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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05672095
Other study ID # 23231
Secondary ID NCI-2022-1020320
Status Not yet recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date July 18, 2024
Est. completion date November 27, 2026

Study information

Verified date April 2024
Source City of Hope Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


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Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Biopsy
Undergo needle or core biopsy
Biospecimen Collection
Undergo blood sample collection
Drug:
Niraparib
Given PO
Other:
Questionnaire Administration
Ancillary studies
Dietary Supplement:
Selenium
Given IV

Locations

Country Name City State
United States City of Hope Medical Center Duarte California

Sponsors (2)

Lead Sponsor Collaborator
City of Hope Medical Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Dose Limiting Toxicity (Phase I) Toxicity will be evaluated by adverse events. Observed toxicities will be summarized based on highest dose, severity, time of onset, duration, probable association with the study treatment and reversibility of outcome. For continuous variable, descriptive statistics (number [n], mean, standard deviation, standard error, median range will be provided. Up to 3 years
Primary Progression-free Survival (PFS) (Phase II) PFS will be estimated using the Kaplan-Meier product limit method. From start of selenium treatment until date of death, relapse/progression, or last contact date, whichever comes first, assessed up to 3 years
Primary Tolerability (Phase II) Tolerability will be assessed using the CTCAE 5.0. Reduction in percentage of patients experiencing nausea and fatigue. Up to 3 years
Secondary Overall Response Rate (ORR) ORR to be evaluated by the proportion of patients with either a complete response or a partial response relative to the total number of patients. Up to 3 years
Secondary Disease Control Rate Clinical benefit response is the best response recorded from start of treatment until disease progression/recurrence relative to the total number of patients. Up to 3 years
Secondary Overall Survival (OS) OS will be calculated using the Kaplan-Meier product limit method. From start of treatment to date of death or last contact date, whichever comes first, assessed up to 3 years
Secondary Response Duration Defined as the time from date of first documented response to documented disease relapse, progression or death whichever comes first. Up to 3 years
Secondary Time to Progression From the start of treatment to disease progression, assessed up to 3 years
Secondary Quality of Life (QOL) QOL will be measured using FACT-O questionnaire. Information will be tabulated and graphically displayed to describe the changes over time. For quantitative scales, data will be represented using means/medians, histogram and boxplots. Up to 3 years
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