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

NCT05672095 | Withdrawn Phase 1 DMC FDA Drug

• 4 other identifiers: 23231NCI-2022-1020320530P30CA033572
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (6)

• Overall Response Rate (ORR)

  Up to 3 years

• Disease Control Rate

  Up to 3 years

• Overall Survival (OS)

  From start of treatment to date of death or last contact date, whichever comes first, assessed up to 3 years

• Response Duration

  Up to 3 years

• Time to Progression

  From the start of treatment to disease progression, assessed up to 3 years

Study Arms (1)

Treatment (selenium, niraparib)

EXPERIMENTAL

Patients receive selenium IV and niraparib PO on study. Patients also undergo CT, MRI, biopsy, and collection of blood samples throughout the trial.

Procedure: Biopsy; Procedure: Biospecimen Collection; Drug: Niraparib; Other: Questionnaire Administration; Dietary Supplement: Selenium

Interventions

Biopsy PROCEDURE

Undergo needle or core biopsy

Also known as: BIOPSY_TYPE, Bx

Treatment (selenium, niraparib)

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Treatment (selenium, niraparib)

Niraparib DRUG

Given PO

Also known as: MK-4827, MK4827

Treatment (selenium, niraparib)

Questionnaire Administration OTHER

Ancillary studies

Treatment (selenium, niraparib)

Selenium DIETARY_SUPPLEMENT

Given IV

Also known as: Se

Treatment (selenium, niraparib)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented informed consent of the participant and/or legally authorized representative
• Assent, when appropriate, will be obtained per institutional guidelines
• Agreement to allow the use of archival tissue from biopsy or tissue block cytology obtained at time of last disease recurrence. If biopsy is not possible or patient refuses, the principal investigator (PI) may allow an earlier biopsy to be tested. If unavailable, exceptions may be granted with Study PI approval
• Age: \>= 18 years
• Eastern cooperative oncology group (ECOG) =\< 2
• Histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal cancer. May not have non epithelial tumors or ovarian tumors with low malignant potential (ie, borderline tumors) or mucinous tumors or small cell carcinoma tumors or low grade serous carcinoma
• Recurrent, platinum resistant disease (defined as progression within \<6 months from completion of platinum-based therapy. The date should be calculated from the last administered dose of platinum therapy)
• Measurable disease per response evaluation criteria in solid tumors (RECIST) 1.1 or evaluable disease (defined as solid and/or cystic abnormalities on radiographic imaging that do not meet RECIST 1.1 definitions for target lesions OR ascites and/or pleural effusion that has been pathologically demonstrated to be disease related in the setting of CA125 \>2x upper limit of normal \[ULN\])
• No more than 4 prior cytotoxic regimens (including primary therapy). Hormonal therapies (tamoxifen, aromatase inhibitors) or other prior poly (ADP-Ribose) polymerase (PARP) inhibitors will not count toward the prior regimen limit. Prior PARP inhibotor therapy is allowed
• Fully recovered from the acute toxic effects (except alopecia) to =\< Grade 1 to prior anti-cancer therapy
• MyChoice HRD test should show BRCA wt and no HRD. No deleterious germline BRCA 1/2 mutations are allowed
• Absolute neutrophil count (ANC) \>= 1,500/mm\^3 (performed within 14 days prior to day 1 of protocol therapy unless otherwise stated)
• Platelets \>= 150,000/mm\^3 (performed within 14 days prior to day 1 of protocol therapy unless otherwise stated)
• Total bilirubin =\< 1.5 X upper limit of normal (ULN) (unless has Gilbert's disease, when =\< 2.0 X ULN is acceptable (performed within 14 days prior to day 1 of protocol therapy unless otherwise stated)
• Aspartate aminotransferase (AST) =\< 2.5 x ULN, unless liver metastases are present, in which case =\< 5 x ULN (performed within 14 days prior to day 1 of protocol therapy unless otherwise stated)

You may not qualify if:

• Chemotherapy, biological therapy, immunotherapy within 21 days prior to Day 1 of protocol
• Radiation therapy encompassing \> 20% of the bone marrow within 2 weeks. Any radiation therapy within 1 week prior to Day 1 therapy
• Colony-stimulating factors (e.g. granulocyte colony-stimulating factor, granulocyte macrophage colony stimulating factor, or recombinant erythropoietin within 4 weeks prior to day 1
• Receipt of a transfusion (platelets or red blood cells) within 4 weeks of D1
• Known Grade 3 or 4 anemia, neutropenia or thrombocytopenia due to prior chemotherapy that persisted \> 4 weeks and was related to the most recent treatment
• Diagnosis, detection, or treatment of another type of cancer ≤ 2 years prior to initiating protocol therapy (except basal or squamous cell carcinoma of the skin and cervical cancer in situ that has been definitively treated
• Strong CYP3A4 inducers/ inhibitors within 14 days prior to Day 1 of protocol therapy
• UGT1A1 inhibitors within 14 days prior to Day 1 of protocol therapy
• Herbal medications containing selenium within 14 days prior to Day 1 of protocol therapy
• Vitamin E within 14 days prior to Day 1 of protocol therapy
• Anticoagulants within 14 days prior to Day 1 of protocol therapy or active thromboembolism. The use of ASA or NSAIDS is allowed
• Live vaccines within 14 days prior to the first dose of study treatment. Seasonal flu vaccines that do not contain live viruses are allowed. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, bacille Calmette Guerin, and typhoid (oral) vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed. Intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines and are not allowed
• History of allergic reactions attributed to compounds of similar chemical or biologic composition (including aluminum) to study agent
• Hypersensitivity to any study agent, or its excipients, when administered alone
• History of Posterior Reversible Encephalopathy Syndrome (PRES)

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Ovarian Neoplasms

Interventions

Biopsy; Specimen Handling; niraparib; Selenium

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Chalcogens; Elements; Inorganic Chemicals; Minerals

Study Officials

• Lorna Rodriguez-Rodriguez

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2023
• First Posted: January 5, 2023
• Study Start: April 18, 2025
• Primary Completion (Estimated): November 27, 2026
• Study Completion (Estimated): November 27, 2026
• Last Updated: May 23, 2025

Record last verified: 2025-05