Status:
COMPLETED
CATCH-R: A Rollover Study to Provide Continued Access to Rucaparib
Lead Sponsor:
pharmaand GmbH
Conditions:
Metastatic Castration-Resistant Prostate Cancer
Ovarian Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ...
Detailed Description
Participants 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 (NCT01891344; NCT019682...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
March 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 8 2023
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT04676334
Start Date
March 22 2021
End Date
March 8 2023
Last Update
May 7 2024
Active Locations (25)
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1
London Regional Cancer Centre
London, Ontario, Canada
2
Institut De Recherche De L'Hospital D'Ottawa
Ottawa, Ontario, Canada
3
Princess Margaret Hospital - Toronto
Toronto, Ontario, Canada
4
Centre Hospitalier de L'Universite de Montreal (CHUM)
Montreal, Quebec, Canada