Niraparib in Metastatic Pancreatic Cancer After Previous Chemotherapy (NIRA-PANC): a Phase 2 Trial

Part of paid clinical trials in Fairway, Kansas.

Sponsor
University of Kansas Medical Center
Study ID
NCT03553004
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

The goal of this clinical research study is to learn if Niraparib can help to control metastatic pancreatic cancer. The safety of this drug will also be studied. Niraparib is FDA approved and commercially available for the treatment of ovarian cancer. Its use in this study is investigational.

Key Dates

Start date
Jan 22, 2019
Status verified
May 2023
Primary completion
Apr 25, 2023
Completion
Feb 1, 2025

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Niraparib Treatment
    * Niraparib 300 milligrams (mg) by mouth daily for 28 days (1 cycle = 28 days) * (Dose reduced to 200mg dose for participants whose baseline weight is less than 77 kilograms (kg) \[169.756 pounds (lbs)\] or baseline platelet count is less than 150,000 microliters (µL)).

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: 8 weeks ]

Locations (6)

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