NCT02677038

Olaparib in Treating Patients With Stage IV Pancreatic Cancer

Olaparib for BRCAness Phenotype in Pancreatic Cancer: Phase II Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Pancreatic Adenocarcinoma
• Pancreatic Ductal Adenocarcinoma
• Stage IV Pancreatic Cancer AJCC v6 and v7

Interventions

Type	Name	Description
DRUG	Olaparib	Given PO

Timeline

• Start date: 2016-11-11
• Primary completion: 2022-07-18
• Completion: 2022-07-18
• First posted: 2016-02-09
• Last updated: 2024-10-01
• Results posted: 2024-10-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study