Clinical trialPhase 3Completed
Olaparib in gBRCA Mutated Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum-Based Chemotherapy
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
- Outcome
- Outcome unknown
- Phase
- Phase 3
- Status
- Completed
- Study type
- Interventional
- Start
- 16 December 2014
- Expected end
- 27 January 2023
- Enrollment
- 154 participants
- Sites
- 103
- Primary outcomes
- 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)
- Sponsor
- Industry
- Results posted
- 2020-01-27
- Last update
- 13 September 2023
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Papers 8
- Builds on itOverall Survival Results From the POLO Trial: A Phase III Study of Active Maintenance Olaparib Versus Placebo for Germl… DOI 10.1200/jco.21.01604↗
- Builds on itHealth-related quality of life scores of metastatic pancreatic cancer patients responsive to first line chemotherapy co… DOI 10.1186/s12885-022-09661-7↗
- Builds on itCost-Effectiveness Analysis of Olaparib Maintenance Treatment for Germline BRCA-Mutated Metastatic Pancreatic Cancer. DOI 10.3389/fphar.2021.632818↗
- Builds on itCost-Effectiveness Analysis of Maintenance Olaparib in Patients with Metastatic Pancreatic Cancer and a Germline BRCA1/… DOI 10.2147/cmar.s283169↗
- Builds on itGeographic and Ethnic Heterogeneity of Germline BRCA1 or BRCA2 Mutation Prevalence Among Patients With Metastatic Pancr… DOI 10.1200/jco.19.01890↗
- Builds on itHealth-related quality of life in patients with a germline BRCA mutation and metastatic pancreatic cancer receiving mai… DOI 10.1093/annonc/mdz406↗
- Builds on itPhase II trial of veliparib in patients with previously treated BRCA-mutated pancreas ductal adenocarcinoma. DOI 10.1016/j.ejca.2017.11.004↗
- BackgroundMaintenance Olaparib for Germline BRCA-Mutated Metastatic Pancreatic Cancer. DOI 10.1056/nejmoa1903387↗