Clinical trialPhase 2Completed
Olaparib in Treating Patients With Stage IV Pancreatic Cancer
Olaparib for BRCAness Phenotype in Pancreatic Cancer: Phase II Study
- Outcome
- Outcome unknown
- Phase
- Phase 2
- Status
- Completed
- Study type
- Interventional
- Start
- 11 November 2016
- Expected end
- 18 July 2022
- Enrollment
- 24 participants
- Sites
- 1
- Primary outcomes
- Objective Response Rate
- Sponsor
- Other
- Results posted
- 2024-10-01
- Last update
- 1 October 2024
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Brief summary public domain (ClinicalTrials.gov)
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 public domain (ClinicalTrials.gov)
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.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Objective Response Rate [5 years 8 months]. Count Of Participants, Participants. Partial Response: Olaparib Monotherapy in Advanced Previously Treated PDAC With BRCAness (n=22): 1. Stable Disease: Olaparib Monotherapy in Advanced Previously Treated PDAC With BRCAness (n=22): 15.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Progression Free Survival [5 years 8 months]. Median, Months (95% Confidence Interval). Olaparib Monotherapy in Advanced Previously Treated PDAC With BRCAness (n=22): 4.83 (3.61 to 7.82).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Survival [5 years 8 months]. Median, Months (95% Confidence Interval). Olaparib Monotherapy in Advanced Previously Treated PDAC With BRCAness (n=22): 16.1 (13.5 to NA) [The upper limit of the 95% CI was not estimable due to insufficient number of participants with events.].