Olaparib in gBRCA Mutated Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum-Based Chemotherapy
Condition: Germline BRCA1/2 Mutations and; Metastatic Adenocarcinoma of the Pancreas
MeSH terms: Adenocarcinoma; Pancreatic Neoplasms
Intervention: Olaparib; Olaparib; Placebo; Placebo
Intervention description: Tablet -100mg; Tablet-150mg; Match Olaparib 100mg placebo; Match Olaparib 150mg placebo
Intervention MeSH terms: Olaparib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 154.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: BRCA, metastatic adenocarcinoma pancreas, maintenance olaparib monotherapy, first line platinum chemotherapy, pancreatic cancer, PARP inhibitor

Summary:

      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:

        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