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

Sponsor

Clovis Oncology, Inc. (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT04179396

Collaborator

(none)

Enrollment

Locations

Arms

33.9

Anticipated Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Metastatic Castration Resistant Prostate Cancer	Drug: Rucaparib Drug: Enzalutamide Drug: Abiraterone	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 5, 2019

Actual Primary Completion Date :

Nov 25, 2021

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm A: Oral rucaparib and enzalutamide	Drug: Rucaparib Oral rucaparib will be administered twice daily Other Names: Rubraca CO-338 Drug: Enzalutamide Enzalutamide will be administered once daily. Enrollment into Arm A will be prioritized over Arm B until the objectives for Arm A have been achieved. Other Names: Xtandi
Experimental: Arm B: Oral rucaparib and abiraterone	Drug: Rucaparib Oral rucaparib will be administered twice daily Other Names: Rubraca CO-338 Drug: Abiraterone Abiraterone will be administered once daily with prednisone Other Names: Zytiga

Arm

Intervention/Treatment

Experimental: Arm A: Oral rucaparib and enzalutamide

Drug: Rucaparib

Oral rucaparib will be administered twice daily

Other Names:

Rubraca

CO-338

Drug: Enzalutamide

Enzalutamide will be administered once daily. Enrollment into Arm A will be prioritized over Arm B until the objectives for Arm A have been achieved.

Other Names:

Xtandi

Experimental: Arm B: Oral rucaparib and abiraterone

Drug: Rucaparib

Oral rucaparib will be administered twice daily

Other Names:

Rubraca

CO-338

Drug: Abiraterone

Abiraterone will be administered once daily with prednisone

Other Names:

Zytiga

Outcome Measures

Primary Outcome Measures

Evaluate the PK of rucaparib in combination with other anticancer agents for mCRPC. [2 years to complete]
Cmin of rucaparib and its metabolite.
Evaluate the number of reported treatment-related AEs/SAEs in combination with other anticancer agents for mCRPC. [2 years to compete]
Number of participants with treatment-related Adverse Events (AEs) and Serious Adverse Events (SAEs) as assessed by CTCAE v5.0 as a measure of safety and tolerability.

Secondary Outcome Measures

Evaluate the preliminary overall response rate (ORR) of rucaparib in combination with other anticancer agents for mCRPC. [2 years to compete]
Preliminary overall response rate (ORR) defined as the proportion of patients with a best overall response of CR or PR according to modified RECIST 1.1 and PCWG3 criteria.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Piedmont Cancer Institute, P.C.	Atlanta	Georgia	United States	30318
2	University of Minnesota	Minneapolis	Minnesota	United States	55455
3	Urology Associates, P.C.	Nashville	Tennessee	United States	37209