Skip to main content

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

Trial Status: Active

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

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

Minnesota

Minneapolis
University of Minnesota / Masonic Cancer Center
Status: ACTIVE

Trial Phase Phase I

Trial Type Treatment

Lead Organization
Clovis Oncology

  • Primary ID CO-338-107
  • Secondary IDs NCI-2019-08649
  • Clinicaltrials.gov ID NCT04179396