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

Clovis Oncology, Inc.0 个研究点目标入组 155 人开始时间: 2021年6月8日最近更新: 2021年11月15日

适应症

试验速览

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•Eligible patients must be currently enrolled in a Clovis-sponsored study of rucaparib that is being closed and have signed and dated an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved Informed Consent Form (ICF); are currently tolerating and benefitting from rucaparib treatment in the parent study, as assessed by the investigator, or have discontinued treatment and be in follow-up for collection of LTFU data; have demonstrated compliance with the parent study requirements and are able and willing to comply with the necessary study visits and assessments as part of the rollover study; and for patients continuing treatment with rucaparib, have not received any intervening anticancer therapy since discontinuing the parent study.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 105
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 50

•Patients will be excluded from receiving further rucaparib treatment if they have been permanently discontinued from rucaparib in the parent study for any reason. Women of childbearing potential (WOCBP) must not be considering getting pregnant during continued treatment and for 6 months following the last dose of rucaparib. Male patients with female partners of reproductive potential or who are pregnant who refuse to use effective contraception during treatment and for 3 months following the last dose of rucaparib are excluded. Male patients who are considering making semen donations during treatment or within 3 months following the last dose of rucaparib will also be excluded.

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