Study of Oral Rucaparib With Other Anticancer Agents in Metastatic Castration Resistant Prostate Cancer Patients (RAMP)
NCT ID: NCT04179396
Last Updated: 2023-06-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
8 participants
INTERVENTIONAL
2019-12-05
2023-01-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A: Oral rucaparib and enzalutamide
Rucaparib
Oral rucaparib will be administered twice daily
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.
Arm B: Oral rucaparib and abiraterone
Rucaparib
Oral rucaparib will be administered twice daily
Abiraterone
Abiraterone will be administered once daily with prednisone
Interventions
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Rucaparib
Oral rucaparib will be administered twice daily
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.
Abiraterone
Abiraterone will be administered once daily with prednisone
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
MALE
No
Sponsors
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pharmaand GmbH
INDUSTRY
Responsible Party
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Locations
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Piedmont Cancer Institute, P.C.
Atlanta, Georgia, United States
University of Minnesota
Minneapolis, Minnesota, United States
Urology Associates, P.C.
Nashville, Tennessee, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CO-338-107
Identifier Type: -
Identifier Source: org_study_id
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