Brief Title
CATCH-R: A Rollover Study to Provide Continued Access to Rucaparib
Official Title
CATCH-R: A Rollover Study to Provide Continued Access to Clinical Therapy With Rucaparib
Brief Summary
This protocol is designed to provide patients currently benefiting from rucaparib treatment in a Clovis-sponsored clinical study with continued access to treatment for as long as they continue to benefit. Patients in long-term follow-up (LTFU) in a parent study may also enroll in this study for continued data collection, as applicable based on parent study objectives.
Detailed Description
Patients enrolled in this study are required to have completed an End-of-Treatment (EOT) Visit with associated assessments as specified in the Clovis-sponsored parent study. Patients who are no longer receiving treatment and are in LTFU in the parent study may enroll into the LTFU portion of this study, as applicable based on parent study objectives, without repeating the EOT visit. The starting dose of rucaparib administered at initiation of this study will be the same as the last dose received in the parent study, or as deemed appropriate by the investigator and based on available dose strength tablets. The first treatment in the rollover study will begin at the next scheduled treatment visit following the EOT Visit in the parent study. Patients enrolled to receive continued rucaparib may be treated until disease progression, as assessed by the investigator, unacceptable toxicity, withdrawal of consent, death, loss to follow-up, or study closure by the sponsor. If a patient demonstrates disease progression per investigator assessment while receiving treatment with rucaparib but continues to derive clinical benefit, then continuation of treatment beyond progression is permitted based on investigator decision and patient consent. If a patient continues treatment post-progression, all study assessments should be continued per institutional standard of care. The patient should be discontinued from treatment once it is clear that no further clinical benefit can be achieved.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Safety follow-up
Condition
Metastatic Castration-Resistant Prostate Cancer
Intervention
Rucaparib
Study Arms / Comparison Groups
Rucaparib
Description: Rucaparib administered at dose and schedule last taken in parent study, or per investigator decision
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
250
Start Date
March 22, 2021
Completion Date
January 2, 2024
Primary Completion Date
November 2, 2023
Eligibility Criteria
Inclusion Criteria: - Currently enrolled in a Clovis-sponsored study of rucaparib that is being closed - Either: (a) Is currently tolerating a rucaparib treatment regimen in the parent study with evidence of clinical benefit, as assessed by the investigator, or (b) Has discontinued treatment and is being followed for collection of LTFU data in the parent study - Demonstrated compliance with the parent study requirements, as assessed by the investigator, and patient is able and willing to comply with the necessary study visits and assessments as part of the rollover study - Provided written informed consent prior to enrolling in this rollover study Exclusion Criteria (applicable only to patients considered for continuation of rucaparib treatment): - Patient has been permanently discontinued from study treatment in the parent study for any reason - Pregnant or breastfeeding female patients - Presence of any other condition that may, in the opinion of the investigator, make the patient inappropriate for continuation of rucaparib treatment.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
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Location Countries
Brazil
Location Countries
Brazil
Administrative Informations
NCT ID
NCT04676334
Organization ID
CO-338-111
Responsible Party
Sponsor
Study Sponsor
Clovis Oncology, Inc.
Study Sponsor
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Verification Date
January 2022