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

Brief Title

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

Official Title

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

Brief 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.

Detailed Description

      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 Phase

Phase 3

Study Type

Interventional

Primary Outcome

Safety follow-up

Condition

Metastatic Castration-Resistant Prostate Cancer

Intervention

Rucaparib

Study Arms / Comparison Groups

 Rucaparib

Description:  Rucaparib administered at dose and schedule last taken in parent study, or per investigator decision

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

Start Date

March 22, 2021

Completion Date

January 2, 2024

Primary Completion Date

November 2, 2023

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 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.

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, ,

Location Countries

Brazil

Location Countries

Brazil

Administrative Informations

NCT ID

NCT04676334

Organization ID

CO-338-111

Responsible Party

Sponsor

Study Sponsor

Clovis Oncology, Inc.

Study Sponsor

, ,

Verification Date

January 2022