Olaparib in gBRCA Mutated Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum-Based Chemotherapy

Key Inclusion Criteria

   - Histologically or cytologically confirmed pancreas adenocarcinoma receiving initial
   chemotherapy for metastatic disease and without evidence of disease progression on
   treatment

   - Patients with measurable disease and/or non-measurable or no evidence of disease
   assessed at baseline by CT (or MRI where CT is contraindicated) will be entered in
   this study.

   - Documented mutation in gBRCA1 or gBRCA2 that is predicted to be deleterious or
   suspected deleterious

   - Patients are on treatment with a first line platinum-based (cisplatin, carboplatin or
   oxaliplatin) regimen for metastatic pancreas cancer, have received a minimum of 16
   weeks of continuous platinum treatment and have no evidence of progression based on
   investigator's opinion.

   - Patients who have received platinum as potentially curative treatment for a prior
   cancer (eg ovarian cancer) or as adjuvant/neoadjuvant treatment for pancreas cancer
   are eligible provided at least 12 months have elapsed between the last dose of
   platinum-based treatment and initiation of the platinum-based chemotherapy for
   metastatic pancreas cancer.

Major Exclusion Criteria:

   - gBRCA1 and/or gBRCA2 mutations that are considered to be non detrimental (eg,
   "Variants of uncertain clinical significance" or "Variant of unknown significance" or
   "Variant, favour polymorphism" or "benign polymorphism" etc.)

   - Progression of tumour between start of first line platinum based chemotherapy for
   metastatic pancreas cancer and randomisation.

   - Cytotoxic chemotherapy or non-hormonal targeted therapy within 28 days of Cycle

   1 Day 1 is not permitted.

   - Exposure to an investigational product within 30 days or 5 half lives (whichever is
   longer) prior to randomisation

   - Any previous treatment with a PARP inhibitor, including Olaparib