Trial of Maintenance With Niraparib- Uterine Serous Carcinoma

Part of paid clinical trials in New Brunswick, New Jersey.

Sponsor
Northwell Health
Study ID
NCT04080284
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Niraparib — DRUG
    Study treatment will be administered orally Q day continuously. Up to three capsules of 100mg strength will be taken at each dose administration. Initiation dose will be defined per current FDA guidelines for Niraparib treatment in ovarian cancer. Dose interruption (no longer than 28 days) will be allowed. Dose reduction will be allowed based on treatment side effects. Dose reductions to 2 capsules daily (200mg) and subsequently to 1 capsule daily (100mg) will be allowed. No further dose reductions will be allowed. The timing of efficacy or safety evaluations should not be affected by dose interruptions or reductions.

Study Details

Uterine serous carcinoma (USC) accounts for up to 40% of endometrial cancer-related deaths. Patients with USC share many genomic and clinical characteristics with patients who has serous ovarian cancer. The objective of this study is to evaluate the efficacy of maintenance Niraparib regimen in patients with advanced or platinum sensitive recurrent uterine serous carcinoma. Additionally, the investigators aim to further describe the safety of this regimen. The investigators hypothesize that Niraparib maintenance will be a well-tolerated treatment and show significant response in patients with uterine serous carcinoma.

Key Dates

Start date
Dec 30, 2019
Status verified
Aug 2025
Primary completion
Jan 1, 2025
Completion
Jan 1, 2025

Study Design

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

Arms

  • Experimental: Niraparib
    Oral niraparib -Cohort - Uterine serous carcinoma

Primary Outcome Measure

PFS [ Time Frame: 1 year ]

Locations (6)

FacilityCityStateZIPSite coordinators
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey07103-
Rutgers NJ School of MedicineNewarkNew Jersey07103-
Imbert Cancer Center Northwell HealthBay ShoreNew York11706-
Greenlawn Cancer Institute, Northwell HealthGreenlawnNew York11740-
RJ Zuckerberg Cancer HospitalNew Hyde ParkNew York11042-
Cancer Institute at Lenox HillNew YorkNew York10075-

Find similar trials in New Brunswick, NJ

By condition
Endometrial cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Rutgers Cancer Institute of New Jersey· New Brunswick, NJRutgers NJ School of Medicine· Newark, NJImbert Cancer Center Northwell Health· Bay Shore, NYGreenlawn Cancer Institute, Northwell Health· Greenlawn, NYRJ Zuckerberg Cancer Hospital· New Hyde Park, NYCancer Institute at Lenox Hill· New York, NY

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