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| # | nctid | status | why_stop | label | phase | diseases | icdcodes | drugs | smiless | criteria |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT01187615 | terminated | 0 | phase 1 | ['small cell lung carcinoma'] | ["['D02.20', 'D02.21', 'D02.22']"] | ['regorafenib (bay73-4506) - sequential / cisplatin / pemetrexed', 'regorafenib (bay73-4506) - continuous / cisplatin / pemetrexed'] | ['[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: - Age >= 18 years. - Histological or cytological diagnosis of metastatic Stage IV or locally advanced, unresectable confirmed Stage IIIB nonsquamous Non-Small Cell Lung Cancer (NSCLC) not amenable to local therapy with curative intent. - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 - 2 - Life expectancy of at least 12 weeks. - Adequate bone marrow, liver, and renal function - Controlled blood pressure [defined as systolic Blood Pressure (BP) <=150 mmHg and diastolic Blood Pressure (BP) <= 90 mmHg] - Men and women of childbearing potential enrolled in this study must use adequate barrier birth control measures during the course of the study Exclusion Criteria: - Sensory neuropathy with sensory alterations or paresthesia (including tingling), interfering with function - Hearing impairment - Persistent proteinuria of Common Toxicity Criteria (CTC) Grade 3 or higher - Cardiac disease: congestive heart failure > New York Heart Association (NYHA) Class II; patients must not have unstable angina (anginal symptoms at rest) or new-onset angina (began within the last 3 months) or myocardial infarction within the past 6 months; cardiac ventricular arrhythmias requiring anti-arrhythmic therapy - Brain metastasis: patients with neurological symptoms should undergo a Computerized Tomography (CT) scan / Magnetic Resonance Imaging (MRI) of the brain to exclude any new or progressive brain metastasis. Patients with brain metastases are excluded from the trial - Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 6 months before start of study medication - Pulmonary hemorrhage/bleeding event > Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 within 4 weeks prior to the start of study treatment. Clinically significant hemoptysis (1 teaspoon or more) in the past 3 months - Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks prior to the start of study treatment - Evidence or history of bleeding diathesis or coagulopathy - Centrally located tumors with radiologic evidence (CT or MRI) of local invasion of major blood vessels - The effect of third space fluid, such as pleural effusion and ascites, on pemetrexed is unknown. In patients with clinically significant third space fluid, consideration should be given to draining the effusion prior to study start - Patients with phaeochromocytoma Excluded Therapies and Medications, Previous and Concomitant - Prior treatment with a systemic chemotherapy for metastatic NSCLC. Patients who underwent prior systemic treatment or radiotherapy for NSCLC in a neoadjuvant or adjuvant setting are eligible, but no chemotherapy treatment within the last 6 month prior to study entry is allowed | |
| 2 | NCT01046487 | completed | 1 | phase 1 | ['cancer'] | ["['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']"] | ['imatinib mesylate, cyclophosphamide (dosing level 1 )', 'imatinib mesylate, cyclophosphamide (dosing level 2)', 'imatinib mesylate, cyclophosphamide (dosing level 3)'] | ['CC1=NC(NC2=NC=C(S2)C(=O)NC2=C(C)C=CC=C2Cl)=CC(=N1)N1CCN(CCO)CC1', 'CC1=NC(NC2=NC=C(S2)C(=O)NC2=C(C)C=CC=C2Cl)=CC(=N1)N1CCN(CCO)CC1', 'CC1=NC(NC2=NC=C(S2)C(=O)NC2=C(C)C=CC=C2Cl)=CC(=N1)N1CCN(CCO)CC1'] | Inclusion Criteria: - Rare tumor - metastatic disease or locally advanced disease, inoperable, with no standard treatment - At least 28 days since the prior treatment - Measurable disease with at least one measurable lesion Exclusion Criteria: - Medullary insufficiency - Cystitis, haemorrhagic cystitis - Hepatic porphyria | |
| 3 | NCT01381887 | completed | 1 | phase 1 | ['diabetes mellitus, type 2'] | ["['E11.65', 'E11.9', 'E11.21', 'E11.36', 'E11.41', 'E11.42', 'E11.44']"] | ['placebo', 'canagliflozin 300mg/placebo', 'canagliflozin 300mg/canagliflozin 150mg', 'canagliflozin 300mg'] | ['CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O', '[H][C@]1(O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O)C1=CC=C(C)C(CC2=CC=C(S2)C2=CC=C(F)C=C2)=C1', '[H][C@]1(O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O)C1=CC=C(C)C(CC2=CC=C(S2)C2=CC=C(F)C=C2)=C1', '[H][C@]1(O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O)C1=CC=C(C)C(CC2=CC=C(S2)C2=CC=C(F)C=C2)=C1'] | Inclusion Criteria: - Patients with T2DM with inadequate glycemic control (based upon fasting glucose measurements >=130 mg/dL and <=250 mg/dL) on metformin monotherapy or on metformin in dual combination with other glucose lowering agents (sulphonylurea [SU] or a meglitinide or a dipeptidyl peptidase-4 [DPP-4] inhibitor) are eligible for enrollment in the study. Exclusion Criteria: - History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy - history of a severe hypoglycemic episode within 6 months before screening - Has repeated (ie, 2 or more over a 1-week period) fasting plasma glucose (FPG) and/or fasting self-monitored blood glucose (SMBG) measurements >=250 mg/dL (13.88 mmol/L) during the pre-treatment phase, despite reinforcement of diet and exercise counseling - History of or current illness considered to be clinically significant by the investigator | |
| 4 | NCT02015676 | completed | 1 | phase 1/phase 2 | ['breast cancer'] | ["['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']"] | ['trastuzumab', 'paclitaxel', 'myocet'] | ['[H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1', '[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=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O'] | Inclusion Criteria: - women 18-70 years of age; - metastatic or locally advanced breast cancer; - HER2 overexpression; - >= 1 measurable lesion. Exclusion Criteria: - prior treatment for advanced breast cancer; - prior treatment with Herceptin; - bone or central nervous system metastasis as the only site of disease; - history of another malignancy (except basal cell skin cancer and cancer in situ of the uterine cervix, and contralateral breast cancer) within 5 years of study. | |
| 5 | NCT01813955 | terminated | patient recruitment insufficient | 0 | early phase 1 | ['schizophrenia', 'cognitive deficits'] | ["['F20.0', 'F20.1', 'F20.2', 'F20.3', 'F20.5', 'F20.89', 'F20.9']", "['R41.841', 'R41.81', 'G31.84', 'I69.315', 'I69.015', 'I69.115', 'I69.815']"] | ['papaverine or placebo'] | ['COC1=C(OC)C=C(CC2=NC=CC3=CC(OC)=C(OC)C=C23)C=C1'] | Inclusion Criteria: - Diagnosed Schizophrenia (WHO ICD 10) - Treatment stable (no regulation in medicine for 6 weeks prior) - Mono antipsychotic treatment - No regular Antidepressants (PN accepted) - No regular Benzodiazepines (PN accepted) Exclusion Criteria: - Dependence syndrome - Severe physical illness - MRI incompatible, non removable objects above shoulders |
| 6 | NCT01213160 | completed | 0 | phase 1 | ['cancer', 'advanced solid malignancies'] | ["['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']"] | ['azd4547'] | ['COC1=CC(OC)=CC(CCC2=CC(NC(=O)C3=CC=C(C=C3)N3C[C@H](C)N[C@H](C)C3)=NN2)=C1'] | Inclusion Criteria: - Japanese patients with advanced solid malignancies Over 25 years old Relatively good overall health other than cancer Exclusion Criteria: - Poor bone marrow function (not producing enough blood cells). Poor liver or kidney function. Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the IP or previous significant bowel resection. | |
| 7 | NCT00722293 | completed | 1 | phase 1 | ['neoplasms, breast'] | ["['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']"] | ['doxorubicin', 'pazopanib (gw786034)', 'epirubicin'] | ['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', 'CN(C1=CC2=NN(C)C(C)=C2C=C1)C1=CC=NC(NC2=CC=C(C)C(=C2)S(N)(=O)=O)=N1', 'CN(C1=CC2=NN(C)C(C)=C2C=C1)C1=CC=NC(NC2=CC=C(C)C(=C2)S(N)(=O)=O)=N1'] | Inclusion Criteria: - Patients must provide written informed consent prior to performance of study specific procedures or assessments, and must be willing to comply with treatment and follow up - Histologically or cytologically confirmed diagnosis of advanced solid tumor that has failed standard therapy or for which there is no standard therapy and is indicated for treatment with anthracyclines. - Age greater than or equal to 18 years. - Adequate organ system function as defined by the protocol. - ECOG performance value of 0 or 1. - Less than or equal to one prior line of chemotherapy for advanced disease. Patients with metastatic disease to the brain should have definitive therapy for their brain metastases, should be asymptomatic. (Patients with previously treated brain metastases who are asymptomatic, off steroids and anti-seizure medications for greater than 3 months are eligible for the study). - There must be measurable disease or evaluable disease for subjects to be included in the cohort expansion phase. Measurable disease is not a criterion for subjects enrolling in the dose escalation phase. - Has a left ventricular ejection fraction (LVEF) greater than or equal to 50% or greater than or equal to the institution's LLN. - Women of childbearing potential must have a negative pregnancy test within 2 weeks of starting study drug and use acceptable birth control methods as outlined in the protocol. - Women may participate if they are of non childbearing potential (bilateral tubal ligation, hysterectomy, post menopausal or bilateral ovariectomy. - Males with female partners of childbearing potential may participate if they practice acceptable methods of birth control as outlined in the study protocol. - Able to swallow and retain oral medications. - Less than or equal to one prior line of chemotherapy for advanced disease. - Life expectancy of at least 12 weeks. Exclusion Criteria: - Prior use of pazopanib or prior treatment with anthracyclines. Prior therapy with other angiogenesis inhibitors is permitted. - Clinically significant gastrointestinal abnormalities which might interfere with oral dosing. - Any unstable or serious concurrent condition (e.g., active infection requiring systemic therapy). - QTc > 480 msecs. - History of any one or more of the following cardiovascular conditions within the past 6 months: - Cardiac angioplasty or stenting - Myocardial infarction - Unstable angina - Symptomatic peripheral vascular disease - Class III or IV congestive heart failure - Any major surgery or trauma within the last 28 days and or presence of non-healing wound, fracture, or ulcer. - Any unstable or serious concurrent condition. - Poorly controlled hypertension [defined as systolic blood pressure (SBP) of =140mmHg or diastolic blood pressure (DBP) of = 90mmHg]. - History of cerebrovascular accident (CVA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months. Subjects with a recent DVT who have been treated with therapeutic agents (excluding therapeutic warfarin) for at least 6 weeks are eligible. - Prior major surgery or trauma within 28 days prior to first dose of study drug and /or presence of any non-healing wound, fracture, or ulcer. - Hemoptysis within 6 weeks prior to first dose of study drug. - Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with patient's safety, provision of informed consent, or compliance to study procedures. - Is unable or unwilling to discontinue prohibited medications for 14 days or five half-lives of a drug prior to Visit 1 and for the duration of the study. - Use of an investigational agent, including an investigational anti-cancer agent, within 28 days or 5 half-lives, whichever is longer, prior to the first dose of study drug. - Is now undergoing and/or has undergone within 28 days immediately prior to first dose of study drug, any cancer therapy (major surgery, investigational agent, tumor embolization, chemotherapy, radiation therapy, immunotherapy, biological therapy, or hormonal therapy). - Clinically assessed as having inadequate venous access for PK sampling. - Lactating and pregnant women should discontinue lactation prior to first use of study drug and refrain from nursing throughout the treatment period and for 14 days after final dose. | |
| 8 | NCT00451880 | completed | 1 | phase 1 | ['cancer', 'non-small-cell lung cancer', 'colorectal cancer', 'papillary thyroid cancer', 'melanoma'] | ["['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']", "['C78.00', 'C78.01', 'C78.02', 'D14.30', 'D14.31', 'D14.32', 'C34.2']", "['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']", "['C43.0', 'C43.31', 'D03.9', 'C43.51', 'C43.9', 'D03.0', 'C43.4']"] | ['xl281', 'famotidine'] | ['NC(N)=NC1=NC(CSCCC(N)=NS(N)(=O)=O)=CS1'] | Key Inclusion Criteria: - The subject has a histologically confirmed solid tumor that is metastatic or unresectable, and for which standard curative or palliative measures do not exist or are no longer effective, and there are no therapies known to prolong survival. Subjects treated at the MTD (once- or twice- daily) must have a diagnosis of colorectal cancer, non-small-cell lung cancer (no longer recruiting), melanoma, or papillary thyroid cancer. Certain other eligibility requirements must also be met. - The subject is ≥18 years old. - The subject has an Eastern Cooperative Oncology Group (ECOG) performance status ≤2. - The subject has adequate organ and marrow function. - The subject is capable of understanding the protocol and has signed the informed consent document. - Sexually active subjects (male and female) must use medically acceptable methods of contraception during the course of the study and for 3 months after study drug discontinuation. - Female subjects of childbearing potential must have a negative pregnancy test at screening. - The subject has had no other diagnosis of malignancy (unless non-melanoma skin cancer, carcinoma in situ of the cervix, or a malignancy diagnosed ≥5 years ago, and has had no evidence of disease for 5 years prior to screening for this study). - The subject must meet certain other eligibility requirements. Key Exclusion Criteria: - The subject has received anticancer treatment (eg, chemotherapy, radiotherapy, cytokines, or hormones) within 28 days (6 weeks for nitrosoureas or mitomycin C) before the first dose of study drug. - The subject has received treatment with a small molecule kinase inhibitor or a hormonal therapy (including investigational kinase inhibitors or hormones) within a certain amount of time before the first dose of study drug. - The subject has received any other investigational agent within 28 days of first dose of XL281. - The subject has not recovered to Grade ≤1 from adverse events (AEs) or to within 10% of baseline values due to investigational or other agents administered more than 30 days prior to study enrollment. Some irreversible toxicities from previous treatment may be allowed. - The subject requires treatment with antacids (continual treatment), proton pump inhibitors, or H2 receptor antagonists. - The subject has a primary brain tumor or known brain metastases. - The subject has an 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. - The subject is pregnant or breastfeeding. - The subject is known to be positive for the human immunodeficiency virus (HIV). - The subject has an allergy or hypersensitivity to components of the XL281 formulation or to famotidine. - The subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee. - The subject is receiving anticoagulation with warfarin or coumarin-related compounds (low-dose warfarin ≤ 1 mg/day, heparin, and low-molecular weight heparin are permitted) - The subject must meet certain other eligibility requirements. | |
| 9 | NCT00096304 | terminated | low accrual | 0 | phase 1 | ['prostate cancer'] | ["['C61', 'D29.1', 'D40.0', 'Z15.03', 'Z80.42', 'Z85.46', 'Z12.5']"] | ['docetaxel', 'epirubicin hydrochloride'] | ['[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'] | DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the prostate - Meets 1 of the following criteria: - Measurable disease with any prostate-specific antigen (PSA) value - Unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan - Histologic confirmation required if measurable disease is confined to a solitary lesion - Non-measurable disease with PSA ≥ 5 ng/mL* - The following are considered non-measurable disease: - Bone lesions - Pleural or pericardial effusion - Ascites - CNS lesions - Leptomeningeal disease - Irradiated lesions unless disease progression was documented after prior radiotherapy NOTE: *Patients with PSA ≥ 5 ng/mL only are not eligible - Progressive systemic disease despite ≥ 1 prior standard endocrine therapy with orchiectomy, luteinizing hormone-releasing hormone (LHRH) agonist, or diethylstilbestrol, as indicated by 1 of the following criteria: - Objective evidence of increase > 20% in the sum of the longest diameters of target lesions from the time of maximal regression OR the appearance of 1 or more new lesions - One or more new lesions on bone scan secondary to prostate cancer AND PSA ≥ 5 ng/mL - Elevated PSA (≥ 5 ng/mL) with 2 consecutive increases from baseline (taken ≥ 1 week apart) - Serum testosterone ≤ 50 ng/dL for patients without bilateral orchiectomy - Patients who have not had a bilateral orchiectomy should continue therapy with primary testicular androgen suppression (e.g., LHRH analogues) PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - Granulocyte count ≥ 1,500/mm^3 - Platelet count ≥ 100,000/mm^3 Hepatic - Meets 1 of the following criteria: - AST or ALT normal AND alkaline phosphatase ≤ 5 times upper limit of normal (ULN) - AST or ALT ≤ 1.5 times ULN AND alkaline phosphatase ≤ 2.5 times ULN - AST or ALT ≤ 5 times ULN AND alkaline phosphatase normal - Bilirubin normal Renal - Creatinine ≤ 1.5 times ULN Cardiovascular - No uncontrolled high blood pressure - No unstable angina - No symptomatic congestive heart failure - No myocardial infarction within the past 6 months - No serious uncontrolled cardiac arrhythmia - No New York Heart Association class III or IV heart disease Other - Fertile patients must use effective contraception during and for at least 3 months after study participation - No peripheral neuropathy ≥ grade 2 - No prior severe hypersensitivity reaction to docetaxel or other drug formulated with polysorbate 80 PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF) Chemotherapy - No prior chemotherapy, including estramustine or suramin for prostate cancer - No other concurrent chemotherapy Endocrine therapy - See Disease Characteristics - At least 4 weeks since prior antiandrogen therapy - No concurrent hormonal therapy except steroids for adrenal insufficiency, hormones for non-disease-related conditions (e.g., insulin for diabetes), or intermittent dexamethasone as an antiemetic Radiotherapy - See Disease Characteristics - At least 4 weeks since prior radiotherapy - At least 8 weeks since prior strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium - No concurrent palliative radiotherapy Surgery - See Disease Characteristics - At least 4 weeks since prior surgery and recovered |
| 10 | NCT00129896 | completed | 1 | phase 1/phase 2 | ['breast cancer'] | ["['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']"] | ['myocet', 'taxotere', 'herceptin'] | ['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: - Written informed consent. - Breast cancer stages II and IIIA with histological diagnoses by true-cut. - Breast cancer tumours overexpressing HER2neu, centrally confirmed by FISH. - No evidence of metastasis: bilateral mammography, thorax x-ray, computed tomography (CT)-scan or abdominal echography and bone scintigraphy. - Estrogen and progesterone hormone receptor status, determined before study registration. - Age >= 18 years old. - Performance status (Karnofsky index) >= 80. - Adequate cardiac function by LVEF in the previous 14 days. - Hematology: neutrophils >= 2.0 x10^9/l; platelets >= 100 x10^9/l; hemoglobin >= 10 g/dl. - Adequate hepatic function: total bilirubin <= 1x upper normal limit (UNL); SGOT and SGPT <= 2.5xUNL; alkaline phosphatase <= 2.5xUNL. - Adequate renal function: creatinine <= 1xUNL; creatinine clearance >= 60 ml/min. - Patients able to comply with study treatment and follow-up. - Negative pregnancy test in the previous 14 days. - Adequate contraceptive method during the study and up to 3 months after definitive surgery. Exclusion Criteria: - HER2neu negative tumours. - Prior systemic therapy for breast cancer. - Prior treatment with anthracyclines or taxanes (paclitaxel, docetaxel) for any previous malignancy. - Prior radiotherapy for breast cancer. - Bilateral invasive breast cancer. - Pregnant or lactating women. - Previous grade >= 2 motor or sensorial neurotoxicity (National Cancer Institute Common Toxicity Criteria [NCI CTC]). - Other serious comorbidities: congestive heart failure or unstable angina; prior history of myocardial infarction in previous year; uncontrolled hypertension (HT); high risk arrhythmias; history of significant neurological or psychiatric disorders; uncontrolled active infection; active peptic ulcer; unstable diabetes mellitus; dyspnea at rest; or chronic therapy with oxygen. - Previous or current history of neoplasms different from breast cancer, except for skin carcinoma, cervical in situ carcinoma, or any other tumor curatively treated and without recurrence in the last 10 years; ductal in situ carcinoma in the same breast; lobular in situ carcinoma. - Chronic treatment with corticosteroids. - Contraindications for administration of corticosteroids, anthracyclines, docetaxel, trastuzumab or egg derivates. - Concomitant treatment with other therapy for cancer. - Males. | |
| 11 | NCT00315861 | completed | 1 | phase 1 | ['ovarian cancer', 'endometrial cancer', 'cervical cancer', 'lung cancer'] | ["['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']", "['N85.00', 'N85.01', 'N85.02', 'N99.85']", "['M50.20', 'M50.21', 'M50.30', 'M50.31', 'M50.80', 'M50.81', 'M50.90']", "['C78.00', 'C78.01', 'C78.02', 'D14.30', 'D14.31', 'D14.32', 'C34.2']"] | ['pemetrexed', 'topotecan'] | ['[H][N]([H])([H])[Pt](Cl)(Cl)[N]([H])([H])[H]', 'CC[C@@]1(O)C(=O)OCC2=C1C=C1N(CC3=CC4=C(C=CC(O)=C4CN(C)C)N=C13)C2=O'] | Inclusion Criteria: - Histologically proven advanced solid tumors - Measurable or evaluable disease - Age ≥ 18 years - Karnofsky performance status ≥ 80% (ECOG 0 or 1) - Adequate liver, bone marrow and kidney function Exclusion Criteria: - More than 3 prior chemotherapy regimens in the metastatic setting - Prior treatment with topotecan or pemetrexed - Clinically significant third space fluid present at the time of treatment - Unable to interrupt aspirin, other non-steroidal anti-inflammatory drugs - Inability to take steroid premedications or vitamin supplementation - The presence of active brain metastases - Prior radiotherapy within 4 weeks prior to the first day of treatment - Prior surgery within 3 weeks prior to the first day of treatment - Prior chemotherapy within 3 weeks prior to the first day of treatment | |
| 12 | NCT01064622 | completed | 0 | phase 1/phase 2 | ['adenocarcinoma of the pancreas', 'recurrent pancreatic cancer', 'stage iv pancreatic cancer'] | ["['C22.0', 'C22.1', 'C4A.9', 'C7B.1', 'D09.9', 'C4A.0', 'C4A.31']", "['C25.3']", "['C25.3']"] | ['vismodegib', 'gemcitabine hydrochloride'] | ['CS(=O)(=O)C1=CC(Cl)=C(C=C1)C(=O)NC1=CC=C(Cl)C(=C1)C1=CC=CC=N1', 'NC1=NC(=O)N(C=C1)[C@@H]1O[C@H](CO)[C@@H](O)C1(F)F'] | Inclusion Criteria: - Patients must have histologically or cytologically confirmed adenocarcinoma of the pancreas - Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan - Patients must have either: - Newly diagnosed chemo-naïve metastatic pancreatic cancer; only patients who have not received any chemotherapy for their metastatic disease are eligible - Recurrent disease after curative-intent surgery which has now recurred and is metastatic; patients who have recurrent disease may have received adjuvant chemotherapy or adjuvant chemoradiation, but may not have received any chemotherapy for metastatic disease; adjuvant therapy must have been completed >= 6 months prior to the diagnosis of recurrent disease, or if not adjuvant therapy received, surgery must have been performed >= 6 months prior to the diagnosis of recurrent disease - Age >= 21 years - Life expectancy > 3 months - Karnofsky performance status >= 80% - Granulocytes >= 1,500/mcL - Platelet count >= 100,000/mcL - Total bilirubin =< 1.5 times upper limit of normal (ULN) - Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 times upper limit of normal (ULN) (=< 5 times ULN in the presence of liver metastases) - Creatinine within normal institutional limit (< 1.5) OR creatinine clearance >= 65 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal - International normalized ratio (INR) =< 1.5 (=< 3 for patients on warfarin) - Patients who are on warfarin anticoagulation are allowed to participate as long as they fit the following 4 criteria: - They are therapeutic on a stable warfarin dose - Their INR target range is no greater than 3 - They are monitored with weekly INR testing - They have no active bleeding or pathological condition that carries high risk of bleeding Other anticoagulants, including enoxaparin (Lovenox) and fondaparinux (Arixtra) are also permitted - Women of child-bearing potential and men must use at least one form of contraception (i.e., barrier contraception) at least 4 weeks prior to study entry and then two forms of contraception (i.e barrier contraception and one other method of contraception), for the duration of study participation, and for at least 12 months post-treatment; for appropriate methods of contraception considered acceptable; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately - Pregnancy Testing: Women of childbearing potential are required to have a negative serum pregnancy test (with a sensitivity of at least 25 mIU/mL) within 10-14 days (at initial screening/consideration for the trial - serum or urine); a pregnancy test (serum or urine) will be administered every 4 weeks if their menstrual cycles are regular or every 2 weeks if their cycles are irregular while on study within the 24-hour period prior to the administration of GDC-0449; a positive urine test must be confirmed by a serum pregnancy test; prior to dispensing GDC-0449, the investigator must confirm and document the patient's use of two contraceptive methods, dates of negative pregnancy test, and confirm the patient's understanding of the teratogenic potential of GDC-0449 - Ability to understand and the willingness to sign a written informed consent document - Patients with recurrent disease after curative-intent surgical resection must have sufficient archival material for correlative studies (20 unstained 5 micron slides and 20 unstained 10 micron slides, or an archival tissue block Exclusion Criteria: - No prior chemotherapy for metastatic pancreatic cancer; patients who have received any chemotherapy and/or radiation therapy in the adjuvant setting must have completed this therapy ≥6 months prior to enrollment on the trial at the time of recurrence - Patients may not be receiving (or received prior to enrollment) any other investigational agents for metastatic disease - Patients with known brain metastases 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 hedgehog antagonist GDC-0449 or any other agents used in this study - History of allergic reactions attributed to compounds of similar chemical or biologic composition to GDC-0449 or other agents used in the study - GDC-0449 inhibits CYP2C8, CYP2C9, and CYP2C19 drug metabolism enzymes in vitro at concentrations that may be clinically relevant. Therefore, caution should be exercised when dosing GDC-0449 concurrently with medications that are substrates of CYP2C8, CYP2C9, and CYP2C19 and have narrow therapeutic windows - Patients with malabsorption syndrome or other condition that would interfere with intestinal absorption; patients must be able to swallow capsules - Patients with clinically active liver disease, including active viral or other hepatitis or cirrhosis are ineligible - Patients with uncontrolled hypocalcemia, hypomagnesemia, hyponatremia, or hypokalemia, defined as less than the lower limit of normal for the institution, despite adequate electrolyte supplementation are excluded from this study - No currently active second malignancy other than non-melanoma skin cancer or carcinoma in-situ of the cervix; patients are not considered to have a "currently active" malignancy if they have completed therapy and have no evidence of recurrence for at least 5 years - Uncontrolled intercurrent illness including, but not limited to, - Ongoing or active infection, - Symptomatic congestive heart failure - Unstable angina pectoris - Cardiac arrhythmia - Psychiatric illness or social situation that would limit compliance with study requirements - Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with GDC-0449; these potential risks may also apply to other agents used in this study - Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with GDC-0449; in addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated | |
| 13 | NCT01925300 | withdrawn | 0 | phase 1 | ['healthy'] | ["['Z76.3', 'Z76.2']"] | ['concor 5mg(bisoprolol hemifumarate 5mg) 2tab', 'crestor 20mg(rosuvastatin calcium 20.80mg) 1tab', 'concor 5mg 2t and crestor 20 mg 1tab'] | ['CC(C)C1=NC(=NC(C2=CC=C(F)C=C2)=C1\\C=C\\[C@@H](O)C[C@@H](O)CC(=O)O)N(C)S(C)(=O)=O', 'CC(C)C1=NC(=NC(C2=CC=C(F)C=C2)=C1\\C=C\\[C@@H](O)C[C@@H](O)CC(=O)O)N(C)S(C)(=O)=O'] | Inclusion Criteria: - Male volunteers in the age between 20 and 55 years old(inclusive) - Body mass index (BMI) in the range of 18.5 to 27 kg/m2(inclusive) - Medically healthy with no clinically significant vital signs (sitting position blood pressure, pulse rate) (90 mmHg ≤ systolic blood pressure ≤ 150 mmHg, 60 mmHg ≤ diastolic blood pressure ≤ 100 mmHg, 50 beats per minute ≤ pulse rate ≤ 100 beats per minute) - Available for the entire study period - Understand the requirements of the study and voluntarily consent to participate in the study Exclusion Criteria: - Subjects with a history of gastrointestinal diseases which might significantly change ADME(Absorption, Distribution, Metabolism and Excretion) of medicines - History of clinically significant arrhythmic, peripheral vascular,thyroid, bronchospasm, asthma disease - Subjects with anaphylaxis to bisoprolol and/or rosuvastatin - History of drug abuse - History of caffeine, alcohol, smoking abuse - caffeine(coffee,tea,coke) or grapefruit juice > 4cups/day - smoking > 20 cigarettes/day - alcohol > 140g/week - Clinical laboratory test values are outside the accepted normal range - AST(Aspartate Transaminase), ALT(ALanine Transaminase)( > 1.5 times to normal range - CK(Creatine Kinase) > 1.5 times to normal range - Estimated GFR(Glomerular Filtration Rate) < 60 mL/min - Subjects with whole blood donation within 60days, component blood donation within 30days and blood transfusion within 30days prior to study medication dosing - Subjects considered as unsuitable based on medical judgement by investigators | |
| 14 | NCT01111188 | terminated | 1 | phase 1 | ['mantle cell lymphoma'] | ["['S33.110S', 'S33.111S', 'S33.120S', 'S33.121S', 'S33.130S', 'S33.131S', 'S33.140S']"] | ['pd 0332991', 'bortezomib'] | ['CC(=O)C1=C(C)C2=CN=C(NC3=NC=C(C=C3)N3CCNCC3)N=C2N(C2CCCC2)C1=O', 'ClCCN(CCCl)P1(=O)NCCCO1'] | Inclusion Criteria: - Patients must have histologically or cytologically confirmed mantle cell lymphoma as defined by the World Health Organization. All patients must have either a demonstrated t(11;14) by karyotype, fluorescent in-situ hybridization (FISH) or positive immunohistochemistry for cyclin D1. - Subjects must have measurable disease, defined as at least one tumor mass of > 1.5 cm in diameter. - Subjects must have received at least one prior chemotherapy-containing regimen and at least one prior rituximab-containing regimen. - Age > = 18 years. - Accessible disease, defined as at least one of the following: - Adenopathy accessible to core needle biopsy - Bone marrow involvement - Circulating lymphoma cells in the peripheral blood - ECOG performance status < = 2 - Patients must have normal organ and marrow function as defined below within 14 days before enrollment: - ANC > = 750 cells/uL - platelets > = 75,000 cells/uL - Hemoglobin > = 8.0 g/dL - total bilirubin < = 1.5 times upper limit of normal - AST(SGOT)/ALT(SGPT) < = 3 times upper limit of normal - Calculated creatinine clearance > = 30 mL/min - The effects of bortezomib and PD 0332991 on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, female subjects must either be post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) prior to study entry and for the duration of the study. Male subjects must agree to use adequate contraception prior to study entry and for the duration of study participation. Should a female subject become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. - Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care. - Subjects must be willing and able to comply with the scheduled visits, treatment plans, laboratory tests, and other procedures Exclusion Criteria: - Patients who have had chemotherapy, radiotherapy, antibodies, or investigational agents within 4 weeks prior to entering the study unless progression has been documented while on treatment, or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. Patients may be receiving prednisone at a maximum dose of 10 mg/day orally, provided the dose has been stable during the prior two weeks before starting treatment. - Patients may not be receiving any other investigational agents. - Prior exposure to PD 0332991 - Prior exposure to bortezomib will only be permitted if there was a documented complete or partial response and progression occurred off therapy - Patients must not have experienced significant hematologic (grade 4) or neuropathic toxicities (grade 3 or 4) due to prior bortezomib therapy - Peripheral neuropathy > = grade 2 (CTCAEv3.0) within 14 days before enrollment. - History of allergic reactions attributed to compounds of similar chemical or biologic composition to bortezomib (e.g. boron or mannitol). - Contraindication to serial core needle biopsies - Known HIV infection - Known malabsorption syndrome that may affect absorption of the drug - Known or suspected CNS involvement - Uncontrolled illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. - Pregnant and lactating women are excluded from the study because the risks to an unborn fetus or potential risks in nursing infants are unknown. Confirmation that the subject is not pregnant must be established by a negative serum B-human chorionic gonadotropin (B-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women. - QTc > 470 msec - Current use or anticipated need for food or drugs that are known potent CYP3A4 inhibitors, including their administration within 7-days prior to the first PD 0332991dose (i.e. grapefruit juice, verapamil, ketoconazole, miconazole, itraconazole, posaconazole, erythromycin, clarithromycin, telithromycin, indinavir, saquinavir, ritonavir, nelfinavir, lopinavir, nefazodone, diltiazem, atazanavir, amprenavir,and fosamprenavir) - Current use or anticipated need for drugs that are known potent CYP3A4 inducers, including their administration within 14-days prior to the first PD 0332991 dose (i.e. carbamazepine, dexamethasone, felbamate, omeprazole, phenobarbital, phenytoin, primidone, rifabutin, rifampin, and St. John's Wort). - Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure (see Appendix 7), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant. - Diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy. | |
| 15 | NCT00560352 | terminated | 0 | phase 1 | ['multiple myeloma'] | ["['C90.01', 'C90.02', 'C90.00']"] | ['dasatinib', 'bortezomib', 'dexamethasone'] | ['CC1=NC(NC2=NC=C(S2)C(=O)NC2=C(C)C=CC=C2Cl)=CC(=N1)N1CCN(CCO)CC1', 'ClCCN(CCCl)P1(=O)NCCCO1', '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'] | Key Inclusion Criteria: - Confirmed diagnosis of multiple myeloma with measurable disease - Evidence of relapsed or refractory disease and at least 2 prior therapies for multiple myeloma - Eastern Cooperative Oncology Group Performance Status of 0 - 2 - Last treatment for multiple myeloma not within 21 days prior to study treatment initiation - Bone marrow transplant not within 3 months prior to study treatment initiation - Required baseline hematology and chemistry parameters. Key Exclusion Criteria: - Clinically significant cardiac disease (New York Heart Association Class III or IV) - Abnormal QT interval corrected for heart rate using Fridericia's formula prolonged (>450 msec) after electrolytes have been corrected on baseline electrocardiogram - Malabsorption syndrome or uncontrolled gastrointestinal toxicities - Dementia, chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation - Clinically significant pleural effusion in the previous 12 months or current ascites - Clinically significant coagulation or platelet function disorder - Intolerance to dasatinib and/or bortezomib - Acute diffuse infiltrative pulmonary disease - Prior or concurrent malignancy, except for adequately treated basal cell or squamous cell skin cancer, adequately treated Stage I or II cancer currently in complete remission, cervical carcinoma in situ, or any other cancer from which the participant has been disease-free for 3 years. | |
| 16 | NCT01292798 | completed | 1 | phase 1/phase 2 | ['diabetic macular edema'] | ["['E10.311', 'E10.319', 'E11.311', 'E11.319', 'E13.311', 'E13.319', 'E10.3513']"] | ['ranibizumab'] | ['CN\\C(NCCSCC1=CC=C(CN(C)C)O1)=C/[N+]([O-])=O'] | Inclusion Criteria: - Ability to provide written informed consent and comply with study assessments for the full duration of the study - Age > 18 years - Diagnosis of diabetes mellitus (type 1 or 2)Any one of the following will be considered to be sufficient evidence that diabetes is present:Current regular use of insulin for treatment of diabetes or current regular use of oral anti-hyperglycemia agent for the treatment of diabetes - Clinical evidence of retinal thickening due to macular edema involving the center of the macula, associated with diabetic retinopathy. - Previous history of two consecutive intravitreal bevacizumab injections for the treatment of diabetic macular edema with documented incomplete resolution of central subfield thickening by OCT (consecutive injections administered < 7 weeks apart and within the past 12 months). - Central diabetic macular edema present on clinical examination and OCT testing with central 1mm subfield thickness greater than 300 microns as measured on SD-OCT. - Visual acuity score greater than or equal to 19 letters (20/400) and less than or equal to 73 letters (20/40) by the ETDRS visual acuity protocol. - Media clarity, pupillary dilation and patient cooperation sufficient to allow OCT testing and retinal photography Exclusion Criteria: - Pregnancy (positive pregnancy test) or known to be pregnant; also pre-menopausal women not using adequate contraception. - Participation in another ocular investigation or trial simultaneously - Blood pressure > 180/110 (systolic above 180 OR diastolic above 110) - Any condition that, in the opinion of the investigator, would preclude participation in the study (e.g. chronic alcoholism, drug abuse) - Evidence of vitreoretinal interface abnormality after ocular exam or OCT that may be contributing to the macular edema - An eye that, in the investigator's opinion, has no chance of improving in visual acuity following resolution of macular edema (e.g. presence of subretinal fibrosis or geographic atrophy) - Presence of another ocular condition that may affect the visual acuity or macular edema during the course of the study (e.g. AMD, uveitis, Irvine-Gas) - Evidence of neovascularization of the iris or retina - Evidence of central atrophy or fibrosis in the study eye - Presence of substantial cataract, one that might decrease the vision by 3 or more lines of vision at sometime during the study. - History of vitreous surgery in the study eye - History of cataract surgery within 6 months of enrollment. - History of YAG capsulotomy within 2 months of enrollment. - Visual acuity <20/400 in the fellow eye - Uncontrolled glaucoma (pressure >30) despite treatment with glaucoma medications. - History of cerebral vascular accident or myocardial infarction within 3 months prior to Day 0. | |
| 17 | NCT01273558 | completed | 1 | phase 1 | ['diabetes mellitus, type 2'] | ["['E11.65', 'E11.9', 'E11.21', 'E11.36', 'E11.41', 'E11.42', 'E11.44']"] | ['canagliflozin'] | ['[H][C@]1(O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O)C1=CC=C(C)C(CC2=CC=C(S2)C2=CC=C(F)C=C2)=C1'] | Inclusion Criteria: - Patients with T2DM who are not receiving treatment with any anti-hyperglycemic agents (AHAs) for at least 12 weeks, or who are receiving treatment with a stable dose and regimen of metformin monotherapy for at least 12 weeks and have a hemoglobin A1c (HbA1c) in the range of >=7% to <=10% Exclusion Criteria: - History of Type 1, "brittle" diabetes or secondary forms of diabetes - History of 1 or more severe hypoglycemic episodes - History of diabetic complications considered to be clinically significant by the Investigator - History of or current illness considered to be clinically significant by the investigator | |
| 18 | NCT00730392 | completed | 1 | phase 1/phase 2 | ['type 1 diabetes'] | ["['E10.65', 'E10.9', 'E10.21', 'E10.36', 'E10.41', 'E10.42', 'E10.44']"] | ['etanercept', 'placebo'] | ['[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'] | Inclusion Criteria: - Males and females subjects with T1DM aged 3-18 years - Positive GAD 65 and/or islet cell antibody - HbA1c at diagnosis above 6% - Insulin regimen with 3 injection of insulin daily (as described below) - White blood count between 3,000-10,000 and platelets > 100,000 - Normal ALT and AST, creatinine < 1.8 mg/dl - T1DM duration equal or less than 4 weeks Exclusion Criteria: - Infection requiring IV antibiotics at diagnosis or within past 14 days from study entry - BMI over 85th percentile for age and gender - Unstable household - Unable to provide compliance with study drug, insulin and study visits, - Evidence of psychiatric disease in the potential study subject and/or primary care taker - And chronic diseases, including additional autoimmune disorders with the exception of euthyroid autoimmune thyroiditis | |
| 19 | NCT01101594 | terminated | study was terminated due to lack of efficacy | 0 | phase 1/phase 2 | ['multiple myeloma'] | ["['C90.01', 'C90.02', 'C90.00']"] | ['hll1-dox (the doxorubicin conjugate of milatuzumab)'] | ['COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O'] | Inclusion Criteria: - Able to provide signed, informed consent; - Male or female, >/= 18 years old; - Multiple myeloma with one or more criteria for measurable disease (serum M protein > 0.5 gm/dl, urinary M protein excretion > 200 mg/24 hours, serum free light chain measurement >20 mg/dl,); - Refractory or relapsed to at least two prior standard systemic anti-myeloma treatment regimens one of which must include either thalidomide, lenalidomide or bortezomib; - Adequate performance status (Karnofsky Scale >/= 70%); - Life expectancy at least 6 months; - Adequate cardiac function: MUGA scan or 2D-ECHO with LVEF 55%, EKG with no medically relevant arrhythmia uncontrolled on medications; - Adequate hematologic status within 2 weeks before study drug administration: - Hemoglobin >/=8.0 g/dL and platelets >/=75,000/mm3 (both without transfusion or other hematologic support within 7 days of laboratory testing) - White blood count (WBC) >/= 2,000/mm3and absolute neutrophil count (ANC) >/=1,500/mm3 (both without the use of colony stimulating factors within 7 days of laboratory testing); - Adequate renal function: serum creatinine </+ 2.5 mg/mL; - Adequate hepatic function - AST and ALT </= 2.5 x the ULN - Total bilirubin </= 1.5 x the ULN Exclusion Criteria: - 1. Pregnant or lactating women. Women of childbearing potential must have a negative pregnancy test Pregnancy testing is not required for post-menopausal or surgically sterilized women; - Patients who are eligible for stem cell transplant. - Women of childbearing potential and fertile men who are not practicing or who are unwilling to practice birth control while enrolled in the study until at least 12 weeks after the last hLL1-dox infusion; - Prior local radiotherapy within 14 days; chemotherapy or kyphoplasty within 21 days, immunotherapy, plasmapheresis, or major surgery within 28 days; prior stem cell transplant within 12 weeks. - Must have no persistent ≥ Grade 2 toxicity from prior treatments; - Prior treatment with any other therapeutic agents for MM or investigational agents within 4 weeks, unless off study, and agreed by Sponsor; - A history of allergic or adverse reactions to anthracycline/anthracenedione agents; - Cumulative life-time anthracycline/anthracenedione exposure exceeding 300 mg/m2 (including daunorubicin, idarubicin, epirubicin or mitoxantrone); - Known to be HIV positive, or any prior hepatitis B or C infection; - Any history of clinically significant autoimmune disease (e.g., collagen vascular disorders, autoimmune hepatitis, Coombs positive anemia/thrombocytopenia, etc.) - Prior history of mediastinal or pericardial external beam radiation therapy. - Prior history of treatment with trastuzumab, unless discussed with and agreed to by Medical Monitor. - Systemic infection or requiring anti-infectives within 7 days before first dose of study drug; - Substance abuse or other concurrent medical conditions that, in the Investigator's opinion, could confound study interpretation or affect the patient's ability to tolerate or complete the study. |
| 20 | NCT00379080 | completed | 0 | phase 1/phase 2 | ['adult brain tumor', 'adult giant cell glioblastoma', 'adult glioblastoma', 'adult gliosarcoma', 'recurrent adult brain tumor'] | ["['G47.13', 'J01.41', 'K11.22', 'K12.0', 'N96', 'F33.8', 'G03.2']"] | ['tandutinib'] | ['COC1=C(OCCCN2CCCCC2)C=C2N=CN=C(N3CCN(CC3)C(=O)NC3=CC=C(OC(C)C)C=C3)C2=C1'] | Criteria: - Histologically confirmed glioblastoma: - Progressive or recurrent disease after prior radiotherapy (with or without chemotherapy) - Patients with a previous low-grade glioma that progressed after prior radiotherapy (with or without chemotherapy) and are found to have glioblastoma by biopsy are eligible - Measurable disease, defined as contrast-enhancing progressive or recurrent glioblastoma by MRI or CT imaging within the past 2 weeks - Must be maintained on a stable corticosteroid regimen from the time of baseline scan to the start of study treatment - Feasibility study only: - Planning to undergo surgical resection or biopsy - Stereotactic biopsy for confirmation of tumor progression or differentiation of tumor progression from treatment-induced effects allowed - Corticosteroids must be tapered to the lowest required steroid dose and patient must be maintained on a stable dose after surgery or biopsy - Karnofsky performance status 60-100% - Absolute neutrophil count >= 1,500/mm^3 - Hemoglobin >= 10 mg/dL - Bilirubin =< 1.5 mg/dL - AST and ALT =< 4 times upper limit of normal - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective barrier method contraception during and for 3 months after completion of study treatment - Mini Mental State Exam score >= 15 - Mean QTc =< 500 msec (with Bazett's correction) by screening electrocardiogram - LVEF >= 40% - No history of familial long QT syndrome - No myocardial infarction within the past 6 months - No severe uncontrolled ventricular arrhythmias - No uncontrolled angina - No electrocardiographic evidence of acute ischemia or active conduction system abnormalities - No ongoing vomiting or nausea >= grade 2 - No gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous alimentation - No active peptic ulcer disease - No other condition that would impair ability to swallow pills or absorb oral medications - No muscular dystrophy - No myasthenia gravis - No other known or suspected primary muscular or neuromuscular disease - No history of allergic reactions attributed to compounds of similar chemical or biologic composition to tandutinib (e.g., erlotinib hydrochloride, gefetinib, or doxazosin mesylate) - Patients who developed an acneiform/maculopustular rash while receiving either gefitinib or erlotinib hydrochloride are eligible unless the rash is considered an allergic reaction (angioedema/urticaria) or Stevens-Johnson syndrome - No ongoing or active infections - No psychiatric illness or social situations that would preclude study compliance - No other serious infection or medical illness - At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) - No other uncontrolled illness - No other malignancy within the past 5 years except for basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast - Recovered from prior therapy - At least 3 months since prior radiotherapy - No prior surgical procedures affecting absorption - No concurrent combination antiretroviral therapy for HIV-positive patients - No other concurrent investigational agents - No concurrent agent that would cause QTc prolongation - No concurrent prophylactic growth factors (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF]) - At least 10 days since prior and no concurrent anticonvulsant drugs that induce hepatic metabolic enzymes (e.g., primidone, oxcarbazepine, phenytoin, carbamazepine, or phenobarbital) - No prior treatment with small molecule inhibitors of platelet-derived growth factor receptor (e.g., sunitinib malate, sorafenib, or imatinib mesylate) - Platelet count >= 100,000/mm^3 - No New York Heart Association class III or IV heart failure - Creatinine =< 1.5 mg/dL OR creatinine clearance >= 60mL/min | |
| 21 | NCT00735878 | terminated | data from a similar did not show efficacy. | 0 | phase 1/phase 2 | ['non small cell lung cancer', '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']"] | ['abt-751 and carboplatin'] | ['COC1=CC=C(C=C1)S(=O)(=O)NC1=C(NC2=CC=C(O)C=C2)N=CC=C1'] | Inclusion Criteria: 1. At least 18 years of age. 2. Pathologically or cytologically confirmed diagnosis of NSCLC . 3. At least one measurable lesion (not amenable to resection) for Response Evaluation Criteria in Solid Tumors (RECIST) tumor assessments. Target lesions must not have been in the previous radiation port. 4. Advanced stage of disease (IIIB with malignant pleural effusion or Stage IV) with no known curative treatment that has progressed despite therapy for recurrent/metastatic disease or prior therapy was discontinued due to intolerable toxicities. During the phase II portion of the study, previously untreated patients with IIIB with malignant pleural effusion or Stage IV NSCLC may be enrolled. 5. For patients participating in the phase I part of the study, no alternative therapy is available that is expected to prolong overall or progression-free survival. Unacceptable toxicities during first- or second-line therapy or evidence for disease progression. 6. Adequate hematologic, renal and hepatic function as follows: - Hematologic: ANC (absolute neutrophil count) ≥ 1200/mm3; Platelets; ≥ 100,000/mm3; hemoglobin: ≥ 8.5 g/dL; - Renal function: serum creatinine ≤ 2.0 mg/dL; renal (CrCl > 50 ml/min by Jelliffe or Cockcroft Gault Formula), - Hepatic function: Bilirubin ≤ 2.0 mg/dL (≤ 3.0 mg/dL for patients with liver metastases); AST (aspartate aminotransferase) and ALT (alanine aminotransferase) ≤ 2.5 X the upper limits of normal (ULN) (≤ 5 X ULN for patients with liver metastases). 7. Adequate performance status, Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-1. 8. Prior platinum (cisplatin, carboplatin or oxaliplatin) therapy is allowed. 9. Patient or patient's legally acceptable representative has voluntarily signed and dated an informed consent form approved by an Institutional Review Board (IRB), prior to any study-specific procedures. Exclusion Criteria: 1. Any other malignancy within 3 years except in situ carcinoma. 2. Untreated central nervous system (CNS) metastasis. 3. A greater than Grade 1 National Cancer Institute Common Toxicity Criteria (NCI CTC) neurology category findings at baseline. 4. Concurrent anti-cancer therapy or radiotherapy. 5. Concurrent therapy with colchicines. 6. Prior therapy with ABT-751. 7. Cytotoxic chemotherapy within 3 weeks of initiating investigational treatment. 8. Any investigational therapy within 4 weeks. 9. Female patients that are pregnant or breastfeeding. 10. Patients of childbearing potential (male and female) that do not agree to use a contraceptive method deemed acceptable by the investigator while in the study and for up to three months following completion of therapy. 11. Documented allergy or hypersensitivity to carboplatin or sulfa. 12. Patient has received more than 2 prior chemotherapy regimens for advanced disease. Adjuvant chemotherapy administered more than 6 months prior to enrollment does not count towards this limit. 13. Patient is classified as 3 or 4 by New York Heart Association (NYHA) Functional Classification, defined as: - Class 3: Patients with marked limitation of physical activity, comfortable at rest, but less than ordinary activity causes symptoms. - Class 4: Patients are unable to carry on any physical activity without symptoms and symptoms are present even at rest. 14. Evidence of clinically significant medical condition(s) that compromises safety, compliance, or study conduct, and/or is considered by the investigator to be unable to tolerate the proposed treatment or procedures. |
| 22 | NCT00494221 | completed | 1 | phase 1/phase 2 | ['metastatic colorectal cancer'] | ["['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']"] | ['azd2171', 'folfox (5-fluorouracil, leucovorin, oxaliplatin)', 'placebo cediranib'] | ['COC1=CC2=C(C=C1OCCCN1CCCC1)N=CN=C2OC1=C(F)C2=C(NC(C)=C2)C=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: - Metastatic colorectal cancer - WHO performance status 0-1 - Life expectancy is 12 weeks or longer Exclusion Criteria: - Patient with uncontrolled brain metastases - Patient with inappropriate laboratory tests values - Patient with poorly controlled hypertension | |
| 23 | NCT02012166 | completed | 1 | phase 1 | ['type 2 diabetes mellitus'] | ["['E11.65', 'E11.9', 'E11.21', 'E11.36', 'E11.41', 'E11.42', 'E11.44']"] | ['mk-0893 10 mg', 'mk-0893 40 mg', 'mk-0893 200 mg', 'mk-0893 1000 mg', 'placebo'] | ['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', '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', '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', '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', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Good health - Body Mass Index of between 18 and 28 kg/m^2, or up to 30 kg/m^2 with approval of sponsor - Non-smoker for at least 6 months - Willing to avoid strenuous physical activity - Willing to avoid alcohol, caffeine, and grapefruit juice consumption Exclusion Criteria: - History of renal, neurologic, gastrointestinal or respiratory disease or any gastrointestinal surgery - History of multiple and/or severe allergies to a prescription, nonprescription or investigational drug or food - History of any cardiovascular/cardiac disease - History of any hepatic disease and primary biliary cirrhosis - History of hypoglycemia or glucose intolerance, type 1 diabetes, or type 2 diabetes - Requires or anticipates use of prescription or nonprescription medications, including herbal remedies - A user of any illicit drugs or a history of drug or alcohol abuse - Surgery, donated a unit of blood, or participated in another clinical study within 4 weeks prior to study participation - History of hypersensitivity to insulin, glucagon, or Sandostatine®. | |
| 24 | NCT00543114 | terminated | lack of efficacy and tolerability | 0 | phase 1 | ['chronic lymphocytic leukemia', 'small lymphocytic leukemia'] | ["['C91.11', 'C91.12', 'C91.10']", "['A87.2', 'K52.832', 'D72.111', 'C91.11', 'C91.12', 'C91.10']"] | ['lenalidomide', 'fludarabine', 'rituximab'] | ['NC1=CC=CC2=C1CN(C1CCC(=O)NC1=O)C2=O', 'ClCCN(CCCl)P1(=O)NCCCO1', 'ClCCN(CCCl)P1(=O)NCCCO1'] | Inclusion Criteria: - 18 years of age or older - Diagnosed with B-CLL/SLL based on the standard histologic and immunophenotypic criteria described in the WHO classification - No prior systemic therapy for CLL/SLL, including chemotherapy or antibody therapy - Currently needs therapy based on 1996 NCI-WG criteria - Measurable disease - ECOG Performance Status of 0-2 - Laboratory test results within parameters outlined in protocol - Able to take aspirin daily as prophylactic anticoagulation Exclusion Criteria: - Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent document - Pregnant or breast-feeding females - Any condition, including the presence of abnormal laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study - Use of any other experimental drug or therapy within 28 days of baseline - Known hypersensitivity to thalidomide - Development of erythema nodosum characterized by a desquamating rash while taking thalidomide or similar drugs - Prior use of lenalidomide - Concurrent use of other anti-cancer agents or treatments - Known positive for HIV - Chronic active Hep B patients not on prophylactic lamivudine - Diagnosis of Mantle Cell Lymphoma |
| 25 | NCT01575405 | completed | 1 | phase 1 | ['hiv prevention'] | ["['B20', 'Z71.7', 'O98.72', 'Z21', 'O98.73', 'R75', 'Z11.4']"] | ['rectal formulation (rf) of tenofovir 1% gel', 'vaginal formulations (original vf and reduced vaginal glycerin formulation rgvf) of tenofovir 1% gel', 'universal hec placebo gel formulation'] | ['C[C@H](CN1C=NC2=C1N=CN=C2N)OCP(O)(O)=O', 'OCC(O)CO', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: 1. ≥ Age of 18 at screening 2. Willing and able to communicate in English 3. Willing and able to provide written informed consent to take part in the study 4. Willing and able to provide adequate locator information 5. Understands and agrees to local sexually transmitted infection (STI) reporting requirements 6. HIV-1 uninfected at screening according to the standard DAIDS algorithm in Appendix II 7. Must have been vaccinated for or have natural immunity to Hepatitis B, which will be verified by a positive Hepatitis B surface antibody (HBsAb) test at screening (Note: One re-screen will be allowed for individuals who are non immune to Hepatitis B but undergo vaccination.) 8. Availability to return for all study visits, barring unforeseen circumstances 9. Willing to abstain from RAI and practices involving insertion of anything in rectum (drug, enema, penis, or sex toy) for 72 hours before and 72 hours after each flexible sigmoidoscopy and study product exposure. 10. Must agree to use study provided condoms for the duration of the study 11. Must be in general good health 12. Must agree not to participate in other concurrent interventional and/or drug trials 13. Per participant report at screening, a history of consensual RAI at least once in the last three months. In addition to the criteria listed above, female participants must meet the following criteria: 14. Willing to abstain from insertion of anything into vagina (drug, douche, penis, or sex toy) other than the swabs/sponges for study related specimen collection for 24 hours before and after each study product exposure 15. Post-menopausal or using (or willing to use) an acceptable form of contraception (e.g., intrauterine device (IUD), hormonal contraception, surgical sterilization, or vasectomization of male partner). If the female participant has female partners only, the method of contraception will be noted as a barrier method in the study documentation. Temporary abstinence due to absence of partner(s) for the duration of the study will be acceptable. Exclusion Criteria: 1. Abnormalities of the colorectal mucosa, or significant colorectal symptom(s), which in the opinion of the clinician represents a contraindication to biopsy (including but not limited to presence of any unresolved injury, infectious or inflammatory condition of the local mucosa, and presence of symptomatic external hemorrhoids). 2. At screening: participant-reported symptoms and/or clinical or laboratory diagnosis of active rectal or reproductive tract infection requiring treatment per current CDC guidelines or symptomatic urinary tract infection (UTI). Infections requiring treatment include symptomatic bacterial vaginosis, symptomatic vaginal candidiasis, other vaginitis, trichomoniasis, Chlamydia (CT), gonorrhea (GC), syphilis, active HSV lesions, chancroid, pelvic inflammatory disease, genital sores or ulcers, cervicitis, or symptomatic genital warts requiring treatment. Note that an HSV-1 or HSV-2 seropositive diagnosis with no active lesions is allowed, since treatment is not required. (Note: In cases of non-anorectal GC/CT identified at screening, one re-screening 2 months after screening visit will be allowed.) 3. Per participant report and/or clinical or laboratory diagnosis, anorectal STI within six months prior to the Screening Visit 4. At screening: 1. Hemoglobin < 10.0 g/dL 2. Platelet count less than 100,000/mm3 3. White blood cell count < 2,000 cells/mm3 or > 15,000 cells/mm3 4. For females: calculated creatinine clearance less than 60 mL/min by the Cockcroft-Gault formula where creatinine clearance in mL/min (140- age in years) x (weight in kg) x (0.85 for female)/72 x (serum creatinine in mg/dL) 5. For males: calculated creatinine clearance less than 60 mL/min by the Cockcroft-Gault formula where creatinine clearance in mL/min = (140 - age in years) x (weight in kg) x (1 for male)/72 x (serum creatinine in mg/dL) 6. Serum creatinine > 1.3× the site laboratory upper limit of normal (ULN) 7. Alanine transaminase (ALT) and/or aspartate aminotransferase (AST) > 2.5× the site laboratory ULN 8. +1 glucose or +1 protein on urinalysis (UA) 9. History of bleeding problems (verified via prothrombin time (PT)/ International Normalized Ratio (INR) test) 10. Positive for Hepatitis B surface antigen (HBsAg) 5. History of significant gastrointestinal bleeding in the opinion of the investigator 6. Known allergic reaction to methylparaben, propylparaben, sorbic acid, glycerin, glycerol, or tenofovir 7. Current known HIV-infected partner(s) 8. By participant report at enrollment, history of excessive daily alcohol use (as defined by the CDC as heavy drinking consisting of an average consumption of more than 2 drinks per day for men, and more than 1 drink per day for women), frequent binge drinking or illicit drug use that includes any injection drugs, methamphetamines (crystal meth), heroin, or cocaine including crack cocaine, within the past 12 months 9. Per participant report at screening, anticipated use and/or unwillingness to abstain from the following medications during the period of study participation: 1. Heparin, including Lovenox® 2. Warfarin 3. Plavix® (clopidogrel bisulfate) 4. Rectally administered medications (including over-the-counter products) 5. Acyclovir, valacyclovir, famciclovir, and TDF 6. >81 mg of aspirin per day AND unwillingness and/or inability to completely stop all use of aspirin or aspirin-containing medications for 3 days before and 3 days after the biopsy collection procedure 7. Non-steroidal anti-inflammatory drugs (NSAIDS) 8. Any other drugs that are associated with increased likelihood of bleeding following mucosal biopsy 10. By participant report at screening, use of systemic immunomodulatory medications, rectally administered medications, rectally administered products (including condoms) containing N-9, or any investigational products within the 4 weeks prior to the Enrollment/Baseline Evaluation Visit and throughout study participation 11. History of recurrent urticaria 12. Any other condition or prior therapy that, in the opinion of the investigator, would preclude informed consent, make study participation unsafe, make the individual unsuitable for the study or unable to comply with the study requirements. Such conditions may include, but are not limited to, current or recent history of severe, progressive, or uncontrolled substance abuse, or renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, or cerebral disease In addition to the criteria listed above, female participants will be excluded if they meet any of the following criteria: 13. Pregnant at the Enrollment/Baseline Visit 14. Breastfeeding at screening or intend to breastfeed during study participation per participant report. | |
| 26 | NCT00068757 | completed | 1 | phase 1 | ['breast cancer'] | ["['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']"] | ['lonafarnib', 'paclitaxel'] | ['NC(=O)N1CCC(CC(=O)N2CCC(CC2)[C@H]2C3=C(CCC4=C2C(Br)=CC(Cl)=C4)C=C(Br)C=N3)CC1', '[H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\\C=C(C)\\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\\C=C\\C=C\\C=C(C)\\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC'] | DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed breast cancer - Stage IIIB, IIIC, or IV - HER2/neu overexpression - 3+ by immunohistochemistry - 2+ allowed if positive fluorescent in situ hybridization - Disease meets the following treatment criteria: - Paclitaxel/trastuzumab (Herceptin®) may be appropriate therapy - Anthracycline therapy is not a suitable approach - No clinical signs of CNS involvement - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age - 18 and over Sex - Male or female Menopausal status - Not specified Performance status - ECOG 0-2 OR - WHO 0-2 Life expectancy - Not specified Hematopoietic - Neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 10.0 g/dL (6.2 mmol/L) Hepatic - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - Alkaline phosphatase less than 2.5 times ULN (5 times ULN if liver metastases are present) - AST and ALT less than 2.5 times ULN (5 times ULN if liver metastases are present) Renal - Creatinine clearance at least 40 mL/min Cardiovascular - Cardiac ejection fraction normal by MUGA - QTc interval no greater than 440 msec - No cardiac dysfunction Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for up to 3 months after study participation - No concurrent severe/unstable systemic disease - No infection - No circumstances that would preclude study participation (e.g., alcoholism or substance abuse) - No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up PRIOR CONCURRENT THERAPY: Biologic therapy - More than 1 year since prior trastuzumab - No concurrent prophylactic growth factors Chemotherapy - More than 1 year since prior paclitaxel - More than 4 weeks since other prior chemotherapy Endocrine therapy - More than 1 day since prior hormonal therapy - More than 2 days since prior high-dose chronic steroids - More than 2 days since prior ethinyl estradiol - No concurrent high-dose chronic steroids - No concurrent ethinyl estradiol Radiotherapy - More than 4 weeks since prior radiotherapy Surgery - Not specified Other - More than 2 days since prior administration of and no concurrent CYP3A4 inducers or inhibitors, including any of the following: - Gestodene - Itraconazole - Ketoconazole - Cimetidine - Erythromycin - Carbamazepine - Phenobarbital - Phenytoin - Rifampin - Sulfinpyrazone - No concurrent grapefruit juice - No other concurrent anticancer agents - No other concurrent investigational therapy | |
| 27 | NCT00096707 | completed | 1 | phase 1 | ['lung cancer', 'breast cancer', 'pancreatic cancer', 'head and neck cancer', 'gastric cancer'] | ["['C78.00', 'C78.01', 'C78.02', 'D14.30', 'D14.31', 'D14.32', 'C34.2']", "['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']", "['C25.3']", "['C76.0', 'C47.0', 'C49.0', 'C77.0', 'D17.0', 'D21.0', 'D36.11']", "['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']"] | ['2-deoxy-d-glucose (2dg)'] | ['[H]C([H])(C=O)[C@@]([H])(O)[C@]([H])(O)[C@]([H])(O)CO'] | Inclusion Criteria: - Males and females, at least 18 years of age - Histologically confirmed, locally advanced or metastatic solid malignancy - Previously treated with at least one chemotherapy regimen for advanced or metastatic disease OR no curative standard treatment is available - Recovered from reversible toxicities of prior therapy - Life expectancy of at least 3 months - ECOG performance status of 0, 1, or 2 - Measurable or nonmeasurable disease by RECIST criteria - Ability to understand the purposes and risks of the study and having signed a written informed consent form - All women of childbearing potential and all men must agree to use effective means of contraception from entry into the study through 3 months after the last dose Exclusion Criteria: - Previous or current CNS metastases (screening CT or MRI is not required in asymptomatic subjects) - Active clinically significant infection requiring antibiotics - Known glucose-6-phosphate dehydrogenase deficiency or history of anemia of unknown etiology - History of clinically significant unexplained episodes of hypotension, fainting, dizziness, or lightheadedness - History or symptoms of cardiovascular disease, particularly coronary artery disease, arrhythmias, or conduction defects with risk of cardiovascular instability, uncontrolled hypertension, clinically significant pericardial effusion, or congestive heart failure - History of transient ischemic attack, stroke, or seizure disorder or any other CNS disease considered to be significant by the investigator - Known autonomic dysfunction or chronic orthostatic hypotension - Evidence of hypoglycemia, clinically significant renal disease, clinically significant liver disease (other than liver metastases), diabetes mellitus, gastrointestinal disorder (that could affect absorption or elimination of orally-administered medications), or obstructive uropathy with significant post-void residual during the past 5 years - Known HIV infection - Other primary malignancies (other than treated basal cell carcinoma of the skin or treated in situ cervical cancer) within the past 5 years - Major surgery within 4 weeks of the start of study treatment, without complete recovery - Antitumor therapy within 21 days of the start of study treatment - Disease progression/relapse on docetaxel therapy within the past 12 months - A history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 - Known sensitivity to methylparaben or propylparaben - Inability to discontinue prohibited medications for 24 hours before and after dosing on Day 1 of Weeks 1, 2, and 3 and Day 5 of Week 1. In addition, patients who cannot discontinue medications known to induce or inhibit CYP 3A4, such as cyclosporine, terfenadine, ketoconazole, erythromycin, and troleandomycin, for the duration of the study are not eligible. - Peripheral neuropathy >= Grade 2 - Hemoglobin <9 g/dL - ANC <1500/μL - Platelet count <100,000/μL - Total bilirubin >1.5 mg/dL - Abnormal liver function - Serum creatinine >1.5 mg/dL unless creatinine clearance is >= 60 mL/min - Serum potassium < lower limit of normal - Elevated fasting blood glucose - Pregnant or nursing women - Participation in an investigational drug or device study within 28 days of the first day of dosing on this study - Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study. - Unwillingness or inability to comply with the study protocol for any other reason - Subjects who live alone | |
| 28 | NCT01192165 | completed | 1 | phase 1 | ['cancer'] | ["['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']"] | ['trametinib (gsk1120212)', 'docetaxel', 'erlotinib', 'pemetrexed', 'carboplatin', 'nab-paclitaxel', 'cisplatin'] | ['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', 'COCCOC1=CC2=C(C=C1OCCOC)C(NC1=CC(=CC=C1)C#C)=NC=N2', '[H][N]([H])([H])[Pt](Cl)(Cl)[N]([H])([H])[H]', 'N[C@@H](CCCNC(N)=N)C(O)=O', '[H][C@]12[C@H](OC(=O)C3=CC=CC=C3)[C@]3(O)C[C@H](OC(=O)[C@H](O)[C@@H](NC(=O)C4=CC=CC=C4)C4=CC=CC=C4)C(C)=C([C@@H](OC(C)=O)C(=O)[C@]1(C)[C@@H](O)C[C@H]1OC[C@@]21OC(C)=O)C3(C)C', '[H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC'] | Inclusion Criteria: - The subject has a solid tumor. Expansion cohorts are limited to non-small cell lung cancer and/or pancreatic cancer with or without a KRAS mutation. - Tumor progression following at least one prior standard therapy, the subject refuses standard therapy, or no standard therapy exists. - The subject has a radiographically measurable tumor. - The subject is able to carry out daily life activities without difficulty. - The subject is able to swallow and retain oral medication. - The subject does not have significant side effects from previous anti-cancer treatment. - The subject has adequate organ and blood cell counts. - Sexually active subjects must use medically acceptable methods of contraception during the course of the study. Exclusion Criteria: - The subject has had major surgery or received certain types of cancer therapy within 2-3 weeks before starting the study. - The subject has a brain tumor. - Current severe, uncontrolled systemic disease. - History of clinically significant heart, lung, or eye/vision problems. - The subject has high blood pressure that is not well-controlled with medication. - The subject has a permanent pacemaker. - The subject is pregnant or breastfeeding. - Positive for Hepatitis B, Hepatitis C, or HIV. | |
| 29 | NCT00473486 | terminated | sorafenib administered in the combination with pemetrexed-carboplatin appears to enhance thrombocytopenia compared to historical data. | 0 | phase 1/phase 2 | ['carcinoma, non-small-cell lung'] | ["['D02.20', 'D02.21', 'D02.22']"] | ['pemetrexed, carboplatin, sorafenib', 'pemetrexed, carboplatin, placebo'] | ['CNC(=O)C1=NC=CC(OC2=CC=C(NC(=O)NC3=CC(=C(Cl)C=C3)C(F)(F)F)C=C2)=C1', '[H][N]([H])([H])[Pt]1(OC(=O)C2(CCC2)C(=O)O1)[N]([H])([H])[H]'] | Inclusion Criteria: - Histologically or cytologically confirmed NSCLC - Locally advanced (stage IIIB with malignant pleural or pericardial effusion) or metastatic (stage IV) NSCLC - No prior systemic chemotherapy - Prior local radiotherapy is allowed if it is completed at least 3 weeks prior to the first dose of study medication; also concomitant palliative radiotherapy to an existing bone lesion for pain control is allowed - Prior surgery is allowed if it is performed at least 4 weeks prior to the first dose of study medication and patient should be fully recovered. - Must have measurable disease with at least one lesion with a longest diameter measured as ≥ 2 cm with conventional techniques or as ≥ 1 cm with spiral CT - Age ≥18 years old - ECOG performance score (PS) 0-1 - Life expectancy of at least 12 weeks - Adequate bone marrow, renal and hepatic function - hemoglobin ≥ 9.0 g/dl - absolute neutrophil count ≥1,500/mm3 - platelet count ≥ 100,000/mm3 - total bilirubin ≤ 1.5 times the upper limit of normal - ALT and AST ≤ 2.5 times the upper limit of normal (≤ 5 x upper limit of normal for patients with liver involvement) - INR ≤ 1.5 and aPTT within normal limits - serum creatinine ≤ 1.5 the upper limit of normal - Patients with creatinine clearance ≥ 45 mL/min - Not pregnant or nursing patients - Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment - Women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation. Men should use adequate birth control for at least six months after the last administration of sorafenib - Signed informed consent prior to any study specific procedures - Compliance and geographic proximity that allow adequate follow-up Exclusion Criteria: - Any prior systemic anticancer therapy including cytotoxic therapy, targeted agents, experimental therapy (treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study enrollment), adjuvant, or neo-adjuvant therapy for NSCLC - Any participation in a clinical trial 30 days prior to study entry and concomitantly to the study - Cardiac disease: Congestive heart failure > class II NYHA. Patients must not have unstable angina (angina symptoms at rest) or new-onset angina (began within the last 3 months) or myocardial infarction within the past 6 months - Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy - Uncontrolled hypertension defined as systolic blood pressure > 150 mm Hg or diastolic pressure > 90 mm Hg, despite optimal medical management - Documented brain metastases (unless the patient is > 6 months from definitive therapy for brain metastases, has a negative imaging study within 4 weeks of study entry and has been off corticosteroids for at least 4 weeks before study enrolment). Brain imaging (CT scan/MRI) is required in symptomatic patients to rule out brain metastases, but is not required in asymptomatic patients. - Patients with seizure disorder requiring medication (such as steroids or antiepileptics) - Known HIV infection or chronic hepatitis B or C - Active clinically serious infections > CTCAE Grade 2 - Presence of clinically significant third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study enrolment - Pulmonary hemorrhage/bleeding event >= CTCAE Grade 2 within 4 weeks of first dose of study drug - Any other hemorrhage/bleeding event > =Grade 3 within 4 weeks of first dose of study drug - Evidence or history of bleeding diathesis or coagulopathy - Therapeutic anticoagulation with vitamin K antagonists such as phenprocoumon, warfarin, or with heparins or heparinoids. Low dose anticoagulation is permitted - Serious, non-healing wound, ulcer, or bone fracture - Major surgery, open biopsy or significant traumatic injury within 4 weeks of first dose of study drug - Known or suspected allergy to sorafenib, carboplatin or pemetrexed - Previous or current cancer that is distinct in primary site or histology from NSCLC except cervical cancer in-situ, treated basal cell carcinoma, superficial bladder tumors (Ta and Tis) or any cancer curatively treated > 3 years prior to study entry - Substance abuse, medical, psychological or social conditions that may interfere with the patients participation in the study - Significant weight loss (> or equal 10% body weight during preceeding 6 weeks) - Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents, other than an aspirin dose ≤ 1.3 grams per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam) - Inability or unwillingness to take folic acid, vitamin B12 supplementation or corticosteroids - Recent (within 30 days of enrolment) or concurrent yellow fever vaccination - Serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to adhere to the protocol. |
| 30 | NCT01028248 | completed | 1 | phase 1 | ['central retinal vein occlusion'] | ["['H34.8132', 'H34.8131', 'H34.8111', 'H34.8121', 'H34.8191', 'H34.8112', 'H34.8122']"] | ['ranibizumab (lucentis)'] | ['CN\\C(NCCSCC1=CC=C(CN(C)C)O1)=C/[N+]([O-])=O'] | Inclusion Criteria: - Ability to provide written informed consent and comply with study assessments for the full duration of the study - Age > 18 years - Clinical evidence of perfused central retinal vein occlusion. A central retinal vein occlusion (CRVO) is defined as an eye that has retinal hemorrhages and a dilated retinal venous system in all 4 quadrants. Other evidence of a CRVO may include telangiectatic capillary bed and collateral vessels at the optic nerve head. - Central macular edema present on clinical examination and OCT testing with a central point thickness and/or central 1mm subfield thickness > 250 microns. - Visual acuity score greater than or equal to 19 letters (20/400) and less than or equal to 73 letters (20/40) by the ETDRS visual acuity protocol. - Media clarity, pupillary dilation and patient cooperation sufficient to allow OCT testing and retinal photography Exclusion Criteria: - Pregnancy (positive pregnancy test) or known to be pregnant; also pre-menopausal women not using adequate contraception. - Participation in another ocular investigation or trial simultaneously - Uncontrolled hypertension - Any condition that, in the opinion of the investigator, would preclude participation in the study (e.g. chronic alcoholism, drug abuse) - Significant diabetic retinopathy (greater than moderate NPDR) or macular edema associated with diabetic retinopathy - Evidence of vitreoretinal interface abnormality after ocular exam or OCT that may be contributing to the macular edema - An eye that, in the investigator's opinion, has no chance of improving in visual acuity following resolution of macular edema (e.g. presence of subretinal fibrosis or geographic atrophy) - Presence of another ocular condition that may affect the visual acuity or macular edema during the course of the study (e.g. AMD, uveitis, Irvine-Gas) - Evidence of neovascularization of the iris or retina (presence of ischemic CRVO) - Evidence of central atrophy or fibrosis in the study eye - Presence of substantial cataract, one that might decrease the vision by 3 or more lines of vision at sometime during the study. - History of grid/focal laser or panretinal laser in the study eye - History of vitreous surgery in the study eye - History of use of intravitreal, peribulbar, or retrobulbar steroids within six months of the study. - History of cataract surgery within 6 months of enrollment. - History of YAG capsulotomy within 2 months of the surgery. - Visual acuity <20/400 in the fellow eye - Uncontrolled glaucoma (pressure >30) despite treatment with glaucoma medications. - History of cerebral vascular accident or myocardial infarction within 3 months prior to Day 0. | |
| 31 | NCT00612794 | completed | 1 | phase 1 | ['type 2 diabetes'] | ["['E11.65', 'E11.9', 'E11.21', 'E11.36', 'E11.41', 'E11.42', 'E11.44']"] | ['exenatide once weekly', 'placebo'] | ['N[C@@H](CCCNC(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: - Body weight ≥50 kg. - Have suboptimal glycemic control as evidenced by an HbA1c defined by the following criteria: *6.5% to 10.0%, inclusive, at study start for patients managed with diet modification and exercise or treated with oral antidiabetics drug but not alpha glucosidase inhibitor or meglitinide derivatives; *6.5% to 9.5%, inclusive, at study start for patients treated with oral antidiabetics including alpha glucosidase inhibitor or meglitinide derivatives. - Have been treated with diet modification and exercise alone or in combination with a stable regimen of oral antidiabetic drugs (sulfonylurea, metformin and thiazolidinedione) for at least 2 months prior to study start. In the case of patients with concomitant use of sulfonylurea, the dose of sulfonylurea must not be more than maximum recommended dose. The patients with concomitant use of alpha glucosidase inhibitors (Glucobay® [acarbose], Basen® [voglibose], or Seibule® [miglitol]) or meglitinide derivatives (Glufast® [mitiglinide] or Fastic®/Starsis® [nateglinide]) can be included in this study, but these drugs must be discontinued after confirmation of eligibility at study start. Exclusion Criteria: - Subjects who have donated more than 200 mL of blood and component blood donation within one month of study start, or those who have donated more than 400 mL of blood within three months of study start. - Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry. - Have participated and received at least one dose of exenatide or other GLP-1 analogs in this study previously, or any other study using exenatide or other GLP-1 analogs. - Are treated with any exogenous insulin within 3 months of screening. - Are continuously treated with any of the following excluded medications within 3 months of screening (more than 7 days per 1 month): *Drugs that directly affect gastrointestinal motility, including Nauzelin® (domperidone), Primperan®/Terperan® (metoclopramide), Ganaton® (itopride), Acenalin® (cisapride), Gasmotin® (mosapride), or Cerekinon® (trimebutine). - Females who are breastfeeding. | |
| 32 | NCT00361244 | terminated | slow accrual | 0 | phase 1/phase 2 | ['colorectal carcinoma'] | ["['C22.0', 'C22.1', 'C4A.9', 'C7B.1', 'D09.9', 'C4A.0', 'C4A.31']"] | ['su011248', 'irinotecan', 'cetuximab'] | ['CCN(CC)CCNC(=O)C1=C(C)NC(\\C=C2/C(=O)NC3=C2C=C(F)C=C3)=C1C', 'CC[C@@]1(O)C(=O)OCC2=C1C=C1N(CC3=CC4=CC=CC=C4N=C13)C2=O', '[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: - Histologic proof of adenocarcinoma of the colon or rectum with evidence of metastatic disease. The site of the primary lesion must be or have been confirmed endoscopically, radiologically, or surgically to be or have been in the large bowel - Patients must have received one (and only one) prior chemotherapy regimen for metastatic disease using 5-FU/LV or Xeloda in combination with oxaliplatin and Avastin. - > 4 weeks must have elapsed from the time of major surgery - > 2 weeks must have elapsed from the time of minor surgery - > 4 weeks must have elapsed from the time of major radiotherapy - Normal organ and marrow function - Measurable disease be RECIST criteria - Older than 18 years of age - ECOG performance status of 0-1 - Life expectancy > 12 weeks Exclusion Criteria: - Previous treatment with irinotecan, cetuximab or SU011248 - Any of the following within the 12 months prior to study drug administration: severe/unstable angina; myocardial infarction; symptomatic congestive heart failure; cerebrovascular accident; or transient ischemic attack. - Known brain metastases or carcinomatous meningitis - Uncontrolled serious medical or psychiatric illness - NCI CTCAE grade 3 or greater hemorrhage within 4 weeks of starting study treatment - Uncontrolled hypertension - Diagnosis of any secondary malignancies with the last 5 years, except for adequately treated basal cell carcinoma, squamous cell skin cancer, localized prostate cancer with a normal PSA within the past 3 months, in situ bladder cancer, or in situ cervical cancer - Pregnant or breastfeeding - Concurrent treatment on another clinical trial |
| 33 | NCT01154062 | completed | 1 | phase 1 | ['macular degeneration'] | ["['H35.30', 'H35.353', 'H35.351', 'H35.352', 'H35.359', 'H35.3130', 'H35.3230']"] | ['pazopanib'] | ['ClCCN(CCCl)P1(=O)NCCCO1'] | Inclusion Criteria: - Age-related macular degeneration patients diagnosed with subfoveal choroidal neovascularization in the study eye, with all of the following characteristics required and confirmed by a central reading center: - CNV caused by AMD that extends under the geometric center of the foveal avascular zone - CNV comprises ≥ 50% of lesion area - Total lesion area no greater than 12 disc areas on fluorescein angiography, where the lesion complex includes CNV, blood, blocked fluorescence not from blood, and serous detachment of the retinal pigment epithelium - classic CNV comprises <50% of the lesion area - fibrosis comprises ≤ 25% of lesion area - Center subfield > 320 microns on SD-OCT (inclusive of subretinal fluid) - if no evidence of classic CNV, then presumed to have recent disease progression because of deterioration (≥ 5 letter decrease in vision or evidence of growth of a CNV lesion on fluorescein angiography ) within last 3 months or evidence of hemorrhage from CNV - Best-corrected ETDRS visual acuity score in the study eye of between 25 and 73 letters (approximately equivalent to Snellen VA of 20/320 to 20/32) at screening. - Male or female ≥ 50 years of age. - A female subject is eligible to participate if she is of non-childbearing potential defined as either pre-menopausal with a documented tubal ligation or hysterectomy, or postmenopausal defined as 12 months of spontaneous amenorrhea. In questionable cases of postmenopausal status a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and estradiol < 40 pg/ml (<140 pmol/L) or value consistent with local laboratory recommended value is confirmatory. - Subject is willing and able to return for all study visits, and is willing and able to comply with all protocol requirements and procedures. - Subject is capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. If the subject is unable to read the consent form due to visual impairment then the consent must be read to the subject verbatim by person administering the consent, a family member or legally acceptable representative. (Note: Consent by legally acceptable representative is allowed where this is in accordance with local laws, regulations and ethics committee policy.) - QTcF <450msec; or QTcF<480msec in subjects with Bundle Branch Block. - AST, ALT, alkaline phosphatase and bilirubin ≤ 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%). Exclusion Criteria: - Additional eye disease in the study eye that could compromise best-corrected visual acuity (e.g. glaucoma with documented visual field loss, clinically significant diabetic retinopathy, ischemic optic neuropathy, infection or retinitis pigmentosa). - CNV in the study eye due to other causes unrelated to age-related macular degeneration. - The presence of retinal angiomatous proliferation (RAP) in the study eye, as determined by the investigator (confirmation by indocyanine green angiography is not required). - Geographic atrophy involving the center of the fovea in the study eye. - Anterior segment and vitreous abnormalities in the study eye that would preclude adequate observation of the fundus for photographs, fluorescein angiography and SD-OCT. - Vitreous, subretinal or retinal hemorrhage in the study eye that is unrelated to AMD. Any previous treatment in the study eye for neovascular AMD, approved or investigational. - Current intravitreal anti-VEGF therapy in the fellow eye. - Within 6 months prior to the Screening Visit, use of any systemically administered anti-angiogenic agent (e.g., bevacizumab, sunitinib, cetuximab, sorafenib, pazopanib), approved or investigational. - Intraocular surgery in the study eye within 3 months of dosing. - Aphakia or total absence of the posterior capsule (Yttrium aluminum garnet (YAG) capsulotomy permitted) in the study eye. - History of vitrectomy in the study eye. - Presence of RPE tear in the study eye. - Subject has uncontrolled glaucoma (intraocular pressure >25 mmHg) despite treatment with anti-glaucoma medication. - Within 6 months prior to the Screening Visit, use of medications known to be toxic to the retina, lens or optic nerve (e.g. desferoximine, chloroquine/hydrochloroquine, chlorpromazine, phenothiazines, tamoxifen, nicotinic acid, and ethambutol). - Use of systemic steroids (>10 mg prednisone or equivalent/day) within 14 days of first dose. - A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening. - Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). Medical history or unresolved medical condition, for example: - Uncontrolled Diabetes Mellitus, with hemoglobin A1c (HbA1c) > 10% - Myocardial infarction or stroke within 6 months of screening - Active bleeding disorder - Major surgery within 3 months of screening - Hepatic impairment - Clinically relevant thyroid disease - Uncontrolled hypertension, based on criteria provided in Section 4.4.1.2. - Subject has a history within the past 2 years of alcohol, substance abuse, or psychiatric disorder likely to confound the efficacy or safety assessments. A history of known HIV infection. - Use of prohibited medications listed in Section 9.2 within the restricted timeframe relative to the first dose of study medication. - History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation. - A condition or situation, which, in the opinion of the investigator, may result in significant risk to the patient, confound the study results or interfere significantly with participation. - History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation. | |
| 34 | NCT01130818 | completed | 1 | phase 1 | ['healthy'] | ["['Z76.3', 'Z76.2']"] | ['glpg0492', 'placebo', 'glpg0492', 'glpg0492'] | ['CN1C(=O)N(C(=O)[C@@]1(CO)C1=CC=CC=C1)C1=CC=C(C#N)C(=C1)C(F)(F)F', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O', 'CN1C(=O)N(C(=O)[C@@]1(CO)C1=CC=CC=C1)C1=CC=C(C#N)C(=C1)C(F)(F)F', 'CN1C(=O)N(C(=O)[C@@]1(CO)C1=CC=CC=C1)C1=CC=C(C#N)C(=C1)C(F)(F)F'] | Inclusion Criteria: - healthy male, age 18-50 years (young subjects) OR ≥60 years (elderly subjects) - BMI between 18-30 kg/m², inclusive - non-smoker Exclusion Criteria: - elevated PSA - drug or alcohol abuse | |
| 35 | NCT00482014 | completed | 1 | phase 1/phase 2 | ['non-small-cell lung cancer'] | ["['C78.00', 'C78.01', 'C78.02', 'D14.30', 'D14.31', 'D14.32', 'C34.2']"] | ['pemetrexed', 'cisplatin', 'carboplatin'] | ['[H][N]([H])([H])[Pt](Cl)(Cl)[N]([H])([H])[H]', '[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', 'N[C@@H](CCCNC(N)=N)C(O)=O'] | Inclusion Criteria: - Inoperable non small cell lung cancer - No weight loss greater than 10% in 3 months prior to enrolling in trial - Adequate kidney function - Adequate liver function - Adequate lung function Exclusion Criteria: - Previous surgery to remove lung tumor - Previous chemotherapy or radiation therapy or lung cancer - Inability to take vitamin supplementation - Heart attack within past 6 months - Active infection | |
| 36 | NCT00201838 | completed | 0 | phase 1/phase 2 | ['pancreatic neoplasms', 'adenocarcinoma'] | ["['C25.3']", "['C22.0', 'C22.1', 'C4A.9', 'C7B.1', 'D09.9', 'C4A.0', 'C4A.31']"] | ['gemcitabine', 'etanercept'] | ['[H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1', '[O-][N+](=O)OC[C@@H](O[N+]([O-])=O)[C@H](CO[N+]([O-])=O)O[N+]([O-])=O'] | Inclusion Criteria: - Must have pathological diagnosis recurring or metastatic Pancreatic Adenocarcinoma - No prior chemotherapy, immunology treatments or hormonal treatments - Measurable disease - Must be >18 years old - ONLY CONTROL ARM IS OPEN TO ACCRUAL Inclusion Criteria: - Pregnant and nursing mothers. - Psychiatric disorders that would interfere with consent ability. - Patients with known brain or leptomeningeal disease. - Patients with history of myocardial infarction with in six previous months. - Any concurrent illness that would constitute a hazard to participation in study. - Known sensitivity to gemcitabine or etanercept. - Prior treatment with etanercept. | |
| 37 | NCT01235039 | completed | 1 | phase 1/phase 2 | ['diabetes mellitus'] | ["['P70.2', 'O24.92', 'Z83.3', 'E10.65', 'E10.9', 'E11.65', 'E11.9']"] | ['viaject®25', 'viaject®7', 'insulin lispro'] | ['[Na+].[Na+].[O-]P([O-])(F)=O'] | Inclusion Criteria: - Age: ≥19 to ≤65 years - Body Mass Index: ≥18 - ≤28 kg/m2 - Diagnosed with Type 1 Diabetes Mellitus for at least 1 year - Insulin antibody less than or equal to 10 µU/mL at screening - Non-smoker, defined as no nicotine consumption for at least one year. - Signed and dated informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject) Exclusion Criteria: - Type 2 Diabetes Mellitus - C-peptide value of >1.0 ng/mL - HbA1c value of > 10.0% - History of hypersensitivity to any of the components in the study medication - History of severe or multiple allergies - Treatment with any other investigational drug in the last 3 months before study entry - Any systemic treatment with drugs known to interfere with glucose metabolism such as systemic corticoids, non-selective beta-blockers, and monoamine oxidase (MAO) inhibitors within 3 months prior to randomization. - Changes (type of drug or dose) in concomitant medication other than insulin or insulin analogues in the last 3 weeks prior to randomization. - Use of non-prescription drugs, except routine vitamins, within 3 weeks prior to the first dose of the test drug. Occasional use of paracetamol/acetaminophen is permitted. - Progressive disease likely to prove fatal (e.g. malignancies) - Current drug or alcohol abuse, or a history of drug or alcohol abuse which in the opinion of the Investigator will impair subject safety or protocol compliance - Significant cardiovascular, respiratory, gastrointestinal, hepatic, renal, neurological, psychiatric and/or hematological disease as evaluated by the Investigator - Clinically significant abnormal hematology or biochemistry screening tests, as judged by the Investigator. In particular, subjects with elevated liver enzymes (AST or ALT >2 times the upper limit of normal) or impaired renal function (serum creatinine values above the upper limit of normal) will not be allowed to enter the trial. - Any serious systemic infectious disease during the four weeks prior to the first dose of study drug, as judged by the Investigator. - History of any illness that, in the opinion of the Investigator, might confound the results of the trial or pose a risk in administering the trial drug to the subject. In particular, subjects with significant cardiovascular disease, anemia (hemoglobin below the lower limit of normal) or hemoglobinopathy will not be allowed to enter the trial. - Blood donation within the last 30 days - A woman who is lactating - Pregnant women or women intending to become pregnant during the study - A sexually active woman - not using adequate contraceptive methods (adequate contraceptive measures include: implants, injectables, combined oral contraceptives, hormonal intrauterine device [IUD], sexual abstinence or vasectomized partner) - Positive serology for HIV, Hepatitis B or Hepatitis C - Abnormal ECG, safety lab or physical examination results that are deemed clinically significant by the Investigator - Lack of compliance or other reasons which, in the opinion of the Investigator, prevent the participation of the subject in the study. | |
| 38 | NCT00179608 | completed | 1 | phase 1 | ['malignant melanoma'] | ["['C43.0', 'C43.31', 'C43.51', 'C43.9', 'C43.4', 'C43.52', 'C43.10']"] | ['cc-5013'] | ['NC1=CC=CC2=C1CN(C1CCC(=O)NC1=O)C2=O'] | Inclusion Criteria: 1. Understand and voluntarily sign an informed consent document 2. Age greater than or equal to 18 years at the time of signing Informed Consent 3. Be able to adhere to the study visit schedule and other protocol requirements 4. Histological documentation of malignant melanoma with evidence of metastatic disease 5. For the 10 patients enrolled at the MTD, at least one measurable lesion must be present (see Appendix II) 6. ECOG performance status of 0, 1 or 2 (see Appendix I) 7. Laboratory tests within these ranges: 1. Absolute neutrophil count greater than or equal to 1,500/uL 2. Platelet count greater than or equal to 100,000/uL 3. Serum creatinine less than or equal to 1.5 mg/dL 4. Total bilirubin less that or equal to 1.5 mg.dL 5. AST (SGOT) / ALT (SGPT) less than or equal to to 2 times upper limit of normal (ULN) 8. Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test within 7 days of starting study drug. In addition, sexually active WCBP must agree to use at least two methods of adequate contraceptive (oral, injectable, or implantable hormonal contraceptive, tubal ligation, intra-uterine device, barrier contraceptive with spermicide, contraceptive skin patch or vasectomized partner) while on study drug 9. All acute adverse effects (excluding alopecia of any prior therapy must have resolved to less than or equal to grade 1 (NCI CTCAE v3.0) 10. Patients must be able to take medications orally Exclusion Criteria: 1. Pregnant or lactating females 2. Any serious medical condition, including psychiatric illnesses that will prevent the patient from signing the informed consent or place the patient at an unacceptable risk if he/she participates in the study. 3. Prior treatment with systemic chemotherapy. Patients who have received prior immunotherapy, including thalidomide, or radiotherapy remain eligible. Lesions within a prior field of radiation may only be used as indicator lesions if there has been evidence of disease progression at that site. 4. Prior history of malignancies (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the patient has been free of the disease for at least 3 years. 5. Use of thalidomide or biologic response modifier therapy within 14 days of Day 1, Cycle 1 6. Prior greater than or equal to grade 2 allergic reaction to thalidomide 7. Prior desquamating rash while taking thalidomide 8. Any prior use of lenalidomide 9. Concurrent use of any other anti-cancer agents 10. Radiation or surgical treatment of melanoma within 28 days of starting study treatment 11. Active infection 12. Central nervous system (CNS) metastases 13. Patients with > grade-2 neuropathy 14. Patients with known HIV positivity or AIDS-related illness | |
| 39 | NCT00411762 | completed | 1 | phase 1/phase 2 | ['pancreatic cancer'] | ["['C25.3']"] | ['capecitabine', 'phy906'] | ['[H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1'] | Inclusion Criteria: - Men or women ≥18 years of age with either a histologic or cytologic diagnosis of locally advanced or metastatic pancreatic adenocarcinoma. However, patients with other solid malignancies will be allowed to participate during the dose escalating Phase I part of the study, who had failed to respond to standard therapy or for which no standard therapy exists. - In the phase I portion, patients may either have had no prior chemotherapy (chemotherapy naive), or have been refractory to or relapsed from standard chemotherapy, including capecitabine-based regimens. However, in the phase II portion of the study, only pancreatic cancer patients with prior gemcitabine therapy will be eligible. No prior 5-FU/capecitabine chemotherapy will be allowed EXCEPT previous adjuvant treatment with 5-FU or capecitabine (radiosensitizing dose) with radiation completed at least 6 weeks prior to study entry. - All patients in both the phase I and phase II portions of this study must have at least one previously unirradiated, unidimensionally measurable lesion by computerized tomography (CT) or magnetic resonance imaging (MRI) scan of ≥ 20 mm (if conventional CT scan) or ≥ 10 mm (if spiral CT scan). - Patients with biliary or gastro-duodenal obstruction must have drainage or by pass prior to starting chemotherapy. - Patients with adequate hepatic function defined as - AST/ALT ≤ 2.5 X ULN; - Total Bilirubin ≤ 2.0 XULN; - Alkaline Phosphatase ≤ 5 X ULN (in presence of liver metastasis); or - Alkaline Phosphatase ≤ 2.5 X ULN (in absence of liver metastasis). - Patients should have an adequate renal function as indicated by a serum creatinine <1.6 mg/dL or calculated creatinine clearance ≥ 50 mL/min. (Calculated by Cockcroft-Gault equation). - Baseline performance status must be Eastern Cooperative Oncology Group (ECOG) 0, 1, or 2. - Women patients who are known to be capable of conception should have a negative serum pregnancy test (beta-human chorionic gonadotropin [beta-hCG]) within 2 weeks of starting the study; all patients should agree to use adequate non-estrogenic birth control methods, consistent with the institute's standard form of contraception if conception is possible during the study. - Provide written informed consent prior to screening. - Patients with adequate hematologic tests: - Hemoglobin ≥ 9.0 g/dL; - Absolute neutrophil count (ANC) ≥ 1.5 x 10 9/L; - Platelet count ≥ 100.0 x 10 9/L; Exclusion Criteria: - Patients who are pregnant or breastfeeding. - Any prior palliative radiation therapy (other than used in the adjuvant therapy of pancreatic cancer > 6 weeks) must have been completed more than 21 days before entry into the study and evaluable lesions must not have been included in the radiation portal. - Patients with prior capecitabine therapy for pancreatic cancer (Phase II). - Patients with active CNS metastases. - Patients with known hypersensitivity or a history of marked intolerance to 5-FU are ineligible. - Because cimetidine can decrease the clearance of 5-FU, patients should not enter on this study until cimetidine is discontinued. - Patients should not receive concurrent therapy with either sorivudine or brivudine, while receiving capecitabine. If a patient has received prior sorivudine or brivudine, then at least four weeks must elapse before the patient receives capecitabine therapy. - Exclude sexually active males unwilling to practice contraception during the study. - Lack of physical integrity of the upper gastrointestinal tract, inability to swallow tablets or those who have malabsorption syndrome. - Clinically significant cardiac disease not well controlled with medication (e.g., congestive heart failure, symptomatic coronary artery disease, and cardiac arrhythmias) or myocardial infarction within the last 12 months. - No concurrent radiotherapy is allowed. - Known DPD (dihydropyrimidine dehydrogenase) deficiency. - Patients who have received any previous treatment consisting of standard chemotherapy (gemcitabine in Phase II study; others in Phase I) within 21 days or an investigational agent (Phase I) within 30 days on study. Toxicity related to the previous therapy must have resolved prior to study entry. - Patients with previous or concurrent malignancy except for inactive non-melanoma skin cancer and/or in situ carcinoma of the cervix, or other solid tumor treated curatively and without evidence of recurrence within the last 3 years prior to study entry. - Patients taking herbal medicine(s), including supplement(s), are eligible if they discontinue the herbal medicine(s)/supplement(s) at least 7 days prior to study entry. - Known allergy or hypersensitivity to PHY906 or any of the components used in the PHY906 formulations, or to capecitabine. - Serious concurrent medical illness, which would jeopardize the ability of the patient to receive the chemotherapy program outlined in this protocol with reasonable safety. - Patients with active infections requiring intravenous antibiotic therapy are not eligible until the infection has resolved. | |
| 40 | NCT01273948 | completed | 1 | phase 1/phase 2 | ['hepatitis c'] | ["['B18.2', 'B17.10', 'B17.11', 'B19.20', 'B19.21', 'B15.0', 'B15.9']"] | ['bavituximab', 'pegylated interferon (peg-ifn)'] | ['NC1=NC(=O)N(C=C1)[C@@H]1O[C@H](CO)[C@@H](O)C1(F)F', '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: 1. Male or female between the ages of 18 and 65 years 2. Chronic hepatitis C virus (HCV) genotype 1 infection 3. HCV RNA level >10,000 IU/mL 4. Chronic HCV infection, defined as: - Previous documentation of positive HCV serology (HCV antibody or RNA) at least 6 months (24 weeks) previously, or - Positive HCV serology (HCV antibody or RNA) with a prior remote (more than 6 months previously) risk factor for acquisition of HCV or - Historical biopsy consistent with chronic HCV infection 5. No clinically significant abnormalities in hematology, coagulation, or chemistry variables: - Hemoglobin >12 g/dL for women; >13 g/dL for men - Total white cell count >3000/mm3 and absolute neutrophil count >1500/mm3 - Platelets >100,000/mm3 - Prothrombin time (PT) and/or international normalized ratio (INR) less than or equal to 1.2 times the local upper limit of normal (ULN) - Conjugated (direct) bilirubin less than or equal to 1.5 times the ULN - Serum creatinine within normal limits - Thyroid-stimulating hormone (TSH) and free thyroxine (T4) within normal limits 6. Female patients: negative urine pregnancy test 7. Ability to provide informed consent Exclusion Criteria: 1. Previous interferon-based antiviral therapy for chronic HCV infection 2. Previous treatment with known immunogenic drugs 3. Concomitant human immunodeficiency (HIV) or hepatitis B virus (HBV) infection 4. Cause of liver disease other than chronic HCV infection, such as autoimmune or alcoholic liver disease 5. Decompensated clinical liver disease, including a history of encephalopathy, bleeding esophageal or gastric varices, or ascites 6. Recipient of liver or other solid-organ transplantation 7. Evidence of clinically significant bleeding, defined as gross hematuria, hemoptysis, or gastrointestinal bleeding 8. History of bleeding diathesis or coagulopathy (eg, von Willebrand disease or hemophilia) 9. History of thromboembolic events (eg, deep-vein thrombosis [DVT] or pulmonary embolism). Previous central venous catheter-related thrombosis is acceptable if there is resolution recorded at least 12 months before enrollment. 10. Requirement for concurrent treatment with oral or parenteral anticoagulants or hormones (estrogen-containing contraceptives, hormone replacement, antiestrogen agents, progestins) 11. Condition requiring daily therapy with antiplatelet agents (eg, thienopyridines, dipyridamole, cilostazol; cardiovascular prophylaxis with aspirin is allowed) or corticosteroids 12. Investigational therapy within 28 days before the first planned dose of study drug 13. Major surgery within 28 days before the first planned dose of study drug 14. Uncontrolled intercurrent disease (eg, diabetes, hypertension, thyroid disease) 15. Ongoing angina pectoris or other symptoms of coronary artery disease (CAD); history of stroke, or transient ischemic attack (TIA) 16. History of suicidal ideation or attempt 17. Condition requiring treatment (past or current) with coumarin-type agents 18. Cardiac arrhythmia requiring medical therapy 19. Serious nonhealing wound (including wound healing by secondary intention, ulcer, or bone fracture) 20. Cancer, autoimmune disease, or any disease or concurrent therapy known to cause significant alteration in immune function (corticosteroids are allowed before study enrollment and during the study to treat an AE) 21. Female patients and female partners of male patients: pregnancy, lactation, or inability/unwillingness to practice effective contraception | |
| 41 | NCT01176903 | completed | 1 | phase 1/phase 2 | ['chronic obstructive pulmonary disease (copd)'] | ["['G91.1', 'I42.1', 'N11.1', 'J05.0', 'G47.33', 'J44.9', 'N13.8']"] | ['glycopyrrolate', 'tiotropium', 'placebo'] | ['C[N+]1(C)CCC(C1)OC(=O)C(O)(C1CCCC1)C1=CC=CC=C1', '[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'] | Inclusion Criteria: - Males and females patients aged 40-75 years; - Written informed consent obtained; - Diagnosis of moderate-severe COPD, according to the GOLD guidelines; - Current or ex-smokers with a smoking history of ≥ 10 pack-years - Post bronchodilator FEV1 between 40% and 80% predicted values (40% ≤ FEV1 < 80%), documented at screening visit ; - Post bronchodilator FEV1/Forced Vital Capacity (FEV1/FVC) ≤ 0.70 (absolute value) documented at screening visit; - Airway reversibility of at least 100 mL within 30 to 45 minutes after inhalation of ipratropium 80µg. Exclusion Criteria: - History of chronic or seasonal allergy - Blood eosinophil count above 600 per µl - Clinically relevant findings on physical examination laboratory and ECG parameters at screening - Occurrence of clinically relevant abnormalities in the 24-h Holter ECG recording at screening; - Significant disease not related to COPD (eg. Myocardial infarction, stroke within the preceding 6 months); - Respiratory tract infection (including upper tract) 4 weeks prior to study entry requiring changing treatment; - Patients requiring oxygen therapy on a daily basis for chronic hypoxemia; - History of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency, or any other significant lung disease which is considered to be clinically significant by the investigator. - Intolerance/hypersensitivity or any contra-indication to treatment with M3 Antagonist or any of the excipients contained in the formulations used in the study. - History of alcohol or substance abuse that in the opinion of the Investigator may be of clinical significance. - Patients treated with slow-release oral or parental corticosteroids 8 weeks prior to Screening Visit. - Patients treated with tiotropium in the 10 days prior to the Screening Visit; - Pregnant or lactating women and female or male subjects not willing to use an acceptable method of contraception. | |
| 42 | NCT00477386 | completed | 1 | phase 1/phase 2 | ['ovarian cancer'] | ["['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']"] | ['decitabine'] | ['CN(C)\\N=N\\C1=C(N=CN1)C(N)=O'] | Inclusion Criteria: - Have recurrent epithelial ovarian cancer, primary peritoneal carcinomatosis or fallopian tube cancer. - Have platinum-resistant (recurrence within 6 months of a platinum-containing regimen) or platinum refractory (progression while on platinum) disease - Have measurable disease according to RECIST or detectable disease. o Measurable disease is defined as the presence of at least one uni-dimensionally measurable lesion greater than or equal to 20 mm by conventional techniques, including palpation, plain x-ray, CT scan or MRI, or greater than or equal to 10 mm by spiral CT scan. o Detectable disease is defined in a patient as one who does not have measurable disease but has at least one of the following conditions: 1) Baseline values of cancer antigen 125 (CA-125) at least twice the upper limit of normal; 2) Ascites and/or pleural effusion attributed to tumor; 3) solid and/or cystic abnormalities on radiographic imaging that do not meet RECIST definitions for target lesions. - >/= 18 years of age. - Give written, informed consent for participation in the protocol. - Be at least 4 weeks from last treatment to allow recovery from prior toxicity (with the exception of hormonal therapy, where a 1-week wash-out period and radiation therapy where a 3-week wash-out period are sufficient). Patients coming off experimental therapy with biological agents not expected to cause myelotoxicity should have been off treatment for at least 3 weeks as wash-out period. - Have had disease that has progressed within 6 months platinum-based chemotherapeutic regimen. - Have no history of platinum allergy. - Have a negative serum pregnancy test prior to the study entry and be practicing an effective form of contraception if hysterectomy and/or oophorectomy were not part of the prior treatment. It is expected that the overwhelming majority of ovarian cancer patients would have had hysterectomy and oophorectomy as part of the original surgery. - Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. - Have acceptable organ function, as evidenced by laboratory data: o Aspartate aminotransferase and alanine aminotransferase less than 2.5 times upper limit of normal (ULN) o Direct bilirubin less than 1.5 times ULN o Alkaline phosphatase less than 2.5 times ULN o Absolute neutrophil count greater than or equal to 1500 cells/mm3 o White cell blood count greater than 3000cells/mm3 o Hemoglobin greater than or equal to 9.0 g/dL (can be post-transfusion) o Platelets greater than 100,000/mm3 (can not be post-transfusion) o Creatinine levels less than 1.5 times ULN Exclusion Criteria: - Not have participated in any clinical trial involving conventional or investigational drugs or devices within the previous 3 weeks. - Not have grade 2 or greater neuropathy. - Have no additional active cancer in addition to the epithelial ovarian cancer within the last 5 years, with the exception of superficial skin cancer (basal cell or squamous cell skin carcinoma), carcinoma in situ of the cervix, Stage I endometrial cancer with less than 50% invasion of the myometrium, or other adequately treated Stage I or II cancer in complete remission. - Be free of active infection requiring antibiotic treatment. - Not have an additional uncontrolled serious medical condition or psychiatric illness. - Not have an immune deficiency and be receiving combination anti-retroviral therapy - Not have known brain metastases, as progressive neurologic dysfunction may develop, that would confound the evaluation of neurologic and other adverse events. - Absence of uncontrolled hypertension, arrhythmia, congestive heart failure or angina. Patients who have had a myocardial infarction or cardiac surgery should be at lease 6 months from the event and free of active symptoms. | |
| 43 | NCT01054300 | completed | 1 | phase 1 | ['diabetes mellitus, type 2', 'adult'] | ["['E11.65', 'E11.9', 'E11.21', 'E11.36', 'E11.41', 'E11.42', 'E11.44']"] | ['ertugliflozin 2 mg single dose', 'ertugliflozin 2 mg split into twice daily', 'ertugliflozin 4 mg single dose', 'ertugliflozin 4 mg split into twice daily', 'placebo'] | ['CCOC1=CC=C(CC2=CC(=CC=C2Cl)[C@]23OC[C@](CO)(O2)[C@@H](O)[C@H](O)[C@H]3O)C=C1', 'CCOC1=CC=C(CC2=CC(=CC=C2Cl)[C@]23OC[C@](CO)(O2)[C@@H](O)[C@H](O)[C@H]3O)C=C1', 'CCOC1=CC=C(CC2=CC(=CC=C2Cl)[C@]23OC[C@](CO)(O2)[C@@H](O)[C@H](O)[C@H]3O)C=C1', 'CCOC1=CC=C(CC2=CC(=CC=C2Cl)[C@]23OC[C@](CO)(O2)[C@@H](O)[C@H](O)[C@H]3O)C=C1', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Participants with type 2 diabetes mellitus, either treatment-naïve or on up to 2 acceptable oral anti-diabetes drugs for at least 8-weeks prior to study. Exclusion Criteria: - Participants with type 1 diabetes mellitus, participants with stroke, unstable angina, heart attack in last 6-months, uncontrolled blood pressure. | |
| 44 | NCT00732784 | completed | 1 | phase 1 | ['healthy'] | ["['Z76.3', 'Z76.2']"] | ['imatinib mesylate'] | ['CN1CCN(CC2=CC=C(C=C2)C(=O)NC2=CC(NC3=NC=CC(=N3)C3=CN=CC=C3)=C(C)C=C2)CC1'] | Inclusion Criteria: - Healthy men or women 18 years of age or older. Healthy subjects are defined as individuals who are free from clinically significant illness or disease (such as coronary arterial disease, chronic heart failure, bleeding disorder, hypertension, chronic renal failure etc.) as determined by their medical history, physical examination, and laboratory studies. For the purposes of this protocol, "clinically significant" is defined as any history or indication of illness or disease, such as those listed above. - Body Mass Index (BMI) < 31 kg/m2 (weight/height2). - Female patients of childbearing potential must have negative pregnancy test within 14 days before initiation of study drug dosing. Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Female patients of reproductive potential must agree to employ an effective barrier method of birth control throughout the study and for up to 7 days following discontinuation of study drug. - Written, voluntary informed consent. Exclusion Criteria: - Abnormal marrow function as defined by leucocyte, neutrophil, or platelet counts outside of normal limits. - Any evidence of renal dysfunction (proteinuria; serum creatinine > upper limit of normal; or if serum creatinine > upper limit of normal, a calculated creatinine clearance < 60 mL/min/1.73 m2). - Impaired hepatic function (liver enzymes greater than the upper limit of normal or bilirubin outside the normal range). - Taking any medications (including over the counter products), herbal products, mineral supplements or vitamins (other than a daily multivitamin preparation), other than contraceptives (for women), within 2 weeks of start of the study. All forms of contraceptive medication are permissible for this study and would not result in a female's exclusion from participation. Patients who take medications on a chronic basis, such as antihypertensive medications or thyroid replacement therapy, etc. are not eligible for the study. - Subjects has received any other investigational agents within 28 days of first day of study drug dosing. - Female subjects who are pregnant or breast-feeding. | |
| 45 | NCT00642655 | completed | 1 | phase 1/phase 2 | ['kidney transplant'] | ["['T86.11', 'T86.12', 'T86.13', 'Z94.0', 'T86.10', 'T86.19', 'Z48.22']"] | ['ivig and rituximab'] | ['ClCCN(CCCl)P1(=O)NCCCO1'] | Inclusion Criteria: - Patients eligible for the study will be those who have anti-HLA antibody (Panel Reactive Antibody [PRA]) of >30% and are eligible for transplantation at Cedars-Sinai Medical Center. We currently anticipate entering 20 patients over the course of the study. We currently have ~100 patients on our wait list that would meet the above criteria. Patients will be selected based on the ability of IVIG to inhibit the cytotoxic anti-HLA antibody activity in vitro. They will then receive IVIG 2gm/kg X1 on day 1 while on hemodialysis. Seven days later, the patients will receive Rituxan® 1gm in the CSMC Cancer Infusion Center as per protocol for Rituxan® infusion. The second Rituxan® infusion will be on day#22. The patients will have monitoring of anti-HLA antibody and outlined tests as shown above. - Able and willing to give written informed consent and comply with the requirements of the study protocol - Adequate liver function, as indicated by normal liver function tests (NL: AST, ALT, Bilirubin and negative tests for hepatitis C and hepatitis B. - Negative serum pregnancy test (for women of child bearing age) - Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for twelve months (1 year) after completion of treatment. Exclusion Criteria: - Treatment with any investigational agent within 4 weeks of screening or 5 half-lives of the investigational drug (whichever is longer) - Receipt of a live vaccine within 4 weeks prior to randomization - Previous Treatment with Rituximab (MabThera® / Rituxan®) - Prior antibody therapy - History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies - History of HIV (positive HIV, HIV conducted during screening) - History of Hepatitis B and/or Hepatitis C - History of recurrent significant infection or history of recurrent bacterial infections - Known active bacterial, viral fungal mycobacterial, or other infection (including tuberculosis or atypical mycobacterial disease, but excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with i.v. antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening - Lack of peripheral venous access - History of drug, alcohol, or chemical abuse within 6 months prior to screening - Pregnancy (a negative serum pregnancy test should be performed for all women of childbearing potential within 7 days of treatment) or lactation - Concomitant malignancies or previous malignancies within the last five years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix. - History of psychiatric disorder - Significant cardiac or pulmonary disease (including obstructive pulmonary disease) - Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications - Inability to comply with study and follow-up procedures Laboratory Exclusion Criteria (at Screening) - Hemoglobin: < 8.5 gm/dL - Platelets: < 100,000/mm - AST or ALT >2.5 x Upper Limit of Normal unless related to primary disease. - Positive Hepatitis B or C serology - Positive HIV | |
| 46 | NCT00567879 | terminated | the study was terminated early due to insufficient evidence of clinical benefit. | 0 | phase 1/phase 2 | ['breast cancer'] | ["['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']"] | ['panobinostat', 'trastuzumab'] | ['[H]\\C(=C(\\[H])C1=CC=C(CNCCC2=C(C)NC3=CC=CC=C23)C=C1)C(O)=NO', '[H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1'] | Key Inclusion criteria: - Age > 18 year old - Confirmed HER2+ ve metastatic breast cancer - Prior treatment and progression on trastuzumab - Patients must have adequate laboratory values - Eastern Cooperative Oncology Group (ECOG) performance status of <2 Key Exclusion criteria: - Patients with active central nervous system (CNS) disease or brain metastases except those who have been previously treated and have been stable for at least 3 months. - Impaired heart function or clinically significant heart disease - Impairment of gastrointestinal (GI) function, or GI disease that may significantly alter the absorption of LBH589 - Ongoing diarrhea - Liver or renal disease with impaired hepatic or renal functions - Concomitant use of any anti-cancer therapy or certain drugs - Female patients who are pregnant or breast feeding - Patients not willing to use an effective method of birth control |
| 47 | NCT00694980 | completed | 1 | phase 1 | ['ulcerative colitis'] | ["['K51.80', 'K51.813', 'K51.814', 'K51.90', 'K51.913', 'K51.914', 'K51.811']"] | ['placebo', 'rhumab beta7'] | ['CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Able and willing to provide written informed consent - 18-70 years of age - Males and females with reproductive potential: Willing to use a reliable method of contraception - Diagnosis of ulcerative colitis - Eligible to receive biologic therapy - Disease duration of >=12 weeks Exclusion Criteria: - Requirement for hospitalization due to severity of ulcerative colitis - Moderate to severe anemia - Any manifestation of ulcerative colitis or other conditions likely to require, in the investigator's judgment, treatment with >20 mg/day of prednisone, or prednisone equivalent, during the course of the study - Pregnant or lactating - Lack of peripheral venous access - Inability to comply with study protocol - History or presence of contraindicated diseases - Congenital immune deficiency - Active or prior infection with HIV or hepatitis B or C - History of severe systemic bacterial, fungal, viral, or parasitic infections - History of any other opportunistic infections within 12 weeks prior to initiation of study treatment - Received a live attenuated vaccine within 4 weeks prior to screening - Hospitalized within 4 weeks prior to screening - Received any contraindicated therapy within 12 weeks prior to screening | |
| 48 | NCT00607308 | completed | 1 | phase 1 | ["alzheimer's disease"] | ["['G30.8', 'G30.9', 'G30.0', 'G30.1']"] | ['placebo'] | ['CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Japanese male or females of non-childbearing potential, ages 50-85 - Diagnosis of probable Alzheimer's disease, consistent with criteria from both: (1) National Institute of Neurological and Communicable Disease and Stroke and Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) 2) Text Revision of The Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) - Mini-Mental Status Exam score of 16-26 inclusive - Rosen-Modified Hachinski Ischemia score < or = 4 Exclusion Criteria: - Diagnosis or history of other dementia or neurodegenerative disorders - Diagnosis or history of clinically significant cerebrovascular disease - Specific findings on magnetic resonance imaging (MRI): cortical infarct, micro hemorrhage, multiple white matter lacunes, extensive white matter abnormalities - History of autoimmune disorders - History of allergic or anaphylactic reactions | |
| 49 | NCT01462773 | completed | 1 | phase 1 | ['melanoma'] | ["['C43.0', 'C43.31', 'D03.9', 'C43.51', 'C43.9', 'D03.0', 'C43.4']"] | ['bortezomib', 'interferon alfa-2b'] | ['ClCCN(CCCl)P1(=O)NCCCO1', 'O'] | Inclusion Criteria: - must have histological or cytological diagnosis of cutaneous melanoma and clinical evidence of metastatic, non-resectable regional lymphatic, or extensive in transit recurrent disease. Patients who have had resected metastases will also be eligible provided they have measurable disease. - have measurable disease. Measurable disease is defined as the presence of at least one measurable lesion. - ECOG performance status ≤ 2 (Karnofsky ≥ 60%). - Female subjects must be either surgically sterilized or willing to use an acceptable method of birth control (ie, a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study. Male subjects must agree to use an acceptable method for contraception for the duration of the study. - Patients must have normal organ and marrow function. - Prior Therapy: Patients with an ECOG performance status of ≤ 2 will be eligible for this protocol regardless of the number of prior treatments provided they have recovered from the reversible effects of prior therapy. Patients are permitted to have received therapy with adjuvant IFN-α2b, if it was completed > 6 months prior to enrollment in the current study. - Patients with brain metastases are eligible for entry into the study, but must have received definitive therapy consisting of external beam radiation therapy, gamma knife therapy or surgical resection and be clinically stable. Four weeks after the definitive therapy is completed, repeat MRI or CT scans must demonstrate stabilization of disease, and there must be no requirement for Decadron. If the patient does not have brain metastases, then only one brain CT or MRI is required prior to enrollment on study. Exclusion Criteria: - Patients meeting any of the following exclusion criteria are not to be enrolled in the study. - Patient has a platelet count of < 100 × 109/L within 14 days before enrollment. - Patient has an absolute neutrophil count of < 1.0 x 109/L within 14 days before enrollment. - Patient has a calculated or measured creatinine clearance of < 30 mL/minute within 14 days before enrollment. - Patient has history of significant brain metastases or other clinically significant central nervous system disease. - Patient has ≥Grade 2 peripheral neuropathy within 14 days before enrollment. - Patient has hypersensitivity to bortezomib, boron or mannitol. - Patients with evidence of proteinuria on urinalysis. - Female subject is pregnant or breast-feeding. - Received other investigational drugs with 14 days before enrollment. - Serious medical or psychiatric illness likely to interfere with participation in this clinical study. - History of serious psychiatric illness that might be exacerbated by IFN-α-2b. | |
| 50 | NCT01042028 | terminated | emergence of folfirinox and slow recruitment | 0 | phase 1/phase 2 | ['pancreatic cancer'] | ["['C25.3']"] | ['everolimus, cetuximab, irinotecan', 'capecitabine, oxaliplatine'] | ['[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', '[H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1'] | Inclusion Criteria: 1. Written informed consent obtained prior to study entry? 2. Patient has histologically/cytologically proven, non-resectable or metastatic, adenocarcinoma of the pancreas? 3. Progressive disease during adjuvant chemotherapy (or within 6 month after) or progressive disease during or after first line chemotherapy? 4. Former treatment with chemotherapeutic agent containing gemcitabine? 5. Is the age of the patient ≥ 18 years? 6. Is the ECOG performance status 0-1? 7. Is the absolute neutrophil count (ANC) ≥ 1.5 x 109/l? 8. Is the platelet count ≥ 75 x 109/l? 9. Is the total bilirubin ≤1.5 x UNL (upper normal limit)? 10. Patient has normal liver function? (If liver metastases are present, there is no upper limit for ALAT/SPGT/alk phosph)? 11. Creatinine clearance ≥ 30 ml/min 12. Is the patient capable of following the treatment and the plan of evaluation? Exclusion Criteria: 1. CTC Grade 3 hyperlipidaemia (>10.34 mmol/l) in spite of treatment 2. Active former or concurrent history of malignant neoplasm, in the last 2 years? 3. Any condition or therapy which, by the investigators opinion, will expose the patient to a risk or will affect the purpose of the clinical trial? 4. Pregnant or breast feeding patient (fertile patients must use contraceptives)? 5. Infections or other serious medical conditions, which can obstruct the patient's possibility of receiving the treatment? (for instance serious heart, metabolic or lung disease) 6. Known hypersensitivity toward one or more of the parts in the treatment? |
| 51 | NCT00456989 | completed | 1 | phase 1/phase 2 | ['prostate cancer'] | ["['C61', 'D29.1', 'D40.0', 'Z15.03', 'Z80.42', 'Z85.46', 'Z12.5']"] | ['taxotere', 'doxil'] | ['[H][N]([H])([H])[Pt](Cl)(Cl)[N]([H])([H])[H]', 'COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O'] | Inclusion Criteria: - Patients must have histologically or cytologically confirmed adenocarcinoma of the prostate. - Androgen-independent disease progression, as shown by: - A castrate testosterone level of < 40 ng/dl (this measurement is required only for patients treated with medical testicular suppression). If testicular suppression is achieved medically, treatment to maintain castrate levels of testosterone must be applied continuously. - A PSA level of at least 4 ng/ml, and rising (with an absolute change of at least 1 ng/ml) on two consecutive measurements at least 2 weeks apart prior to study entry. - Patients must be off anti-androgens such as flutamide (Eulexin) or nilutamide (Nilandron) for at least four weeks, and six weeks for bicalutamide (Casodex), without evidence of response; or have evidence of progression since anti-androgen withdrawal. - None or one previous cytotoxic therapy is allowed. (For this study, a combination of agents given at the same period of time is considered one chemotherapy treatment) - Age > 18 years of age. - Life expectancy of greater than 12 weeks. - ECOG performance status 0, 1 or 2 (Karnofsky >50%; see Appendix B). - Patients must have adequate bone marrow function as defined below: - absolute neutrophil count > 1,500/ul - platelets > 100,000/ul - hemoglobin > 8 g/dl - Patients must have adequate liver function as defined below: - total bilirubin normal, albumin > 3.0 g/dl, and no ascites - AST(SGOT) and ALT(SGPT) and Alkaline Phosphatase must be within the range allowing for eligibility - Patients must have adequate renal function as defined by a creatinine < 2.5 mg/dl or a creatinine clearance > 30 mL/min (measured or estimated by the Cockroft formula) for patients with creatinine levels above 2.5 mg/dl - Patients must have recovered from acute toxicities from chemotherapy or radiotherapy administered prior to entering this study. Alopecia may not be resolved and peripheral neuropathy (grade 1) may be present. - Patients must have a MUGA scan or 2-d echocardiogram indicating an ejection fraction of > 50% within 42 days prior to first dose of study drug. The method used at baseline must be used for later monitoring. - Patients with reproductive potential must use an adequate contraceptive method (e.g., abstinence, intrauterine device, oral contraceptives, barrier device with spermicide or surgical sterilization) during treatment and for three months after completing treatment. - Ability to understand and willingness to sign a written informed consent document Exclusion Criteria: - Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. - Patients who have had two or more prior chemotherapy treatment(s) (For this study, a combination of agents given at the same period of time is considered one chemotherapy treatment). - Patients receiving any other investigational agent(s). - Patients with symptomatic brain metastases or actively receiving any therapy for brain metastasis (because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events). - Active second malignancy in the last 5 years except for non-melanoma skin cancer or carcinoma-in-situ. - History of cardiac disease, with New York Heart Association Class II or greater, or clinical evidence of congestive heart failure. - History of hypersensitivity reactions attributed to a conventional formulation of doxorubicin HCL, the components of Doxil, docetaxel or other drugs formulated with polysorbate 80. - 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. | |
| 52 | NCT00234000 | terminated | the study was closed due to poor enrollment | 0 | phase 1 | ['leukemia', 'myelodysplastic syndromes'] | ["['C95.91', 'C95.92', 'Z80.6', 'Z85.6', 'C90.11', 'C90.12', 'C91.01']", "['D46.9', 'D46.C', 'D46.Z']"] | ['arsenic trioxide', 'azacitidine'] | ['O=[As]O[As]=O', 'NC1=CC=CC2=C1CN(C1CCC(=O)NC1=O)C2=O'] | Inclusion Criteria: - Confirmed diagnosis of MDS by standard criteria. Patients within each of the FAB diagnostic groups of RA, RARS, RAEB, RAEBt, and CMML are eligible. For patients with lower-risk MDS only: documented red blood cell dependence, defined as the inability to maintain a hematocrit of > 25% without transfusion support. - Adequate marrow iron stores - In patients with serum erythropoietin less than 200 IU/mL at screening, failure to have responded to a 2 to 3 month trial of recombinant erythropoietin - Serum creatinine or serum bilirubin < 1.5 times the upper limit of normal; higher levels are acceptable if ALT levels < 2 x upper limits of normal - Women of childbearing potential must have a negative serum pregnancy test prior to azacitidine/treatment. - Women of childbearing potential should be advised to avoid becoming pregnant and should be advised to not father a child while receiving treatment with azacitidine - Age > 18 years Exclusion Criteria: - Treatment with growth factors within the 30 days before first treatment with ATO/Azacitidine, except that patients with serum erythropoietin < 200 IU/mL who failed to respond to a trial with EPO are not excluded regardless of the time since last EPO - Treatment with cytotoxic or experimental agents within 30 days before first treatment with ATO/Azacitidine - Absolute QT interval > 460 msec in the presence of adequate serum potassium and magnesium values - Active serious infections that are not controlled by antibiotics - Pregnant or lactating women - Inability or unwillingness to comply with the treatment protocol, follow-up, or research tests - NYHA Class III or IV heart failure - Poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol |
| 53 | NCT01562938 | completed | 1 | phase 1 | ['respiratory syncytial virus'] | ["['J12.1', 'J20.5', 'J21.0', 'Z29.11', 'B97.4']"] | ['placebo', 'medi-557', 'medi-557'] | ['CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - 18-45 years - written informed consent obtained from subject prior to performing any protocol related procedures - healthy by medical history and physical exam - females of child-bearing potential must use 2 effective methods of birth control for 14 days prior to 1st dose and through 1 year after administration of study drug - nonsterilized, sexually active males with female partner of child-bearing potential must use 2 effective methods of birth control from Day 1 through Day 361 - weight </= 110kg with a body mass index of <32kg/m2 - ability to complete a follow-up period of approximately 360 days Exclusion Criteria: - inability to complete a follow-up period of 360 days - any condition in the opinion of investigator that would interfere with evaluation of IP or interpretation of subject safety or study results - concurrent enrollment in another clinical study - employees of the site or other individuals involved with the conduct of the study or immediate family members of such individuals - receipt of immunoglobulin or blood products within 60 days prior to randomziation - receipt of any investigational drug therapy within 6 months prior to IP dosing - clinically abnormal ECG at screening - blood donation in excess of 400mL, wihtin 6 months prior to randomization - previous receipt fo biologics - history of immunodeficiency - history of allergic disease or reactions likely to be exacerbated by any component of the IP - previous medical history or evidence of interurrent illness that may compromise the safety of the subject - positive lab test for Hep A, B, C or HIV - pregnancy or nursing mother - history of alcohol or drug abuse within past 2 years - positive urine Class A drug screen - acute illness within 7 days prior to randomization - fever >/= 99.5F witin 7 days prior to randomization - any drug therapy within 7 days prior to randomization - systolic BP >150mmHG and/or diastolic BP>90mmHg - receipt of vaccine within 14 days prior to randomization - abnormal study labs (hem/wbc/platelet/BUN - see protocol for specific information) | |
| 54 | NCT00660036 | terminated | due to new safety information | 0 | phase 1 | ['acute myeloid leukemia'] | ["['C92.A1', 'C92.A2', 'C92.61', 'C92.62', 'C92.A0', 'C92.60']"] | ['gemtuzumab ozogamicin', 'mitoxantrone', 'etoposide'] | ['OCCNCCNC1=CC=C(NCCNCCO)C2=C1C(=O)C1=C(C(O)=CC=C1O)C2=O', 'OCCOCCN1CCN(CC1)C(C1=CC=CC=C1)C1=CC=C(Cl)C=C1'] | Inclusion Criteria: - Able to understand and have the ability to provide written consent - Between 18 and 70 years of age - Patients with CD33 positive (determined as CD33 expression in ≥ 20% of leukemic blasts) de novo AML that did not respond to first line induction therapy - ECOG Performance Status of 0-2 - Patients must have the following laboratory values within 48 hours prior to beginning protocol treatment: Serum creatinine ≤ 1.5 mg/ml and calculated creatinine clearance ≥ 50mL/min (using the Cockcroft-Gault equation); AST ≤ 59 IU/L; ALT ≤ 72 IU/L; Total bilirubin ≤ 1.3 mg/ml; Note: Hematologic abnormalities will not be used as a criteria for entry or exclusion. - Patients must have left ventricular ejection fraction (LVEF) ≥50% - Females of child-bearing potential must have a negative pregnancy test during screening and all subjects must agree to use an effective method of contraception. Exclusion Criteria: - Patients with acute promyelocytic leukemia - Prior use of mitoxantrone or etoposide or gemtuzumab ozogamicin - Antecedent hematologic disorder preceding initial presentation of AML or therapy related AML - History of thromboembolic event within the past 12 months - Hepatitis B or C or HIV positive serology - Symptomatic central nervous system (CNS) involvement - History of congestive heart failure - Myocardial infarction in the past 6 months - Uncontrolled, life-threatening infection that is not responding to antimicrobial therapy - History of psychiatric disorder which may compromise compliance with the protocol or which does not allow for appropriate informed consent - Patient may not be receiving any other anti neoplastic investigational agents - INR> 1.5 or patient is receiving systemic anticoagulation (e.g warfarin) - Patient undergone autologous or allogeneic stem cell transplantation - Other active malignancies except for non-melanoma skin cancer or cervical intraepithelial neoplasia - Women who are pregnant or breastfeeding. |
| 55 | NCT00208117 | terminated | unable to enroll subjects | 0 | phase 1 | ['depression', 'coronary artery disease (cad)', 'acute coronary syndrome (acs)'] | ["['F32.A', 'F53.0', 'P91.4', 'Z13.31', 'Z13.32']", "['I25.84', 'I25.41', 'I25.42', 'Z98.61', 'Q24.5', 'T46.3X6S', 'I25.82']"] | ['sertraline (zoloft)', 'simvastatin (zocor)'] | ['CN[C@H]1CC[C@@H](C2=CC(Cl)=C(Cl)C=C2)C2=CC=CC=C12', '[H][C@]12[C@H](C[C@@H](C)C=C1C=C[C@H](C)[C@@H]2CC[C@@H]1C[C@@H](O)CC(=O)O1)OC(=O)C(C)(C)CC'] | Inclusion Criteria: 1. Age 18 - 60 2. Mild depression 3. Inflammatory markers: CRP > 2 Exclusion Criteria: 1. Non-English or Non-Spanish speakers 2. Active suicidal or homicidal ideation 3. Current alcohol or other substance abuse 4. Psychotic features 5. Current personality disorder 6. History of bipolar depressive disorder 7. Any current psychotic disorder 8. Current major depressive disorder 9. Current depression treatment or treatment within preceding 6 weeks 10. History of chronic liver and/or renal disease 11. Current use or contraindication to any of the tested medications 12. Absence of a response to a previous adequate trial of any of the tested medications 13. Pregnant or lactating women 14. History of coronary artery disease 15. Current use of statins 16. Current, regular aspirin use 17. Antibiotic use within the previous four weeks 18. History of diabetes 19. Inflammatory diseases 20. Meets NCEP guidelines for cholesterol lowering therapy |
| 56 | NCT01009801 | terminated | due to slow patient recruitement. | 0 | phase 1/phase 2 | ['liver cancer'] | ["['D13.4', 'Z85.05', 'C22.8', 'C78.7', 'C22.9', 'D37.6']"] | ['doxorubicin-eluting beads', 'everolimus'] | ['COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O', '[H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\\C=C(C)\\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\\C=C\\C=C\\C=C(C)\\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC'] | DISEASE CHARACTERISTICS: - Histologically, cytologically, or radiologically confirmed hepatocellular carcinoma - Intermediate stage B (according to Barcelona Clinic Liver Cancer classification) - Child-Pugh score < 8 - No tumor involvement > 50% of whole liver - No advanced stage disease (i.e., either portal invasion [segmental portal obstruction] or extrahepatic spread) - No presence or history of metastatic disease - Candidate for transarterial chemoembolization after multidisciplinary discussion (tumor board) - Not on an active waiting list for liver transplantation PATIENT CHARACTERISTICS: - WHO performance status 0-1 - Hemoglobin ≥ 90 g/L - Absolute neutrophil count ≥ 1.5 x 10^9/L - Platelet count ≥ 100 x 10^9/L - Bilirubin ≤ 1.5 x upper limit of normal (ULN) - ALT ≤ 4 x ULN - INR ≤ 2 - Creatinine ≤ 1.5 x ULN - Not pregnant or nursing - Fertile patients must use effective contraception during and for 12 months after completion of study therapy - Negative pregnancy test - None of the following contraindications: - Complete portal vein thrombosis - Large arterio-portal or arterio-venous fistula within the liver - Allergy to contrast media - Contraindication to hepatic artery catheterization, such as severe peripheral vascular disease precluding catheterization - No active heart disease, including any of the following: - NYHA class II-IV congestive heart failure - Active coronary artery disease (myocardial infarction > 6 months prior to trial entry allowed) - Cardiac arrhythmias requiring anti-arrhythmic therapy (beta-blockers or digoxin permitted) - Uncontrolled hypertension - No hypertension, defined as systolic blood pressure (BP) > 150 mm Hg or diastolic BP > 90 mm Hg despite optimal medical management - No thrombotic or embolic events within the past 6 months including any of the following: - Cerebrovascular accident (including transient ischemic attacks) - Pulmonary embolism - Deep vein thrombosis - No serious non-healing wounds, including wounds healing by secondary intention, acute or non-healing ulcers, or bone fractures within 3 months of fracture - No evidence of bleeding diathesis - No history of hemoptysis - No clinically serious infection > grade 2 (NCI CTCAE Version 3.0) except for HBV and HCV infection - No known HIV infection - No CTCAE acute adverse events grade > 2 after prior TACE therapy - No other prior or concurrent malignancy that is distinct in primary site or histology from HCC, except carcinoma in situ of the cervix, treated nonmelanoma skin cancer, superficial bladder tumor (Ta, Tis, T1), or any cancer curatively treated > 3 years prior to entry - No psychiatric disorder precluding understanding of information on trial related topics, giving informed consent, filling out QL forms, or interfering with compliance for oral drug intake - No serious underlying medical condition, at the judgment of the investigator, which could impair the ability of the patient to participate in the trial (e.g., active autoimmune disease, uncontrolled diabetes) - No known hypersensitivity to trial drugs or hypersensitivity to any other component of the trial drugs - No contraindication to have MRI (e.g., pacemaker) - No organ allograft - No known impairment of swallowing that would preclude administration of everolimus - Completed baseline quality of life, BL-HEA, and EQ5D questionnaires (Phase II only) - Able to comply and have geographic proximity to allow proper staging and follow-up PRIOR CONCURRENT THERAPY: - At least 4 weeks since prior transarterial embolization/chemoembolization [limited to 5 treatments], radiofrequency ablation, cryoablation, radiation therapy or percutaneous ethanol injection - At least 4 weeks since prior sorafenib - At least 30 days since treatment with other experimental drugs or other anticancer therapy, or treatment in another clinical trial - At least 30 days since use of biologic response modifiers (e.g., G-CSF and other hematopoietic growth factors) - More than 4 weeks since prior and no concurrent major surgery - More than 3 weeks since prior and no concurrent radiotherapy - Concurrent erythropoietin allowed provided no dose adjustment is undertaken within 1 month prior to the trial or during the trial - No concurrent anticancer drugs (e.g., bevacizumab, and any drugs that target VEGF or VEGF receptors) - No concurrent investigational drugs - No concurrent known strong CYP3A4 inhibitors (e.g., ketoconazole, fluconazole, itraconazole, voriconazole, erythromycin, clarithromycin, diltiazem, verapamil, and protease inhibitors) - No concurrent known strong CYP3A4 inducers (e.g., carbamazepine, continuous treatment with dexamethasone [> 2 mg/day for > 7 days], phenobarbital, phenytoin, rifampicin, and St. John's wort) - No concurrent grapefruit, grapefruit juice, and products containing bitter oranges - No concurrent systemic corticosteroids (e.g., > 1 mg/kg prednisolone) for more than 2 weeks - No concurrent angiotensin converting enzyme inhibitors (ACE-I) |
| 57 | NCT01005979 | terminated | slow accrual | 0 | phase 1 | ['leukemia, lymphocytic, chronic, b-cell', 'chronic lymphocytic leukemia', 'lymphoma, small lymphocytic'] | ["['C91.11', 'C91.12', 'C91.10']", "['C91.11', 'C91.12', 'C91.10']", "['S33.110S', 'S33.111S', 'S33.120S', 'S33.121S', 'S33.130S', 'S33.131S', 'S33.140S']"] | ['lenalidomide, rituximab, and cyclophosphamide'] | ['NC1=CC=CC2=C1CN(C1CCC(=O)NC1=O)C2=O'] | Inclusion Criteria: 1. Understand and voluntarily sign an informed consent form. 2. Age ≥ 18 years at the time of signing the informed consent form. 3. Able to adhere to the study visit schedule and other protocol requirements. 4. Relapsed/refractory B-cell CLL or SLL 5. All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least 2 weeks prior to treatment in this study. 6. Patients must have received at least one prior therapy and must meet the NCI Working Group (NCI WG) Criteria for treatment of B-CLL as described in Appendix D. 7. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 at study entry (see Appendix C). 8. Laboratory test results within these ranges (unless related to CLL involvement): - Absolute neutrophil count ≥ 1000 /mm3 - Platelet count ≥ 50,000/mm³ - Serum creatinine ≤ 1.5 mg/dL. Serum creatinine > 1.5 mg/dL requires creatinine clearance of ≥ 60 mL/min by Cockroft-Gault formula. - Total bilirubin ≤ 1.5 mg/dL - Aspartate aminotransferase (AST) (SGOT) and alanine aminotransferase (ALT) (SGPT) ≤ 2 x upper limit of normal (ULN) or ≤ 5 x ULN if hepatic metastases are present. 9. Disease free of second malignancies for ≥ 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the cervix or breast. 10. Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 milli-International Units (mIU)/mL within 10 - 14 days prior to and again within 24 hours of starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure. See Appendix A: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods, AND also Appendix B: Education and Counseling Guidance Document. 11. Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to acetylsalicylic acid [ASA] may use warfarin or low molecular weight heparin). Exclusion Criteria: 1. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. 2. Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide). 3. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study. 4. Evidence of laboratory tumor lysis syndrome (TLS) by Cairo-Bishop criteria (Appendix J) (subjects may be enrolled upon correction of electrolyte abnormalities). 5. Use of any other experimental drug or therapy within 28 days of baseline. 6. Known hypersensitivity to thalidomide. 7. The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs. 8. Any prior use of lenalidomide. 9. Concurrent use of other anti-cancer agents or treatments. 10. Known positive for HIV or infectious hepatitis, type A, B or C. |
| 58 | NCT00074022 | completed | 0 | phase 1/phase 2 | ['recurrent non-small cell lung cancer', 'recurrent prostate cancer', 'stage iii prostate cancer', 'stage iiia non-small cell lung cancer', 'stage iiib non-small cell lung cancer', 'stage iv non-small cell lung cancer', 'stage iv prostate cancer', 'unspecified adult solid tumor, protocol specific'] | ["['C78.00', 'C78.01', 'C78.02', 'D14.30', 'D14.31', 'D14.32', 'C34.2']", "['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']", "['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']", "['C61', 'D29.1', 'D40.0', 'Z15.03', 'Z80.42', 'Z85.46', 'Z12.5']", "['H01.009', 'H02.209', 'H02.009', 'H02.109', 'H04.209', 'H05.409', 'H10.509']"] | ['docetaxel'] | ['[H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1'] | Inclusion Criteria: - Histologically or cytologically confirmed diagnosis of 1 of the following: - Solid tumor malignancy (phase I only)* - Prostate cancer (phase I only)* - Non-small cell lung cancer (phase I and II)* - Recurrent, metastatic, locally advanced unresectable, or treatment-refractory disease - Measurable disease - At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan - Previously irradiated lesions are considered measurable provided they have demonstrated progression before study entry - No bone-only disease - Must have measurable disease other than bone lesions - No stage IIIA or IIIB non-small cell lung cancer without a malignant pleural or pericardial effusion that is eligible for first-line radical combined chemotherapy and radiotherapy - No known progressive or symptomatic brain metastases - Asymptomatic brain metastases allowed - Performance status - ECOG 0-2 - Performance status - Karnofsky 60-100% - More than 3 months - WBC at least 3,000/mm^3 - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - No history of coagulopathy - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - AST/ALT no greater than 2 times ULN (3.5 times ULN if liver metastases are present) - INR no greater than 1.3 - APTT no greater than 1.25 times ULN - Creatinine no greater than 1.5 times ULN - Creatinine clearance at least 50 mL/min - No symptomatic congestive heart failure - No evidence of cardiac dysfunction - No unstable angina pectoris - No cardiac arrhythmia - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No active peptic ulcer disease - No poorly controlled diabetes mellitus - No pre-existing grade 2 or greater neuropathy - No ongoing or active infection - No contraindication to corticosteroids - No psychiatric illness or social situation that would limit compliance with study requirements - No prior allergic reaction attributed to compounds of similar chemical or biological composition to study drugs - No other concurrent uncontrolled illness - One, and only one, prior chemotherapy regimen for advanced disease (not including adjuvant therapy) allowed - Neoadjuvant/adjuvant chemotherapy allowed - More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin) and recovered - Prior multiple lines of endocrine therapy for advanced solid tumors allowed - More than 4 weeks since prior endocrine therapy and recovered - Concurrent steroids allowed - See Disease Characteristics - More than 4 weeks since prior radiotherapy and recovered - No concurrent radiotherapy to sole site of measurable disease - Prior surgery allowed - No concurrent anticoagulant therapy - Concurrent low-dose warfarin for central line thrombosis prophylaxis allowed - No concurrent combination antiretroviral therapy for HIV-positive patients - No other concurrent investigational or commercial agents or therapies intended to treat the malignancy - Concurrent bisphosphonates allowed | |
| 59 | NCT00731952 | completed | 1 | phase 1 | ['non small cell lung cancer'] | ["['C78.00', 'C78.01', 'C78.02', 'D14.30', 'D14.31', 'D14.32', 'C34.2']"] | ['velcade and vorinostat'] | ['CC(C)C[C@H](NC(=O)[C@H](CC1=CC=CC=C1)NC(=O)C1=CN=CC=N1)B(O)O'] | Inclusion Criteria - Histologically confirmed NSCLC (clinical stage IB, IIA, IIB, IIIA, or selected IIIB (T4N0-1M0)), exclusive of patients with MPE - Planned surgical resection - Age > 18 years - ECOG performance status 0-1 - Patient has adequate organ and marrow function, as defined below: - Patient has a platelet count of > 100 x 109/L - Patient has a WBC count of > 3.5 x 109/L - Patient has an absolute neutrophil count of > 1.5 x 109/L - Patient has hemoglobin of > 8 gm/dl. Patients may receive transfusions, erythropoietin or darbepoetin to achieve this hemoglobin level. - Patient has a serum creatinine of < 2.0 mg/dL - Patient has AST < 1.5 x ULN - Patient has bilirubin < 1.5 x ULN - Patient has INR < 1.5 x ULN - Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care. - Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (ie, a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study. - Male subject agrees to use an acceptable method for contraception for the duration of the study Exclusion Criteria - Previous chemotherapy or radiation therapy within 5 years before enrollment. - Prior history of treatment for a known NSCLC within the last 5 years of if > 5 years but still thought by the investigator to represent recurrent disease. - Prior exposure to either Velcade or Vorinostat - Prior exposure to any HDAC inhibitors within the previous 30 days. Patients who have received such agents for other indications may enroll after 30-day wash-out period. Subject may not take any other HDAC inhibitor during this trial. - Patient has >/= Grade 2 peripheral neuropathy within 14 days before enrollment. - Myocardial infarction within 6 months prior to enrollment or has NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or ECG evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant. - Patient has hypersensitivity to VELCADE, boron or mannitol. - Patient has known allergy to any component of Vorinostat (MK-0683) - Female subject is pregnant or breast-feeding. Confirm by a negative serum B-hCG pregnancy test result obtained during screening (not required for post-menopausal or surgically sterilized women). - Patient is participating or has participated in another investigational trial, and has received other investigational drugs/therapies within 30 days of enrollment - Serious medical or psychiatric illness likely to interfere with participation in this clinical study. - Patient has history of GI surgery or other procedures that might, in the opinion of the investigator, interfere with the absorption or swallowing of the study drugs. - Subject is currently taking herbal remedy and/or homeopathic agent which cannot (or the patient is unwilling) be discontinued during the conduct of this trial. | |
| 60 | NCT00924001 | terminated | study was stopped due to low accrual | 0 | phase 1/phase 2 | ['melanoma', 'malignant melanoma', 'melanoma, experimental'] | ["['C43.0', 'C43.31', 'D03.9', 'C43.51', 'C43.9', 'D03.0', 'C43.4']", "['C43.0', 'C43.31', 'C43.51', 'C43.9', 'C43.4', 'C43.52', 'C43.10']", "['C43.0', 'C43.31', 'D03.9', 'C43.51', 'C43.9', 'D03.0', 'C43.4']"] | ['dmf5 melanoma reactive til', 'cyclophosphamide', 'fludarabine', 'aldesleukin'] | ['ClCCN(CCCl)P1(=O)NCCCO1', 'ClCCN(CCCl)P1(=O)NCCCO1'] | -INCLUSION CRITERIA: 1. Measurable metastatic melanoma that is refractory to standard treatment including high dose aldesleukin. 2. Unsuitable autologous cells for Institutional Review Board (IRB) approved Surgery Branch adoptive cell therapy studies. 3. Greater than or equal to 18 years of age. 4. Life expectancy of greater than three months. 5. Willing to sign a durable power of attorney. 6. Able to understand and sign the Informed Consent Document. 7. Human leukocyte antigen A (HLA-A) 0201 positive. 8. Willing to practice birth control during treatment and for four months after receiving the preparative regimen. 9. Clinical performance status of Eastern Cooperative Oncology Group (ECOG) 0 or 1. 10. Hematology: - Absolute neutrophil count greater than 1000/mm^3 without support of filgrastim. - WBC greater than 3000/mm^3. - Hemoglobin greater than 8.0 g/dl. - Platelet count greater than 100,000/mm^3. 11. Serology: - Seronegative for human immunodeficiency virus (HIV) antibody. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who are HIV seropositive can have decreased immune - competence and thus be less responsive to the experimental treatment and more susceptible to its toxicities.) - Seronegative for hepatitis B antigen and hepatitis C antibody unless antigen negative. 12. Chemistry: - Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) less than three times the upper limit of normal. - Serum creatinine less than or equal to 1.6 mg/dl. - Total bilirubin less than or equal to 2.0 mg/dl, except in patients with Gilbert's Syndrome who must have a total bilirubin less than 3.0 mg/dl. 13. More than four weeks must have elapsed since any prior systemic therapy at the time the patient receives the preparative regimen, and patients' toxicities must have recovered to a grade 1 or less (except for toxicities such as alopecia or vitiligo). 14. Six weeks must have elapsed since prior Ipilimumab (MDX-010) therapy to allow antibody levels to decline. 15. Patients who have previously received MDX-010 must have a normal colonoscopy with normal colonic biopsies. EXCLUSION CRITERIA: 1. Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant. 2. Active systemic infections, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease. 3. Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease). 4. Opportunistic infections (The experimental treatment being evaluated in his protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities.) 5. Symptomatic central nervous system (CNS) lesions (Patients maybe eligible after treatment of their symptomatic lesions.) 6. Systemic steroid therapy. 7. History of severe immediate hypersensitivity reaction to any of the agents used in this study. 8. History of coronary revascularization or ischemic symptoms. 9. Patients with a prolonged (greater than 20 pk/yrs) history of cigarette smoking or symptoms of respiratory dysfunction with pulmonary function tests (PFT's) indicating an forced expiratory volume (FEV1) less than 60 percent predicted for age. 10. Patients with a history of clinically significant atrial and/or ventricular arrhythmias including but not limited to: atrial fibrillation, ventricular tachycardia, heart block or greater than or equal to age 60 with an left ventricular ejection fraction (LVEF) of less than 45 percent on cardiac evaluation (echocardiogram, multi-gated acquisition scan (MUGA), etc.) will be excluded. 11. Positive allo-specific reactivity of the DMF5 cells to the patient's peripheral blood mononuclear cells (PBMC). 12. Documented penicillin allergy. |
| 61 | NCT01870999 | completed | 1 | phase 1 | ['schizophrenia'] | ["['F20.0', 'F20.1', 'F20.2', 'F20.3', 'F20.5', 'F20.89', 'F20.9']"] | ['aripiprazole im depot', 'aripiprazole tablets'] | ['ClC1=CC=CC(N2CCN(CCCCOC3=CC4=C(CCC(=O)N4)C=C3)CC2)=C1Cl', 'ClC1=CC=CC(N2CCN(CCCCOC3=CC4=C(CCC(=O)N4)C=C3)CC2)=C1Cl'] | Inclusion Criteria: - diagnosis of schizophrenia as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria - good physical health as determined by normal medical history, clinical laboratory results, electrocardiograms (ECGs) and physical examinations - ability to provide informed consent and/or consent from a legally acceptable representation - body mass index (BMI) of 18 to 35 kg/m^2 Exclusion Criteria: - sexually active males and females of child-bearing potential who are not practicing double barrier birth control or are not abstinent during the study plus 30 days for female or 90 days for males following the last dose of medication - history of drug or alcohol abuse within 6 months and/or positive urine drug screen - participants who consume alcohol beverages routinely - participants who consume alcohol beverages during the screening period - use of any antipsychotic medication, other prohibited psychotropic medication, and any cytochrome P450 2D6 (CYP2D6) and cytochrome P450 3A4 (CYP3A4) inhibitors or CYP3A4 inducers within 14 days - use of any prescription medication unless approved by Medical Monitor or Study Director - history of current hepatitis or carrier of HBsAg (Hepatitis B surface antigen) and/or Hepatitis C Virus antibodies (anti-HCV) - females who are pregnant or lactating - participants who have participated in any clinical trial involving a psychotropic medication within one month prior to enrollment; participants who have participated in a previous IM Depot study within the last 1 year; patients who have previously enrolled and received study medication in an aripiprazole IM Depot clinical trial - donation of blood or plasma to a blood bank or in a clinical study (except a screening visit)within 30 days prior to enrollment - any major surgery within 30 days prior to enrollment - blood transfusion within 30 days prior to enrollment - evidence of organ dysfunction or any clinically significant deviation from normal in the physical, electrocardiographic, or clinical laboratory examinations - patient represents a significant risk of committing suicide based on history - patients currently in an acute relapse - patients with Axis I (DSM-IV) diagnosis of schizoaffective or bipolar disorder - patients who are considered treatment-resistant to antipsychotic medication - patients with a history of neuroleptic malignant syndrome - any other sound medical reason as determined by the clinical investigator | |
| 62 | NCT01033032 | completed | 1 | phase 1/phase 2 | ['metastatic breast cancer'] | ["['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']"] | ['amrubicin'] | ['[H][C@@]1(C[C@@](N)(CC2=C1C(O)=C1C(=O)C3=CC=CC=C3C(=O)C1=C2O)C(C)=O)O[C@H]1C[C@H](O)[C@H](O)CO1'] | Inclusion Criteria: 1. Females >=18 years of age. 2. Histologic diagnosis of HER2-negative breast cancer. HER-2 negativity must be confirmed by one of the following: - FISH-negative (FISH ratio <2.2), or - IHC 0-1+, or - IHC 2-3+ AND FISH-negative (FISH ratio <2.2) 3. Evidence of metastatic or locally advanced, inoperable breast cancer. 4. Minimum of 1 and maximum of 2 prior metastatic breast cancer chemotherapy regimens. 5. Patients with prior anthracycline therapy are eligible, provided their previous anthracycline was ≥6 months prior to study entry. 6. Measurable disease per RECIST criteria version 1.1 7. Left ventricular ejection fraction (LVEF) ³50% by echocardiogram (ECHO) or multiple gated acquisition scan (MUGA). 8. Patients must have QTc interval of <=450 msec. 9. No intercurrent significant medical conditions or cardiac illness. 10. Patients must be >=3 weeks since last chemotherapy, and recovered from all acute toxicities, with the exception of alopecia. 11. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-2. 12. Adequate organ function including the following: - ANC >=1500 cells/mL - Platelet count >=100,000 cells/mL - Hemoglobin >=9 g/dL - Total bilirubin <=1.5 x ULN; AST/ALT <=2.5 x ULN, (except if due to hepatic metastases, then <=5 x ULN) - Serum creatinine <1.5 x ULN 13. Women of childbearing potential must have a negative serum or urine pregnancy test performed <=7 days prior to start of treatment. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she must agree to inform her treating physician immediately. 14. Patients must be accessible for treatment and follow-up. 15. Patients must be able to understand the investigational nature of this study and give written informed consent prior to study entry. 16. Patients who are on anticoagulation are acceptable if the therapeutic anticoagulation is stable. Additionally, the patient's INR must be adequate if the patient is receiving treatment with coumadin. 17. Prior hormonal therapy for metastatic breast cancer is permitted; however, the therapy must be discontinued prior to the patient's enrollment in this study. Exclusion Criteria: 1. Any concurrent therapy with other investigational, chemotherapeutic, or hormonal therapy. 2. Prior treatment with >=3 regimens of cytotoxic therapy in the advanced disease setting. (Any number of previous hormonal therapies are acceptable, as long as the therapy is discontinued prior to the patient's enrollment into this study). 3. Major surgery or systemic therapy <=3 weeks of study treatment. 4. Prior high-dose chemotherapy requiring hematopoietic stem cell support. 5. Prior radiation therapy to >25% of the bone marrow. 6. Uncontrolled brain metastases. Patients with treated brain metastases (resection or radiotherapy) are eligible if brain metastases have responded to treatment as documented by CT or MRI scan obtained at >=2 weeks after completion of radiation therapy, neurologic symptoms are absent, and steroids have been discontinued. 7. Suspected, diffuse idiopathic interstitial lung disease or pulmonary fibrosis. 8. Diagnosis of second malignancy within the last 3 years (with the exception of carcinoma in situ of the cervix, squamous or basal cell skin cancer, thyroid cancer, ductal carcinoma in situ [DCIS], or lobular carcinoma in situ [LCIS]). 9. Any of the following <=12 months prior to starting study treatment: - myocardial infarction; - severe unstable angina; - congestive heart failure; - ongoing cardiac dysrhythmia. 10. Family history of idiopathic cardiomyopathy or uncontrolled heart arrhythmia. 11. Patients with previous allergy or hypersensitivity to anthracyclines. 12. Patients who have had a ≥10% drop in LVEF on previous anthracycline therapy. 13. Palliative radiotherapy to areas of metastatic breast cancer must have been completed >7 days prior to the first dose of study treatment. The exception is radiotherapy for brain metastases, which must be completed >=21 days prior to study treatment. (Note: Any measurable lesion that has been previously irradiated will not be considered as a target lesion). 14. Concurrent severe, intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements. 15. History of seropositive HIV, or patients who are receiving immunosuppressive medications that increase the risk of neutropenic complications. 16. Mental condition that would prevent patient comprehension of the nature of, and risk associated with, the study. 17. Use of any non-approved or investigational agent <=30 days of administration of the first dose of study drug. Patients may not receive any other investigational or anti-cancer treatments while participating in this study. | |
| 63 | NCT00714649 | completed | 1 | phase 1/phase 2 | ['head and neck cancer'] | ["['C76.0', 'C47.0', 'C49.0', 'C77.0', 'D17.0', 'D21.0', 'D36.11']"] | ['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: - More than 18 years - Histologically proven squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx - patients selected for a primary surgical treatment - No distant metastases - No active second malignancy during the last 5 years - No prior or concurrent evidence of uncontrolled severe pathology precluding administration of surgery - life expectancy more than 3 months - Not pregnant or nursing; fertile patients both male or female, must use effective contraception - Signed informed consent - Performance Status ECOG 0-1 Exclusion Criteria: - Nasopharynx cancer - Past or current malignancy other than HNSCC - performance Status ECOG above 2 - Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol - Use of any investigationals agents within 4 weeks prior ti entry - Previous exposure to EGFR targeting therapy - Known grade hypersensitivity to cetuximab | |
| 64 | NCT01218477 | completed | 1 | phase 1/phase 2 | ['leukemia'] | ["['C95.91', 'C95.92', 'Z80.6', 'Z85.6', 'C90.11', 'C90.12', 'C91.01']"] | ['dasatinib', 'bms-833923'] | ['CC1=NC(NC2=NC=C(S2)C(=O)NC2=C(C)C=CC=C2Cl)=CC(=N1)N1CCN(CCO)CC1'] | Key Inclusion Criteria - Age ≥18 years - Diagnosis of chronic myeloid leukemia (CML) and cytogenetic positive for the Philadelphia chromosome (Ph+), documented Ph+ cells on bone marrow assessment (BMA) ≤6 weeks prior to treatment - Either chronic-phase CML, with <15% blasts in peripheral blood and bone marrow, or advanced-phase CML, including Ph+ acute lymphoblastic leukemia (ALL) (> 5% blasts) or hematologic progression with ≥15% blasts not in complete cytogenetic remission - Resistance or suboptimal response to imatinib, dasatinib, or nilotinib and no known T315I/A Abl-kinase mutation. Key Exclusion Criteria - Known Abl-kinase T315I or T315A mutation - CCyR at baseline - Any serious or uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy - Uncontrolled or significant cardiovascular disease - Grade 3 or higher peripheral blood counts - Serum calcium or phosphate below the lower limit of normal - Baseline hypomagnesemia and amylase or lipase at least Grade 1 or higher - Reduced renal function, defined as serum creatinine level >3*upper limit of normal - Prior therapies for CML or Ph+ ALL permitted, with the following restriction: - Therapy permitted with corticosteroids, hydroxyurea, or anagrelide prior to starting treatment and during the first 4 weeks on study - 6 months or longer after stem cell transplantation - 28 days or longer after any investigational agent - 7 days or longer after any standard chemotherapy agent - Concomitant use of medications with a known risk of causing Torsades de Pointes - Concomitant use of strong inhibitors of the CYP3A4 isoenzyme | |
| 65 | NCT00100971 | terminated | protocol is withdrawn due to inadequate accrual | 0 | phase 1 | ['leukemia'] | ["['C95.91', 'C95.92', 'Z80.6', 'Z85.6', 'C90.11', 'C90.12', 'C91.01']"] | ['autologous tumor cell vaccine', 'therapeutic autologous dendritic cells'] | ['[O-][N+](=O)OCC(CO[N+]([O-])=O)(CO[N+]([O-])=O)CO[N+]([O-])=O'] | DISEASE CHARACTERISTICS: - Diagnosis of acute myeloid leukemia (AML) by bone marrow biopsy - Newly diagnosed - Must have adequate dendritic cells and AML blasts isolated from bone marrow and/or peripheral blood - No clinical evidence of CNS leukemia PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Not specified Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Not specified Renal - Not specified Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - HIV negative - No clinically significant autoimmune disease - No other active malignancy except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy - More than 3 months since prior immunotherapy Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified |
| 66 | NCT01241461 | completed | 1 | phase 1 | ['cancer'] | ["['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']"] | ['ly2584702'] | ['CN1C=C(N=C1C1CCN(CC1)C1=C2C=NNC2=NC=N1)C1=CC=C(F)C(=C1)C(F)(F)F'] | Inclusion Criteria: - Have histological or cytological evidence of a diagnosis of advanced and/or metastatic cancer (solid tumors) that is refractory to standard therapy and/or therapies known to provide clinical benefit, or for which no standard therapy exists. - Have the presence of disease amenable to efficacy assessment as defined by the Response Evaluation Criteria In Solid Tumors (RECIST). Japanese patients who have advanced non-measurable disease with elevation of a validated tumor marker may be eligible, if discussed and agreed upon by the investigator and Lilly. - Have adequate organ function including: - Hematologic: Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10^9/liter (L), platelets greater than or equal to 100 x 10^9/L, and hemoglobin greater than or equal to 9 gram/deciliter (g/dL) (transfusions are not allowed prior to enrollment within 2 weeks). - Hepatic: Bilirubin less than or equal to 1.5 times upper limit of normal (ULN), alkaline phosphatase (ALP), alanine transaminase (ALT) and aspartate transaminase (AST) less than or equal to 2.5 times ULN, or 5 times ULN for patients with hepatic metastases. Patients with bone metastases may enter with alkaline phosphatase values less than 5 times ULN, as long as other hepatic parameters meet inclusion criteria. - Renal: Serum creatinine less than or equal to 1.5 times ULN. - Have a performance status of less than or equal to 2 on the Eastern Cooperative Oncology Group scale - Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, cancer-related hormonal therapy prior to study enrollment and recovered from the acute effects of therapy. - Have an estimated life expectancy of 12 weeks or greater - Are able to swallow capsules Exclusion Criteria: - Have received treatment within 4 weeks of the initial dose of study drug with a drug that has not received regulatory approval for any indication. - Have serious preexisting medical conditions or serious concomitant systemic disorders that, in the opinion of the investigator, would preclude participation in this study. - Prior clinical history of tuberculosis (patient doubt tuberculosis is screening required), and positive test results in hepatitis B surface antigen (HBSAg), or hepatitis C antibodies (HCAb) (screening required). - Have symptomatic central nervous system (CNS) malignancy or metastasis. Patients with treated CNS metastases are eligible provided their disease is radiographically stable, asymptomatic, and they are not currently receiving corticosteroids and/or anticonvulsants. Screening of asymptomatic patients without history of CNS metastasis is not required. - Have hematologic malignancies, or lymphoma. | |
| 67 | NCT00567931 | completed | 1 | phase 1 | ['unspecified adult solid tumor, protocol specific'] | ["['H01.009', 'H02.209', 'H02.009', 'H02.109', 'H04.209', 'H05.409', 'H10.509']"] | ['1-methyl-d-tryptophan'] | ['CN1C=C(C[C@@H](N)C(O)=O)C2=CC=CC=C12'] | Inclusion Criteria: - Histologically confirmed solid malignancy that is metastatic or unresectable and for which standard effective antineoplastic therapy does not exist or is no longer effective - Patients are eligible for enrollment into the trial regardless of the types of previous therapies administered - Patients with known brain metastases will only be eligible after their tumors have been treated with definitive resection and/or radiotherapy and they are neurologically stable for at least 1 month off steroids - No known untreated brain metastases - ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100% - Life expectancy > 4 months - WBC ≥ 3,000/μL - ANC ≥ 1,500/μL - Platelet count ≥ 100,000/μL - Total bilirubin ≤ 1.5 times upper limit of normal (ULN) - AST and ALT ≤ 2.5 times ULN - Creatinine normal OR creatinine clearance ≥ 60 mL/min - No history of gastrointestinal disease causing malabsorption or obstruction, including, but not limited to, any of the following: - Crohn's disease - Celiac sprue - Tropical sprue - Bacterial overgrowth/blind-loop syndrome - Strictures - Adhesions - Achalasia - Bowel obstruction - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective double-method contraception during and for at least 1 month after completion of study treatment - No history of allergic reactions (significant urticaria, angioedema, anaphylaxis) attributed to compounds of similar chemical or biologic composition to 1-methyl-d-tryptophan (including L-tryptophan or 5-hydroxy-tryptophan supplements) - No active autoimmune disease (i.e., psoriasis, extensive atopic dermatitis, asthma, inflammatory bowel disorder, multiple sclerosis, uveitis, vasculitis), chronic inflammatory condition, or any condition requiring concurrent use of any systemic immunosuppressants or steroids for any reason - Mild-intermittent asthma requiring only occasional beta-agonist inhaler use or mild localized eczema allowed - No uncontrolled concurrent illness including, but not limited to, any of the following: - Ongoing or active infection - Symptomatic congestive heart failure - Unstable angina pectoris - Myocardial infarction or percutaneous coronary interventions within the past 6 months - Cardiac arrhythmia - Active autoimmune diseases - Major psychiatric illness or social situation that would limit compliance with study requirements as judged by the primary investigator at each site - Patients with well-controlled, chronic medical conditions under the supervision of the patient's primary physician (i.e., hypertension, hyperlipidemia, coronary heart disease, diabetes mellitus) are eligible - No HIV-positive patients or patients with other acquired/inherited immunodeficiencies - No other active malignancy - No concurrent immunosuppressants, including steroids - Recovered from all prior therapy - No prior gastric bypass surgery - No prior extensive small bowel resection - No prior experimental active immunotherapy consisting of targeted monoclonal antibodies or pharmaceutical compounds - Commercially available active immunotherapy (e.g., adjuvant interferon) must have completed therapy over 1 year prior to enrollment and have no evidence of autoimmune sequelae - Prior therapy with approved monoclonal antibodies (e.g., bevacizumab, cetuximab, panitumumab, or trastuzumab) allowed - At least 4 weeks since prior and no other concurrent investigational agents - More than 4 weeks since prior chemotherapy or radiotherapy (6 weeks for nitrosoureas or mitomycin C) - No concurrent supplements containing L-tryptophan or derivatives - No patients with an allo-transplant of any kind (including those with a xenograft heart valve) - No other concurrent commercial agents or therapies | |
| 68 | NCT00640315 | completed | 1 | phase 1 | ['hypertension, pulmonary', 'pulmonary disease, chronic obstructive'] | ["['I27.0', 'I27.20', 'I27.21', 'I27.24', 'I27.29', 'P29.30', 'I27.22']", "['J44.9', 'J44.1', 'J44.0']"] | ['riociguat (adempas, bay63-2521) 1.0 mg', 'riociguat (adempas, bay63-2521) 2.5 mg'] | ['COC(=O)N(C)C1=C(N)N=C(N=C1N)C1=NN(CC2=C(F)C=CC=C2)C2=C1C=CC=N2', 'COC(=O)N(C)C1=C(N)N=C(N=C1N)C1=NN(CC2=C(F)C=CC=C2)C2=C1C=CC=N2'] | Inclusion Criteria: - Patients with pulmonary hypertension due to COPD, undergoing routine invasive measurement of hemodynamic parameters. - Catheters for measurement of hemodynamic parameters (PAP [pulmonary artery pressure], PCWP [pulmonary capillary wedge pressure], CO [cardiac output], SBP [systolic blood pressure]) must be in place independent of the trial. Exclusion Criteria: - Acute exacerbation of COPD, - Pre-existing lung disease other than COPD, - Acute or severe chronic left heart failure, - Severe coronary artery disease, - Uncontrolled arterial hypertension; - Severe left ventricular hypertrophy, - Congenital or acquired valvular or myocardial disease, - Systolic blood pressure < 100 mmHg, - Heart rate < 55 bpm or >105 bpm, - PaO2 (arterial partial oxygen pressure)/FiO2 (fraction of inspired oxygen) < 50 mmHg, - PaCO2 (arterial partial pressure of carbon dioxide) > 55 mmHg, - Severe hepatic insufficiency, - Severe renal insufficiency. | |
| 69 | NCT00892801 | terminated | terminated due to low accrual. study was closed to accrual prematurely and did not continue on to phase ii. | 0 | phase 1 | ['lung cancer', 'metastatic cancer'] | ["['C78.00', 'C78.01', 'C78.02', 'D14.30', 'D14.31', 'D14.32', 'C34.2']", "['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']"] | ['rad001'] | ['[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](O)[C@@H](C1)OC'] | DISEASE CHARACTERISTICS: - Radiographically confirmed brain metastases with histopathologically confirmed primary non-small cell lung cancer that will benefit from whole-brain radiotherapy - Must have ≥ 1 measurable intracranial site of disease, according to RECIST criteria, that has not been previously treated with stereotactic radiation - Must have stable extracranial disease for 4 weeks PATIENT CHARACTERISTICS: - ECOG performance status 0-2 - Life expectancy ≥ 12 weeks - ANC > 1,500/mm³ - Platelets > 100,000/mm³ - Hemoglobin > 11 g - BUN ≤ 25 mg - Serum creatinine < 1.5 times upper limit of normal (ULN) - Serum bilirubin ≤ 1.5 times ULN - Serum transaminases ≤ 2 times ULN (< 5 times ULN if patient has liver metastases) - Cholesterol ≤ 300 mg/dL - Triglycerides ≤ 2.5 times ULN - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment - No other malignancies within the past 3 years, except for adequately treated carcinoma in situ of the cervix or basal or squamous cell carcinomas of the skin - No severe and/or uncontrolled medical conditions or other conditions that could affect participation in the study, including any of the following: - Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within the past 6 months, or serious uncontrolled cardiac arrhythmia - Severely impaired lung function (i.e., FEV1 < 0.8 cc) - Uncontrolled diabetes as defined by fasting serum glucose ≥ 1.5 times ULN - Any active (acute or chronic) or uncontrolled infection/disorders - Non-malignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with the study therapy - Liver disease, such as cirrhosis, chronic active hepatitis, or chronic persistent hepatitis - No known history of HIV seropositivity - No impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of everolimus (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection) - No active, bleeding diathesis - No known hypersensitivity to everolimus or other rapamycin (i.e., sirolimus, temsirolimus) or to its excipients - No history of noncompliance to medical regimens PRIOR CONCURRENT THERAPY: - See Disease Characteristics - Recovered from the acute toxicities of any prior therapy - Prior surgical resection of a brain metastasis allowed - The extent of surgical resection in patients having prior resection of 1 of multiple metastases shall be documented as a biopsy, subtotal resection, or total resection as described by the operative report and/or post-operative imaging - At least 3 weeks since prior major surgery or completion of extracranial radiation - At least 3 weeks since prior and no concurrent systemic anticancer therapy, other than the study medications administered as part of this study protocol - At least 6 weeks since prior nitrosoureas - More than 1 week since prior and no concurrent immunization with attenuated live vaccines - More than 3 weeks since prior chemotherapy - No prior brain radiotherapy of any form - No concurrent chronic treatment with systemic steroids or other immunosuppressive agents, except steroids for neurological stability following the diagnosis of brain metastases - No prior treatment with an mTOR inhibitor - No concurrent anti-vitamin K medication, except low dose coumarin - No concurrent drugs or substances known to be inhibitors or inducers of the isoenzyme CYP3A - No other concurrent investigational therapy |
| 70 | NCT00444236 | terminated | the sponsor decided to terminate the study due to slow enrollment. | 0 | phase 1 | ['exercise triggered asthma', 'gastroesophageal reflux'] | ["['K21.9', 'K21.00', 'K21.01']"] | ['nexium', 'placebo'] | ['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: - We plan to take athletes (cyclists) with GER (heartburn symptoms on a daily-weekly basis which are either improved by a trial of acid suppression or objectively documented via pH/endoscopic testing- this may include during exercise) who experience one or more of the following symptoms during exercise, limiting their perceived ability to exercise to full capacity: - choking - cough - wheezing - shortness of breath - chest tightness during exercise - Athletes will be defined as persons who exercise on a routine basis (at least 3 times a week on average) for at least the past 6 months. - Subjects must be at least 18 years old. Exclusion Criteria: - Pregnancy - Age less than 18 years or greater than 65 years - Abnormal methacholine challenge tests will not exclude one from enrollment as (has been documented in a prior study) often patients with GER will have heightened bronchial reactivity. |
| 71 | NCT00591214 | completed | 1 | phase 1 | ['chronic hepatitis c'] | ["['B18.2', 'B18.0', 'B18.1', 'B18.8', 'B18.9', 'K71.3', 'K71.4']"] | ['mp-424 (telaprevir)'] | ['[H][C@@]12CCC[C@]1([H])[C@H](N(C2)C(=O)[C@@H](NC(=O)[C@@H](NC(=O)C1=NC=CN=C1)C1CCCCC1)C(C)(C)C)C(=O)N[C@@H](CCC)C(=O)C(=O)NC1CC1'] | Inclusion Criteria: - Patients diagnosed with genotype 1b chronic hepatitis C - Patients naive to the concomitant medications with interferon Exclusion Criteria: - Patients diagnosed with decompensated cirrhosis - Patients diagnosed with positive HBs(Hepatitis B virus surface) antigen in the test | |
| 72 | 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 | |
| 73 | NCT00088023 | terminated | 0 | phase 1 | ['neoplasms'] | ["['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']"] | ['pt-523 for injection'] | ['NC1=NC(N)=C2N=C(CNC3=CC=C(C=C3)C(=O)N[C@@H](CCCNC(=O)C3=CC=CC=C3C(O)=O)C(O)=O)C=NC2=N1'] | Inclusion Criteria: - Presence of metastatic or inoperable malignancy, other than leukemia or a primary central nervous system (CNS) tumor, for which there is no known curative or survival prolonging palliative therapy, or failure of these therapies . - Age greater than or equal to 18 years. - Life expectancy greater than or equal to 2 months. - ECOG performance status 0 - 2. - Adequate organ function and bone marrow reserve. - Use of appropriate contraceptive method. - Sign patient informed consent. Exclusion Criteria: - Active brain metastases. - Presence of third-space fluid collections (pleural effusion, ascites). - Major surgery within 3 weeks prior to dosing. - Prior chemotherapy or radiation therapy within 3 weeks prior to dosing (6 weeks for nitrosoureas or mitomycin-C). Prior antifolate therapy is permitted, as long as it has not been administered within 3 weeks prior to dosing with PT-523. - Prior bone marrow transplantation. - Presence of uncontrolled serious medical or psychiatric illness. - Patients requiring radiation therapy. There are no limitations on the extent or type of prior therapy received by the patient other than the time intervals indicated above, as long as the patient has demonstrated complete recovery from any adverse effects, and fulfills all relevant inclusion criteria. | |
| 74 | NCT01044966 | terminated | the study was terminated due to lack of adequate patient enrollment into trial. | 0 | phase 1/phase 2 | ['glioblastoma multiforme', 'glioma', 'astrocytoma', 'brain tumor'] | ["['L51.0', 'L51.8', 'L51.9']", "['C71.7', 'C71.9', 'C79.31', 'D33.0', 'D33.1', 'D33.2', 'D49.6']"] | ['itv depocyt + temozolomide'] | ['NC1=NC(=O)N(C=C1)[C@@H]1O[C@H](CO)[C@@H](O)[C@@H]1O'] | Inclusion Criteria: - Age Patients must be at least 18 years of age but no older than 85 years. - Diagnosis Patients with the histological diagnosis of recurrent GBM made either by biopsy or resection of recurrent disease. Cytological evidence of malignant cells in CSF and/or clinical and radiographic evidence of leptomeningeal disease are irrelevant in terms of inclusion or exclusion into this study. Bihemispheric extension ("butterfly GBM"), multi-focality, and/or subependymal spread are not contraindications to enrollment. - Prior therapy Patients must have had an initial diagnosis of "malignant glioma" (WHO grade III or IV) and failed initial surgical resection followed by standard adjuvant therapy including external beam radiotherapy to a 2cm margin of 60 Gy, and standard temozolomide chemotherapy of 150 to 200 mg per square meter for 5 days during each 28-day cycle prior to "recurrence." Patients must not have received more than one other systemic or ITV adjuvant chemotherapy regimen in addition to temozolomide prior to enrollment, not including intracavitary Gliadel wafer placement. Prior Gliadel wafer placement is not a contradiction to patient enrollment in this trial. - Performance Status Patients must have Karnofsky performance status (KPS) of ≥ 60%. - Recovery from Prior Therapy Patients must have recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy, prior to entering this study and must be without significant systemic illness (e.g. infection unresponsive to treatment after 7 days). Such that they are healthy enough to safely undergo tumor biopsy and Ommaya reservoir placement. Patients must not have received any systemic therapy for recurrent disease within 3 weeks (6 weeks if a nitrosourea), or irradiation within 8 weeks prior to treatment on this study. - Hematologic Status Patients must have a platelet count > 75,000/mm3 and ANC > 1500/mm3 within 72 hours prior to ITV DepoCyt treatment. - Hepatic and Renal Status Patients must have adequate liver function (total bilirubin < 2.0 mg%; ALT, and AST < 4 times normal); adequate renal function (serum creatinine <1.6 mg, and BUN < 22); normal serum electrolytes (sodium, potassium, calcium, magnesium, and phosphorus). - Informed Consent (See Appendix) All patients or their legal guardians must sign a document of informed consent indicating their awareness of the investigational nature and the risks of this study. Exclusion Criteria: - Patients younger than 18 or older than 85 years of age. - Patients with histological diagnoses other than recurrent GBM. - Patients with a Karnofsky performance status (KPS) < 60%. - Patients that have received more than one other systemic or ITV adjuvant chemotherapy regimen in addition to temozolomide, not including intracavitary Gliadel wafer placement. - Patients concurrently receiving other therapies (either brachytherapy or systemic) designed specifically to treat the recurrent GBM. - Patients within 8 weeks of receiving stereotactic or external beam irradiation. - Patients with a platelet count < 75,000/mm3 and ANC < 1500/mm3 within 72 hours prior to ITV DepoCyt and/or oral temozolomide treatment. - Patients with liver dysfunction (total bilirubin > 2.0 mg%; ALT, and AST > 4 times normal). - Patients with renal dysfunction (serum creatinine >1.6 mg, and BUN > 22). - Patients with abnormal serum electrolytes (sodium, potassium, calcium, magnesium, and phosphorus). - Patients with contraindications to having placement of a ventricular access device such as Ommaya reservoir. - Patients with clinical and/or neuroradiographic evidence of hydrocephalus or increased intracranial pressure. - Patients with signs and symptoms of systemic infection precluding them from receiving chemotherapy or prohibiting Ommaya reservoir placement. - Pregnant and breast feeding women will be excluded. All other women of childbearing years must have a negative serum pregnancy test. - Patients with a ventricular-peritoneal or ventricular-atrial shunt. - Prisoners will be excluded from this study. - Patients or their legal guardians not willing or able to sign the informed consent document. |
| 75 | NCT01166789 | completed | 0 | phase 1 | ['irritable bowel syndrome'] | ["['K58.2', 'K58.8', 'K58.0', 'K58.1', 'K58.9']"] | ['lubiprostone', 'placebo'] | ['[H][C@@]12CC(=O)[C@H](CCCCCCC(O)=O)[C@@]1([H])CC[C@@](O)(O2)C(F)(F)CCCC', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - clinical diagnosis of IBS-C - meeting Rome III diagnostic criteria for IBS-C - age 18 or older Exclusion Criteria: - use of laxatives or prokinetics within two weeks prior to the study or during the study - use of IBS-specific compounds, opiates, anticholinergics, or any drug likely to cause constipation as a side-effect - use of analgesics for 48 hours prior to the study - hypothyroid condition - history of bowel resection except appendectomy or cholecystectomy - psychotic disorder, major depression, substance abuse (other than tobacco), or other psychiatric condition likely to interfere with the conduct of the study. Subjects treated for depression more than 2 years ago or for situational circumstances may be eligible for the study at the investigator's discretion - renal disease - inflammatory or ischemic disease of the rectum - known to be an unreliable subject - Because this study involves exposure to radiation, subjects who are pregnant or planning to become pregnant, employees currently working with radiation, and subjects who have participated in research involving radiation within the past year will also be excluded. | |
| 76 | NCT00291577 | completed | 0 | phase 1 | ['breast neoplasms'] | ["['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']"] | ['sunitinib (sutent)', 'taxotere'] | ['CCN(CC)CCNC(=O)C1=C(C)NC(\\C=C2/C(=O)NC3=C2C=C(F)C=C3)=C1C', '[H][N]([H])([H])[Pt](Cl)(Cl)[N]([H])([H])[H]'] | Inclusion Criteria: - Breast cancer with evidence of unresectable, locally recurrent or metastatic disease - Candidate for treatment with docetaxel Exclusion Criteria: - Prior chemotherapy in the advanced disease setting - Inflammatory breast cancer - HER2 positive disease | |
| 77 | NCT00801931 | terminated | poor accrual | 0 | phase 1/phase 2 | ['leukemia', 'lymphoma', 'neuroblastoma', 'immunodeficiencies', 'anemia'] | ["['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']", "['D84.89', 'D81.89', 'D83.8', 'D80.8']", "['D53.2', 'D64.9', 'D46.4', 'D53.0', 'D53.9', 'D61.3', 'D61.9']"] | ['alemtuzumab', 'melphalan', 'busulfan', 'phenytoin', 'fludarabine', 'cyclophosphamide', 'horse antithymocyte globulin', 'rabbit antithymocyte globulin', 'thiotepa'] | ['N[C@@H](CCCNC(N)=N)C(O)=O', 'N[C@@H](CC1=CC=C(C=C1)N(CCCl)CCCl)C(O)=O', 'CS(=O)(=O)OCCCCOS(C)(=O)=O', 'OC(=O)C1=CC=CC=C1O', 'ClCCN(CCCl)P1(=O)NCCCO1', 'ClCCN(CCCl)P1(=O)NCCCO1', 'CN(C)CCOC(C)(C1=CC=CC=C1)C1=CC=CC=N1'] | Inclusion Criteria: - Patients will be eligible for double cord blood stem cell transplant (TNC ≥ 4x107/kg of two combined units) if available single cord blood has TNC ≤4.0 x 107/kg and they lack a matched (5-6/6) family donor, a 10/10 unrelated adult donor, and/or if their disease status required emergent stem cell transplant and they could not wait 2-3 months for searching for a matched unrelated adult donor. - Adequate renal function defined as:Serum creatinine <1.5 x normal, or Creatinine clearance or radioisotope glomerular filtration rate (GFR) >60 ml/min/m2 or >60 ml/min/1.73 m2 or an equivalent GFR as determined by the institutional normal range. - Adequate liver function defined as:Total bilirubin <1.5 x normal, or serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase (AST)) or serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase (ALT)) <3.0 x normal - Adequate cardiac function defined as:Shortening fraction >27% by echocardiogram, or Ejection fraction >47% by radionucleotide angiogram or echocardiogram. - Adequate pulmonary function defined as:Uncorrected diffusing capacity of the lungs for carbon monoxide (DLCO) 50% by pulmonary function test.For children who are uncooperative, no evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry >94% on room air. Eligibility for Moderate Intensity, Reduced Intensity Regimen and Fanconi's Anemia (Regimens C, D and E) - Adequate renal function defined as: Serum creatinine <2.0 x normal, or Creatinine clearance or radioisotope GFR 40 ml/min/m2 or >40 ml/min/1.73 m2 or an equivalent GFR as determined by the institutional normal range. - Adequate liver function defined as:Total bilirubin <2.5 x normal, or SGOT (AST) or SGPT (ALT) <5.0 x normal - Adequate cardiac function defined as:Shortening fraction of >25% by echocardiogram, or Ejection fraction >40% by radionucleotide angiogram or echocardiogram. - Adequate pulmonary function defined as:Uncorrected DLCO >35% by pulmonary function test. For children who are uncooperative, no evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry >94% on room air. Exclusion Criteria: - Females who are pregnant or breast-feeding - Patients with documented uncontrolled infection at the time of study entry |
| 78 | NCT00087477 | terminated | 0 | phase 1/phase 2 | ['malignant melanoma'] | ["['C43.0', 'C43.31', 'C43.51', 'C43.9', 'C43.4', 'C43.52', 'C43.10']"] | ['pivanex'] | ['CCCC(=O)OCOC(=O)C(C)(C)C'] | Inclusion Criteria: - Histologically or cytologically confirmed melanoma, previously treated with chemotherapy or IL-2 - Recurrent or progressive disease after treatment. - Measurable disease. - Males and females, age ≥ 18 years. - Adequate renal function with creatinine ≥ 1.5 mg/dl. - Adequate liver function with alkaline phosphatase <= 2.5 X upper limit of normal, SGOT and SGPT <= 1.5 X upper limit of normal and total bilirubin <= 1.5 X upper limit of normal. - Adequate bone marrow function: platelets ≥ 100,000/mm3, hemoglobin ≥ 9 g/dL, and absolute neutrophil count (ANC)≥ 1,500 cells/mm3. - Able to give informed consent. - Must have discontinued previous surgery, radiation therapy or cancer chemotherapy at least four weeks prior to randomization (six weeks if a prior nitrosourea or mitomycin C), with recovery from treatment-associated toxicity. Localized palliative radiation therapy to non-target lesions is permitted within the four weeks prior to randomization. - A predicted life expectancy of at least 6 months. - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Exclusion Criteria: - Receipt of more than three (3) systemic treatment regimens for malignant melanoma (including IL-2). - A second malignancy within the last 5 years other than curatively treated carcinoma-in-situ or non-melanoma skin cancer. - Pregnant or lactating females. Females of childbearing potential must have a negative pregnancy test and all male and female patients of reproductive potential must agree to use adequate birth control. - Known HIV-positive patients. - Acute medical problems, such as ischemic heart or lung disease or uncontrolled systemic infection. - Patients with any underlying medical conditions or circumstance, which would contraindicate therapy with study treatment, affect compliance or impair evaluation of study endpoints. - Patients receiving investigational agents within 4 weeks of randomization. - Known allergy to reagents in the study. - Symptomatic or untreated brain metastases - Patients with brain metastases are eligible if they are clinically and neurologically stable for ≥ 4 weeks since therapy (radiation therapy, radiosurgery/gamma knife, surgical resection) as determined by the investigator and either off corticosteroids or on a stable dose of corticosteroids. | |
| 79 | NCT00327327 | completed | 1 | phase 1 | ['pancreatic adenocarcinoma'] | ["['C22.0', 'C22.1', 'C4A.9', 'C7B.1', 'D09.9', 'C4A.0', 'C4A.31']"] | ['imexon', 'gemcitabine'] | ['NC1=NC(=O)N2CC12', '[H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1'] | Inclusion Criteria: - Inoperable cancer of the pancreas. - Blood cell counts and blood chemistries in or near normal range. - Able to perform the activities of daily living. - A projected life expectancy of at least 2 months. - If female, neither pregnant nor nursing. - Willing to use contraceptives to prevent pregnancy. - No other serious illnesses. - No other active malignancy. - No serious infections. - No current other drug therapy for the cancer or steroid therapy. - Prior radiation is permitted as is chemotherapy given during radiation or to prevent relapse after surgical removal of the disease. Exclusion Criteria: - Prior chemotherapy for metastatic disease. - Brain metastases | |
| 80 | NCT00473616 | terminated | termination of the study was made after a full review of program data and assessment of the current risk-benefit profile. | 0 | phase 1 | ['advanced solid tumors', 'cancer', 'advanced solid malignancies'] | ["['K74.02', 'G47.22', 'H35.3133', 'H35.3134', 'H35.3113', 'H35.3114', 'H35.3123']", "['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']"] | ['azd7762', 'irinotecan'] | ['[H][C@@]1(CCCNC1)NC(=O)C1=C(NC(O)=N)C=C(S1)C1=CC(F)=CC=C1', 'CC[C@@]1(O)C(=O)OCC2=C1C=C1N(CC3=CC4=CC=CC=C4N=C13)C2=O'] | Inclusion Criteria: - Advanced solid tumors for which standard treatment doesn't exist or is no longer effective. - Must be suitable for treatment with irinotecan - Relatively good overall health other than your cancer Exclusion Criteria: - Poor bone marrow function (not producing enough blood cells) - Serious heart conditions - Poor liver or kidney function - Any prior anthracycline treatment |
| 81 | NCT00163098 | completed | 0 | phase 1/phase 2 | ['pulmonary disease, chronic obstructive'] | ["['J44.9', 'J44.1', 'J44.0']"] | ['uk-369,003'] | ['CCOC1=NC=C(C=C1C1=NC2=C(CC)N(CCOC)N=C2C(=O)N1)S(=O)(=O)N1CCN(CC)CC1'] | Inclusion Criteria: - GOLD criteria 2 to 4 - 10 pack year history of smoking Exclusion Criteria: - Women of child bearing potential | |
| 82 | NCT01078961 | completed | 0 | phase 1 | ['melanoma'] | ["['C43.0', 'C43.31', 'D03.9', 'C43.51', 'C43.9', 'D03.0', 'C43.4']"] | ['bortezomib', 'sorafenib'] | ['ClCCN(CCCl)P1(=O)NCCCO1', '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: - Histological or cytological confirmation of malignant melanoma that is metastatic or unresectable - Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension as 10mm or greater with spiral CT scan - Patients may have received up to 4 prior treatments for their disease including immunotherapies such as high-dose interleukin 2 and antibodies directed against the human cytotoxic T-lymphocyte antigen 4 - 18 years of age or older - Life expectancy of greater than three months - ECOG Performance status of 0 or 1 - Adequate organ and marrow function as outlined in the protocol - Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment - INT < 1.5 or a PT/PTT within normal limits. Patients receiving anti-coagulation treatment wih an agent such as warfarin or heparin may be allowed to participate. For patients on warfarin, the INR should be measured prior to initiation of sorafenib and monitored at least weekly, or as defined by the local standard of care, until INR is stable - Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation. Exclusion Criteria: - Chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events dur to agents administered more than 4 weeks earlier - Participants may not be receiving any other study agents - Known, active CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any unstable or untreated brain metastasis, or history of stroke within the past 12 months - Prior therapy with bortezomib, sorafenib, or other proteasome inhibitor - History of allergic reactions attributed to compounds of similar chemical or biologic composition to sorafenib and bortezomib - Participants receiving any medications or substances that are inducers of CYP3A4 - Known cardiac disease including congestive heart failure > class II NHYA, unstable angina or new onset angina, myocardial infarction within the past 6 months, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities. Prior to study entry, any ECG abnormality at screening has to be documented by the investigator as not medically relevant - Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy - Uncontrolled intercurrent illness - Pregnant women - Individuals with a history of a different malignancy are ineligible except for the circumstances outlined in the protocol - HIV-positive individuals on combination antiretroviral therapy - Uncontrolled hypertension despite optimal medical management - Thrombolic or embolic events - Pulmonary hemorrhage/bleeding event CTCAE Grade 2 or greater within 4 weeks of first dose of study drug - Any other hemorrhage/bleeding event CTCAE Grade 3 or greater within 4 weeks of first dose of study drug - Serious non-healing wound, ulcer or bone fracture - Evidence or history of bleeding diathesis or coagulopathy - Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study drug - Any condition that impairs patient's ability to swallow whole pills - Any malabsorption problem - Known hypersensitivity to boron or mannitol - Grade 2 or greater peripheral neuropathy within 14 days before enrollment | |
| 83 | NCT00634660 | completed | 1 | phase 1 | ['phenylketonuria'] | ["['E70.0']"] | ['ravpal-peg'] | ['COCCOCCCCCC(=O)NCCCC[C@H](N)C(O)=O'] | Inclusion Criteria: - Diagnosis of PKU with both of the following: - Current blood Phe concentration of ≥600 µmol/L at Screening. - Average blood Phe concentration of ≥600 µmol/L over the past 3 years, using available data. - Willing and able to provide written, signed informed consent, or, in the case of participants under the age of 18, provide written assent (if required) and written informed consent by a parent or legal guardian, after the nature of the study has been explained, and prior to any research-related procedures. - Willing and able to comply with all study procedures. - Between the ages of 16 and 50 years, inclusive. - Females of childbearing potential must have a negative pregnancy test at Screening and be willing to have additional pregnancy tests during the study. Females considered not of childbearing potential include those who have been in menopause at least 2 years, or had tubal ligation at least 1 year prior to Screening, or who have had total hysterectomy. - Sexually active subjects must be willing to use an acceptable method of contraception while participating in the study. - Stable diet with no significant modifications during the 4 weeks preceding the administration of study drug. - In generally good health as evidenced by physical examination, clinical laboratory evaluations (hematology, chemistry, and urinalysis), and electrocardiogram (ECG) at Screening. Exclusion Criteria: - Use of any investigational product or investigational medical device within 30 days prior to Screening, or requirement for any investigational agent prior to completion of all scheduled study assessments. - Pregnant or breastfeeding at Screening or planning to become pregnant (self or partner) or to breastfeed at any time during the study. - Concurrent disease or condition that would interfere with study participation or safety (eg, history or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurological, oncologic, or psychiatric disease). - Any condition that, in the view of the Principal Investigator (PI), places the subject at high risk of poor treatment compliance or of not completing the study. - Known hypersensitivity to rAvPAL PEG or its excipients. - Alanine aminotransferase (ALT) concentration > 2 times the upper limit of normal. - Creatinine above the upper limit of normal. - Donation of blood or plasma within 30 days prior to the administration of study drug. - Use of any over-the-counter (OTC) medication, including vitamins, within 7 days prior to the administration of study drug, without evaluation and approval by the Investigator. - Use of any prescription medication within 14 days prior to the administration of study drug without evaluation and approval by the Investigator. - Treatment with any drug known to affect hepatic enzyme activity, including (but not limited to) barbiturates, phenothiazines, cimetidine, or carbamazepine, within 30 days prior to study drug administration. - Use of any tobacco products within 60 days prior to study drug administration. - Positive urine screen for use of nicotine (cotinine) or drugs of abuse (amphetamines, barbiturates, benzodiazepines, cocaine, cannabinoids, and opiates). - Positive test or has been treated for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV). | |
| 84 | NCT02211833 | completed | 1 | phase 1 | ['carcinoma, non-small-cell lung'] | ["['D02.20', 'D02.21', 'D02.22']"] | ['bi 2536', 'pemetrexed'] | ['[H][N]([H])([H])[Pt](Cl)(Cl)[N]([H])([H])[H]'] | Inclusion Criteria: 1. Pathologic or cytologic confirmed diagnosis of NSCLC 2. Recurrent, advanced or metastatic NSCLC that had progressed following 1 prior chemotherapy regimen for advanced disease. Patients could have received prior adjuvant chemotherapy as long as the disease free interval was longer than 1 year. 3. Measurable disease by 1 or more techniques (CT, MRI) according to RECIST criteria 4. Male or female aged 18 years or older 5. Life expectancy of at least 3 months 6. Eastern Cooperative Oncology Group (ECOG) performance score 0-2 7. Written informed consent that was consistent with International Conference on Harmonization (ICH) - Good Clinical Practice (GCP) guidelines Exclusion Criteria: 1. Treatment with an investigational drug in another clinical study within the 28 days prior to the start of therapy or concomitantly with this study 2. Anti-cancer therapy for NSCLC (except radiotherapy for palliative reasons) within the 28 days prior to Day 1 of treatment period 1 of this trial 3. Any persisting toxicities that were deemed to be clinically significant from the previous therapy 4. Received more than 1 prior chemotherapy regimen for advanced disease (not including prior adjuvant therapy). Patients could have received prior epidermal growth factor receptor tyrosine kinase inhibitors 5. Unwilling or unable to take folic acid and vitamin B12 supplementation 6. Active brain metastases (stable for <28 days, symptomatic, or requiring concurrent steroids). Patients who had received prior whole brain irradiation and whose brain metastases were stable according to the criteria above were not excluded 7. Other active malignancy diagnosed within the past 3 years (other than non-melanomatous skin cancer and cervical intraepithelial neoplasia) 8. Concomitant intercurrent illnesses including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness or social situation that would have limited compliance with trial requirement or which were considered relevant for the evaluation of the efficacy or safety of the trial drug 9. Unable or unwilling to interrupt concomitant administration of NSAIDS 5 days prior to the day of and up to 2 days after the administration of pemetrexed 10. Received prior therapy with pemetrexed 11. Absolute neutrophil count (ANC) ≤1 500/μL, platelet count ≤100 000/μL, or haemoglobin <9 mg/dL 12. Total bilirubin >1.5 mg/dL (26 μmol/L), alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≥2.5 x the upper limit of normal (ULN), except in cases of known liver metastasis where a maximum 5 x ULN was acceptable 13. Serum creatinine level >1.5 mg/dL and or creatinine clearance <45 mL/min 14. Sexually active and unwilling to use a medically acceptable method of contraception 15. Pregnancy or breast feeding 16. Known or suspected active alcohol or drug abuse 17. Unable to comply with the protocol 18. Any known hypersensitivity to the trial drugs or their excipients | |
| 85 | NCT02211872 | completed | 1 | phase 1 | ['neoplasms'] | ["['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']"] | ['bi 2536 bs, intravenous'] | ['CC[C@]1(O)C[C@@H]2CN(C1)CCC1=C(NC3=CC=CC=C13)[C@@](C2)(C(=O)OC)C1=C(OC)C=C2N(C=O)[C@@H]3[C@]4(CCN5CC=C[C@](CC)([C@@H]45)[C@@H](OC(C)=O)[C@]3(O)C(=O)OC)C2=C1'] | Inclusion Criteria: - Patients with confirmed diagnosis of advanced, non resectable and / or metastatic solid tumours, who had failed conventional treatment, or for whom no therapy of proven efficacy exists, or who were not amenable to established forms of treatment - Evaluable tumour deposits - Age of 18 years or older - Life expectancy of at least 6 months - Written informed consent consistent with international conference of harmonization (ICH) - good clinical practice (GCP) and local legislation - Eastern Cooperative Oncology Group (ECOG, R01-0787) performance score ≤ 2 - And full recovery from all therapy-related toxicities from previous chemo-, hormone-, immuno-, or radiotherapies Exclusion Criteria: - Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the trial protocol - Pregnancy or breastfeeding - Active infectious disease - Known brain metastases - Second malignancy requiring therapy - Absolute neutrophil count less than 1500/mm3 - Platelet count less than 100 000/mm3 - Bilirubin greater than 1.5 mg/dL (> 26 μmol/L, international system of units (SI) equivalent) - Aspartate amino transferase (AST) and / or alanine amino transferase (ALT) greater than 2.5 times the upper limit of normal (if related to liver metastases greater than five times the upper limit of normal) - Serum creatinine greater than 1.5 mg/dL (> 132 μmol/L, SI unit equivalent) - Sexually active women and men who are unwilling to use a medically acceptable method of contraception - Treatment with other investigational drugs or participation in another clinical trial within the past four weeks before start of therapy or concomitantly with this trial (except for present trial drug) - Chemo-, radio or immunotherapy within the past four weeks before start of therapy or concomitantly with this trial - Patients unable to comply with the trial protocol - Or active alcohol or drug abuse | |
| 86 | NCT00241358 | completed | 1 | phase 1/phase 2 | ['leukemia, myeloid, acute', 'leukemia, myelogenous, chronic', 'leukemia, lymphoblastic, acute', 'lymphocytic leukemia, chronic', 'myelodysplastic syndromes', 'multiple myeloma', 'lymphoma, non-hodgkin', 'hodgkin disease'] | ["['C92.A1', 'C92.A2', 'C92.61', 'C92.62', 'C92.A0', 'C92.60']", "['C91.01', 'C91.02', 'C91.00']", "['C91.11', 'C91.12', 'C91.10']", "['D46.9', 'D46.C', 'D46.Z']", "['C90.01', 'C90.02', 'C90.00']", "['S33.110S', 'S33.111S', 'S33.120S', 'S33.121S', 'S33.130S', 'S33.131S', 'S33.140S']", "['C81.77', 'C81.97', 'C81.17', 'C81.27', 'C81.37', 'C81.47', 'C81.70']"] | ['amd3100'] | ['C(N1CCCNCCNCCCNCC1)C1=CC=C(CN2CCCNCCNCCCNCC2)C=C1'] | Inclusion Criteria: Donor criteria: - Donor is 18 to 70 years of age inclusive - If female and of child-bearing age, must be: - non-pregnant, - not breast feeding and - using adequate contraception - Donor is a 6/6 HLA-matched sibling willing to donate peripheral blood stem cell for transplant - Donor must be willing to provide written informed consent. - Adequate cardiac function with no history of congestive heart failure and no history of atrial fibrillation or ventricular tachyarrhythmia. - Adequate renal function as defined by a serum creatinine clearance of ≥75% of normal (Cockcroft-Gault equation) - Adequate hepatic function as defined by a total bilirubin <2x normal or absence of hepatic fibrosis/cirrhosis - Adequate neurologic function as defined by: - No evidence of a severe central or peripheral neurologic abnormality. - No history of cerebrovascular accident or seizure disorder requiring anticonvulsant medication - Must be HIV-1 & 2 antibody, HIV-1 antigen, and HTLV-I & II antibody sero-negative, by FDA licensed test. - Must have an ECOG performance status of 0 or 1 - Must demonstrate ability to be compliant with study regimen. - Must not have an active infection at the time of study entry - Not have active alcohol or substance abuse within 6 months of study entry - Not currently enrolled in another investigational agent study - Not have any medical condition, which, in the opinion of the clinical investigator, would interfere with his/her evaluation Recipient criteria: - 18 to 65 years of age inclusive - Willing and has a 6/6 HLA-matched sibling willing to donate PBSC for transplant - Provide signed informed consent - If female and of child-bearing age, must be: - non-pregnant, - not breast feeding, and - using adequate contraception Patient must have one of the following diagnoses: - AML in 1st or subsequent remission or in relapse - ALL in 1st or subsequent remission or in relapse - MDS and intermediate 1 or 2, or high risk by the International Prognostic Scoring System - CML in accelerated or second chronic phase - NHL or HD in 2nd or greater complete remission, partial remission,or refractory relapse - CLL Rai Stage 2-4, failing at least 2 prior regimens - MM Stage 2-3 - Adequate cardiac function with a left ventricular ejection fraction ≥ 40% - Adequate pulmonary function defined as: - No severe or symptomatic restrictive or obstructive lung disease, and - formal pulmonary function testing showing an forced expiratory volume at 1 second (FEV1) ≥50% of predicted and a diffusion capacity of the lung for carbon monoxide (DLCO) ≥40% of predicted, corrected for hemoglobin - Adequate renal function as defined by a serum creatinine clearance of ≥75% of normal (Cockcroft-Gault equation) - Adequate hepatic function as defined by a total bilirubin <2x normal or absence of hepatic fibrosis/cirrhosis - Adequate neurologic function as defined by no evidence of a severe central or peripheral neurologic abnormality. Patients with a history of previous central nervous system tumor involvement are eligible provided they are without symptoms or signs and the CNS is now free of disease on lumbar puncture and CT scan of the brain - No evidence of active infection at the time of the transplant preparative regimen or at the time of transplantation - Patient must be HIV-1 & 2 antibody, HIV-1 antigen, and HTLV-I & II antibody sero-negative, by FDA licensed test - ECOG performance status of 0 or 1 - Must demonstrate ability to be compliant with medical regimen - Not have active alcohol or substance abuse within 6 months of study entry - Not be concurrently enrolled on another study involving an investigational agent - Not have any medical condition, which, in the opinion of the clinical investigator, would interfere with the evaluation of the patient | |
| 87 | NCT01820143 | completed | 1 | phase 1 | ['healthy', 'pharmacokinetics', 'pharmacodynamics', 'ilaprazole'] | ["['Z76.3', 'Z76.2']"] | ['ilaprazole', 'esomeprazole'] | ['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: - Prior to any study-specific procedures being performed, the subject voluntarily signed the approved informed consent/PIPEDA authorization form after having it fully explained and all questions answered. - The subject was between 18 and 55 years, inclusive, and was generally in good health. - Pregnancy test results for all females were negative in order to enter and remain in the study. A serum pregnancy test was performed on all females at Screening, Day -1 of each period, and Day 6 of Period 4 only, or if a subject prematurely discontinued. Results must have been negative in order for study drug to be administered. - Female subject was using, and agreed to continue the use of, a double-barrier method of birth control. Oral, patch, implants, or injectable contraceptives were accepted as 1 method if the subject had been taking them for greater than 2 months at the Screening Visit. Subjects who had a bilateral tubal ligation, hysterectomy, or bilateral oophorectomy for a minimum of 6 months, or surgical sterilization of partner (vasectomy for 6 months minimum), or were postmenopausal (defined as the absence of menses for 2 years or the absence of menses for 12 months and follicle-stimulating hormone [FSH] level of >40 IU/L) did not require the use of birth control. - Subject had a negative breath test result for H pylori prior to enrollment. - At the Screening Visit, subject had a body mass index (BMI) within the range of 18 to 30 kg/m2, as determined by the following calculation. - Subject was in general good health as evidenced by a medical history, a complete physical examination, and ECG without clinically significant abnormalities. Exclusion Criteria: - Subject had current evidence of cardiovascular, central nervous system, hepatic, hematopoietic, renal, or metabolic dysfunction; serious allergy, asthma, history of significant sensitivity to any drug; or lactose intolerance that would contraindicate taking ilaprazole or esomeprazole or would interfere with the conduct of the study. | |
| 88 | NCT00984438 | withdrawn | no accrual | 0 | phase 1/phase 2 | ['glioblastoma multiforme'] | ["['L51.0', 'L51.8', 'L51.9']"] | ['bcnu wafer', 'irinotecan', 'bevacizumab'] | ['ClCCNC(=O)N(CCCl)N=O', 'CC[C@@]1(O)C(=O)OCC2=C1C=C1N(CC3=CC4=CC=CC=C4N=C13)C2=O', '[H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1'] | Inclusion Criteria: - Histopathologically proven diagnosis of GBM in the past with MRI findings compatible with disease recurrence. Multifocal disease is permitted. - Must have had prior treatment with standard doses of Temodar - KPS >50; ECOG <3 - Predicted life expectancy of > 3 months - Study entry must be within 5 weeks of surgical resection Exclusion Criteria: - Prior exposure to VEGF inhibitors or Irinotecan - Intracranial bleed as defined by CT or MRI less than 6 months prior to entry - GI bleed less than 6 months prior to entry - Uncontrolled concurrent illness that would limit compliance with study requirements |
| 89 | NCT00379574 | completed | 1 | phase 1/phase 2 | ['lymphoma, large-cell, diffuse', 'lymphoma, b-cell'] | ["['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']"] | ['bortezomib', 'cyclophosphamide', 'doxorubicin', 'vincristine', 'prednisolone', 'lenograstim'] | ['ClCCN(CCCl)P1(=O)NCCCO1', 'ClCCN(CCCl)P1(=O)NCCCO1', 'COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O', 'CC[C@]1(O)C[C@@H]2CN(C1)CCC1=C(NC3=CC=CC=C13)[C@@](C2)(C(=O)OC)C1=C(OC)C=C2N(C=O)[C@@H]3[C@]4(CCN5CC=C[C@](CC)([C@@H]45)[C@@H](OC(C)=O)[C@]3(O)C(=O)OC)C2=C1', '[H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)C=C[C@]12C'] | Inclusion Criteria: - Histologically confirmed DLBCL - Age 70 years or less - Previously untreated - Performance status: ECOG 0-2 - Advanced stage: stage III, IV, or non-contiguous stage II - Measurable disease: 1 cm or more by spiral CT - Normal liver function Exclusion Criteria: - Platelet count less than 75,000/microL within 14 days before enrollment. - Absolute neutrophil count of less than 1,500/microlL within 14 days before enrollment. - Cr more than 2.0 mg/dL and/or calculated or measured creatinine clearance less than 50 mL/min within 14 days before enrollment. - Peripheral neuropathy of Grade 2 or worse within 14 days before enrollment. - Hypersensitivity to bortezomib, boron or mannitol. - Female subject is pregnant or breast-feeding. - Other investigational drugs with 14 days before enrollment - Serious medical or psychiatric illness likely to interfere with participation in this clinical study. - Uncontrolled or severe cardiovascular disease, including MI within 6 months of enrolment, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis | |
| 90 | NCT01335204 | terminated | lack of funding | 0 | phase 1/phase 2 | ['prostate cancer', 'prostatic neoplasms'] | ["['C61', 'D29.1', 'D40.0', 'Z15.03', 'Z80.42', 'Z85.46', 'Z12.5']", "['B38.81', 'N42.31', 'Z87.430', 'N40.0', 'N40.1']"] | ['cabazitaxel plus bavituximab'] | ['[H][C@]12[C@H](OC(=O)C3=CC=CC=C3)[C@]3(O)C[C@H](OC(=O)[C@H](O)[C@@H](NC(=O)OC(C)(C)C)C4=CC=CC=C4)C(C)=C([C@@H](OC)C(=O)[C@]1(C)[C@H](C[C@H]1OC[C@@]21OC(C)=O)OC)C3(C)C'] | Inclusion Criteria: - Written informed consent has been obtained. - Adults 18 years of age or older with a life expectancy of at least 3 months. - Histologically confirmed castration-resistant prostate cancer (CRPC). Patient must have demonstrated a rising PSA level above the androgen-deprivation therapy (ADT) nadir, on at least two determinations four weeks or more apart. ADT is defined as treatment with a Luteinizing-hormone-releasing hormone (LHRH) agonist or orchiectomy. - Treatment with only one prior chemotherapy regimen, which must contain docetaxel as a single agent or in combination with other agents. Patients may be intolerant of, or resistant to, the cytotoxic drug combination. - Patients on ADT must be willing to continue ADT for the duration of their participation in this protocol. ADT cannot be initiated, and ADT dose/agents may not be changed during the study. - Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. - Adequate hematologic function (absolute neutrophil count [ANC] ≥ 1,500 cells/μL; hemoglobin ≥ 8 g/dL, platelets ≥ 100,000/μL). - Adequate renal function (serum creatinine ≤ 1.5 mg/dL or calculated creatinine clearance ≥ 60 mL/min). - Adequate hepatic function (bilirubin ≤ 1.0 x upper limit of normal [ULN], alanine aminotransferase [ALT] ≤ 1.5 x ULN, aspartate aminotransferase [AST] ≤ 1.5 x ULN). - Prothrombin time (PT) / international normalized ratio (INR) ≤ 1.5 × ULN. - Activated partial thromboplastin (aPTT) time ≤ 1.5 × ULN. - Prostate-specific antigen (PSA) level of at least 2 ng/mL. - New York Heart Association classification I or II. - All patients of reproductive potential must agree to use an approved form of contraception (as determined by the investigator). Exclusion Criteria: - Known history of bleeding diathesis or coagulopathy (e.g., von Willebrand disease or hemophilia). - Any history of thromboembolic events (e.g., deep vein thrombosis or pulmonary thromboembolism); central venous catheter-related thrombosis > 6 months before Screening is allowed. - Ongoing therapy with oral or parenteral anticoagulants; patients on low-dose anticoagulants to maintain patency of central venous catheters are eligible. - Grade 2 or higher peripheral neuropathy (e.g., numbness, tingling, and/or pain in distal extremities). - Radiotherapy (teletherapy or brachytherapy) , chemotherapy or estrogen agonist within 28 days before Study Day 1. - Systemic radiotherapy (Sm-153, Sr-89) within 56 days before study day 1. - Symptomatic or clinically active brain metastases. - Major surgery within 28 days of Study Day 1. - Uncontrolled intercurrent disease (eg, diabetes, hypertension, thyroid disease). - Any history of cerebrovascular accident, or transient ischemic attack at any time, or history of symptomatic coronary artery disease < 6 months before screening. - A history of any condition requiring anti-platelet therapy (eg, phosphodiesterase inhibitors, adenosine diphosphate receptor antagonists), with the exception of general cardiovascular prophylaxis with aspirin (≤ 325 mg/day). - Serious non-healing wound (including wound healing by secondary intention, ulcer, or bone fracture). - Known chronic infection with human immunodeficiency virus (HIV) or viral hepatitis. - Contraindication to intravenous (IV) contrast media. |
| 91 | NCT02273388 | active, not recruiting | 1 | phase 1 | ['neoplasms'] | ["['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']"] | ['bi 6727'] | ['[H][C@@]1(CC[C@@]([H])(CC1)N1CCN(CC2CC2)CC1)N=C(O)C1=CC(OC)=C(NC2=NC=C3N(C)C(=O)[C@@]([H])(CC)N(C(C)C)C3=N2)C=C1'] | Inclusion criteria: 1. Patients with confirmed diagnosis of advanced, non resectable and / or metastatic solid tumours, who have failed conventional treatment, or for whom no therapy of proven efficacy exists, or who are not amenable to established forms of treatment 2. Age 18 years or older 3. Written informed consent consistent with ICH-GCP and local legislation 4. Eastern Cooperative Oncology Group (ECOG, R01-0787) performance score ¿ 2 5. Recovery from CTCAE Grade 2 - 4 therapy-related toxicities from previous chemo-, hormone-, immuno-, or radiotherapies (except alopecia) The 18 additional patients recruited at the MTD must also meet the following criterion: 6. Measurable tumour deposits (RECIST) by one or more techniques (CT, MRI) Exclusion criteria: 1. Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol 2. Pregnancy or breastfeeding 3. Active infectious disease or known chronic Hepatitis B/Hepatitis C infection 4. Clinical evidence of active brain or leptomeningeal disease during the past 12 months 5. Second malignancy currently requiring active therapy 6. Absolute neutrophil count less than 1500 / mm3 7. Platelet count less than 100 000 / mm3 8. Bilirubin greater than 1.5 mg / dl (> 26 ¿mol / L, SI unit equivalent) 9. Aspartate amino transferase (AST) and / or alanine amino transferase (ALT) greater than 2.5 times the upper limit of normal (if related to liver metastases greater than five times the upper limit of normal) 10. Serum creatinine greater than 1.5 mg / dl (> 132 ¿mol / L, SI unit equivalent) 11. Known history of relevant QT-prolongation, e.g. long QT-syndrome 12. Women and men who are sexually active and unwilling to use a medically acceptable method of contraception 13. Treatment with other investigational drugs or participation in another clinical trial within the past four weeks before start of therapy or concomitantly with this trial (except for present trial drug) 14. Chemo-, radio or immunotherapy within the past four weeks before start of therapy or concomitantly with this trial. This restriction does not apply to steroids and bisphosphonates. 15. Patients unable to comply with the protocol 16. Active alcohol or drug abuse | |
| 92 | NCT00836628 | withdrawn | slow accrual | 0 | phase 1 | ['refractory brain tumors'] | ["['D46.4', 'D46.1', 'D46.A', 'D46.0', 'D46.20', 'D46.21', 'D46.22']"] | ['busulfan'] | ['CS(=O)(=O)OCCCCOS(C)(=O)=O'] | Inclusion Criteria: Age: Age >2 year and ≤ 21 years Histologic Diagnosis Any histological proven (confirmed by institutional pathology report; pathology slides from outside referring outside institutions are not required.) recurrent or progressive CNS tumor. (optic pathway and brainstem gliomas allowed without histologic verification, but must have diagnostic imaging). Life Expectancy Patients must have a life expectancy of ≥ 2 months. Prior Therapy There is no limit to the number of prior therapies a patient has received - Must be ≥ 3 weeks from myelosuppressive chemotherapy (6 weeks from nitrosoureas) and have demonstrated recovery (ANC ≥ 1000/uL) from their last course of chemotherapy - ≥ 6 months following allogeneic stem cell transplantation - ≥ 3 months following autologous stem cell transplantation - ≥ 3 months from craniospinal radiation - ≥ 4 weeks from focal radiation - ≥ 7 days from any past biologic/immunotherapy - ≥ 1 week from any hematopoietic growth factors Concomitant Medication - Patients taking Itraconazole or Phenytoin will be excluded. Patients must be off of these medications for at least 3 days prior to entering this trial. If the patient is taking phenytoin for seizures at the time of study enrollment, it must be stopped at least 3 days prior to starting therapy and Clonazepam will be substituted during the Busulfex ® infusions and for 24 hours following the infusion. - Patients on growth stimulating factors, such as GCSF, will be allowed to continue these medications only as indicated in the study. - Patients may be taking steroids while participating in this trial, but should be on a stable dose for >1 week prior to enrollment. - Medications interacting with the CYP3A4 substrate should also be avoided while the patient is on study. - Patients should also be on Pneumocystis prophylaxis while participating in this study. Pentamidine will be required, with a recommended dose of 4 mg/kg given intravenously every month. Pentamidine should continue throughout the duration of the trial. Organ Function Requirements Adequate Bone Marrow Function Defined As - Peripheral absolute neutrophil count (ANC) greater than or equal to 1000/ul (off growth factors x 48 hrs) - Platelet count greater than or equal to 100,000/uL (transfusion independent) - Hemoglobin greater than or equal to 8.0 gm/dL (may receive RBC transfusions) Adequate Renal Function Defined As - Serum creatinine less than or equal to 1.5 x upper limit of normal, or - Estimated creatinine clearance GFR greater than or equal to 70 ml/min/1.73 m² by the Schwartz formula Adequate Liver Function Defined As - Total bilirubin within normal range - SGPT (ALT) within normal range Adequate Pulmonary Function Defined As - Oxygen saturation >92% on room air Central Nervous System Function Defined As - Patients with seizure disorder may be enrolled; Patients MUST be on an anti-seizure medication upon enrollment, but this medication CANNOT be phenytoin or carbamezepine. - Patients must not be in status, coma or assisted ventilation prior to study enrollment. - Stable neurologic exam of at least 1 week duration Performance Level Karnofsky/ Lansky 50 or greater Exclusion Criteria: - Pregnancy/Contraception: patients who are pregnant or breast-feeding will not be eligible. - Patients of childbearing potential must practice an effective method of birth control while participating on the study. - Females > 13 years of age or those who have achieved menarche must have a negative pregnancy test prior to study entry. |
| 93 | NCT00379639 | completed | 1 | phase 1 | ['pancreatic cancer'] | ["['C25.3']"] | ['romidepsin', 'gemcitabine'] | ['C\\C=C1/NC(=O)[C@H]2CSSCC\\C=C\\[C@H](CC(=O)N[C@H](C(C)C)C(=O)N2)OC(=O)[C@@H](NC1=O)C(C)C', '[H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1'] | Inclusion Criteria: - histologically confirmed advanced solid tumors - measurable or evaluable disease - written informed consent - Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 Exclusion Criteria: - Prior treatment with romidepsin or gemcitabine - Prior chemotherapy treatment within 3 weeks prior to the first day of treatment or prior treatment with an investigational agent within 4 weeks prior to the first day of treatment. Patients must have recovered from all therapy-related toxicities (Common Terminology Criteria grade ≤ 1) - Prior radiotherapy within 4 weeks prior to the first day of treatment. Patients who have not fully recovered or whose acute toxicity related to prior radiotherapy has not returned to baseline are ineligible. - Prior surgery within 3 weeks prior to the first day of treatment, excluding surgical biopsies and port placements - Concomitant use of any other anti-cancer therapy - Concomitant use of any investigational agent - Use of any investigational agent within 4 weeks of study entry - Any known cardiac abnormalities, including congenital long QT syndrome, QTcF interval >480 milliseconds, myocardial infarction within 12 months of study entry, coronary artery disease (CAD), congestive heart failure (CHF), evidence of cardiac ischemia at screening, known history of sustained ventricular tachycardia (VT), ventricular fibrillation (VF), Torsade de Pointes, or cardiac arrest, hypertrophic cardiomegaly or restrictive cardiomyopathy chronic hypertension, any cardiac arrhythmia requiring anti-arrhythmic medication - Serum potassium <3.8 mmol/L or serum magnesium <2.0 mg/dL (electrolyte abnormalities can be corrected with supplementation to meet inclusion criteria) - Concomitant use of drugs that may cause a prolongation of the QTc - Concomitant use of CYP3A4 inhibitors - Clinically significant active infection - Known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C - Inadequate bone marrow or other organ function as evidenced by: - Hemoglobin <9 g/dL (Transfusions and/or erythropoietin are permitted.) - Absolute neutrophil count (ANC) ≤1.5 x 10^9 cells/L - Platelet count <100 x 10^9 cells/L or platelet count <75 x 10^9 cells/L if bone marrow disease involvement is documented - Total bilirubin >2.0 x upper limit of normal (ULN) - Aspartate transaminase/serum glutamic oxaloacetic transaminase (AST/SGOT) and alanine transaminase/serum glutamic pyruvic transaminase (ALT/SGPT) >2.0 x ULN or >3.0 x ULN in the presence of demonstrable liver metastases - Serum creatinine >2.0 x ULN - Patients who are pregnant or breast-feeding - Any significant medical or psychiatric condition that might prevent the patient from complying with all study procedures | |
| 94 | NCT01031108 | completed | 1 | phase 1 | ['diabetes mellitus, type 2'] | ["['E11.65', 'E11.9', 'E11.21', 'E11.36', 'E11.41', 'E11.42', 'E11.44']"] | ['placebo', 'srt2104'] | ['CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O', 'CC1=C(SC(=N1)C1=CC=CN=C1)C(=O)NC1=CC=CC=C1C1=CN2C(CN3CCOCC3)=CSC2=N1'] | Inclusion Criteria: - Ambulatory male and female subjects (of any race) either with type 2 diabetes or otherwise healthy cigarette smokers (≥ 10 cigarettes/day for at least 1 year) within the age range of 18-70 years (inclusive) at the time of Screening. - If a subject is diabetic, HbA1c at Screening is < 9.0% - If a subject is diabetic, fasting plasma glucose (FPG) ≤ 13.875 mmol/L (≤ 250 mg/dL). - If a subject is diabetic, an official diagnosis of type 2 diabetes must be documented for at least 6 months prior to first dose of test article. - If a subject is diabetic, subject must be on an existing, stable, hypoglycemic therapy or a stable dietary regimen to control their disease for at least 3 months prior to Screening. Note: If a subject is a diabetic and a smoker, then they are not eligible for the trial. A minimum 5 year non-smoking history is required for all type 2 diabetic subjects to be enrolled into the study. - Female subjects of child-bearing potential, willing to use reliable contraception (see Section 5.10) for the duration of the study, through to the 30 day safety follow up visit (a female of child-bearing potential is defined as any female, regardless of her age with functioning ovaries and no documented impairment of oviductal or uterine function that would cause sterility. Females with oligomenorrhea or who are perimenopausal, and young females who have begun to menstruate are considered to be of child-bearing potential) - All male subjects must agree with their partners to use double-barrier birth control or abstinence while participating in the study and for 12 weeks following the last dose of study drug. - Willingness to provide written informed consent to participate in the study. - Subject may be on concomitant treatments for other conditions, provided the medical condition necessitating the treatment and therapy is stable for at least 3 months prior to screening and the treatment is not counterindicated by the study protocol. - Subject is not currently on a therapeutic regimen of ACE inhibitors, anti-coagulants, anti-platelets, or any other medications or treatments which may influence coagulation (with the exception of 81 mg or less of aspirin/acetylsalicylic acid daily). - Body Mass Index (BMI) of 18.5-38 kg/m^2 (inclusive). - Resting supine blood pressure (BP) <160/90 mmHg. - Absence of significant disease (other than type 2 diabetes) or clinically significant abnormal laboratory values on the laboratory evaluations, medical history, or physical examination during screening; normal end organ function at the discretion of the principal investigator. - Negative test result at screening for HIV 1 and 2. - Negative test result at screening for hepatitis B & C virus. - Have a normal 12-lead electrocardiogram (ECG) or one with changes considered to be clinically insignificant on medical review. QTcB must be < 450 msec for males and females. QTcB must be <480 msec in subjects with Bundle Branch Block. - Comprehension of the nature and purpose of the study and compliance with the requirements of the entire protocol. - Able to communicate in person and by telephone in a manner that allows all protocol procedures to be carried out safety and reliably in the opinion of the investigative site staff. Exclusion Criteria: - If diabetic, any major illness in the past 3 months or any significant ongoing chronic medical illness not related to diabetes which in the opinion of the principal investigator or medical monitor could risk subject safety or interpretation of the results. - If an otherwise healthy cigarette smoker, any major illness or injury in the past 3 months or any significant ongoing chronic medical illness (including diabetes) which in the opinion of the principal investigator or medical monitor could risk subject safety or interpretation of the results. - Renal or liver impairment, defined as alkaline phosphatase and/or bilirubin ≥ 1.5 x ULN (an isolated bilirubin >1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin is <35%), serum creatinine level of ≥ 123.76 µmol/L (≥ 1.4 mg/dL ) in females and ≥ 132.60 µmol/L (≥ 1.5 mg/dL ) in males, and > 2 × ULN for liver transaminases (ALT and AST), respectively. - History of or current gastrointestinal diseases or surgeries influencing drug absorption, except for appendectomy. - History, within 3 years, of drug abuse (including benzodiazepines, opioids, amphetamine, cocaine, and THC). - History of alcoholism (more than 2 years), moderate drinkers (more than three drinks per day) or having consumed alcohol within 48 hours prior to first dose of test article (one drink is equal to one unit of alcohol [one glass wine, half pint beer, one measure of spirit]). - Participation in any clinical trial within the past 3 months prior to the first dose of test article in the current study. - History of difficulty in donating blood or accessibility of veins in left or right arm. - Donation of blood or loss of blood (greater than 500 mL) within 3 months prior to receiving the first dose of test material. - Use of any dietary or herbal supplements within 2 weeks prior the first dose of study drug, with the exception of an Investigator approved vitamin. - History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates their participation. - Active neoplastic disease or history of neoplastic disease within 5 years of study entry (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ). - A positive pre-study drug screen. | |
| 95 | NCT00486265 | terminated | aml assess. of response in part b patients find treatment failure in all 8 evaluable for marrow response following a maximum of 2 induction courses of therapy | 0 | phase 1 | ['acute myelogenous leukemia'] | ["['C95.91', 'C95.92', 'Z80.6', 'Z85.6', 'C90.11', 'C90.12', 'C91.01']"] | ['azd4877'] | ['CC(C)C(N(CCCN)C(=O)C1=CC=C(C)C=C1)C1=NC2=C(C(C)=NS2)C(=O)N1CC1=CC=CC=C1'] | Inclusion Criteria: - Part A: Relapsed or refractory leukemia for which no standard therapies are anticipated to result in a durable remission - Part B: AML who have had no more than two prior relapses or failed to achieve remission after at least one induction treatment. - Patients with prior allogeneic transplants who remain clinically stable for ≥2 weeks or more off immunosuppressive therapy Exclusion Criteria: - Promyelocytic acute myelogenous leukemia - Prior allogeneic transplant requiring immunosuppressive therapy or treating physician does not consider patient to be a candidate for allogeneic transplantation. - Liver injury |
| 96 | NCT00183248 | completed | 0 | phase 1/phase 2 | ['kidney transplantation', 'kidney disease', 'kidney failure'] | ["['N26.2', 'Q63.0', 'Q63.2', 'Z52.4', 'I75.81', 'N19', 'N20.0']", "['I12.9', 'N18.9', 'Q61.9', 'I12.0', 'D63.1', 'N18.1', 'N18.5']", "['N19', 'T86.12', 'N17.8', 'N17.9', 'O90.4', 'N99.0', 'N17.0']"] | ['alemtuzumab', 'mycophenolate mofetil', 'sirolimus', 'tacrolimus'] | ['N[C@@H](CCCNC(N)=N)C(O)=O', 'N[C@@H](CCCNC(N)=N)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'] | Inclusion Criteria: - Weight greater than 40 kg (88.2 lbs) - Will be receiving a living-related (1-haplotype-matched donor/recipient) primary kidney allograft - Negative B-cell and T-cell cytotoxic and flow cytometry crossmatch (1-haplotype-matched donor/recipient pairs with a minimum of 1 HLA DR 1A and 1B locus in common and panel-reactive antibodies [PRA] of less than 10%) - Normal echocardiogram (ECG) with an ejection fraction of greater than 50% - Received full course of vaccination for hepatitis B virus (HBV), completed at least 6 weeks before transplantation, OR has naturally acquired immunity - Willing to comply with the study visits - Willing to use acceptable forms of contraception Exclusion Criteria: - Previously received or is receiving an organ transplant other than a kidney - Receiving an ABO (blood type) incompatible donor kidney - Human Immunodeficiency Virus (HIV) infected - Antibody positive for hepatitis C virus (HCV) - Surface antigen positive for hepatitis B virus (HBV) - Recipient or donor is positive for tuberculosis (TB), under treatment for suspected TB, or previously exposed to TB (positive Mantoux test) - Current cancer or a history of cancer within the 5 years prior to study entry. Patients who have had successfully treated nonmetastatic basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix are not excluded. - Significant liver disease, defined as having continuously elevated aspartate aminotransferase (AST SGOT) or alanine aminotransferase (ALT SGPT) levels greater than 3 times the upper value of the normal range within 28 days prior to study entry - Uncontrolled concomitant infections, severe diarrhea, vomiting, active upper gastrointestinal tract malabsorption, active peptic ulcer, or any other unstable medical condition that could interfere with this study - Currently receiving an investigational drug or received an investigational drug within 30 days prior to transplant - Currently receiving any immunosuppressive agent - Anticipated contraindication to taking medications orally or via nasogastric tube by the morning of Day 2 following completion of the transplant procedure - Require certain medications - Known hypersensitivity to any of the study medications, thymoglobulin daclizumab, or corticosteroids - Certain screening laboratory values. More information on this criterion can be found in the protocol. - Any form of substance abuse, psychiatric disorder, or other condition that, in opinion of the investigator, may interfere with the study - Anticipated contraindication to tacrolimus administration for longer than 5 days post-transplant - Currently undergoing peritoneal dialysis - PRA value less than 10% at any time prior to study entry - Graves disease. Patients with Graves disease adequately treated with radioiodine ablative therapy are not excluded. - Cytomegalovirus (CMV) or Epstein-Barr virus (EBV) negative kidney recipient receiving a kidney from a CMV or EBV positive donor - Pregnancy or breastfeeding | |
| 97 | NCT01191216 | completed | 0 | phase 1 | ['unspecified adult solid tumor, protocol specific'] | ["['H01.009', 'H02.209', 'H02.009', 'H02.109', 'H04.209', 'H05.409', 'H10.509']"] | ['1-methyl-d-tryptophan', 'docetaxel'] | ['CN1C=C(C[C@@H](N)C(O)=O)C2=CC=CC=C12', '[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 or cytologically confirmed metastatic solid malignancy - Preference will be given to patients whose malignancies are treated with docetaxel as part of routine therapy - Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan - Patients with known brain metastases will only be eligible after their tumors have been treated with definitive resection and/or radiotherapy and they are neurologically stable for at least 1 month off steroids - ECOG performance status ≤ 2 (Karnofsky ≥ 60%) - Life expectancy of greater than 4 months - Leukocytes ≥ 3,000/μL - Absolute neutrophil count ≥ 1,500/μL - Platelets ≥ 100,000/μL - Total bilirubin normal - AST/ALT ≤ 1.5 times upper limit of normal - Creatinine normal OR creatinine clearance ≥ 60 mL/min - Negative pregnancy test - Not pregnant or nursing - Sexually active women of child-bearing potential must agree to use two forms of contraception (hormonal and barrier method of birth control or abstinence) prior to study entry, for the duration of study participation, and for a minimum of 1 month after completion of the study; men should be discouraged from fathering children while on treatment - No history of gastrointestinal disease causing malabsorption or obstruction such as, but not limited to, Crohn's disease, celiac sprue, tropical sprue, bacterial overgrowth/blind loop syndrome, gastric bypass surgery, strictures, adhesions, achalasia, bowel obstruction, or extensive small bowel resection - No patients with any active autoimmune disease (i.e., psoriasis, extensive atopic dermatitis, asthma, IBD, M.S., uveitis, vasculitis), chronic inflammatory condition, or any condition requiring concurrent use of any systemic immunosuppressants or steroids for any reason - Mild-intermittent asthma requiring ONLY occasional beta-agonist inhaler use or mild localized eczema allowed - No uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction or percutaneous coronary interventions within the last 6 months, cardiac arrhythmia, active autoimmune diseases, or major psychiatric illness/social situations that would limit compliance with study requirements as judged by the primary investigator at each site - Patients with well-controlled, chronic medical conditions under the supervision of the patient's primary physician (i.e., hypertension, hyperlipidemia, coronary heart disease, diabetes mellitus) are eligible - No HIV-positive patients or those with other acquired/inherited immunodeficiencies - No patients with more than one active malignancy at the time of enrollment - No history of allergic reactions (significant urticaria, angioedema, anaphylaxis) attributed to compounds of similar chemical or biologic composition to 1-methyl-d-tryptophan (this wouldi nclude L-tryptophan or 5-hydroxy-tryptophan supplements) or history of severe hypersensitivity reactions to docetaxel or to other drugs formulated with polysorbate 80 - No patients with an allo-transplant of any kind (this would include those with a xenograft heart valve) - No prior treatment with experimental systemic immunotherapies such as CTLA-4 mAb (with the exception of vaccines) - No patients who have received any prior experimental active immunotherapy consisting of targeted monoclonal antibodies or pharmaceutical compounds - Patients who have received prior experimental vaccine may be enrolled if approved by the PI - Patients who have received commercially available active immunotherapies such as adjuvant interferon must have completed therapy over 1 year prior to enrollment and have no evidence of autoimmune sequelae - Prior therapy with approved monoclonal antibodies such as bevacizumab, cetuximab, panitumumab, or trastuzumab allowed - No patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier - Patients may not have received docetaxel in the metastatic setting previously, but are eligible for the trial if they received docetaxel in the adjuvant setting and at least one year elapsed between completion of adjuvant chemotherapy and disease recurrence - Patients may have received any number of prior chemotherapy treatments - Patients may not be concomitantly receiving any other investigational agents or standard therapies with the intent of treating their malignancy while on study - No supplements containing L-tryptophan or derivatives there of are allowed to be taken while on study | |
| 98 | NCT00867126 | terminated | low accrual | 0 | early phase 1 | ['pancreatic cancer'] | ["['C25.3']"] | ['pioglitazone hydrochloride'] | ['CCC1=CN=C(CCOC2=CC=C(CC3SC(=O)NC3=O)C=C2)C=C1'] | DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed adenocarcinoma of the pancreas - Metastatic disease - Previously treated disease - Disease progression after first-line gemcitabine hydrochloride-based chemotherapy - Radiologically measurable disease PATIENT CHARACTERISTICS: - ECOG performance status 0-2 - ANC ≥ 1,500/mm^3 - Platelet count ≥ 100,000/mm^3 - Hemoglobin ≥ 9 g/dL - Serum creatinine < 1.5 times upper limit of normal (ULN) OR creatinine clearance > 45 mL/min - Total bilirubin ≤ 1.5 times ULN - AST and ALT ≤ 2.5 times ULN (5 times ULN if liver metastases are present) - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 3 months after completion of study treatment - No NYHA class III-IV congestive heart failure - No unstable angina - No second malignancy except for localized nonmelanoma skin cancer - No psychiatric or addictive disorders that would preclude giving informed consent PRIOR CONCURRENT THERAPY: - Prior systemic therapy with fluorouracil, capecitabine, oxaliplatin, or erlotinib hydrochloride allowed - More than 12 months since prior and no other concurrent thiazolinediones - More than 6 months since prior treatment with immunosuppressive or immunomodulatory agents - No other concurrent anticancer therapy |
| 99 | NCT01756404 | completed | 1 | phase 1 | ['healthy'] | ["['Z76.3', 'Z76.2']"] | ['canagliflozin (jnj-28431754)', 'placebo'] | ['[H][C@]1(O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O)C1=CC=C(C)C(CC2=CC=C(S2)C2=CC=C(F)C=C2)=C1', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Volunteers must have a body mass index (BMI = weight in kg/height in m2) of 30.0 to 39.9 kg/m2 - Volunteers must be non-diabetic as confirmed by fasting plasma glucose <126 mg/dL - Volunteers must be non-smoker or non-tobacco users (not smoked cigarettes or used tobacco-containing products for 3 months prior to screening) Exclusion Criteria: - History of or currently active illness considered to be clinically significant by the Investigator or any other illness that the Investigator considers should exclude the patient from the study or that could interfere with the interpretation of the study results - History of having taken anti-obesity medications (prescription or non-prescription) within 3 months of the screening visit, or anticipates a need to take any of these drugs during the course of the study - History of gastric banding, gastric bypass or other gastric-reduction surgery - History of eating disorder or recent significant changes in body weight due to dieting or nutritional treatment | |
| 100 | NCT01561430 | terminated | study terminated due to abnormal liver biochemical tests in some participants. | 0 | phase 1/phase 2 | ["alzheimer's disease"] | ["['G30.8', 'G30.9', 'G30.0', 'G30.1']"] | ['ly2886721', 'placebo'] | ['NC1=N[C@]2(COC[C@H]2CS1)C1=C(F)C=CC(NC(=O)C2=CC=C(F)C=N2)=C1', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: Meets criteria for MCI due to AD or Mild AD All participants will be required to undergo assessment via the Mini Mental State Examination (MMSE) scale at screening - Participants with MMSE scores of 20 to 26, inclusive, may be enrolled provided they meet the criteria for mild AD, as follows: - Participant meets the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable AD - Clinical Dementia Rating Scale (CDR) score of 0.5 or 1 - Positive scan for the presence of amyloid beta - Participants with MMSE of 27 to 30, inclusive, may be enrolled as participants with MCI due to AD provided they meet the following criteria: - Gradual and progressive change in memory function as reported by the participant or a caregiver during a period of more than 6 months - Free and Cued Selective Reminding Test with Immediate Recall (FCSRT-IR): free recall ≤22 and total recall ≤46 - Absence of dementia - Preservation of functional independence - Exclusion of other potential (vascular, traumatic, or medical) causes of cognitive decline, where possible - Positive scan for the presence of amyloid beta - Women must be postmenopausal - Men are required to use an approved barrier method of contraception if their partners are pregnant, or of childbearing potential and not using approved contraceptive methods Exclusion Criteria: - Participant in another drug or device study - Have a history of frontotemporal dementia, Lewy body disease, vascular dementia, Huntington's disease, Parkinson's disease, progressive supranuclear palsy (PSNP), or other movement disorder - Participants are not on a stable standard of care (acetylcholinesterase inhibitors, memantine) initiated less than 2 months prior to entry or have less than 4 weeks of stable therapy. Note: Stable standard of care is allowed. - Have had a serious infectious disease affecting the brain in the past 5 years - Have had a serious or repeat head injury - Have significant retinal impairment or disease - Have had a stroke or other circulation problems that are affecting current health - Have had a seizure - Have major depressive disorder and are not on a stable dose of medication. Participants who no longer meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (DSM-IV) criteria for major depression may be included - History of schizophrenia, bipolar disorder, or severe mental illness - History of alcohol or drug abuse - Have asthma, chronic obstructive pulmonary disease (COPD), or other breathing disease that is not controlled with medicine - Have human immunodeficiency virus (HIV) or syphilis - Are taking blood thinners |