Ovarian Cancer Clinical Trial
CATCH-R: A Rollover Study to Provide Continued Access to Rucaparib
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.
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.
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.
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There is 1 Location for this study
London Ontario, , Canada
Ottawa Ontario, , Canada
Toronto Ontario, , Canada
Montréal Quebec, , Canada
Sherbrooke Quebec, , Canada
Haifa , , Israel
Kfar Saba , , Israel
Candiolo Torino, , Italy
Bologna , , Italy
Milano , , Italy
Napoli , , Italy
Roma , , Italy
Białystok Podlaskie, , Poland
Olsztyn Warminsko-Mazurskie, , Poland
Ufa Bashkortosta, , Russian Federation
Sochi Krasnodar, , Russian Federation
Saransk Mordovia, , Russian Federation
Arkhangel'sk Primorskiy, , Russian Federation
Pyatigorsk Stavropol, , Russian Federation
Moscow , , Russian Federation
Omsk , , Russian Federation
Ryazan' , , Russian Federation
Saint Petersburg , , Russian Federation
London England, , United Kingdom
Middlesex England, , United Kingdom
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