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

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Status and phase: Completed; Phase 1

Conditions: Metastatic Castration Resistant Prostate Cancer

Treatments: Drug: Abiraterone; Drug: Enzalutamide; Drug: Rucaparib

Study type: Interventional

Funder types: Industry

Identifiers

NCT04179396

CO-338-107

Details and patient eligibility

About

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

Enrollment: 8 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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8 participants in 2 patient groups

Arm A: Oral rucaparib and enzalutamide

Experimental group

Treatment:

Drug: Enzalutamide

Drug: Rucaparib

Arm B: Oral rucaparib and abiraterone

Experimental group

Treatment:

Drug: Rucaparib

Drug: Abiraterone