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

Titre officiel

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

Sommaire:

Ce protocole est conçu pour permettre aux patients bénéficiant actuellement d’un traitement par le rucaparib dans le cadre d’une étude clinique commanditée par Clovis de continuer à bénéficier du traitement aussi longtemps qu’ils en profiteront. Les patients faisant l’objet d’un suivi à long terme (SLT) dans une étude principale peuvent également s’inscrire dans cette étude pour la poursuite de la collecte de données, le cas échéant en fonction des objectifs de l’étude principale.

Description de l'essai

Primary Outcome:

  • Safety follow-up
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.

Voir cet essai sur ClinicalTrials.gov

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