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

Conditions

• Germline BRCA1/2 Mutations and
• Metastatic Adenocarcinoma of the Pancreas

Eligibility Criteria

Sex

ALL

Age

18 Years - 130 Years

Healthy Volunteers

Not accepted

Interventions

• Olaparib — DRUG
  Tablet -100mg
• Olaparib — DRUG
  Tablet-150mg
• Placebo — DRUG
  Match Olaparib 100mg placebo
• Placebo — DRUG
  Match Olaparib 150mg placebo

Study Details

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

Key Dates

Start date

Dec 16, 2014

Status verified

Jun 2023

Primary completion

Jan 15, 2019

Completion

Jan 27, 2023

Study Design

Enrollment

154 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Olaparib
  Olaparib tablets po. 300 mg twice daily
• Placebo Comparator: Placebo
  Placebo tablets twice daily

Primary Outcome Measure

Progression-free Survival (PFS) by Blinded Independent Central Review (BICR) Using Modified Response Evaluation Criteria in Solid Tumours. This Study Used Modified RECIST Version (v) 1.1 (RECIST v1.1) [ Time Frame: Up to 4 years ]

Locations (20)

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