Prostate Cancer Clinical Trial

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

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

View Eligibility Criteria

Eligibility 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

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

8

Study ID:

NCT04179396

Recruitment Status:

Completed

Sponsor:

zr Pharma & GmbH

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There are 3 Locations for this study

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Piedmont Cancer Institute, P.C.
Atlanta Georgia, 30318, United States
University of Minnesota
Minneapolis Minnesota, 55455, United States
Urology Associates, P.C.
Nashville Tennessee, 37209, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

8

Study ID:

NCT04179396

Recruitment Status:

Completed

Sponsor:


zr Pharma & GmbH

How clear is this clinincal trial information?

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