18 Years to 99 Years
Accepting Healthy Volunteers?
Key Inclusion Criteria
- Histologically or cytologically confirmed pancreas adenocarcinoma receiving initial
chemotherapy for metastatic disease and without evidence of disease progression on
- 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
- Documented mutation in gBRCA1 or gBRCA2 that is predicted to be deleterious or
- 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
- 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