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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
pharmaand GmbH
Study ID
NCT04179396
Phase
PHASE1
Status
Completed

Conditions

  • Metastatic Castration Resistant Prostate Cancer

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rucaparib — DRUG
    Oral rucaparib will be administered twice daily
  • Enzalutamide — DRUG
    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.
  • Abiraterone — DRUG
    Abiraterone will be administered once daily with prednisone

Study Details

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

Key Dates

Start date
Dec 5, 2019
Status verified
Jun 2023
Primary completion
Nov 25, 2021
Completion
Jan 18, 2023

Study Design

Enrollment
8 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Oral rucaparib and enzalutamide
  • Experimental: Arm B: Oral rucaparib and abiraterone

Primary Outcome Measure

Evaluate the PK of Rucaparib in Combination With Other Anticancer Agents for mCRPC. [ Time Frame: 1 week rucaparib only run-in and 1 cycle (28 days) of combination treatment ]

Locations (3)

FacilityCityStateZIPSite coordinators
Piedmont Cancer Institute, P.C.AtlantaGeorgia30318-
University of MinnesotaMinneapolisMinnesota55455-
Urology Associates, P.C.NashvilleTennessee37209-

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