NCT03601923

Niraparib in Patients With Pancreatic Cancer

Phase 2 Proof-of-Concept Trial Testing the PARP Inhibitor Niraparib in Patients With Pancreatic Cancer Harboring Deficiencies in Homologous Recombination DNA Repair

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is studying an investigational therapy as a possible treatment for pancreatic cancer. The drugs involved in this study are: -Niraparib

Detailed description

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. The FDA (the U.S. Food and Drug Administration) has not approved niraparib for this specific disease but it has been approved for other uses. Niraparib belongs to a class of anti-cancer agents known as PARP (poly ADP ribose polymerase) inhibitors. PARP is a protein in the body that repairs damage to DNA (one of the building blocks of a cell). In cells that are rapidly growing, such as cancer cells, blocking repair of DNA may be of benefit, since it will cause the cell to die. In this research study, the investigators are looking to test the effectiveness of niraparib in patients with pancreatic cancer. The trial is focused on pancreatic cancer patients that have marker, a mutation in a DNA repair gene, suggesting that their cancer might be susceptible to niraparib.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Niraparib	Niraparib belongs to a class of anti-cancer agents known as PARP (poly ADP ribose polymerase) inhibitors. PARP is a protein in the body that repairs damage to DNA (one of the building blocks of a cell). In cells that are rapidly growing, such as cancer cells, blocking repair of DNA may be of benefit, since it will cause the cell to die. Niraparib will be given at an initial dose of 200mg or 300 mg by mouth once daily depending on the patient's platelet count and weight at the start of the trial.

Timeline

• Start date: 2018-08-22
• Primary completion: 2025-12-31
• Completion: 2026-02-28
• First posted: 2018-07-26
• Last updated: 2026-03-25

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study