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

Sponsor
pharmaand GmbH
Study ID
NCT04676334
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rucaparib — DRUG
    Rucaparib will be administered daily.

Study Details

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.

Key Dates

Start date
Mar 22, 2021
Status verified
Apr 2024
Primary completion
Mar 8, 2023
Completion
Mar 8, 2023

Study Design

Enrollment
34 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Rucaparib
    Rucaparib administered at dose and schedule last taken in parent study, or per investigator decision.
  • No Intervention: Long-term Follow-up
    Participants discontinued rucaparib treatment and were in long-term follow-up in the parent study.

Primary Outcome Measure

Number of Participants Experiencing SAEs and AESIs [ Time Frame: From first dose of rucaparib through 28 days after receiving last dose of rucaparib (approximately 20 months) ]

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