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

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ClinicalTrials.gov Identifier: NCT04676334
Recruitment Status : Enrolling by invitation
First Posted : December 21, 2020
Last Update Posted : July 19, 2021
Sponsor:
Information provided by (Responsible Party):
Clovis Oncology, Inc.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 22, 2021
Estimated Primary Completion Date : November 2, 2023
Estimated Study Completion Date : January 2, 2024


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




Primary Outcome Measures :
  1. Safety follow-up [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04676334


Locations
Show Show 45 study locations
Sponsors and Collaborators
Clovis Oncology, Inc.
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Responsible Party: Clovis Oncology, Inc.
ClinicalTrials.gov Identifier: NCT04676334    
Other Study ID Numbers: CO-338-111
First Posted: December 21, 2020    Key Record Dates
Last Update Posted: July 19, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Clovis Oncology, Inc.:
rucaparib
mCRPC
ovarian cancer
PARP inhibitor
PARPi
CRPC
solid tumor
Clovis Oncology
Antineoplastic agents
Genital Neoplasms, male
Prostatic Neoplasms
Ovarian Neoplasms
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Fallopian Tube Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Fallopian Tube Diseases
Rucaparib
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents