Olaparib in Treating Patients With Stage IV Pancreatic Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 24
Summary
- Conditions
- Metastatic Pancreatic Adenocarcinoma
- Pancreatic Ductal Adenocarcinoma
- Stage IV Pancreatic Cancer AJCC v6 and v7
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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...
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.
Tracking Information
- NCT #
- NCT02677038
- Collaborators
- National Cancer Institute (NCI)
- AstraZeneca
- Investigators
- Principal Investigator: Milind Javle M.D. Anderson Cancer Center
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