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

NCT04676334 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: CO-338-1112020-001538-37
• Study Type: interventional
• Target: 34
• Locations: 6 countries
• Sites: 25

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.

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

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

Rucaparib

EXPERIMENTAL

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

Drug: Rucaparib

Long-term Follow-up

NO INTERVENTION

Participants discontinued rucaparib treatment and were in long-term follow-up in the parent study.

Interventions

Rucaparib DRUG

Rucaparib will be administered daily.

Also known as: CO-338, Rubraca

Rucaparib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• pharmaand GmbH: lead

Study Sites (25)

London Regional Cancer Centre

London, Ontario, Canada

Location

Institut De Recherche De L'Hospital D'Ottawa

Ottawa, Ontario, Canada

Location

Princess Margaret Hospital - Toronto

Toronto, Ontario, Canada

Location

Centre Hospitalier de L'Universite de Montreal (CHUM)

Montreal, Quebec, Canada

Location

CIUSSS de l'Estrie - CHUS

Sherbrooke, Quebec, Canada

Location

Carmel Medical Center

Haifa, Israel

Location

Meir Medical Center

Kfar Saba, Israel

Location

Istituto per la Ricerca e la Cura del Cancro Istituto di Candiolo

Candiolo, Torino, Italy

Location

Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi

Bologna, Italy

Location

Istituto Europeo di Oncologia

Milan, Italy

Location

Istituto Nazionale per lo studio e la cura dei tumori "Fondazione Pascale" Oncologia Medica

Napoli, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli

Roma, Italy

Location

Białostockie Centrum Onkologii im. Marii Skłodowskiej-Curie

Bialystok, Podlaskie Voivodeship, Poland

Location

Wojewódzki Szpital Specjalistyczny w Olsztynie

Olsztyn, Warmian-Masurian Voivodeship, Poland

Location

Republic Clinical Oncology Dispensary of the Ministry of Healthcare of Republic of Bashkortostan

Ufa, Bashkortosta, Russia

Location

State Healthcare Institution Oncologic Dispensary No. 2 - Health Department of Krasnodar Region

Sochi, Krasnodarskiy Kray, Russia

Location

Arkhangelsk Clinical Oncological Dispensary

Arkhangel'sk, Primorskiy (Maritime) Kray, Russia

Location

Republican oncological dispensary of Republic of Mordovia

Saransk, Respublika Mordoviya, Russia

Location

Pyatigorsk Oncological Dispensary

Pyatigorsk, Stavropol Kray, Russia

Location

N.N. Blokhin Russian Cancer Research Center

Moscow, Russia

Location

Omsk Regional Clinical Oncologic Dispensary

Omsk, Russia

Location

Ryazan Regional Clinical Oncology Dispensary

Ryazan, Russia

Location

Almazov National Medical Research Centre

Saint Petersburg, Russia

Location

University College London Hospitals

London, England, United Kingdom

Location

East and North Hertfordshire NHS Trust

Middlesex, England, United Kingdom

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms; Genital Neoplasms, Male; Prostatic Neoplasms

Interventions

rucaparib

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Fallopian Tube Diseases; Genital Diseases, Male; Male Urogenital Diseases; Prostatic Diseases

Limitations and Caveats

Only SAE and AESI safety data were collected, other (non-serious) AEs were not collected. Safety data were collected only for the Rucaparib arm (participants who received rucaparib during this study); safety data were not collected for the Long-term Follow-up arm (participants who did not receive rucaparib during this study).

Results Point of Contact

• Title: Medical Information Department
• Organization: pharmaand GmbH

medinfo@pharmaand.com

+43/1/3560006

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2020
• First Posted: December 21, 2020
• Study Start: March 22, 2021
• Primary Completion: March 8, 2023
• Study Completion: March 8, 2023
• Last Updated: May 7, 2024
• Results First Posted: May 7, 2024

Record last verified: 2024-04

Locations

RU (9); PL (2); GB (2); IL (2); CA (5); IT (5)