Niraparib and Selenium for the Treatment of Recurrent BRCA Negative Platinum Resistant Ovarian Cancer

Sponsor
City of Hope Medical Center
Study ID
NCT05672095
Phase
PHASE1/PHASE2
Status
Withdrawn

Conditions

  • Platinum-Resistant Fallopian Tube Carcinoma
  • Platinum-Resistant Ovarian Carcinoma
  • Platinum-Resistant Primary Peritoneal Carcinoma
  • Recurrent Fallopian Tube Carcinoma
  • Recurrent Ovarian Carcinoma
  • Recurrent Primary Peritoneal Carcinoma

Eligibility Criteria

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

Interventions

  • Biopsy — PROCEDURE
    Undergo needle or core biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Niraparib — DRUG
    Given PO
  • Questionnaire Administration — OTHER
    Ancillary studies
  • Selenium — DIETARY_SUPPLEMENT
    Given IV

Study Details

This phase I/II trial tests the safety, side effects and best dose of a combination therapy (niraparib and selenium) in treating patients with BRCA negative ovarian cancer that has come back (recurrent) and does not respond to platinum based therapy (platinum resistant). Selenium is a form of the trace element with potential antineoplastic activity which may help block the formation of growths that may become cancer. Niraparib is in a class of medications called poly (ADP-ribose) polymerase inhibitors. It works by killing cancer cells and helps maintain the response of certain types of ovarian, fallopian tube and peritoneal cancers. Giving selenium and niraparib may kill more cells in patients with ovarian cancer.

Key Dates

Start date
Apr 18, 2025
Status verified
May 2025
Primary completion
Nov 27, 2026
Completion
Nov 27, 2026

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (selenium, niraparib)
    Patients receive selenium IV and niraparib PO on study. Patients also undergo CT, MRI, biopsy, and collection of blood samples throughout the trial.

Primary Outcome Measure

Dose Limiting Toxicity (Phase I) [ Time Frame: Up to 3 years ]

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