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

Last updated: April 10, 2024
Sponsor: pharmaand GmbH
Overall Status: Completed

Phase

3

Condition

Fallopian Tube Cancer

Malignant Ascites

Peritoneal Cancer

Treatment

Rucaparib

Clinical Study ID

NCT04676334
CO-338-111
2020-001538-37
  • Ages > 18
  • All Genders

Study 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

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 Design

Total Participants: 34
Treatment Group(s): 1
Primary Treatment: Rucaparib
Phase: 3
Study Start date:
March 22, 2021
Estimated Completion Date:
March 08, 2023

Study 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.

Connect with a study center

  • Hospital Haroldo Juaçaba Instituto do Câncer do Ceará

    Fortaleza, Ceara
    Brazil

    Site Not Available

  • Instituto de Oncologia do Paraná (IOP)

    Curitiba, Parana
    Brazil

    Site Not Available

  • Instituto Nacional de Câncer Hospital do Câncer II

    Santo Cristo, Rio De Janeiro
    Brazil

    Site Not Available

  • CEPON - Centro de pesquisas Oncologicas

    Florianópolis, Santa Catarina
    Brazil

    Site Not Available

  • Hospital de Câncer de Barretos

    Barretos, Sao Paulo
    Brazil

    Site Not Available

  • Instituto Brasileiro de Controle do Cancer (IBCC)

    São Paulo, Sao Paulo
    Brazil

    Site Not Available

  • London Regional Cancer Centre

    London, Ontario
    Canada

    Site Not Available

  • Insitut De Recherche De L'Hospital D'Ottawa

    Ottawa, Ontario
    Canada

    Site Not Available

  • Institut De Recherche De L'Hospital D'Ottawa

    Ottawa, Ontario
    Canada

    Site Not Available

  • Princess Margaret Hospital - Toronto

    Toronto, Ontario
    Canada

    Site Not Available

  • Centre Hospitalier de L'Universite de Montreal (CHUM)

    Montréal, Quebec
    Canada

    Site Not Available

  • CIUSSS de l'Estrie - CHUS

    Sherbrooke, Quebec
    Canada

    Site Not Available

  • Vseobecna fakultni nemocnice v Praze

    Praha 2, Praha
    Czechia

    Site Not Available

  • Fakultní nemocnice v Motole

    Praha 5, Praha
    Czechia

    Site Not Available

  • Fakultní Nemocnice Ostrava

    Ostrava,
    Czechia

    Site Not Available

  • Országos Onkológiai Intézet

    Budapest,
    Hungary

    Site Not Available

  • Carmel Medical Center

    Haifa,
    Israel

    Site Not Available

  • Meir Medical Center

    Kfar Saba,
    Israel

    Site Not Available

  • Tel Aviv Sourasky Medical Center, Oncology Dept.

    Tel Aviv,
    Israel

    Site Not Available

  • Istituto per la Ricerca e la Cura del Cancro Istituto di Candiolo

    Candiolo, Torino
    Italy

    Site Not Available

  • Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi

    Bologna,
    Italy

    Site Not Available

  • Istituto Europeo di Oncologia

    Milano,
    Italy

    Site Not Available

  • Istituto Nazionale per lo studio e la cura dei tumori "Fondazione Pascale" Oncologia Medica

    Napoli,
    Italy

    Site Not Available

  • Fondazione Policlinico Universitario Agostino Gemelli

    Roma,
    Italy

    Site Not Available

  • Białostockie Centrum Onkologii im. Marii Skłodowskiej-Curie

    Białystok, Podlaskie
    Poland

    Site Not Available

  • Wojewódzki Szpital Specjalistyczny w Olsztynie

    Olsztyn, Warminsko-Mazurskie
    Poland

    Site Not Available

  • Republic Clinical Oncology Dispensary of the Ministry of Healthcare of Republic of Bashkortostan

    Ufa, Bashkortosta
    Russian Federation

    Site Not Available

  • State Healthcare Institution Oncologic Dispensary No. 2 - Health Department of Krasnodar Region

    Sochi, Krasnodar
    Russian Federation

    Site Not Available

  • Republican oncological dispensary of Republic of Mordovia

    Saransk, Mordovia
    Russian Federation

    Site Not Available

  • Arkhangelsk Clinical Oncological Dispensary

    Arkhangel'sk, Primorskiy
    Russian Federation

    Site Not Available

  • Pyatigorsk Oncological Dispensary

    Pyatigorsk, Stavropol
    Russian Federation

    Site Not Available

  • N.N. Blokhin Russian Cancer Research Center

    Moscow,
    Russian Federation

    Site Not Available

  • Omsk Regional Clinical Oncologic Dispensary

    Omsk,
    Russian Federation

    Site Not Available

  • Ryazan Regional Clinical Oncology Dispensary

    Ryazan',
    Russian Federation

    Site Not Available

  • Almazov National Medical Research Centre

    Saint Petersburg,
    Russian Federation

    Site Not Available

  • Centro Oncológico Regional de Galicia

    La Coruña, La Coruna
    Spain

    Site Not Available

  • Hospital Universitari Vall DHebron

    Barcelona,
    Spain

    Site Not Available

  • Universidad Autonoma de Madrid (UAM) - Hospital Universitario La Paz

    Madrid,
    Spain

    Site Not Available

  • City Clinical Hospital Number 4 of Dnipro City Council

    Dnipropetrovs'k,
    Ukraine

    Site Not Available

  • National Cancer Institute of the Ministry of Health of Ukraine

    Kyiv,
    Ukraine

    Site Not Available

  • Lviv Regional Oncology Dispensary

    Lviv,
    Ukraine

    Site Not Available

  • University College London Hospitals

    London, England
    United Kingdom

    Site Not Available

  • East and North Hertfordshire NHS Trust

    Middlesex, England
    United Kingdom

    Site Not Available

  • NHS Greater Glasgow and Clyde

    Glasgow, Scotland
    United Kingdom

    Site Not Available

  • Rocky Mountain Cancer Center

    Lakewood, Colorado 80228
    United States

    Site Not Available

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