Niraparib in Patients With Pancreatic Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Pancreatic Cancer
- 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
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...
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.
Tracking Information
- NCT #
- NCT03601923
- Collaborators
- Tesaro, Inc.
- Investigators
- Principal Investigator: James Cleary, MD, PhD Dana-Farber Cancer Institute