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

Phase 3

Completed

Conditions: Ovarian Cancer
Peritoneal Cancer
Epithelial Ovarian Cancer
Other Solid Tumor
Metastatic Castration-Resistant Prostate Cancer
Fallopian Tube Cancer

Interventions: Drug: Rucaparib

Registration Number: NCT04676334

Lead Sponsor: pharmaand GmbH

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 34

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.

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of Participants Experiencing SAEs and AESIs	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.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (25): Carmel Medical Center
🇮🇱
Haifa, Israel
Istituto per la Ricerca e la Cura del Cancro Istituto di Candiolo
🇮🇹
Candiolo, Torino, Italy
Institut De Recherche De L'Hospital D'Ottawa
🇨🇦
Ottawa, Ontario, Canada
Princess Margaret Hospital - Toronto
🇨🇦
Toronto, Ontario, Canada
Meir Medical Center
🇮🇱
Kfar Saba, Israel
CIUSSS de l'Estrie - CHUS
🇨🇦
Sherbrooke, Quebec, Canada
Białostockie Centrum Onkologii im. Marii Skłodowskiej-Curie
🇵🇱
Białystok, Podlaskie, Poland
Republic Clinical Oncology Dispensary of the Ministry of Healthcare of Republic of Bashkortostan
🇷🇺
Ufa, Bashkortosta, Russian Federation
Arkhangelsk Clinical Oncological Dispensary
🇷🇺
Arkhangel'sk, Primorskiy, Russian Federation
East and North Hertfordshire NHS Trust
🇬🇧
Middlesex, England, United Kingdom
Republican oncological dispensary of Republic of Mordovia
🇷🇺
Saransk, Mordovia, Russian Federation
Pyatigorsk Oncological Dispensary
🇷🇺
Pyatigorsk, Stavropol, Russian Federation
Omsk Regional Clinical Oncologic Dispensary
🇷🇺
Omsk, Russian Federation
Fondazione Policlinico Universitario Agostino Gemelli
🇮🇹
Roma, 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
London Regional Cancer Centre
🇨🇦
London, Ontario, Canada
N.N. Blokhin Russian Cancer Research Center
🇷🇺
Moscow, Russian Federation
Wojewódzki Szpital Specjalistyczny w Olsztynie
🇵🇱
Olsztyn, Warminsko-Mazurskie, Poland
State Healthcare Institution Oncologic Dispensary No. 2 - Health Department of Krasnodar Region
🇷🇺
Sochi, Krasnodar, Russian Federation
Centre Hospitalier de L'Universite de Montreal (CHUM)
🇨🇦
Montréal, Quebec, Canada
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