A Trial of Niraparib in Platinum-Sensitive Castration-Resistant Prostate Cancer With DNA Repair Defects

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Abramson Cancer Center at Penn Medicine
Study ID
NCT04288687
Phase
PHASE2
Status
Completed

Conditions

  • Prostate Adenocarcinoma

Eligibility Criteria

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

Interventions

  • Niraparib Pill — DRUG
    Niraparib 200 mg by mouth daily (2 x 100 mg pills)

Study Details

This study is designed to evaluate the initial safety and effectiveness of an investigational drug, niraparib, given to patients who have recently received platinum-based chemotherapy for the treatment of prostate cancer. The study enrolls participants with history of advanced prostate cancer that is growing despite standard hormonal therapies, such as androgen-deprivation therapy.

Key Dates

Start date
Oct 19, 2020
Status verified
Jan 2026
Primary completion
Feb 20, 2024
Completion
Feb 20, 2024

Study Design

Enrollment
11 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Niraparib Arm (only arm)
    Niraparib 200 mg by mouth daily (2 x 100 mg pills) on a 28 day cycle

Primary Outcome Measure

6-Month Radiographic Progression-Free Survival (rPFS6) [ Time Frame: 6 months from initiation of maintenance niraparib therapy ]

Locations (1)

FacilityCityStateZIPSite coordinators
Abramson Cancer Center of the University of PennsylvaniaPhiladelphiaPennsylvania19104-

Find similar trials in Philadelphia, PA

By research site
Abramson Cancer Center of the University of Pennsylvania· Philadelphia, PA

Related Studies