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Brief Title: Olaparib in Treating Patients With Stage IV Pancreatic Cancer
Official Title: Olaparib for BRCAness Phenotype in Pancreatic Cancer: Phase II Study
Study ID: NCT02677038
Brief 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.
Detailed 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
M D Anderson Cancer Center, Houston, Texas, United States
Name: Milind Javle
Affiliation: M.D. Anderson Cancer Center
Role: PRINCIPAL_INVESTIGATOR