NCT05672095

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

Phase I/II Trial of Niraparib/Selenium Combination Treatment in Patients With BRCA1/2-Wild Type Recurrent Platinum-Resistant Ovarian Cancer

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVES: I. To assess the safety, tolerability and feasibility of administering niraparib/selenium combination therapy. (Phase I) II. To determine the anti-tumor activity of niraparib/selenium combination therapy, as assessed by median progression-free survival (PFS). (Phase II) III. To evaluate the tolerability of the combination therapy as assessed by a reduction in nausea, fatigue over historical rates. (Phase II) SECONDARY OBJECTIVES: I. To evaluate the impact of treatment on quality of life over time, as evaluated by the Functional Assessment of Cancer Therapy - Ovarian Cancer (FACT-O) scores. (Phase I and Phase II) II. To estimate overall survival (OS), overall response rate (ORR), disease control rate (DCR), response duration and time to progression (TTP). (Phase I and Phase II) CORRELATIVE OBJECTIVES: I. To evaluate the molecular effects of selenium/niraparib combination therapy in ovarian tumors, as assessed by (Phase I and Phase II): Ia. Changes in RAD51 foci formation which is a surrogate marker to examine homologous recombination by looking at tumor tissue prior to study and after 2 months of study therapy; Ib. By DNA full exome and RNA sequencing of tumors, protein profiling, prior to study and after 2 months of study therapy; Ic. Changes in RAD51AP1 expression in tumor tissue by Western blot prior to study and after 2 months of study therapy; Id. Changes in the endosomal vesicles (EV) markers in the urine, vaginal secretions, malignant effusions and plasma. OUTLINE: This is a dose-escalation study of niraparib and selenium followed by a dose-expansion study. Patients are assigned to 1 of 2 phases. Patients receive selenium intravenously (IV) and niraparib orally (PO) on study. Patients also undergo computed tomography (CT), magnetic resonance imaging (MRI), biopsy, and collection of blood samples throughout the trial.

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

Interventions

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

Timeline

• Start date: 2025-04-18
• Primary completion: 2026-11-27
• Completion: 2026-11-27
• First posted: 2023-01-05
• Last updated: 2025-05-23

Regulatory

• FDA-regulated drug study