CATCH - R

• Research type

  Research Study

• Full title

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

• IRAS ID

  1003782

• Contact name

  Safa Khan

• Contact email

  praregulatoryaffairs@prahs.com

• Sponsor organisation

  Clovis Oncology, Inc.

• Eudract number

  2020-001538-37

• Clinicaltrials.gov Identifier

  NCT04676334

• Research summary

  This is a multicenter, open-label rollover study providing rucaparib as treatment across multiple solid tumour types for participants previously enrolled in a parent study and who, in the opinion of the investigator, would benefit from continued treatment following closure of the parent study. This study is also designed to continue collection of LTFU (long term follow up) data following closure of the parent study(ies). The study will enroll participants who are continuing rucaparib treatment and/or for whom LTFU data are being collected following participation in a Clovis-sponsored study that is being closed.

  Participants continuing rucaparib will receive the same treatment at the start of this study as they last received in the parent study or may receive a different dose per investigator decision and available dose strength tablets. It is anticipated that participants will have received approximately a minimum of 6 months rucaparib treatment in the parent study before rolling into this study. Those participants who have consented to LTFU will be followed for data collection, as applicable based on parent study objectives. Participants will be assessed for disease status/progression per institutional standard of care.
  Treatment will continue until the participants no longer receives benefit, in the opinion of the investigator, unacceptable toxicity, withdrawal of consent, death, loss to follow-up, or study closure by the Sponsor. Participants receiving rucaparib will have all protocol-required assessments specified in the Schedule of Assessments until the discontinuation of treatment, with a final safety assessment approximately 28 days following the last dose of study treatment. Participants will be followed approximately every 12 weeks for collection of LTFU data.

  Overall, it is estimated that the study duration will be approximately 5 years and that approximately 500 participants at approximately 100 sites, worldwide, may participate.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  21/LO/0466

• Date of REC Opinion

  9 Aug 2021

• REC opinion

  Further Information Favourable Opinion