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

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Trial ID: NCT02184195

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


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

Intervention(s):

drug: Olaparib

drug: Olaparib

drug: Placebo

drug: Placebo

Recruiting

I'm Interested

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Ivy Lau
650-721-8899

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