Ovarian Cancer Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

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 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 is for people with:

Ovarian Cancer

Phase:

Phase 3

Estimated Enrollment:

34

Study ID:

NCT04676334

Recruitment Status:

Completed

Sponsor:

pharmaand GmbH

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There is 1 Location for this study

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

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 3

Estimated Enrollment:

34

Study ID:

NCT04676334

Recruitment Status:

Completed

Sponsor:


pharmaand GmbH

How clear is this clinincal trial information?

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