Study of Oral Rucaparib With Other Anticancer Agents in Metastatic Castration Resistant Prostate Cancer Patients (RAMP)

• Status: Active, not recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Clovis Oncology, Inc.
• Treatments: Antineoplastic Agents; Rucaparib

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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