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Clinical Trial Summary

This phase II trial studies how well olaparib works in treating patients with stage IV pancreatic cancer. Olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.


Clinical Trial Description

PRIMARY OBJECTIVES: I. To determine the efficacy of olaparib monotherapy in stage IV pancreatic ductal adenocarcinoma (PDAC) with breast cancer, early onset (BRCA)ness. SECONDARY OBJECTIVES: I. To further determine the efficacy of olaparib in the study population. SAFETY OBJECTIVES: I. To assess the safety and tolerability of olaparib. EXPLORATORY OBJECTIVES: I. To identify tissue based biomarkers of defective homologous recombination repair (HRD). OUTLINE: Patients receive olaparib orally (PO) twice daily (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and then every 8 weeks thereafter. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02677038
Study type Interventional
Source M.D. Anderson Cancer Center
Contact
Status Completed
Phase Phase 2
Start date November 11, 2016
Completion date July 18, 2022

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