Phase I/II Safety, PK & Efficacy Study of Oral Rucaparib

• Research type

  Research Study

• Full title

  A Phase I/II, Open-Label, Safety, Pharmacokinetic, and Preliminary Efficacy Study of Oral Rucaparib in Patients with gBRCA Mutation Ovarian Cancer, or Other Solid Tumor

• IRAS ID

  95258

• Contact name

  Rebecca Kristeleit

• Sponsor organisation

  Clovis Oncology Inc.

• Eudract number

  2011-004250-26

• ISRCTN Number

  n/a

• Research summary

  The purpose of the phase I/II, open label clinical trial is to investigate the safety, efficacy and PK properties of the experimental drug rucaparib, which is under investigation for the treatment of cancer. In Part 1, rucaparib will be given on a continuous daily basis to patients with solid tumours who have progressed on prior treatment. The starting dose will be 40mg daily which, will be escalated in 20%-100% increments in subsequent groups of patients. In Part 2, rucaparib will be administered at the optimal dose identified in Part 1 of the study to patients with locally advanced or metastatic breast cancer with evidence of a germline mutation of the BRCA1 or BRCA2 gene (gBRCA) who have failed at least one, but no more than three, prior regimens in the advanced or metastatic setting. It is anticipated that rucaparib will promote cell death in the BRCA-deficient tumour cells of these patients, thereby limiting tumour progression and providing therapeutic benefit. This is a multicenter, multinational study. Patients will be enrolled from 4 study sites in Part 1, and from 25 to 40 study sites in Part 2. The first part of the study will take last 10-12 months. Part 1 will include 28??40 patients, and part 2 will have up 44 patients; patients will enrol into either Part 1 or Part 2 of the study, not both.

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  11/LO/2036

• Date of REC Opinion

  2 Feb 2012

• REC opinion

  Further Information Favourable Opinion