CATCH-R: A Rollover Study to Provide Continued Access to Rucaparib (CATCH-R)
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04676334|
Recruitment Status : Enrolling by invitation
First Posted : December 21, 2020
Last Update Posted : July 19, 2021
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Castration-Resistant Prostate Cancer Ovarian Cancer Epithelial Ovarian Cancer Fallopian Tube Cancer Peritoneal Cancer Other Solid Tumor||Drug: Rucaparib||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||CATCH-R: A Rollover Study to Provide Continued Access to Clinical Therapy With Rucaparib|
|Actual Study Start Date :||March 22, 2021|
|Estimated Primary Completion Date :||November 2, 2023|
|Estimated Study Completion Date :||January 2, 2024|
Rucaparib administered at dose and schedule last taken in parent study, or per investigator decision
Rucaparib will be administered daily.
- Safety follow-up [ Time Frame: Baseline up to approximately 3 years ]Serious adverse events and adverse events of special interest reported until 30 days after the last dose of study drug.
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): NCT04676334