Phase 3
N=34
CATCH-R: A Rollover Study to Provide Continued Access to Rucaparib
Metastatic Castration-Resistant Prostate Cancer · Ovarian Cancer · Epithelial Ovarian Cancer · Fallopian Tube Cancer · Peritoneal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT04676334 ↗Enrolled (actual)
34
Serious AEs
10.0%
Results posted
May 2024
Primary outcome: Primary: Number of Participants Experiencing SAEs and AESIs — 2; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Rucaparib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- pharmaand GmbH
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Experiencing SAEs and AESIs |
2; 0 | — |
Summary
This protocol is designed to provide participants currently benefiting from rucaparib treatment in a Clovis-sponsored clinical study with continued access to treatment for as long as they continue to benefit. Participants 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.
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 participant 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 participants considered for continuation of rucaparib treatment):
- Participant 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 participant inappropriate for continuation of rucaparib treatment.
Data sourced from ClinicalTrials.gov (NCT04676334). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.