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

April 10, 2024 updated by: pharmaand GmbH

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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; NCT01968213; NCT02855944). Participants who are no longer receiving treatment and are in LTFU in the parent study (NCT02855944) 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.

Participants 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 participant 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 participant consent. If a participant continues treatment post-progression, all study assessments should be continued per institutional standard of care. The participant should be discontinued from treatment once it is clear that no further clinical benefit can be achieved.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada
        • London Regional Cancer Centre
      • Ottawa, Ontario, Canada
        • Institut De Recherche De L'Hospital D'Ottawa
      • Toronto, Ontario, Canada
        • Princess Margaret Hospital - Toronto
    • Quebec
      • Montréal, Quebec, Canada
        • Centre Hospitalier de l'Universite de Montreal (CHUM)
      • Sherbrooke, Quebec, Canada
        • CIUSSS de l'Estrie - CHUS
  • Israel
      • Haifa, Israel
        • Carmel Medical Center
      • Kfar Saba, Israel
        • Meir Medical Center
  • Italy
      • Bologna, Italy
        • Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
      • Milano, Italy
        • Istituto Europeo Di Oncologia
      • Napoli, Italy
        • Istituto Nazionale per lo studio e la cura dei tumori "Fondazione Pascale" Oncologia Medica
      • Roma, Italy
        • Fondazione Policlinico Universitario Agostino Gemelli
    • Torino
      • Candiolo, Torino, Italy
        • Istituto per la Ricerca e la Cura del Cancro Istituto di Candiolo
  • Poland
    • Podlaskie
      • Białystok, Podlaskie, Poland
        • Białostockie Centrum Onkologii im. Marii Skłodowskiej-Curie
    • Warminsko-Mazurskie
      • Olsztyn, Warminsko-Mazurskie, Poland
        • Wojewodzki Szpital Specjalistyczny w Olsztynie
  • Russian Federation
      • Moscow, Russian Federation
        • N.N. Blokhin Russian Cancer Research Center
      • Omsk, Russian Federation
        • Omsk Regional Clinical Oncologic Dispensary
      • Ryazan', Russian Federation
        • Ryazan Regional clinical oncology dispensary
      • Saint Petersburg, Russian Federation
        • Almazov National Medical Research Centre
    • Bashkortosta
      • Ufa, Bashkortosta, Russian Federation
        • Republic Clinical Oncology Dispensary of the Ministry of Healthcare of Republic of Bashkortostan
    • Krasnodar
      • Sochi, Krasnodar, Russian Federation
        • State healthcare institution oncologic dispensary no. 2 - health department of krasnodar region
    • Mordovia
      • Saransk, Mordovia, Russian Federation
        • Republican oncological dispensary of Republic of Mordovia
    • Primorskiy
      • Arkhangel'sk, Primorskiy, Russian Federation
        • Arkhangelsk Clinical Oncological Dispensary
    • Stavropol
      • Pyatigorsk, Stavropol, Russian Federation
        • Pyatigorsk Oncological Dispensary
  • United Kingdom
    • England
      • London, England, United Kingdom
        • University College London Hospitals
      • Middlesex, England, United Kingdom
        • East and North Hertfordshire NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rucaparib
Rucaparib administered at dose and schedule last taken in parent study, or per investigator decision.
Drug: Rucaparib
Rucaparib will be administered daily.
Other Names:
  • Rubraca
  • CO-338
No Intervention: Long-term Follow-up
Participants discontinued rucaparib treatment and were in long-term follow-up in the parent study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
An SAE was any untoward medical occurrence that occurred at any dose, or after informed consent was given and prior to dosing if the SAE was related to a study procedure, that: resulted in death; was life-threatening; required in-patient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly or birth defect; or was an important medical event that may not have resulted in death, was not life-threatening, or did not require hospitalization but may be considered an SAE, based on appropriate medical judgment. An AESI was defined as any AE of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate. A summary of all SAEs regardless of causality is located in the 'Reported Adverse Events' Section.
From first dose of rucaparib through 28 days after receiving last dose of rucaparib (approximately 20 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

pharmaand GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 22, 2021

Primary Completion (Actual)

March 8, 2023

Study Completion (Actual)

March 8, 2023

Study Registration Dates

First Submitted

December 14, 2020

First Submitted That Met QC Criteria

December 18, 2020

First Posted (Actual)

December 21, 2020

Study Record Updates

Last Update Posted (Actual)

May 7, 2024

Last Update Submitted That Met QC Criteria

April 10, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CO-338-111
  • 2020-001538-37 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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