Abbreviations
OLAP
PLB
92
62
Phase:
3
Double blind
Pancreatic
BRCA1/2 MT
meta
L1
- 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.
- 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