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']"] | ['doxorubicin hydrochloride', 'cyclophosphamide', 'paclitaxel', 'tamoxifen citrate', 'aromatase inhibition therapy'] | ['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', 'ClCCN(CCCl)P1(=O)NCCCO1', '[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=CC(NCC2=C(C)C3=C(C=C2)N=C(N)N=C3N)=CC(OC)=C1OC'] | Inclusion Criteria: - Histologically confirmed adenocarcinoma of the breast with involvement of at least one axillary or internal mammary lymph node on routine histologic examination with hematoxylin and eosin staining; NOTE: patients with axillary or internal mammary node involvement only demonstrated by immunohistochemistry are not eligible - Patients must have completed definitive breast surgery including total mastectomy and axillary dissection (modified radical mastectomy), total mastectomy and sentinel node biopsy, lumpectomy and axillary dissection, or lumpectomy and sentinel node biopsy; NOTE: axillary dissection is strongly encouraged in patients with lymph node involvement identified on sentinel node biopsy - Margins of lumpectomy or mastectomy must be histologically free of invasive breast cancer and ductal carcinoma in situ (DCIS); patients with resection margins positive for lobular carcinoma in situ (LCIS) are eligible - (ARM A ONLY) Interval between last surgery for breast cancer (lumpectomy, mastectomy, sentinel node biopsy, axillary dissection or re-excision of lumpectomy margins) and D1 must be > 28 days and =< 84 days - ECOG performance status of 0-2 - Absolute neutrophil count >= 1000/mm^3 - Platelet count >= 100,000/mm^3 - Total bilirubin =< 1.5 mg/dL - AST =< 2 upper limit of normal - Serum creatinine =< 1.5 mg/dL - Urine protein: creatinine ratio < 1.0 - PT INR =< 1.5 - PTT =< 1.5 x normal - LVEF >= institutional limits of normal by MUGA or ECHO - Prior to registration the investigator must specify if radiation is planned; patients who have undergone a lumpectomy must receive radiation; post-mastectomy radiation is at the investigator's discretion - Patients with HER2+ (3+ by IHC or FISH+) breast cancer are not eligible and should be treated with a trastuzumab-based adjuvant therapy - Patients with synchronous bilateral breast cancer (diagnosed within one month) are eligible if the higher TMN stage tumor meets the eligibility criteria for this trial - Patients must not have clinical evidence of inflammatory disease or fixed axillary nodes (N2) at diagnosis - Patients must not have received prior cytotoxic chemotherapy, hormonal therapy or radiation for this breast cancer; prior treatment with an anthracycline, anthracenedione or taxane for any condition is not allowed; NOTE: prior use of tamoxifen for chemoprevention is allowed but must be discontinued at study entry; similarly prior raloxifene use is allowed but must be discontinued at study entry - Patients must not have had a major surgical procedure within 4 weeks of entry; NOTE: non-operative biopsy or placement of a vascular access device is not considered a major surgery - Patients must not have clinically significant cardiovascular disease including: - New York Heart Association (NYHA) grade II or greater congestive heart failure - Grade II or greater peripheral vascular disease - Uncontrolled hypertension defined as SBP > 160 or DBP > 90 - Any prior history of cerebrovascular disease including TIA or stroke - Patients must not require therapeutic anticoagulation; patients with a history of deep venous thrombosis or pulmonary embolism are not eligible; NOTE: prophylactic use of anticoagulants to maintain patency of a vascular assess device is permitted - Patients may not require regular use of aspirin (daily for >= 10 days at doses of > 325 mg/day) or regular therapeutic doses of other nonsteroidal anti-inflammatory agents known to inhibit platelet function; additionally, patients using any of the following drugs known to inhibit platelet function are not eligible: dipyridamole (Persantine), ticlopidine (Ticlid), clopidogrel (Plavix) and cilostazol (Pletal); NOTE: regular use of Cox-2 inhibitors is permitted; NOTE: low-dose aspirin is permitted - Patients must not have a non-healing wound or fracture; patients with an abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months are excluded - Patients must not have hypersensitivity to paclitaxel or drugs using the vehicle Cremophor, Chinese hamster ovary cell products or other recombinant human antibodies - Patients who have experienced myocardial infarction or unstable angina within 12 months are excluded - Patients who have had experienced an arterial thrombotic event within 12 months are excluded - Patients must not have uncontrolled or clinical significant arrhythmia - Women must not be pregnant or breast-feeding due to the potential harmful effects of bevacizumab on the developing fetus; all females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy - Women of childbearing potential and sexually active males are required to use an accepted and effective method of contraception while on study and for at least 3-4 months after the last dose of bevacizumab | |
| 70 | NCT00317044 | completed | 1 | phase 2 | ['asthma', 'gerd'] | ["['J45.998', 'J82.83', 'J45.909', 'J45.991', 'J45.20', 'J45.30', 'J45.40']"] | ['esomeprazole', 'esomeprazole', 'placebo'] | ['COC1=CC2=C(NC(=N2)[S@@](=O)CC2=NC=C(C)C(OC)=C2C)C=C1', 'COC1=CC2=C(NC(=N2)[S@@](=O)CC2=NC=C(C)C(OC)=C2C)C=C1', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Adults with diagnosis of asthma since at least 6 months. - Symptoms of asthma during run-in. - At least 3 months history and present symptoms of 1 or more of the following: burning feeling behind breastbone, pain behind breastbone, acid taste in the mouth. Exclusion Criteria: - Patients with clinically relevant abnormalities. - Patients with a smoking history of ≥10 pack-year. - Patients who have had previous surgery on the esophagus or the stomach. | |
| 71 | NCT01518998 | completed | 1 | phase 2 | ['hypertension'] | ["['I15.0', 'I97.3', 'K76.6', 'P29.2', 'G93.2', 'H40.053', 'I10']"] | ['fimasartan , amlodipine, placebo'] | ['CCCCC1=NC(C)=C(CC(=S)N(C)C)C(=O)N1CC1=CC=C(C=C1)C1=C(C=CC=C1)C1=NN=NN1'] | Inclusion Criteria: 1. Subjects who agreed to participate in this study and submitted the written informed consent 2. Subjects aged 20 to 75 years 3. Essential hypertension subjects who are measured more 90mmHg, less than 114mmHg of sitting diastolic blood pressure (SiDBP) at baseline(day 0). 4. Subjects who considered to understand this study , be cooperative, and able to be followed-up whole of the study period. Exclusion Criteria: 1. Severe hypertension patients; more 115mmHg of SiDBP and/or more 185 mmHg of Sitting systolic blood pressure (SiSBP) 2. Patients with secondary hypertension 3. Patients with significant investigations - abnormal renal function (Creatinine more 1.5 times than upper limit of normal), abnormal liver function (AST, ALT more 2 times than upper normal), moderate fatty lever needed medication 4. Patients with significant investigations - Hypokalemia(Less than 3.5mmol/L), Hyperkalemia(exceeded 5.5mmol/L) 5. Patients with sodium ion or body fluid is depleted and not able to correct 6. Patients with hypotension who has sign and symptom 7. Patients with surgical and medical disease it is able to be affect to absorption, distribution, metabolism, excretion 8. Patients with severe insulin dependent or uncontrolled diabetes mellitus (HbA1c > 9%, regimen change of oral hypoglycemic agent, using insulin) 9. Patients with severe heart disease, ischemic heart disease within 6months, peripheral vascular disease, Percutaneous Transluminal Coronary Angiography (PTCA), Coronary Artery Bypass Graft (CABG) 10. Patients with significant ventricular tachycardia, atrial fibrillation, atrial flutter or other significant arrhythmia 11. Patients with hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically significant aortic valve or mitral valve disease 12. Patients with severe cerebrovascular disease 13. Patients with wasting disease, autoimmune disease, connective tissue disease at present and/or previous. 14. Patients with known severe or malignancy retinopathy 15. Patients with hepatitis B or C or HIV positive reaction 16. Patients who have a story or evidence of alcohol or drug abuse within 2years 17. Patients who are measured the mean difference of mean blood pressure of both arm under SiDBP 10mmHg or SiSBP 20mmHg at screening and baseline visit 18. Patients with history of allergic reaction to any angiotensin II antagonist 19. Patients with any chronic inflammation disease needed to chronic inflammation therapy 20. Patients with the medical histories of malignant tumor within 5years, except local basal cell carcinoma of the skin 21. Childbearing and breast-feeding women 22. Female who plan to become pregnancy or have a possibility of pregnancy but don't prevent conception with acknowledged methods 23. Patients who took medicine within 12 weeks from screening visit or is going on the progress of other clinical trial 24. Subject who are judged unsuitable to participate in this study by investigator | |
| 72 | NCT00497198 | completed | 1 | phase 2 | ['type 2 diabetes'] | ["['E11.65', 'E11.9', 'E11.21', 'E11.36', 'E11.41', 'E11.42', 'E11.44']"] | ['mci-196', 'placebo of mci-196 tablet'] | ['CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Patients whose fasting blood glucose levels during the observation period are between 130mg/dL and 200mg/dL. - Patients whose HbA1c is 7.0% or above during the observation period. Exclusion Criteria: - Patients with serious cardiac, hepatic or renal complications. - Patients with serious diabetic complications. - Patients with complete biliary obstruction or ileus. - Pregnant, lactating, and probably pregnant patients, and patients who can not agree to contraception. | |
| 73 | NCT00668785 | terminated | study was terminated due to low enrollment | 0 | phase 2 | ['proliferative diabetic retinopathy', 'macular edema'] | ["['H35.23', 'H35.20', 'H35.21', 'H35.22', 'E10.3553', 'E11.3553', 'E13.3553']", "['H59.033', 'H34.8130', 'H59.031', 'H59.032', 'H59.039', 'H34.8110', 'H34.8120']"] | ['ranibizumab'] | ['CN\\C(NCCSCC1=CC=C(CN(C)C)O1)=C/[N+]([O-])=O'] | Inclusion Criteria: - Pre-PRP protocol refraction, fluorescein angiography, and optical coherence tomography AND 7-14 day post-PRP OCT - Ability to provide written informed consent and comply with study assessments for the full duration of the study - Age 21 years or older - Previously untreated PDR patients with high risk characteristics who develop edema within 7-14 days post PRP therapy. This edema, determined by a masked investigator, will be characterized as either increased foveal thickness (>10% increase from pre-PRP foveal thickness), and/or increased macular volume on OCT (>10% increase from pre-PRP macular volume). Exclusion Criteria: - Pregnancy (positive pregnancy test) prior to enrollment in the study - Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated. - Participation in another simultaneous medical investigation or trial - Pre-PRP clinically significant diabetic macular edema (CSME) that would make the patient eligible for macular laser prior to PRP - Neovascularization of the iris or neovascular glaucoma - Increased central foveal thickness for any other reason - Concurrent macular diseases that could confound the results of this study - Prior vitrectomy in the study eye - Prior treatment with intravitreal injection including pegaptanib sodium, ranibizumab, bevacizumab or triamcinolone acetonide |
| 74 | NCT01231581 | completed | 0 | phase 2 | ['cancer'] | ["['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']"] | ['gsk1120212', 'gemcitabine', 'placebo'] | ['CN1C(=O)C(C)=C2N(C(=O)N(C3CC3)C(=O)C2=C1NC1=CC=C(I)C=C1F)C1=CC(NC(C)=O)=CC=C1', '[H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - 18 years old or older - Histologically or cytologically confirmed diagnosis of metastatic (Stage IV) adenocarcinoma of the pancreas with measurable or non-measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 - Performance status score of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG) scale - All prior treatment related toxicities must be Common Terminology Criteria for Adverse Events (CTCAE) (Version 4.0) ≤ Grade 1 (except alopecia) at the time of randomization - Adequate baseline organ function - Able to swallow and retain orally administered medication and does not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels Exclusion Criteria: - Prior systemic therapy (i.e., chemotherapy, immunotherapy, hormone therapy, , targeted therapy or any investigational anti-cancer drug) for metastatic pancreatic adenocarcinoma. (Prior treatment with 5-FU based or gemcitabine administered as a radiation sensitizer during and up to 4 weeks after radiation therapy is allowed. Prior systemic chemotherapy in the adjuvant setting is allowed ; however, prior therapy with gemcitabine is allowed only if tumor recurrence occurred at least 6 months after completing the last dose of gemcitabine) - History of another malignancy. Exception: Subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible. Subjects with second malignancies that are indolent or definitively treated may be enrolled. Consult GSK Medical Monitor if unsure whether second malignancies meet requirements specified above - Any serious and/or unstable pre-existing medical (aside from malignancy exception above), psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the Investigator or GSK Medical Monitor - History of interstitial lung disease or pneumonitis - History or current evidence / risk of retinal vein occlusion (RVO) or central serous retinopathy (CSR) - Symptomatic or untreated leptomeningeal or brain metastases or spinal cord compression - History of acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting within the past 6 months | |
| 75 | NCT00337077 | completed | 0 | phase 2 | ['adenocarcinoma of the prostate', 'hormone-refractory prostate cancer', 'recurrent prostate cancer', 'stage iv prostate cancer'] | ["['C22.0', 'C22.1', 'C4A.9', 'C7B.1', 'D09.9', 'C4A.0', 'C4A.31']", "['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']"] | ['eribulin mesylate'] | ['[H][C@@]12O[C@@]3([H])CCC4CC(=O)C[C@H]5[C@H](C[C@H]6O[C@H](C[C@@H](C)C6=C)CC[C@@H]6O[C@H](CC6=C)CC[C@@]67C[C@@H](O[C@H]1[C@@H](O6)[C@@]3([H])O4)[C@@H]2O7)O[C@H](C[C@H](O)CN)[C@@H]5OC'] | Inclusion Criteria: - Histologically confirmed adenocarcinoma of the prostate - Progressive metastatic disease or stable metastatic disease with rising PSA - Previously treated with bilateral orchiectomy or other primary hormonal therapy with evidence of treatment failure - Patients who have not undergone bilateral orchiectomy must continue luteinizing hormone-releasing hormone (LHRH)-agonist therapy (e.g., leuprolide or goserelin) or LHRH antagonist therapy (e.g. abarelix) while receiving study treatment - Patients who did not have an orchiectomy must have a testosterone level < 50 ng/dL to confirm androgen suppression within the past 4 weeks - ECOG performance status 0-2 - Adequate bone marrow function - Bilirubin =< 1.5 mg/dL - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 times upper limit of normal - Creatinine =< 2.0 mg/dL OR creatinine clearance >= 40 mL/min - Fertile patients must use effective contraception - A taxane-based regimen, mitoxantrone, or other cytotoxic chemotherapy regimen allowed provided there is evidence of disease progression - At least 4 weeks since prior chemotherapy or radiotherapy - At least 4 weeks since prior flutamide (6 weeks for bicalutamide or nilutamide) and there is continued evidence of disease progression - Disease progression after antiandrogen withdrawal must be confirmed by rising PSA after the required 4-6 week washout period (e.g., PSA level higher than the last PSA obtained while on antiandrogen therapy) - More than 4 weeks since prior estrogen, estrogen-like agents (e.g., PC-SPES, saw palmetto, or other herbal products that may contain phytoestrogens), or any other hormonal therapy (including megestrol, finasteride, ketoconazole, or systemic corticosteroids) - Concurrent bisphosphonates (e.g., pamidronate sodium or zoledronate) allowed provided the patient has been receiving the bisphosphonate for >= 4 weeks and there is evidence of disease progression Exclusion Criteria: - Active angina pectoris - Known New York Heart Association class III-IV heart disease - Myocardial infarction within the past 6 months - Evidence of ventricular dysrhythmias or other unstable arrhythmia (rate-controlled atrial fibrillation is allowed if the patient is asymptomatic from a cardiac standpoint) - Peripheral neuropathy > grade 2 - Other prior malignancy (excluding nonmelanomatous skin cancer treated with curative intent) unless the malignancy was treated with curative intent and the patient has been disease free for >= 5 years - Serious concurrent medical illness or active infection that would preclude study treatment - No concurrent strong inhibitors or inducers of CYP3A4 - More than 2 prior chemotherapy regimens for hormone-refractory disease - Other concurrent investigational agents - Other concurrent anticancer therapy, including chemotherapy, gene therapy, biologic therapy, or immunotherapy - Concurrent palliative radiotherapy - Concurrent estrogen, estrogen-like agents, or any other hormonal therapy - Carcinomatous meningitis or brain metastases - Prior strontium chloride Sr 89, samarium 153 lexidronam pentasodium, or other radioisotopes - Concurrent therapeutic anticoagulation with warfarin (Unfractionated heparin [standard, low-dose, or adjusted dose] or low molecular weight heparin allowed | |
| 76 | NCT00569153 | completed | 1 | phase 1/phase 2 | ['prostatic neoplasms'] | ["['B38.81', 'N42.31', 'Z87.430', 'N40.0', 'N40.1']"] | ['tak-700'] | ['CNC(=O)C1=CC=C2C=C(C=CC2=C1)[C@@]1(O)CCN2C=NC=C12'] | Inclusion Criteria: - Subject is male and at least 18 years of age. - Subject has histologically- or cytologically-confirmed prostate adenocarcinoma with metastatic, progressive disease while on androgen deprivation therapy. - Subject has radiograph-documented (computed tomography, magnetic resonance imaging or x-ray) metastatic disease. - Subject has undergone orchiectomy or is expected to continue receiving luteinizing hormone-releasing hormone analogue therapy, and has a testosterone level of <50 ng/dL at screening. - Subject has discontinued all antiandrogen therapy (within 30 days for flutamide and within 6 weeks for all others) prior to their first dose of study drug. - Subject has a prostate-specific antigen level ≥5 ng/mL. - Subject meets all screening laboratory values as specified in the protocol. - Subject has a screening ejection fraction that is above the lower limit of the institutional normal range. - Subject has ECOG performance status of 0 to 2. - Subject has normal or, in the opinion of the investigator, clinically insignificant, physical examination findings, ECG and chest x-ray results. - Subjects, even if surgically sterilized (ie, status postvasectomy), who: agree to practice effective barrier contraception during the entire study treatment period and for 4 months after the last dose of study drug, or agree to completely abstain from heterosexual intercourse. Exclusion Criteria: - Subject has known hypersensitivity to TAK-700 or related compounds. - Subject has received prior therapy with aminoglutethimide or ketoconazole within 30 days prior to the first dose of study drug. - Subject has received prior chemotherapy for prostate cancer. - Subject has received any investigational compound within 30 days prior to first dose of study drug. - Subject has received prior herbal product known to decrease prostate-specific antigen levels (eg, Saw Palmetto, PC-SPES) within 30 days prior to the first dose of study drug. - Subject has received radiation therapy for prostate cancer within 30 days prior to first dose of study drug. - Chronic therapy with oral or other systemically administered corticosteroids, such as prednisone, within 30 days prior to Screening. Chronic therapy is defined as the use of corticosteroids for more than 7 days within a 30-day period. - Subject has current spinal cord compression, current bilateral hydronephrosis, or current bladder neck outlet obstruction. - Subject has a history of adrenal insufficiency. - Subject has a history of myocardial infarction, ischaemic symptomatic heart disease, cardiac arrhythmias or thromboembolic events (eg, deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events), or any other cardiac condition (e.g., pericardial effusion restrictive cardiomyopathy) within 12 months prior to first dose of study drug. - Subject has any symptoms which the investigator deems related to prostate cancer, i.e., bone pain, pelvic pain. - Subject has a history of congestive heart failure (New York Heart Association Class II or greater. - Subject has history of another malignancy other than basal cell carcinoma or state 1 squamous cell carcinoma of the skin, within the last 5 years. - Subject has uncontrolled hypertension. - Subject is known to have HIV infection, chronic Hepatitis B or C or any other serious medical condition or psychiatric illness that might affect life expectancy or make it difficult to successfully manage and follow the subject according to protocol. - Subject is unable to understand verbal or written English or any other language for which a certified translation of the institutional review board (IRB)-approved informed consent has been provided. - Subject is unwilling or unable to comply with the protocol or cooperate fully with the investigator and site personnel. | |
| 77 | NCT01220297 | terminated | low accrual | 0 | phase 2 | ['hematologic diseases', 'acute-graft-versus-host disease', 'leukemia', 'non-hodgkin lymphoma (nhl)', 'hodgkin lymphoma'] | ["['E70.338', 'E70.339', 'P09.3', 'O28.0', 'P61.8', 'P61.9', 'T45.8X1A']", "['D89.810', 'D89.812']", "['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']", "['S33.110S', 'S33.111S', 'S33.120S', 'S33.121S', 'S33.130S', 'S33.131S', 'S33.140S']"] | ['sirolimus', 'mycophenolate mofetil (mmf)', 'carmustine', 'etoposide', 'cyclophosphamide (cyclo, cy)', 'ftbi'] | ['CC(=O)CC(C1=CC=CC=C1)C1=C(O)C2=C(OC1=O)C=CC=C2', 'COC(=O)\\C=C\\C(O)=O', 'ClCCNC(=O)N(CCCl)N=O', 'OCCOCCN1CCN(CC1)C(C1=CC=CC=C1)C1=CC=C(Cl)C=C1', 'ClCCN(CCCl)P1(=O)NCCCO1'] | INCLUSION CRITERIA - Acute myelogenous leukemia (AML), beyond 2nd remission or relapsed/refractory disease, age 2 to 60 years - AML, in first or subsequent remission or relapsed/refractory disease, age 51 to 60 years of age - AML with multilineage dysplasia - Acute lymphoblastic leukemia (ALL), beyond 2nd remission or relapsed/refractory disease, age 2 to 60 years - ALL, age 51 - 60 years in first or subsequent remission or relapsed/refractory disease - Chronic myeloid leukemia (CML), beyond 2nd chronic phase or in blast crisis - Myelodysplastic syndrome (MDS), including World Health Organization (WHO)classifications of refractory anemia with excess blasts-1 (RAEB-1), RAEB-2 and therapy-related MDS - MDS with poor long-term survival including myeloid metaplasia and myelofibrosis - Myeloproliferative disorders - High-risk non-Hodgkin lymphoma (NHL) in 1st emission - Relapsed or refractory NHL - Hodgkin lymphoma (HL) beyond first remission - Males and females of any ethnic background, 2 to 60 years of age - Karnofsky Performance Status (KPS) ≥ 70% or Lansky performance status > 70% for patients < 16 years of age. - Related, matched-donor identified [6/6 human leukocyte antigen (HLA)-A, B and DRB1] - Willingness to take oral medications during the transplantation period - Ability to understand and the willingness to sign a written informed consent document EXCLUSION CRITERIA - Prior myeloablative allogeneic or autologous hematopoietic stem cell transplant (HSCT) - HIV infection - Pregnant - Lactating - Evidence of uncontrolled active infection - Serum creatinine > 1.5 mg/dL or 24-hour creatinine clearance < 50 mL/min - Direct bilirubin, Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2 x upper limit of normal (ULN) - Carbon monoxide diffusing capacity (DlCO) < 60% predicted (adults) OR and in-room air oxygen saturation < 92% (children) - Left ventricular ejection fraction < 45% (adults) OR shortening fraction < 26%(children) - Fasting cholesterol > 300 mg/dL or Triglycerides > 300 mg/dL while on lipid-lowering agents. - Receiving investigational drugs unless cleared by the Principal Investigator (PI). - Prior malignancies except basal cell carcinoma or treated carcinoma in-situ. - Cancer treated with curative intent ≤ 5 years (EXCEPTION BY PI DISCRETION) (Cancer treated with curative intent > 5 years will be allowed). |
| 78 | NCT00321685 | completed | 0 | phase 2 | ['rectal adenocarcinoma', 'stage ii rectal cancer ajcc v7', 'stage iii rectal cancer ajcc v7'] | ["['C22.0', 'C22.1', 'C4A.9', 'C7B.1', 'D09.9', 'C4A.0', 'C4A.31']"] | ['capecitabine', 'fluorouracil', 'leucovorin calcium', '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', 'NC1=NC(=O)C2=C(NC[C@H](CNC3=CC=C(C=C3)C(=O)N[C@@H](CCC(O)=O)C(O)=O)N2C=O)N1', '[H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1'] | Inclusion Criteria: - Patients must have histologically confirmed, locally advanced, non-metastatic primary T3 or T4 adenocarcinoma of the rectum - Patients must not have evidence of tumor outside of the pelvis including liver metastases, peritoneal seeding, or metastatic inguinal lymphadenopathy - Patients must not have intra-operative radiotherapy (IORT) or brachytherapy treatment to the pelvis - The distal border of the tumor must be at or below the peritoneal reflection, defined as within 12 centimeters of the anal verge by proctoscopic examination - Transmural penetration of tumor through the muscularis propria must be demonstrated by either of the following: computed tomography (CT) scan plus endorectal ultrasound, or a magnetic resonance imaging (MRI); an endorectal coil or pelvic MRI is allowed - For the patient to be eligible, the surgeon must prospectively define the tumor as either initially resectable or potentially resectable after pre-operative chemoradiation; clinically resectable tumors are defined as completely resectable with negative margins based on routine examination of the non-anesthetized patient; patients whose tumors are not resectable are not eligible; before pre-operative (op) treatment, the surgeon should estimate and record the type of resection anticipated: pelvic exenteration, posterior pelvic exenteration, APR, LAR, or LAR/coloanal anastomosis - Patients with tumors that are clinically fixed, clinical stage T4N0-2, M0 are eligible if it is believed that their tumors are potentially resectable after chemoradiation; based on the following: - Clinically fixed tumors on rectal examination with tumor adherent to the pelvic sidewall or sacrum - Sciatica attributed to sacral root invasion with CT scan/MRI evidence of the lack of clear tissue plane will be considered evidence of fixation - Hydronephrosis on CT scan or intravenous pyelogram (IVP) or ureteric or bladder invasion as documented by cystoscopy and cytology or biopsy, or invasion into prostate - Vaginal or uterine involvement - Patients must have Eastern Cooperative Oncology Group (ECOG) performance status 0-1 - A surgical evaluation must confirm patient's ability to tolerate the proposed surgical procedure - Patients must have a caloric intake > 1500 kilocalories/day (d) - Within 4 weeks prior to registration, the patient's absolute neutrophil count (ANC) level must be >= 1,500/mm^3 - Within 4 weeks prior to registration, the patients platelet level must be >= 100,000/mm^3 - Within 4 weeks prior to registration, serum creatinine must be < 1.5 X upper limit of normal (ULN); if serum creatinine > 1.5 x ULN, then creatinine clearance must be >= 50 mL/mm - Within 4 weeks prior to registration, serum bilirubin must be =< 1.5 X ULN - Within 4 weeks prior to registration, alkaline phosphatase (alk phos) must be < 2 x ULN - Within 4 weeks prior to registration, serum glutamic oxaloacetic transaminase (SGOT) must be < 2 x ULN - Carcinoembryonic antigen (CEA) must be determined prior to initiation of therapy - Within 4 weeks prior to registration, urine protein/creatinine (UPC) ratio must be < 1; patients with a ratio of >= 1 must undergo a 24-hour urine collection which must be an adequate collection and must demonstrate < 1 gram (gm) of protein in order to participate - Within 4 weeks prior to registration, albumin must be >= 2 gm/dl - Absence of clinical evidence of high-grade (lumen diameter < 1 cm) large bowel obstruction, unless diverting colostomy has been performed - Eligible patients of reproductive potential (both sexes) must agree to use an accepted and effective method of contraceptive during study therapy and for at least 6 months after the completion of bevacizumab - Women must not be pregnant or breast-feeding; all females of childbearing potential must have a serum pregnancy test to rule out pregnancy within 2 weeks of registration - Patients must have had no prior chemotherapy for rectal cancer or pelvic irradiation therapy - Patients with prior malignancies, including pelvic cancer, are eligible if they have been disease free for > 5 years; patients with prior in situ carcinomas are eligible provided there was complete removal - Patients must have no active inflammatory bowel disease or other serious medical illness or disease that might limit the patient's ability to receive protocol therapy - Patients with a history of cerebrovascular accident (CVA)/transient ischemic attack (TIA) at any time, or myocardial infarction/unstable angina within 12 months of study entry are not eligible - Patients with > grade 1 peripheral neuropathy are not eligible - Patients must have urine protein/creatinine (UPC) ratio of < 1.0; patients with a UPC ratio >= 1.0 must undergo a 24-hour urine collection, which must be an adequate collection and must demonstrate < 1 gm of protein in order to participate - Patients with a history of hypertension must measure < 150/90 mmHg and be on a stable regimen of anti-hypertensive therapy - Patients with clinically significant peripheral vascular disease are not eligible - Patients must not have any of the following: - Unstable angina (within 12 months of study entry) - New York Heart Association (NYHA) grade II or higher congestive heart failure - Evidence of bleeding diathesis/coagulopathy - Serious non-healing wound or bone fracture - Patients with a history of the following within 28 days prior to registration are not eligible: - Abdominal fistula - Gastrointestinal perforation - Intrabdominal abscess - Patients with a history of the following within 28 days prior to day 0 (first treatment day) are not eligible: - Major surgical procedure - Open biopsy - Significant traumatic injury - Patients must not have core biopsy within 7 days prior to day 0 (first treatment day) - Patients with prothrombin time (PT) (international normalized ratio [INR]) > 1.5 are not eligible, unless the patient is on full-dose anticoagulants; if so, the following criteria must be met for enrollment: - The subject must have an in-range INR (usually between 2 and 3), be on a stable dose of warfarin or on a stable dose of low molecular weight heparin - The subject must not have active bleeding or a pathological condition that is associated with a high risk of bleeding | |
| 79 | NCT00423098 | completed | 0 | phase 2 | ['lupus nephritis'] | ["['B26.83', 'A51.44', 'N11.8', 'N11.9', 'N12']"] | ['mycophenolate sodium', 'prednisone', 'methylprednisolone'] | ['COC1=C(C\\C=C(/C)CCC(O)=O)C(O)=C2C(=O)OCC2=C1C', '[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', '[H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)CC[C@]12C'] | Inclusion criteria - Male or female patients with systemic lupus erythematosus (SLE)(at least 4 classification criteria) - Aged ≥18 years, - Proliferative lupus nephritis classified as ISN/RPS class III or IV - Renal biopsy within the last 24-month preceding the study entry - Proteinuria defined as >0.5 gram urine protein per gram urine creatinine at screening and baseline - Clinical activity defined by one or more of the following changes in renal function: Serum creatinine >1.0 mg/dl (88.4 μmol/l) - Microscopic hematuria defined as >5 red cells per high power field - Presence of cellular casts Exclusion criteria - Patients with calculated creatinine clearance <30 ml/min (using the Cockcroft-Gault formula) - Patients having received an intravenous (i.v.) corticosteroid bolus during the last 3 months, - Patients having received oral or i.v. cyclophosphamide during the last 3 month - Patients having received mycophenolate mofetil (MMF) within the preceding 3 months - Use of any antibody therapy within the past 6 months - Pregnant or nursing (lactating) women or women of child-bearing potential who are planning to become pregnant, or are not willing to use effective means of contraception throughout the study and during one month after the end of the study. - Use of other investigational drugs within 1 month of enrollment (except for antibodies: within 6 months of enrollment - History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures, - History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin. Other protocol-defined inclusion/exclusion criteria may apply. | |
| 80 | NCT01005251 | completed | 0 | phase 2 | ['gastroesophageal reflux disease', 'heartburn', 'regurgitation'] | ["['K21.9', 'K21.00', 'K21.01']", "['R12']"] | ['lesogaberan (azd3355)', 'lesogaberan (azd3355)', 'lesogaberan (azd3355)', 'lesogaberan (azd3355)', 'placebo'] | ['NC[C@@H](F)CP(O)=O', 'NC[C@@H](F)CP(O)=O', 'NC[C@@H](F)CP(O)=O', 'NC[C@@H](F)CP(O)=O', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Provision of informed consent prior to any study specific procedures - Have at least 6 months history of GERD - Continuously treated during the last 4 weeks before enrolment with daily optimized unchanged PPI therapy for any GERD indication Exclusion Criteria: - Patients that have not experienced any GERD symptom improvement at all during PPI treatment - Prior surgery of the upper gastrointestinal tract. - Subject who have any of the following conditions or diseases: Heart disease, Angina, Seizure disorders such as epilepsy, Congestive Heart Failure (CHF), Liver disease such as Cirrhosis or Hepatitis, Kidney disease, Lung disease or lung cancer, Cancer | |
| 81 | NCT00221637 | terminated | slow recruitment and treatments beyond expiry date | 0 | phase 2/phase 3 | ['neuralgia', 'neuropathic peripheral pain'] | ["['G50.0', 'M54.81', 'B02.22', 'M79.2']"] | ['sodium valproate'] | ['CCCC(CCC)C(O)=O'] | Inclusion Criteria: - peripheral neuropathic pain - signed written informed consent Exclusion Criteria: - central neuropathic pain - current or past hepatic disease |
| 82 | NCT00115739 | terminated | study was closed early due to slow accrual | 0 | phase 2 | ['thyroid cancer'] | ["['C73', 'D34', 'D44.0', 'Z85.850']"] | ['imatinib'] | ['CC1=NC(NC2=NC=C(S2)C(=O)NC2=C(C)C=CC=C2Cl)=CC(=N1)N1CCN(CCO)CC1'] | Inclusion Criteria: - Patients with histologically confirmed anaplastic thyroid carcinoma, who have measurable disease. - Patients with brain metastases are eligible if they have been stable for at least six weeks post-radiation therapy. - Age 18 years, male or female. - Karnofsky performance status (KPS) of > 70%. - Life expectancy of at least 12 weeks. - Hematologic: ANC 1,500 mm3, hemoglobin 8.0 g/dl, platelets 100,000/mm3 - Normal serum calcium level within normal limits for the institution documented within 14 days prior to registration. - All patients (including those with liver metastases) must have adequate hepatic function as defined by a serum bilirubin 1.5 x the institutional upper limit of normal (ULN), and ALT and AST <2.5 x ULN, obtained within 14 days prior to registration. - Patients must have a serum creatinine less than 1.5 x the institutional upper limits of normal (adjusted for age) within 14 days of registration. - Women of childbearing potential must have a negative pregnancy test at baseline, prior to receiving any study drug. (Pregnant or lactating patients are excluded.) - Patients of reproductive potential must practice effective contraception while on study and for at least six months after receiving the last dose of study drug. - All patients must sign an informed consent prior to enrollment. - No prior history of non-thyroid malignancy, except adequately treated skin cancer or in situ cervical carcinoma or any other cancer in complete remission for at least two years. - Prior chemotherapy, chemoradiation, radiation therapy, or surgery must have been completed at least 28 days prior to registration, and all toxicities must have resolved. Patients who have been treated with nitrosourea or mitomycin C must be off of these drugs for at least 6 weeks prior to registration. - Patients must be able to take oral medications. Exclusion Criteria: - Anaplastic thyroid cancer that does not overexpress PDGF receptors or c-Abl by immunohistochemistry - Any medical or psychiatric illness which, in the opinion of the principal investigator, would compromise the patient's ability to tolerate this treatment regimen. - No concurrent radiotherapy (to the primary tumor) or chemotherapy may be given to the patient during the administration of the study drug. - Pregnant or lactating women, women of childbearing potential with either a positive pregnancy test (PPT) at baseline, or sexually active females not using reliable contraceptive methods while on study and for at least six months after chemotherapy. (Postmenopausal women must have been amenorrheic for least 12 months to be considered of non-childbearing potential). - Sexually active males not using reliable contraceptive methods while on the study and for at least six months after chemotherapy. - Patients with malabsorption syndromes will be excluded. - Serious concurrent infections. - Patients who have had previous organ allografts will be excluded. - Prisoners. - Patients with chronic liver disease (i.e chronic active hepatitis and cirrhosis). - Patients with a known diagnosis of human immunodeficiency virus (HIV) infection. - Patients who have had major surgery within 2 weeks of study entry. - Patients with grade III/IV cardiac problems as defined by the New York Heart Association Criteria (i.e. congestive heart failure, myocardial infarction within 6 months of study entry). |
| 83 | NCT01278134 | completed | 0 | phase 2 | ['hepatitis c, chronic'] | ["['B18.2', 'B18.0', 'B18.1', 'B18.8', 'B18.9', 'K71.3', 'K71.4']"] | ['copegus placebo', 'ro5024048', 'danoprevir', 'peginterferon alfa-2a [pegasys]', 'ribavirin [copegus]', 'ritonavir'] | ['NC(=O)C1=NN(C=N1)[C@@H]1O[C@H](CO)[C@@H](O)[C@H]1O', 'CC(C)C(=O)OC[C@H]1O[C@@H](N2C=CC(N)=NC2=O)[C@](C)(F)[C@@H]1OC(=O)C(C)C', 'CC(C)(C)OC(=O)N[C@H]1CCCCC\\C=C/[C@@H]2C[C@]2(NC(=O)[C@@H]2C[C@H](CN2C1=O)OC(=O)N1CC2=CC=CC(F)=C2C1)C(=O)NS(=O)(=O)C1CC1', 'NC(=O)C1=NN(C=N1)[C@@H]1O[C@H](CO)[C@@H](O)[C@H]1O', 'NC(=O)C1=NN(C=N1)[C@@H]1O[C@H](CO)[C@@H](O)[C@H]1O', 'CC(C)[C@H](N1CCCNC1=O)C(=O)N[C@H](C[C@H](O)[C@H](CC1=CC=CC=C1)NC(=O)COC1=C(C)C=CC=C1C)CC1=CC=CC=C1'] | Inclusion Criteria: - Adult patient, >/= 18 years of age - Chronic Hepatitis C of >/= 6 months duration at screening - HCV genotype 1 and quantifiable HCV RNA at screening (Roche COBAS TaqMan HCV test) - Naïve for treatment with interferon (pegylated or non-pegylated) - Body Mass Index (BMI) 18-35 inclusive, minimum weight 45 kg - Females of child-bearing potential and males with female partners of childbearing potential must use 2 forms of effective non-hormonal contraception Exclusion Criteria: - Pregnant or lactating women and males with female partners who are pregnant or lactating - Decompensated liver disease or impaired liver function - Cirrhosis or incomplete/transition to cirrhosis - Non-hepatitis C chronic liver disease - Hepatitis B or HIV infection - History of neoplastic disease within the last 5 years, except for localized or in situ carcinoma of the skin - History of pre-existing renal disease (except for nephrolithiasis) or severe cardiac disease - History of drug or alcohol abuse within the last year or alcohol consumption of > 2 units per day; cannabinoid use is excepted | |
| 84 | NCT00831493 | terminated | slow accrual. | 0 | phase 1/phase 2 | ['pancreatic cancer'] | ["['C25.3']"] | ['vorinostat'] | ['ONC(=O)CCCCCCC(=O)NC1=CC=CC=C1'] | Inclusion Criteria: 1. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 2. Patients must be >/= 18 years of age. There will be no upper age restriction. 3. Cytologic or histologic proof of adenocarcinoma of the pancreas. Patients can have tumor originating in any part of the pancreas. Islet cell tumors are not eligible. Only patients with non- metastatic, unresectable disease (American Joint Committee on Cancer (AJCC) 2002 stage T4 NX M0) are eligible. Patients who cannot undergo resection because of underlying medical problems are also eligible. Patients with regional nodal disease are eligible. 4. All patients must be staged with a physical exam, chest x-ray/CXR, and contrast-enhanced helical thin-cut abdominal CT. Unresectability is defined by CT criteria: a) evidence of tumor extension to the celiac axis or superior mesenteric (SM) artery, or b) evidence on either CT or angiogram of occlusion of the SM vein or SM/ portal vein confluence. If a tumor does not meet this definition and is found to be unresectable at surgical exploration, then that tumor is considered unresectable. 5. Patients may have received prior chemotherapy but not prior radiation therapy to the upper abdomen. 6. Bone marrow function: absolute neutrophil count (ANC) >1,500/ul. Platelets >100,000/ul. 7. Hepatic function: Total bilirubin less than 1.5mg/dL. If the patient required an endobiliary stent and/or external biliary drain, the bilirubin level must have declined on consecutive measurements indicating adequate biliary decompression; alanine aminotransferase (ALT) </= 5 times the upper limit of normal. 8. Renal function: Blood urea nitrogen (BUN) </= 30 mg% and creatinine </= 1.5 mg% 9. Patients must be willing to sign informed consent indicating that they are aware of the investigational nature of the study, and are aware that participation is voluntary. Exclusion Criteria: 1. Prior abdominal radiotherapy. 2. Participation in any other experimental drug study in the 30 days preceding initiation of treatment on the current study. 3. Prior treatment with HDAC inhibitors (except valproic acid with a 30-day washout period) 4. Prior history of cancer within the last five years except for basal cell carcinoma of the skin or carcinoma in situ of the cervix. Patients with previous malignancies but without evidence of disease for 5 years will be allowed to enter the trial. 5. Pregnant or lactating women. Women of childbearing potential with either a positive or no pregnancy test at baseline. Women / men of childbearing potential not using a reliable contraceptive method (oral contraceptive, other hormonal contraceptive, intrauterine device, diaphragm or condom). (Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential). Patients must agree to continue contraception for 30 days from the date of the last study drug administration. 6. Serious, uncontrolled, concurrent infection(s) requiring intravenous (IV) antibiotics or nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this therapy. 7. Current treatment of active hepatitis virus or HIV infection with interferon, ribavirin, telbivudine, entecavir, lamivudine, adefovir, efavirenz, zidovudine, tenofovir, emtricitabine, or ritonavir. 8. Psychiatric disorders rendering patients incapable of complying with the requirements of the protocol. 9. Inability to comply with study and/or follow-up procedures. |
| 85 | NCT00233363 | completed | 1 | phase 2 | ['xerostomia', "sjogren's syndrome"] | ["['M35.00', 'M35.01', 'M35.03', 'M35.0B', 'M35.02', 'M35.05', 'M35.08']"] | ['rebamipide'] | ['OC(=O)C(CC1=CC(O)=NC2=CC=CC=C12)NC(=O)C1=CC=C(Cl)C=C1'] | Inclusion Criteria: 1. Patients with Sjögren's syndrome (Revised Japanese criteria for Sjögren's syndrome (1999): 1998 research report on immunological intractable diseases specified by the Japanese Ministry of Health and Welfare) 2. Patients aged 20 years or older at time of consent 3. Patients with dry mouth 4. Patients with decreased salivation Exclusion Criteria: 1. Patients who have developed dry mouth clearly due to a cause other than Sjögren's syndrome 2. Patients in whom Saxon test cannot be performed (artificial tooth, tooth implant, etc.) 3. Patients who have received rebamipide within 3 months prior to obtaining informed consent 4. Patients who are pregnant, possibly pregnant, or lactating 5. Patients with a history of hypersensitivity to rebamipide 6. Patients who have received any other investigational drug within 3 months prior to obtaining informed consent 7. Patients who are otherwise judged inappropriate for inclusion in the study by the investigator or subinvestigator | |
| 86 | NCT00242918 | completed | 0 | phase 2 | ['prostate cancer'] | ["['C61', 'D29.1', 'D40.0', 'Z15.03', 'Z80.42', 'Z85.46', 'Z12.5']"] | ['docetaxel', 'zd1839'] | ['[H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1', 'COC1=C(OCCCN2CCOCC2)C=C2C(NC3=CC(Cl)=C(F)C=C3)=NC=NC2=C1'] | Inclusion Criteria: - prostate carcinoma: clinical stage T2b-3 or serum PSA>20 ng/ml or Gleason sum score 8-10. - clinical T2 patients are eligible if endorectal coil MRI shows T3 disease, or Gleason 4+3 cancer in 5 or more biopsies (minimum of 10 biopsies total required) - ECOG performance status of 0, 1 or 2 - adequate hematological, liver and renal function - existing peripheral neuropathy < grade 1 - ability to tolerate oral medications. Exclusion Criteria: - Concurrent or prior treatment with radiation, cytotoxic, biologic therapy for prostate cancer - any major surgery within four weeks - prior hormonal therapy (except finasteride for obstructive voiding symptoms- -evidence of metastatic disease, confirmed by physical examination, computed tomography of the abdomen and pelvis within 45 days and by bone scan within 60 days of signing informed consent | |
| 87 | NCT01276548 | completed | 1 | phase 2 | ['ovarian cancer'] | ["['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']"] | ['genexol®-pm 260mg/m2 plus carboplatin 5 auc', 'genexol® 175mg/m2 plus carboplatin 5 auc'] | ['N[C@@H](CCCNC(N)=N)C(O)=O', 'N[C@@H](CCCNC(N)=N)C(O)=O'] | Inclusion Criteria: 1. Subjects who aged 18 years or older 2. Subjects whose written informed consent was obtained complying with the local regulatory requirements prior to their participation in the trial 3. Subjects who have histologically or cytologically confirmed unresectable or metastatic epithelial cancer of the exocrine pancreas. High-quality contrast-enhanced CT scanning is required to evaluate resectability. Measurable disease is not required. Exclusion Criteria: 1. Subjects who have received prior radiation therapy (XRT) for pancreatic cancer unless progression was documented after XRT and 6 weeks have elapsed between completion of XRT and start of trial medication. 2. Subjects who have had systemic treatment such as chemotherapy or immunotherapy, for pancreatic cancer. However, prior use of chemotherapy, e.g. 5-FU or capecitabine, for radiation sensitization is allowed. If gemcitabine was given in the adjuvant setting, only subjects relapsed with cancer after 6 months of completing the last dose of gemcitabine can participate in the trial. 3. Subjects who have had a major surgery within 2 weeks prior to the screening/baseline visit | |
| 88 | NCT00612105 | completed | 0 | phase 2 | ['postherpetic neuralgia'] | ["['B02.22']"] | ['retigabine', 'placebo'] | ['CCOC(=O)NC1=C(N)C=C(NCC2=CC=C(F)C=C2)C=C1', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Ability to provide informed consent - Male or female subjects - 18-85 years of age - PHN for more than 6 months after the healing of herpes zoster skin rash - Has a pain score at screening and randomization that qualifies Exclusion Criteria: - Other significant pain that may potentially confound PHN pain assessment - Previous neurolytic or neurosurgical therapy for PHN - Subject has evidence of a progressive central nervous system (CNS) disease (e.g. CNS lupus, tumors, multiple sclerosis, Alzheimer's), lesion, or encephalopathy - Significant psychiatric or neuropsychiatric disorders including but not limited to severe depression, bipolar disorder or schizophrenia spectrum disorder, history of suicide attempt, or recent history of suicidal ideation - Has clinically significant abnormalities on physical examination, vital signs, ECG, or laboratory tests at the screening visit | |
| 89 | NCT00268593 | completed | 0 | phase 2 | ['prostate cancer'] | ["['C61', 'D29.1', 'D40.0', 'Z15.03', 'Z80.42', 'Z85.46', 'Z12.5']"] | ['pi-88', 'docetaxel', 'prednisone'] | ['[H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1', '[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'] | Inclusion Criteria: - Histologically/cytologically proven prostate adenocarcinoma that is unresponsive or refractory to hormone therapy - Patients must have received prior hormonal therapy, defined as castration by orchiectomy and/or luteinizing hormone releasing hormone (LHRH) agonists - Patients must have documented progression detected by PSA increase, physical examination and/or imaging - Patients must have achieved stable pain control for a minimum of seven consecutive days prior to study entry. - Prior radiation therapy (to < 25% of the bone marrow only) is permitted. At least 4 weeks must have elapsed since the completion of radiation therapy and the patient must have recovered from side effects prior to study entry. - Prior surgery is allowed. At least 4 weeks must have elapsed since the completion of surgery - Life expectancy > 3 months - ECOG Performance score of < 2. - Neutrophil count > 1.5 x 109/L (1,500/mm3) - Haemoglobin > 10 g/dL - Platelet count > 100 x 109/L (100,000/mm3) - Total bilirubin < the upper limit of normal (ULN) of the institution - ALT (SGPT) and AST (SGOT) < 1.5 x the ULN of the institution - Calculated creatinine clearance, using Cockroft and Gault formula, >60 mL/min - APTT and PT < 1.5 X ULN - Patients (or legally acceptable representative) must have voluntarily given written informed consent to participate in this study. - Patients must be willing to comply with the scheduled visit, treatment plans, laboratory tests, and other study procedures Exclusion Criteria: - Prior cytotoxic chemotherapy - Prior isotope therapy (e.g., strontium, samarium) - Prior radiotherapy to >25% of bone marrow (whole pelvic irradiation is not allowed) - Prior treatment with biological response modifiers within the previous 4 weeks - Prior malignancy except the following: adequately treated basal cell or squamous cell skin cancer, or any other cancer from which the patient has been disease-free for > 5 years - Known brain or leptomeningeal involvement - Symptomatic peripheral neuropathy > grade 2 according to the NCI Common Terminology Criteria for Adverse Events v3 (NCI CTCAE v3) - Serious intercurrent medical illness that does not permit adequate follow-up and compliance with the study protocol - History of immune-mediated thrombocytopenia, thrombotic thrombocytopenic purpura or other platelet disease, or laboratory evidence of anti-heparin antibodies - Use of drugs that may inhibit the metabolism of docetaxel (cyclosporin, terfenadine, ketoconazole, erythromycin, troleandomycin) within the previous week or during the study - Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational drug within 30 days prior to study screening - Treatment with any other anti-cancer therapy (except LHRH agonists) including any prescribed compounds and/or over-the-counter (OTC) products for the treatment of prostate cancer must be stopped prior to day of enrolment - Treatment with systemic corticosteroids used for reasons other than specified by the protocol must be stopped prior to day of enrolment - Concomitant bisphosphonate therapy is not allowed. Patients already receiving bisphosphonates must be stopped prior to day of enrolment - Concomitant use of aspirin (> 150 mg/day), non-steroidal anti-inflammatory drugs (except specific COX-2 inhibitors), heparin, low molecular weight heparin (LMWH), warfarin (> 1 mg/day) or anti-platelet drugs (abciximab, clopidogrel, dipyridamole, ticlopidine and tirofiban). Low-dose aspirin (≤ 150 mg/day) and low-dose warfarin (≤ 1 mg/day) are permitted as concomitant medications - Treatment with heparin or low molecular weight heparin within the previous two weeks is not permitted - History of allergy and/or hypersensitivity to heparin or other anti-coagulants/thrombolytic agents - History of acute or chronic gastrointestinal bleeding within the last two years, inflammatory bowel disease or other abnormal bleeding tendency - Patients at risk of bleeding due to open wounds or planned surgery - Myocardial infarction, stroke or congestive heart failure within the past three months - Uncontrolled or serious infection within the past four weeks | |
| 90 | NCT00566397 | completed | 1 | phase 2 | ["alzheimer's disease"] | ["['G30.8', 'G30.9', 'G30.0', 'G30.1']"] | ['pf-04494700', 'pf-04494700', 'placebo'] | ['CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Mini Mental State Exam (MMSE) score between 14-26 (inclusive) at screening. - Participants must be receiving acetylcholinesterase inhibitors on a stable dose for at least 4 months prior to randomization Exclusion Criteria: - Current evidence or history of neurological, psychiatric and any other illness that could contribute to non-Alzheimer's dementia. - Known history of familial AD or any evidence for early onset AD known or possibly associated with genetic mutations. - Evidence or history of diabetes mellitus Type 1 or Type 2. - History or symptoms of autoimmune disorders. | |
| 91 | NCT00660816 | completed | 0 | phase 2 | ['lung cancer'] | ["['C78.00', 'C78.01', 'C78.02', 'D14.30', 'D14.31', 'D14.32', 'C34.2']"] | ['erlotinib hydrochloride', 'pemetrexed disodium', 'docetaxel'] | ['COCCOC1=CC2=C(C=C1OCCOC)C(NC1=CC(=CC=C1)C#C)=NC=N2', '[H][C@@](CCC(O)=O)(NC(=O)C1=CC=C(CCC2=CNC3=C2C(O)=NC(=N)N3)C=C1)C(O)=O', '[H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1'] | INCLUSION CRITERIA - Pathologic diagnosis of stage IIIB (with pleural effusion) or IV non-small cell lung cancer - Progression following at least twelve weeks of treatment with single-agent erlotinib (or in combination with other experimental agents) during which time the patients experienced a clinical benefit as assessed by his/her treating physician and corroborated by radiographic assessment (at least one CT scan following at least 4 weeks of erlotinib monotherapy demonstrating stable disease or response on erlotinib therapy). - At least one measurable lesion as defined by modified Response Evaluation Criteria In Solid Tumors (RECIST) criteria - Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 - Life expectancy of at least 12 weeks - Absolute neutrophil count (ANC) >= 1.5x10(9)/L - Platelet count >= 100x 10(9) - Hemoglobin >= 8.0 g/dl - Serum creatinine =< 1.5 upper limit of normal OR calculated creatinine clearance >= 45 mL/min - Total bilirubin =< 1.5 x upper limit of normal (ULN) - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN - Available baseline diagnostic tumor specimen for correlative studies, any diagnostic material will be acceptable- paraffin block, cell block, fine needle aspirate etc. - Patients must provide verbal and written informed consent to participate in the study - Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures - Patient must be able to take folic acid, vitamin B12 as well as dexamethasone therapy as per protocol guidelines - Patient must be able to interrupt nonsteroidal anti-inflammatory drugs (NSAIDs) 2 days before (5 days for long-acting NSAIDs), the day of, and 2 days following administration of pemetrexed (this exclusion criteria applies only to patients who have not received pemetrexed chemotherapy prior) EXCLUSION CRITERIA - Active central nervous system disease (CNS) metastases, as indicated by clinical symptoms, cerebral edema or progressive growth (subjects with a clinical history of CNS metastases or cord compression are allowable if they have been definitively treated and are clinically stable for at least 4 weeks before first dose of study treatment for prior whole brain radiation and 2 weeks for prior gamma knife therapy) - More than 1 prior cytotoxic chemotherapy regimen for relapsed or metastatic disease (not including erlotinib) - Any prior epidermal growth factor receptor (EGFR) inhibitor therapy except for erlotinib - Major surgery, chemotherapy, or investigational agents within 3 weeks of treatment day 1 (except for erlotinib). Radiation therapy within 2 weeks of treatment day 1 (except for erlotinib). - Prior treatment with both pemetrexed and docetaxel chemotherapy - Pregnancy or breastfeeding or not receiving adequate contraception (including the patients spouse) - Other severe acute or chronic medical or psychiatric conditions 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 patient inappropriate for entry into this study - Patients who must receive pemetrexed and have the presence of third space fluid which cannot be controlled by drainage - Patients who must receive docetaxel and who have peripheral neuropathy > grade 2 - Patients who must receive docetaxel and who have had a hypersensitivity reaction to medications formulated with polysorbate 80 | |
| 92 | NCT01407874 | completed | 1 | phase 2 | ['gout', 'hyperuricemia', 'arthritis', 'joint disease', 'renal insufficiency'] | ["['M10.9', 'M10.08', 'M10.00', 'M10.011', 'M10.012', 'M10.019', 'M10.021']", "['E79.0']", "['A01.04', 'A02.23', 'A39.83', 'A39.84', 'A54.42', 'B06.82', 'B26.85']", "['N25.0', 'Q61.4', 'N23', 'N26.9', 'P96.0', 'Q60.0', 'Q60.1']"] | ['placebo', 'ulodesine (bcx4208) 5 mg', 'ulodesine (bcx4208) 10 mg'] | ['CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O', 'OC[C@H]1CN(CC2=CNC3=C2N=CNC3=O)C[C@@H]1O', 'OC[C@H]1CN(CC2=CNC3=C2N=CNC3=O)C[C@@H]1O'] | Inclusion Criteria: 1. Age ≥ 18 to < 70 years 2. Have read and signed the Informed Consent Form 3. Documented diagnosis of gout 4. Documented moderate renal insufficiency 5. Calculated creatinine clearance of ≥ 30 and < 60 mL/min 6. Willing and able to take allopurinol 200 mg every day for the duration of the Treatment 7. Female participants must be sexually abstinent for 4 weeks prior to Day 1 and continue abstinence for 4 weeks after completion of study drug, surgically sterile, postmenopausal,use oral contraceptives for three months prior to study drug dosing through 4 weeks after completion of study drug, an intrauterine device for 8 weeks prior to study drug dosing through 4 weeks after completion of study drug,double barrier contraception method for 4 weeks prior to study drug dosing through 4 weeks after completion of study drug administration 8. Male participants must be sexually abstinent for 4 weeks prior to Day 1 and continue abstinence through 90 days after completion of study drug, be > 1 year postvasectomy, agree to use a condom with spermicide from the start of study drug dosing through 90 days after completion of study drug. 9. Willing and able to provide authorization for the use and disclosure of personal health information in accordance with Health Insurance Portability and Accountability Act (HIPAA) Exclusion Criteria: 1. Unable to tolerate allopurinol 200 mg every day 2. Prior randomization in a clinical study with BCX4208 3. Unstable cardiac disease such as: unstable angina, symptomatic arrhythmia, signs or symptoms compatible with NYHA Class III or Class IV functional status for congestive heart failure or angina, history of long QT syndrome, or QTc interval < 350 msec or > 475 msec 4. Poorly controlled hypertension 5. History of severe renal insufficiency 6. Alanine aminotransferase or aspartate aminotransferase values > 2.0 x upper limit of normal 7. CD4+ cell counts by flow cytometry < 500 cells/mm3 8. Hemoglobin < 10 g/dL or > 18 g/dL (males) or < 10 g/dL or > 17 g/dL (females) 9. White blood cell count < 3.7 x 109/L or > 11 x 109/L 10. Female subjects who are pregnant, breastfeeding, or planning a pregnancy within the next 4 months 11. Positive serology for hepatitis B surface antigen or hepatitis C antibody or HIV type 1 12. Immunocompromised due to illness or organ transplant 13. Use of systemic immunosuppressive medications or disease-modifying antirheumatic drugs 14. Use of azathioprine or 6-mercatopurine within 14 days of first dose of allopurinol 15. Use of hydrochlorothiazide in doses > 50 mg per day 16. Planned use of herbal or dietary supplements 17. Recipient of any live or attenuated vaccine within 6 weeks of Screening 18. Planned use of uric acid-lowering drugs other than allopurinol 19. Use of systemic corticosteroids within 4 weeks prior to Day 1 20. Use of any investigational drug within 30 days prior to signing the ICF 21. History of clinically significant and relevant drug allergies 22. History of chronic or recurrent infections 23. History of any type of cancer not successfully treated or in full remission for 12 months prior to Screening 24. History of alcohol or drug abuse within the year prior to the signing of the ICF, or current evidence of substance dependence or abuse 25. Use of other prohibited medications within the timeframes specified in the protocol 26. Other medical conditions which, in the opinion of the Principal Investigator, would jeopardize the safety of the study subject | |
| 93 | NCT00025272 | completed | 0 | phase 2 | ['lung cancer'] | ["['C78.00', 'C78.01', 'C78.02', 'D14.30', 'D14.31', 'D14.32', 'C34.2']"] | ['carboplatin', 'etoposide', 'topotecan hydrochloride'] | ['N[C@@H](CCCNC(N)=N)C(O)=O', 'OCCOCCN1CCN(CC1)C(C1=CC=CC=C1)C1=CC=C(Cl)C=C1', 'CC[C@@]1(O)C(=O)OCC2=C1C=C1N(CC3=CC4=C(C=CC(O)=C4CN(C)C)N=C13)C2=O'] | DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed extensive stage small cell lung cancer - Measurable or evaluable disease - Pleural effusions allowed, but not considered measurable or evaluable disease - Brain metastases allowed provided neurologically stable at study entry PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - More than 2 months Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 1.5 mg/dL Renal: - Creatinine no greater than 1.5 mg/dL Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - Able to swallow capsules - No concurrent or prior malignancy within the past 5 years except inactive nonmelanomatous skin cancer or carcinoma in situ of the cervix - No other serious medical or psychiatric illness that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy Endocrine therapy: - Not specified Radiotherapy: - Prior radiotherapy for brain metastasis allowed - No other prior radiotherapy - No other concurrent radiotherapy Surgery: - Not specified | |
| 94 | NCT00630656 | completed | 1 | phase 2 | ['severe sepsis'] | ["['R65.20', 'R65.21']"] | ['talactoferrin alfa', 'placebo'] | ['CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Age greater than or equal to 18 years - Onset of severe sepsis within the previous 24 hours - Must be receiving antibiotic therapy - Informed consent form signed by patient, legal next-of-kin or legal guardian - Able to take medication by mouth or feeding tube Exclusion Criteria: - Receipt of investigational medication within 4 weeks prior to participation in the study - Pregnant or breast-feeding - Severe congestive heart failure - Known severe HIV infection - Presence of severe burns - Patients on high dose immunosuppressants - Patients whose death is considered imminent - Patients whose life expectancy for concurrent illness is less than 6 months - Severe hypoxic encephalopathy or persistent vegetative state - Severe liver disease - Patient, legal representative or patient's primary physician not committed to providing full, aggressive life support | |
| 95 | NCT00409708 | completed | 1 | phase 2 | ['attention deficit hyperactivity disorder'] | ["['F90.2', 'F90.8', 'F90.9', 'F90.0', 'F90.1']"] | ['extended release methylphenidate (ritalin la ) plus behavior therapy'] | ['COC(=O)C(C1CCCCN1)C1=CC=CC=C1'] | Inclusion Criteria: - Children of both genders, 6-12 years old - Written informed consent by the parent and the patient (over 7) - Diagnosis of ADHD - Age-appropriate cognitive functioning - All patients who had at least one post-baseline cytogenetic assessment in the core study can enter the observation phase. Exclusion Criteria: - History of malignant neoplasm - History of seizures (except childhood febrile seizures) - Hyperthyroidism - Concurrent medical condition which may interfere with study Other protocol-defined inclusion/exclusion criteria may apply | |
| 96 | NCT00705406 | completed | 0 | phase 2 | ['acute, uncomplicated human influenza'] | ["['J47.9', 'A38.9', 'F10.10', 'F10.20', 'F11.10', 'F11.20', 'F12.10']"] | ['peramivir', 'placebo'] | ['[H][C@@]1([C@@H](NC(C)=O)C(CC)CC)[C@H](O)[C@H](C[C@H]1NC(N)=N)C(O)=O', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Male and non-pregnant female subjects age ≥18 years. - A positive Influenza A or B Rapid Antigen Test (RAT) performed with a commercially available test kit on an adequate anterior nasal specimen, in accordance with the manufacturer's instructions. A negative initial RAT should be repeated within one hour. - Presence of fever at time of screening of ≥38.0 ºC (≥100.4 ºF) taken orally, or ≥38.5 ºC (≥101.2 ºF) taken rectally. A subject self-report of a history of fever or feverishness within the 24 hours prior to screening will also qualify for enrollment in the absence of documented fever at the time of screening. - Presence of at least one respiratory symptom (cough, sore throat, or nasal symptoms) of at least moderate severity. - Presence of at least one constitutional symptom (myalgia [aches and pains], headache, feverishness, or fatigue) of at least moderate severity. - Onset of symptoms no more than 36 hours before presentation for screening. - Written informed consent. Exclusion Criteria: - Women who are pregnant or breast-feeding. - Presence of clinically significant signs of acute respiratory distress - History of severe chronic obstructive pulmonary disease (COPD) or severe persistent asthma. - History of heart failure or angina requiring daily pharmacotherapy with symptoms consistent with New York Heart Association Class III or IV functional status within the past 12 months. - Screening ECG which suggests acute ischemia or presence of medically significant dysrhythmia. - History of chronic renal impairment requiring hemodialysis and/or known or suspected to have moderate or severe renal impairment (actual or estimated creatinine clearance <50 mL/min). - Clinical evidence of worsening of any chronic medical condition (temporally associated with the onset of symptoms of influenza) which, in the investigator's opinion, indicates that such finding(s) could represent complications of influenza. - Current clinical evidence, including clinical signs and/or symptoms consistent with otitis, bronchitis, sinusitis and/or pneumonia, or active bacterial infection at any body site that requires therapy with oral or systemic antibiotics. - Presence of immunocompromised status due to chronic illness, previous organ transplant, or use of immunosuppressive medical therapy which would include oral or systemic treatment with > 10 mg prednisone or equivalent on a daily basis within 30 days of screening. - Currently receiving treatment for viral hepatitis B or viral hepatitis C. - Presence of known HIV infection with a CD4 count <350 cell/mm3. - Current therapy with oral warfarin or other systemic anticoagulant. - Receipt of any doses of rimantadine, amantadine, zanamivir, or oseltamivir in the 7 days prior to screening. - Immunized against influenza with live attenuated virus vaccine (FluMist®) in the previous 21 days. - Immunized against influenza with inactivated virus vaccine within the previous 14 days. - Receipt of any intramuscular injection with the previous 7 days. - History of alcohol abuse or drug addiction within 1 year prior to admission in the study. - Participation in a previous study of intramuscular or intravenous peramivir or previous participation in this study. - Participation in a study of any investigational drug or device within the last 30 days. | |
| 97 | NCT00218465 | completed | 0 | phase 2 | ['nicotine dependence'] | ["['F17.200', 'F17.210', 'F17.208', 'F17.209', 'F17.218', 'F17.219', 'F17.228']"] | ['gw468816', 'placebo comparator: placebo'] | ['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 2. WOMEN aged 18-65 years, inclusive 3. Self-report of smoking 10 or more cigarettes per day in the past 6 months and expired air CO >10 ppm at the time of enrollment 4. DSM-IV criteria for current Nicotine Dependence satisfied 5. Subjects must be willing to take the study medication and be motivated to quit smoking (willing to set a quit date within 2 weeks of entry into the protocol) 6. Women of childbearing potential must have a negative urine pregnancy test (quantitative HCG) at baseline and at week 8, prior to receiving the first dose of study medication and females must agree to use an approved form of contraception from the day of the first dose of study medication for 90 days after the last dose of study medication. Approved forms of contraception include any of the following: - Complete abstinence from intercourse from 2 weeks prior to administration of the study drug, through the treatment phase and for 90 days after discontinuation of study medication. - Sterilization of male partner - Implant of levonorgestrel - Injectable progesterone - Intrauterine device (IUD) with <1 percent rate of failure per year - Any other method with published rate of failure of <1 percent per year Due to induction of cytochrome p450 3A4, oral contraceptives may be continued during the study but cannot be relied upon as a sole means of contraception, and a second method of contraception such as a barrier method will be required and reimbursed by the study. Exclusion Criteria: 1. Pregnant or able to become pregnant and not willing to use approved contraception 2. Severe unstable medical illness including cardiovascular, hepatic, renal, respiratory, metabolic, neurological, or hematological disease by history, physical examination or clinical laboratory test results such that hospitalization for treatment of that illness is likely within the next two months 3. Life-threatening arrhythmia, cerebro-vascular or cardiovascular event within six months of enrollment 4. Elevation over 1.5 times upper limit of normal value (ULN) of any of the following laboratory results: Total, conjugated, or unconjugated bilirubin; alkaline phosphatase, alanine transferase (ALT), aspartate aminotransferase (AST), creatine phosphokinase (CPK), or lactate dehydrogenase (LDH). 5. Use of tobacco-containing products other than cigarettes (e.g., cigar, pipe) 6. Abuse or dependence of any substance other than nicotine or caffeine in the past 6 months. Abuse of alcohol is here defined as an average weekly intake of greater than 21 units or an average daily intake of greater than three units (males) or defined as an average weekly intake of greater than 14 units or an average daily intake of greater than two units (females). One unit is equivalent to a half-pint (220mL) of beer or one (25mL) measure of spirits or one glass (125mL) of wine. 7. Diagnosis of major depressive disorder in the past 6 months 8. Lifetime DSM-IV diagnosis of organic mental disorder, schizophrenia, schizoaffective disorder, bipolar disorder, delusional disorder or psychotic disorders not elsewhere classified 9. History of non-response in the past month to an adequate trial of nicotine re placement therapy, defined as nicotine replacement > 21 mg per day patch (or equivalent dose of gum, inhaler, nasal spray, or lozenge) for at least 4 weeks. 10. History of multiple adverse drug reactions 11. Use of an investigational drug or device within 4 weeks of enrollment 12. Concurrently enrolled in a study that involves exposure to a drug or device. 13. Urine positive for drugs of abuse at screening visit. 14. Use of statins during the period of the investigation. | |
| 98 | NCT01626859 | completed | 1 | phase 2/phase 3 | ['schizophrenia'] | ["['F20.0', 'F20.1', 'F20.2', 'F20.3', 'F20.5', 'F20.89', 'F20.9']"] | ['mp-214 low dose', 'mp-214 middle dose', 'mp-214 high dose'] | ['CN(C)C(=O)N[C@H]1CC[C@H](CCN2CCN(CC2)C2=C(Cl)C(Cl)=CC=C2)CC1', 'CN(C)C(=O)N[C@H]1CC[C@H](CCN2CCN(CC2)C2=C(Cl)C(Cl)=CC=C2)CC1'] | Inclusion Criteria: - Written informed consent obtained from the patient before the initiation of any study-specific procedures - Patients diagnosed with schizophrenia according to the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia - Patients with normal physical examination, laboratory, vital signs, and/or electrocardiogram (ECG) Exclusion Criteria: - Patients with a DSM-IV-TR diagnosis of schizoaffective disorder, schizophreniform disorder, other psychotic disorders other than schizophrenia, or bipolar I or II disorder | |
| 99 | NCT01219686 | terminated | recruitment difficulties | 0 | phase 2/phase 3 | ['unipolar depression'] | ["['F32.A', 'F53.0', 'P91.4', 'Z13.31', 'Z13.32']"] | ['escitalopram, pindolol', 'escitalopram', 'escitalopram'] | ['CC(C)NCC(O)COC1=CC=CC2=C1C=CN2', 'CN(C)CCCC1(OCC2=C1C=CC(=C2)C#N)C1=CC=C(F)C=C1', 'CN(C)CCCC1(OCC2=C1C=CC(=C2)C#N)C1=CC=C(F)C=C1'] | Inclusion Criteria: - patients aged between 18 and 65 years old - patients suffering from major depression according to DSM-IV with a MADRS score of at least 25 and not treated by an antidepressant at the time of inclusion with the exception of non-responders to antidepressant for a period of at least 6 weeks or not tolerating an ongoing antidepressant necessitating a change of the antidepressant(excluding fluoxetine and irreversible MAOI) - informed consent Exclusion criteria: - any other Axis I disorder excluding anxiety disorder not dominating the clinical picture, nicotine abuse - non-responders to escitalopram in the past - already taking pindolol - pregnancy and breast feeding - contraindication to one of the two treatments (medical conditions, drug treatments) - significant somatic comorbidity interfering with the study procedures - high risk of suicidality - women of childbearing age not having a safe means of contraception |
| 100 | NCT00423293 | completed | 0 | phase 2 | ['anal cancer'] | ["['C21.1', 'C44.500', 'C44.590', 'D12.9', 'C21.8']"] | ['fluorouracil', 'mitomycin c'] | ['[H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1', 'CO[C@]12[C@H]3N[C@H]3CN1C1=C([C@H]2COC(N)=O)C(=O)C(N)=C(C)C1=O'] | DISEASE CHARACTERISTICS: - Histologically confirmed carcinoma of the anal canal, including any of the following subtypes: - Squamous cell - Basaloid - Cloacogenic - Primary invasive disease - T2-4, N0-3 disease - Clinically positive small inguinal nodes (i.e., < 1 cm in size) must be confirmed by biopsy (preferably fine-needle aspiration) within the past 6 weeks - Biopsy is not required for enlarged inguinal, perirectal, or pelvic nodes on exam or CT scan that are found to be ≥ 1.0 cm and are considered to be clinically positive PATIENT CHARACTERISTICS: - Zubrod performance status 0-1 - Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention allowed) - ALT and AST < 3 times upper limit of normal - Absolute neutrophil count ≥ 1,800/mm³ - Serum creatinine ≤ 1.5 mg/dL - Platelet count ≥ 100,000/mm³ - Bilirubin < 1.4 mg/dL - WBC ≥ 3,000/mm³ - INR ≤ 1.5 - No known AIDS - HIV-positive patients without AIDS are eligible - HIV test required for patients with clinical suspicion of AIDS - No other invasive malignancy within the past 3 years except for nonmelanomatous skin cancer - No severe, active comorbidity, defined as any of the following: - Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months - Transmural myocardial infarction within the past 6 months - Acute bacterial or fungal infection requiring IV antibiotics - Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study treatment - Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects - Uncontrolled diabetes mellitus, uncompensated heart disease, and/or uncontrolled high blood pressure, that in the opinion of the patient's treating physician, requires an immediate change in management - Patients may be eligible if appropriate changes in management have resulted in adequate control of the above mentioned conditions - Other immunocompromised status (e.g., organ transplantation or chronic glucocorticoid use) - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: - See Disease Characteristics - No prior radiation therapy to the pelvis that would result in overlap of radiation therapy fields - No prior systemic chemotherapy for cancer of the anus - No prior surgery for cancer of the anus that removed all macroscopic anal cancer - No concurrent sargramostim (GM-CSF) - No concurrent amifostine |