Clinical trial NCT04676334: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Metastatic Castration-Resistant Prostate Cancer
Ovarian Cancer
Epithelial Ovarian Cancer
Fallopian Tube Cancer
Peritoneal Cancer
Other Solid Tumor
Keywords: rucaparib
mCRPC
ovarian cancer
PARP inhibitor
PARPi
CRPC
solid tumor
Clovis Oncology
Antineoplastic agents
Genital Neoplasms, male
Prostatic Neoplasms
Ovarian Neoplasms
Lead sponsor: pharmaand GmbH
Sponsor class: INDUSTRY
First posted: 2020-12-21
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Number of Participants Experiencing SAEs and AESIs
timeFrame: From first dose of rucaparib through 28 days after receiving last dose of rucaparib (approximately 20 months)
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: Canada
facility: London Regional Cancer Centre
state: Ontario
city: Ottawa
country: Canada
facility: Institut De Recherche De L'Hospital D'Ottawa
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital - Toronto
state: Ontario
city: Montréal
country: Canada
facility: Centre Hospitalier de L'Universite de Montreal (CHUM)
state: Quebec
city: Sherbrooke
country: Canada
facility: CIUSSS de l'Estrie - CHUS
state: Quebec
city: Haifa
country: Israel
facility: Carmel Medical Center
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Candiolo
country: Italy
facility: Istituto per la Ricerca e la Cura del Cancro Istituto di Candiolo
state: Torino
city: Bologna
country: Italy
facility: Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia
city: Napoli
country: Italy
facility: Istituto Nazionale per lo studio e la cura dei tumori "Fondazione Pascale" Oncologia Medica
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli
city: Białystok
country: Poland
facility: Białostockie Centrum Onkologii im. Marii Skłodowskiej-Curie
state: Podlaskie
city: Olsztyn
country: Poland
facility: Wojewódzki Szpital Specjalistyczny w Olsztynie
state: Warminsko-Mazurskie
city: Ufa
country: Russian Federation
facility: Republic Clinical Oncology Dispensary of the Ministry of Healthcare of Republic of Bashkortostan
state: Bashkortosta
city: Sochi
country: Russian Federation
facility: State Healthcare Institution Oncologic Dispensary No. 2 - Health Department of Krasnodar Region
state: Krasnodar
city: Saransk
country: Russian Federation
facility: Republican oncological dispensary of Republic of Mordovia
state: Mordovia
city: Arkhangel'sk
country: Russian Federation
facility: Arkhangelsk Clinical Oncological Dispensary
state: Primorskiy
city: Pyatigorsk
country: Russian Federation
facility: Pyatigorsk Oncological Dispensary
state: Stavropol
city: Moscow
country: Russian Federation
facility: N.N. Blokhin Russian Cancer Research Center
city: Omsk
country: Russian Federation
facility: Omsk Regional Clinical Oncologic Dispensary
city: Ryazan'
country: Russian Federation
facility: Ryazan Regional Clinical Oncology Dispensary
city: Saint Petersburg
country: Russian Federation
facility: Almazov National Medical Research Centre
city: London
country: United Kingdom
facility: University College London Hospitals
state: England
city: Middlesex
country: United Kingdom
facility: East and North Hertfordshire NHS Trust
state: England
Study officials:
References: