NCT00103428终止1 期
A Phase 1/2a Dose-Escalation Trial of Intravenous CG7870 in Combination With Docetaxel in Chemotherapy-Naïve Patients With Metastatic Hormone-Refractory Prostate Cancer
Cell Genesys2 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2004年8月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 69
- 试验地点
- 2
- 主要终点
- Metastatic hormone refractory prostate cancer
研究概览
简要总结
V-0039 is a Phase 1/2 dose escalation trial of CG7870 in combination with Docetaxel in metastatic hormone-refractory patients who have not received chemotherapy.
All patients will receive docetaxel. In the dose escalation phase of the study, patients will receive treatment intravenously with CG7870 at one of up to four dose levels. In the Phase 2 portion of this study, additional patients will be added at the maximum tolerated dose that is determined in Phase 1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed adenocarcinoma of the prostate
- •Metastatic prostate cancer deemed to be unresponsive or refractory to hormone therapy (after discontinuation of anti-androgen therapy)
- •Detectable metastases by bone scan, and/or CT scan, and/or MRI, and/or CXR
- •ECOG performance status 0-1
排除标准
- •Transitional cell, small cell, neuroendocrine, or squamous cell prostate cancer
- •History of deep vein thrombosis or pulmonary embolus
- •Patients taking anticoagulants (such as coumadin or Heparin). The use of aspirin while on study is acceptable.
- •History of a bleeding disorder or recent clinically significant bleeding
- •Seropositive for HIV
- •History of Hepatitis B, Hepatitis C, or chronic liver disease
- •Prior gene therapy or immunotherapy
- •Prior chemotherapy for prostate cancer
- •Radiation therapy within 4 weeks of the first treatment.
- •History of myocardial infarction within 6 months of the first treatment
- •History of cerebrovascular accident
- •History of previous malignancy, except for the following: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, adequately treated Stage I or II cancer currently in complete remission, or any other cancer that has been in complete remission for at least 5 years
- •Evidence of active prostatitis
- •Known hypersensitivity to docetaxel or to other drugs formulated with polysorbate 80
结局指标
主要结局
Metastatic hormone refractory prostate cancer
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
撤回
2 期
Phase 2 Trial Of CP-751,871 And Docetaxel In Advanced Breast CancerBreast CancerNCT00678626Pfizer
已完成
1 期
Phase I/II Dose Escalation Study of VELCADE® and Docetaxel in Patients With Advanced Androgen-Independent Prostate CancerProstatic NeoplasmsNCT00064610Millennium Pharmaceuticals, Inc.102
Unknown
2 期
A Study of SHR3680 in Combination With Docetaxel in the Treatment of mCRPCProstate Cancer MetastaticNCT04603833Jiangsu HengRui Medicine Co., Ltd.150
撤回
2 期
A Study Of Docetaxel Or Docetaxel Plus PF-3512676 To Treat Patients With Advanced Breast Cancer.Breast NeoplasmsNCT00471159Pfizer
已完成
1 期
VEGF Trap and Docetaxel in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube CancerFallopian Tube CancerMalignant Tumor of PeritoneumRecurrent Ovarian Epithelial CancerNCT00436501National Cancer Institute (NCI)58