Olaparib in gBRCA Mutated Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum-Based Chemotherapy
Trial ID or NCT#
NCT02184195
Status
NOT RECRUITING
Purpose
A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Maintenance Olaparib Monotherapy in Patients with gBRCA Mutated Metastatic Pancreatic Cancer whose Disease Has Not Progressed on First Line Platinum Based Chemotherapy
Official Title
A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Maintenance Olaparib Monotherapy in Patients With gBRCA Mutated Metastatic Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum Based Chemotherapy
Eligibility Criteria
Ages Eligible for Study: 18 Years to 130 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
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
Contact us to find out if this trial is right for you.
Contact
Ivy Lau
650-721-8899
View on ClinicalTrials.gov
