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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04179396
Recruitment Status : Recruiting
First Posted : November 27, 2019
Last Update Posted : April 17, 2020
Sponsor:
Information provided by (Responsible Party):
Clovis Oncology, Inc.

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : December 5, 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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 Name: 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 Name: Zytiga




Primary Outcome Measures :
  1. Evaluate the PK of rucaparib in combination with other anticancer agents for mCRPC. [ Time Frame: 2 years to complete ]
    Cmin of rucaparib and its metabolite.

  2. Evaluate the number of reported treatment-related AEs/SAEs in combination with other anticancer agents for mCRPC. [ Time Frame: 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 :
  1. Evaluate the preliminary overall response rate (ORR) of rucaparib in combination with other anticancer agents for mCRPC. [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04179396


Contacts
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Contact: Clovis Oncology Clinical Trial Navigation 855-262-3040 clovistrials@emergingmed.com

Locations
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United States, Georgia
Piedmont Cancer Institute, P.C. Active, not recruiting
Atlanta, Georgia, United States, 30318
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Clovis Oncology Clinical Trial Navigation    855-262-3040    clovistrials@emergingmed.com   
United States, Tennessee
Urology Associates, P.C. Recruiting
Nashville, Tennessee, United States, 37209
Contact: Clovis Oncology Clinical Trial Navigation    855-262-3040    clovistrials@emergingmed.com   
Sponsors and Collaborators
Clovis Oncology, Inc.
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Responsible Party: Clovis Oncology, Inc.
ClinicalTrials.gov Identifier: NCT04179396    
Other Study ID Numbers: CO-338-107
First Posted: November 27, 2019    Key Record Dates
Last Update Posted: April 17, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Clovis Oncology, Inc.:
CRPC
PARP inhibitor
RAMP
homologous recombination
DNA repair
DNA defect
DNA anomaly
mCRPC
enzalutamide
abiraterone
Zytiga
Xtandi
ADT
AR
ARi
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Rucaparib
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents