A Phase 1b, Open-label, Parallel Arm Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Oral Rucaparib in Combination With Other Anticancer Agents in Patients With Metastatic Castration Resistant Prostate Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 3
- 主要终点
- Evaluate the PK of Rucaparib in Combination With Other Anticancer Agents for mCRPC.
研究概览
简要总结
Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Oral Rucaparib in Combination with Other Anticancer Agents in Patients with Metastatic Castration Resistant Prostate Cancer
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
- •Have signed an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent form prior to any study-specific evaluation
- •Be ≥18 yrs of age at the time the informed consent form is signed
- •Be either AR-directed therapy-naive or have received 1-2 lines of AR-directed therapy in the castration-resistant setting.
- •Adequate organ function
- •ECOG 0 or 1
- •Have a histologically or cytologically confirmed adenocarcinoma or poorly differentiated carcinoma of the prostate that is metastatic
- •Be surgically or medically castrated, with serum testosterone levels of ≤ 50 ng/dL (1.73 nM)
- •Have disease progression after initiation of most recent therapy
排除标准
- •Active second malignancy, with the exception of curatively treated non melanoma skin cancer, carcinoma in situ, or superficial bladder cancer
- •Have received greater than 2 previous lines of chemotherapy for mCRPC
- •Prior treatment with any PARP inhibitor
- •Symptomatic and/or untreated central nervous system metastases
- •Pre-existing duodenal stent and/or any gastrointestinal disorder or defect that would, in the opinion of the investigator, interfere with absorption of study drug
- •Spinal cord compression, symptomatic and/or untreated central nervous system (CNS) metastases or leptomeningeal disease. Patients with asymptomatic previously treated CNS metastases are eligible provided they have been clinically stable for at least 4 weeks
- •Any clinically significant cardiovascular disease
- •Taking any concomitant medications or herbs that could interfere or interact with the study drug
研究组 & 干预措施
Arm A: Oral rucaparib and enzalutamide
干预措施: Rucaparib (Drug)
Arm A: Oral rucaparib and enzalutamide
干预措施: Enzalutamide (Drug)
Arm B: Oral rucaparib and abiraterone
干预措施: Rucaparib (Drug)
Arm B: Oral rucaparib and abiraterone
干预措施: Abiraterone (Drug)
结局指标
主要结局
Evaluate the PK of Rucaparib in Combination With Other Anticancer Agents for mCRPC.
时间窗: 1 week rucaparib only run-in and 1 cycle (28 days) of combination treatment
Cmin of rucaparib and its metabolite. Rucaparib only run-in Cmin includes run-in D6, D7 and Cycle 1 D1. All of these samples were collected following rucaparib monotherapy. Rucaparib and other anticancer agent Combination Cmin includes Cycle 1 (D8, D15, and D22).
Incidence of Dose-Limiting Toxicities (DLTs) in Participants Taking Rucaparib in Combination With Other Anticancer Agents for mCRPC
时间窗: First 2 cycles of rucaparib combination treatment (56 days) for Arm A
A DLT is defined according to criteria specified in the protocol and assessed by the investigator, based on toxicity grade (according to the NCI CTCAE v5.0), clinical significance, and possible relationship to the study drug combination. The toxicity cannot be a recognized adverse effect of enzalutamide, abiraterone or prednisone/prednisolone and/or attributable to mCRPC or mCRPC-related processes under investigation.
次要结局
- Preliminary Overall Confirmed Response Rate (ORR) of Rucaparib in Combination With Other Anticancer Agents for mCRPC.(2 years to complete)