Niraparib in High-grade Endometrial Cancer Trial

Sponsor
Sir Mortimer B. Davis - Jewish General Hospital
Study ID
NCT05289648
Phase
EARLY_PHASE1
Status
Withdrawn

Conditions

Eligibility Criteria

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

Interventions

Study Details

The study will investigate the effect of niraparib on tumor tissue in chemotherapy naïve, newly diagnosed, high-grade endometrial cancer patients. Biomarkers of cognate molecular pathways as well as investigational assays will be used to study the antineoplastic effect of the drug.

Key Dates

Start date
May 1, 2024
Status verified
Dec 2024
Primary completion
Oct 31, 2025
Completion
Jan 31, 2026

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Preoperative Niraparib
    Single arm. Following the initial assessment and endometrial biopsy the participants will receive niraparib for 28 days. After the treatment period the patients will be surgically staged. All participants will receive the standard of care.

Primary Outcome Measure

Tumor cells proliferation before and after the treatment [ Time Frame: Day 30 (day of surgery) ]

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