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

Ovarian Cancer Clinical Trial

— CATCH-R  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04676334
• Other study ID #: CO-338-111
• Secondary ID: 2020-001538-37
• Status: Completed
• Phase: Phase 3
• Start date: March 22, 2021
• Est. completion date: March 8, 2023

Study information

• Verified date: April 2024
• Source: pharmaand GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: March 8, 2023
• Est. primary completion date: March 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Epithelial Ovarian Cancer
• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Metastatic Castration-Resistant Prostate Cancer
• Ovarian Cancer
• Ovarian Neoplasms
• Peritoneal Cancer

Intervention

Drug:
• Rucaparib
Rucaparib will be administered daily.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
pharmaand GmbH

Countries where clinical trial is conducted

Canada,  Israel,  Italy,  Poland,  Russian Federation,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Experiencing SAEs and AESIs	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.	From first dose of rucaparib through 28 days after receiving last dose of rucaparib (approximately 20 months)