Recruitment

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