Conditions: Ovarian Breast Prostate Pancreatic Advanced Tumours
Keywords: olaparib PARP inhibitors genetic BRCA1 mutation BRCA2 mutation solid tumour refractory
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 298
Healthy volunteers: no

Brief summary:
To assess the efficacy of oral olaparib in patients with advanced cancer who have a confirmed genetic BRCA1 and/or BRCA2 mutation, by assessment of tumour response

Detailed description:

Arms:
arm 1: Olaparib is available as a film-coated tablet containing 150 mg or 100 mg of olaparib. Subjects will be administered study treatment orally at a dose recommended by Investigator. Full dose: 300 mg twice daily (bid) or Reduced doses: 200 mg twice daily (bid) or 100 mg twice daily (bid). The planned dose of 300 mg bid will be made up of two x 150 mg tablets twice daily, with 100 mg tablets used to manage dose reductions.

Interventions: intervention 1: olaparib
Intervention descriptions: intervention 1: Tablets Oral BID

Protocol document: