A Phase Ib/II Study of Copanlisib Combined With Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Maximum Tolerated Dose
研究概览
简要总结
This is a single arm Phase Ib/II, open label, safety, pharmacokinetic and efficacy clinical study in adult patients with metastatic castration-resistant prostate cancer (mCRPC). Patients will be treated with the combination of copanlisib and rucaparib for as long as the patient does not have clinically significant progressive disease and/or unacceptable toxicity and/or as long as the investigator deems that the patient is benefiting from treatment. Treatment may also be stopped if the patient withdraws consent, or study termination occurs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
Dose Level -2
300 mg Rucaparib, 45 mg (day 1 & 15) Copanlisib
干预措施: Rucaparib (Drug)
Dose Level -2
300 mg Rucaparib, 45 mg (day 1 & 15) Copanlisib
干预措施: Copanlisib (Drug)
Dose Level -1
400 mg Rucaparib, 45 mg (day 1 & 15) Copanlisib
干预措施: Rucaparib (Drug)
Dose Level -1
400 mg Rucaparib, 45 mg (day 1 & 15) Copanlisib
干预措施: Copanlisib (Drug)
Dose Level 1
400 mg Rucaparib, 45 mg Copanlisib
干预措施: Rucaparib (Drug)
Dose Level 1
400 mg Rucaparib, 45 mg Copanlisib
干预措施: Copanlisib (Drug)
Dose Level 2
500 mg Rucaparib, 45 mg Copanlisib
干预措施: Rucaparib (Drug)
Dose Level 4
600 mg Rucaparib, 60 mg Copanlisib
干预措施: Rucaparib (Drug)
Dose Level 2
500 mg Rucaparib, 45 mg Copanlisib
干预措施: Copanlisib (Drug)
Dose Level 3
600 mg Rucaparib, 45 mg Copanlisib
干预措施: Rucaparib (Drug)
Dose Level 3
600 mg Rucaparib, 45 mg Copanlisib
干预措施: Copanlisib (Drug)
Dose Level 4
600 mg Rucaparib, 60 mg Copanlisib
干预措施: Copanlisib (Drug)
结局指标
主要结局
Maximum Tolerated Dose
时间窗: Cycle 1 (each cycle is 28 days) through pre-dosing cycle 2, approximately 1 month.
To evaluate the maximum tolerated dose of copanlisib with rucaparib in patients with metastatic castration-resistant prostate cancer.
Response
时间窗: Every 28 days on treatment, then every 3 months until progression of disease up to 3 years.
To estimate the overall response rate of the combination of copanlisib and rucaparib in patients with metastatic castration-resistant prostate cancer.
次要结局
未报告次要终点