Spots Global Cancer Trial Database for CATCH-R: A Rollover Study to Provide Continued Access to Rucaparib
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Trial Identification
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
Study ID: NCT04676334
Interventions
Study Description
Brief 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.
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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Contact Details
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