NCT01090765已完成1 期
A Phase I/II Study of TRC105 in Metastatic Castrate Resistant Prostate Cancer (CRPC)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Phase I: Maximum Tolerated Dose (MTD) of TRC105 Given Every Two Weeks.
研究概览
简要总结
Background:
- Currently, there is no curative therapy for metastatic castrate-resistant prostate cancer (CRPC), a leading cause of death in men. However, researchers are exploring new treatments that involve drugs that prevent angiogenesis (the process by which new blood vessels are formed) and can slow or prevent tumor growth.
- TRC105 is an experimental drug that blocks angiogenesis, and has been studied for possible use in treating different kinds of cancer. However, it has not been validated to treat prostate cancer in general or CRPC in particular.
Objectives:
- To determine the effects of TRC105 as a treatment for CRPC
- To determine the safety and effectiveness of TRC105 in treating CRPC
Eligibility:
- Men at least 18 years of age who have been diagnosed with castrate-resistant prostate cancer for which existing treatments have not been effective.
Design:
- Eligible individuals will have a series of blood and other tests to determine their suitability for participating in the study.
- Participants will receive intravenous infusions of TRC105 in a 28-day treatment cycle. Participants will receive i.v. (intravenous) infusions of TRC105 every two weeks on days 1 and 15 of each 28-day cycle (cohorts 1, 2, 3, 5, and 6) and every week on days 1, 8, 15, and 22 of each 28 day cycle (cohort 4).
- Participants will receive different doses of TRC105 depending on when they enter the study, up to a maximum tolerated dose or optimum treatment dose.
- Frequent blood and urine tests will be performed during treatment, as well as other tests of cancer progression as directed by the study doctors. Participants will receive medicines to help prevent possible adverse side effects of TRC105, such as allergic reaction to the drug.
- Participants will continue treatment with TRC105 until they or the study team decides that the medication is not beneficial. No additional testing will be required unless participants discontinue the treatment because of side effects (which the study doctors will follow until the side effects are resolved).
详细描述
Background:
- Inhibition of angiogenesis has demonstrable antitumor efficacy against castrate-resistant prostate cancer (CRPC). TRC105 is a human/murine chimeric immunoglobulin heavy constant gamma 1 (IgG1) kappa monoclonal antibody that binds to human CD105 (endoglin), thus inhibiting angiogenesis and tumor growth. Data from an ongoing phase I clinical trial suggest that TRC105 is well tolerated with evidence of clinical efficacy in patients with metastatic CRPC.
Primary Objectives:
- Define the maximum tolerable dose (MTD) of TRC105 given every one to two weeks.
Secondary Objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
TRC105 1 mg/kg every 2 weeks
Experimental
Intravenous infusion at 1 mg/kg every 2 weeks
干预措施: TRC105 (Drug)
TRC105 3 mg/kg every 2 weeks
Experimental
Intravenous infusion at 3 mg/kg every 2 weeks
干预措施: TRC105 (Drug)
TRC105 10 mg/kg every 2 weeks
Experimental
Intravenous infusion at 10 mg/kg every 2 weeks
干预措施: TRC105 (Drug)
TRC105 10 mg/kg weekly
Experimental
Intravenous infusion at 10 mg/kg weekly
干预措施: TRC105 (Drug)
TRC105 15 mg/kg every 2 weeks
Experimental
Intravenous infusion at 15 mg/kg every 2 weeks
干预措施: TRC105 (Drug)
TRC105 20 mg/kg every 2 weeks
Experimental
Intravenous infusion at 20 mg/kg every 2 weeks
干预措施: TRC105 (Drug)
结局指标
主要结局
Phase I: Maximum Tolerated Dose (MTD) of TRC105 Given Every Two Weeks.
时间窗: 6 months
The MTD, to be administered in the phase II portion, is defined as the highest dose studied for which the incidence of dose limiting toxicity (DLT) was less than 33%. TRC105 was administered at 20 mg/kg intravenous every two weeks until MTD was achieved.
次要结局
- Number of Participants With Adverse Events(Date treatment consent signed to date off study, approximately 43 months, 5 days)
- Dose Limiting Toxicity (DLT)(First 28 days on study)
- Prostatic-Specific Antigen (PSA) Decline(1- week intervals up to 6 months)
- Clinical Response(56 days (one cycle = 28 days, restaging post cycle 2))
研究者
William Dahut Jr., M.D.
Principal Investigator
National Institutes of Health Clinical Center (CC)
研究点 (1)
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