CATCH-R: A Rollover Study to Provide Continued Access to Rucaparib

• Status: Enrolling by invitation
• Trial end date: 2024-01-02
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Clovis Oncology, Inc.
• Treatments: Rucaparib

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.