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 iconNOT 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:
  1. * 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. 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