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

Sponsor

Clovis Oncology, Inc. (Industry)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04676334

Collaborator

(none)

250

Enrollment

Locations

Arm

33.4

Anticipated Duration (Months)

6.6

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This protocol is designed to provide patients currently benefiting from rucaparib treatment in a Clovis-sponsored clinical study with continued access to treatment for as long as they continue to benefit. Patients 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.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Castration-Resistant Prostate Cancer Ovarian Cancer Epithelial Ovarian Cancer Fallopian Tube Cancer Peritoneal Cancer Other Solid Tumor	Drug: Rucaparib	Phase 3

Detailed Description

Patients 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. Patients who are no longer receiving treatment and are in LTFU in the parent study 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.

Patients 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 patient 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 patient consent. If a patient continues treatment post-progression, all study assessments should be continued per institutional standard of care. The patient should be discontinued from treatment once it is clear that no further clinical benefit can be achieved.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

250 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 22, 2021

Anticipated Primary Completion Date :

Nov 2, 2023

Anticipated Study Completion Date :

Jan 2, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Rucaparib Rucaparib administered at dose and schedule last taken in parent study, or per investigator decision	Drug: Rucaparib Rucaparib will be administered daily. Other Names: CO-338 Rubraca

Arm

Intervention/Treatment

Experimental: Rucaparib

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

Drug: Rucaparib

Rucaparib will be administered daily.

Other Names:

CO-338

Rubraca

Outcome Measures

Primary Outcome Measures

Safety follow-up [Baseline up to approximately 3 years]
Serious adverse events and adverse events of special interest reported until 30 days after the last dose of study drug.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 patient 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 patients considered for continuation of rucaparib treatment):

Patient 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 patient inappropriate for continuation of rucaparib treatment.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rocky Mountain Cancer Center	Lakewood	Colorado	United States	80228
2	Hospital Haroldo Juaçaba Instituto do Câncer do Ceará	Fortaleza	Ceara	Brazil
3	Instituto de Oncologia do Paraná (IOP)	Curitiba	Parana	Brazil
4	Instituto Nacional de Câncer Hospital do Câncer II	Santo Cristo	Rio De Janeiro	Brazil
5	CEPON - Centro de pesquisas Oncologicas	Florianópolis	Santa Catarina	Brazil
6	Hospital de Câncer de Barretos	Barretos	Sao Paulo	Brazil
7	Instituto Brasileiro de Controle do Cancer (IBCC)	São Paulo	Sao Paulo	Brazil
8	London Regional Cancer Centre	London	Ontario	Canada
9	Insitut De Recherche De L'Hospital D'Ottawa	Ottawa	Ontario	Canada
10	Princess Margaret Hospital - Toronto	Toronto	Ontario	Canada
11	Centre Hospitalier de L'Universite de Montreal (CHUM)	Montréal	Quebec	Canada
12	CIUSSS de l'Estrie - CHUS	Sherbrooke	Quebec	Canada
13	Fakultní nemocnice v Motole	Praha 5	Praha	Czechia
14	Fakultní Nemocnice Ostrava	Ostrava		Czechia
15	Országos Onkológiai Intézet	Budapest		Hungary
16	Carmel Medical Center	Haifa		Israel
17	Meir Medical Center	Kfar Saba		Israel
18	Istituto per la Ricerca e la Cura del Cancro Istituto di Candiolo	Candiolo	Torino	Italy
19	Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi	Bologna		Italy
20	Istituto Europeo di Oncologia	Milano		Italy
21	Istituto Nazionale per lo studio e la cura dei tumori "Fondazione Pascale" Oncologia Medica	Napoli		Italy
22	Fondazione Policlinico Universitario Agostino Gemelli	Roma		Italy
23	Białostockie Centrum Onkologii im. Marii Skłodowskiej-Curie	Białystok	Podlaskie	Poland
24	Wojewódzki Szpital Specjalistyczny w Olsztynie	Olsztyn	Warminsko-Mazurskie	Poland
25	Republic Clinical Oncology Dispensary of the Ministry of Healthcare of Republic of Bashkortostan	Ufa	Bashkortosta	Russian Federation
26	State Healthcare Institution Oncologic Dispensary No. 2 - Health Department of Krasnodar Region	Sochi	Krasnodar	Russian Federation
27	Republican oncological dispensary of Republic of Mordovia	Saransk	Mordovia	Russian Federation
28	Arkhangelsk Clinical Oncological Dispensary	Arkhangel'sk	Primorskiy	Russian Federation
29	Pyatigorsk Oncological Dispensary	Pyatigorsk	Stavropol	Russian Federation
30	N.N. Blokhin Russian Cancer Research Center	Moscow		Russian Federation
31	Omsk Regional Clinical Oncologic Dispensary	Omsk		Russian Federation
32	Ryazan Regional Clinical Oncology Dispensary	Ryazan'		Russian Federation
33	Almazov National Medical Research Centre	Saint Petersburg		Russian Federation
34	Centro Oncológico Regional de Galicia	La Coruña	La Coruna	Spain
35	Hospital Universitari Vall DHebron	Barcelona		Spain
36	Universidad Autonoma de Madrid (UAM) - Hospital Universitario La Paz	Madrid		Spain
37	University College London Hospitals	London	England	United Kingdom
38	East and North Hertfordshire NHS Trust	Middlesex	England	United Kingdom