EUCTR2009-012802-38-NL进行中（未招募）不适用
Evaluation of the activity of temsirolimus with FLT-PET in patients with renal cell cancer - temsirolimus-RCC-imaging
niversity Medical Centre Nijmegen St Radboud0 个研究点开始时间: 2009年5月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.This study will be conducted in subjects with histologically confirmed, advanced (stage IV or recurrent disease) RCC who have received at least one prior angiogenesis inhibitor for their disease.
- •2.Subjects must have a Karnofsky performance status = 70.
- •3.Subject must have at least 1 measurable lesion that can be accurately measured in at least 1 dimension with the longest diameter = 10-mm when measured by spiral computerized tomography (CT, 5-mm slice thickness contiguous)
- •4.Age = 18 years.
- •5.Absolute neutrophil count (ANC) = 1.5 x 109/L (1500 cells/mm3), platelet count = 100 x 109/L (100,000 cells/ mm3), hemoglobin = 8.0 g/dL (5.0 mmol/L).
- •6.Adequate renal function (serum creatinine = 1.5 times the ULN) or creatinin clearance of = 50 ml/min
- •7.Adequate hepatic function (bilirubin = 1.5 times the ULN, aspartate transaminase (AST) = 3 times the ULN [= 5 times the ULN if liver metastases are present]).
- •8.Fasting serum cholesterol = 350 mg/dL (9.0 mmol/L), triglycerides = 400 mg/dL (4.56 mmol/L).
- •9.Subjects receiving cytochrome P450 (CYP) 3A4 inducers or inhibitors must be on stable doses for at least 1 week prior to randomization.
- •10.Life expectancy of at least 8 weeks.
- •11.Negative pregnancy test for female patients of childbearing potential
- •12.Women and men enrolled into this trial must use adequate birth control measures during the course of the trial.
- •13.Signed and dated written informed consent form
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Subjects with central nervous system (CNS) metastases. Subjects with a prior history of CNS metastases will be eligible if the screening magnetic resonance imaging (MRI)/CT (with contrast) indicates no residual disease.
- •2.Prior investigational therapy/agents within 2 weeks of randomization.
- •3.Prior treatment with a mTOR inhibitor
- •4.History of other prior malignancy in past 5 years, other than basal cell carcinoma, squamous cell carcinoma of the skin, or cervical carcinoma in situ.
- •5.Not recovered from prior surgery and/or surgery or radiation therapy within 4 weeks of randomization.
- •6.Immunocompromised subjects, including subjects known to be human immunodeficiency virus (HIV) positive, hepatitis B positive, or hepatitis C positive.
- •7.Active infection or serious intercurrent illness.
- •8.Presence of unstable angina or myocardial infarction within the previous 6 months (prior to screening), use of ongoing maintenance therapy for life-threatening arrhythmia, known pulmonary hypertension, or pneumonitis.
- •9.Pregnant or nursing women, women who are of childbearing potential who are not using an effective contraceptive method, or men with partners of childbearing potential who are not using an effective contraceptive method. Agree to use effective contraceptive methods, must continue for 3 months after the last dose of CCI-779. A woman of childbearing potential is defined as a woman who is biologically capable of becoming pregnant.
- •10.Any other major illness that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in this study.
研究者
相似试验
招募中
2 期
Evaluation of the activity of temsirolimus with FLT-PET in patients with renal cell cancerrenal cell carcinomaNL-OMON33063niversitair Medisch Centrum Sint Radboud50
进行中（未招募）
1 期
Evaluation de l’efficacité du temsirolimus chez des patients récidivant d’un cancer de la vessie après une première ligne de chimiothérapie. Essai clinique de phase II multicentrique. - VESTOREUCTR2009-011049-15-FRInstitut Bergonié - Département d’Oncologie Médicale
进行中（未招募）
不适用
A therapy and pharmacokinetics study of temsirolimus in patients with refractory and recidivated primary CNS lymphoma - Temsirolimus in PZNSPatients with refractory and recidivated primary CNS lymphomaEUCTR2009-011277-33-DECharité - University Hospital of Berlin
进行中（未招募）
不适用
Activity, tolerability and safety of Temsirolimus in women with ovarian cancer who progressed during the previous platinum chemotherapy alternatively within 6 months from completion of therapy or advanced endometrial carcinomaplatinum-refractory ovarian carcinoma or advanced endometrial carcinomaMedDRA version: 15.1Level: PTClassification code 10014733Term: Endometrial cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 15.1Level: PTClassification code 10066697Term: Ovarian cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-000299-33-DEAGO Research GmbH
进行中（未招募）
1 期
/AAdvanced hormone - and chemotherapy - resistant prostate cancerEUCTR2011-002087-24-GRHellenic Oncology Research Group (HORG)