Clinical Trials /

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

NCT04179396

Description:

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

Related Conditions:
  • Prostate Adenocarcinoma
  • Prostate Undifferentiated Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: CO-338-107
  • NCT ID: NCT04179396

Conditions

  • Metastatic Castration Resistant Prostate Cancer

Interventions

DrugSynonymsArms
RucaparibRubraca, CO-338Arm A: Oral rucaparib and enzalutamide
EnzalutamideXtandiArm A: Oral rucaparib and enzalutamide
AbirateroneZytigaArm B: Oral rucaparib and abiraterone

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
Arm A: Oral rucaparib and enzalutamideExperimental
  • Rucaparib
  • Enzalutamide
Arm B: Oral rucaparib and abirateroneExperimental
  • Rucaparib
  • Abiraterone

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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Male
Healthy Volunteers:No

Primary Outcome Measures

Measure:Evaluate the PK of rucaparib in combination with other anticancer agents for mCRPC.
Time Frame:2 years to complete
Safety Issue:
Description:Cmin of rucaparib and its metabolite.

Secondary Outcome Measures

Measure:Evaluate the preliminary overall response rate (ORR) of rucaparib in combination with other anticancer agents for mCRPC.
Time Frame:2 years to compete
Safety Issue:
Description: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.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Clovis Oncology, Inc.

Trial Keywords

  • CRPC
  • PARP inhibitor
  • RAMP
  • homologous recombination
  • DNA repair
  • DNA defect
  • DNA anomaly
  • mCRPC
  • enzalutamide
  • abiraterone
  • Zytiga
  • Xtandi
  • ADT
  • AR
  • ARi

Last Updated

January 9, 2020