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Platinum-Resistant Fallopian Tube CarcinomaPhase 1/2NCT05672095

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

A Phase 1/2 study testing Biopsy, Biospecimen Collection and Niraparib in people with Platinum-Resistant Fallopian Tube Carcinoma and Platinum-Resistant Ovarian Carcinoma, run by City of Hope Medical Center.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Biopsy, Biospecimen Collection and Niraparib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
18 Apr 2025to 27 Nov 2026
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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)
  • Alanine aminotransferase (ALT) =< 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)
  • Serum Creatinine =< 1.5 x ULN or creatine clearance of >= 60 mL/min per 24 hour urine test or the Cockcroft-Gault formula (performed within 14 days prior to day 1 of protocol therapy unless otherwise stated)
  • Prothrombin (PT) =< 1.25 x ULN (performed within 14 days prior to day 1 of protocol therapy unless otherwise stated)
  • Hemoglobin >= 9 g/dL (performed within 14 days prior to day 1 of protocol therapy unless otherwise stated)
  • Women of childbearing potential (WOCBP): negative highly sensitive urine or serum pregnancy test (highly sensitive urine test will be required if serum pregnancy test is not available) (performed within 14 days prior to day 1 of protocol therapy unless otherwise stated)
  • Normal blood pressure or adequately controlled hypertension (performed within 14 days prior to day 1 of protocol therapy unless otherwise stated)
  • Agreement by subjects of childbearing potential* to use a highly effective method of birth control or abstain from heterosexual activity for the course of the study through at least 180 days after the last dose of protocol therapy
  • Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for > 1 year (women only)

Who cannot join

  • 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
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  • 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)
  • Issues with tolerating oral medication (e.g. inability to swallow pills, malabsorption issues, ongoing nausea or vomiting)
  • Active diarrhea
  • Clinically significant uncontrolled illness or medical disorder, nonmalignant systemic disease, or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (90 days) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric order that prohibits obtaining informed consent
  • Known history of immunodeficiency virus (HIV) or hepatitis B or hepatitis C infection
  • Other active malignancy
  • Females only: Pregnant or breastfeeding
  • Major surgery (other than debulking or exploratory surgery for ovarian cancer) for any reason within 3 weeks prior to randomization and/or incomplete recovery from surgery
  • Prior organ transplantation including allogenic stem cell transplantation
  • Diagnosis of Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML)
  • Known leptomeningeal disease, carcinomatous meningitis, or radiologic signs of CNS hemorrhage. Known symptomatic brain metastases requiring steroids. Patients with previously diagnosed brain metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to study enrollment, have discontinued corticosteroid treatment for these metastases for at least 4 weeks and are neurologically stable
  • Active infections
  • Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
  • Patients must not have uncontrolled hypertension as defined by systolic blood pressure (SBP) >= 160mmHg or diastolic blood pressure (DBP) >= 90mmHg; patients whose blood pressure can be controlled medically are allowed to be rescreened once BP is under control
  • Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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:

  1. 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.

Being tested
Biopsy, Biospecimen Collection, Niraparib, Questionnaire Administration, Selenium
Medical subject headings
Fallopian Tube Neoplasms, Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BiopsyProcedure or surgery

    Also called BIOPSY_TYPE, Bx

    Undergo needle or core biopsy

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood sample collection

  • NiraparibDrug

    Also called MK-4827, MK4827

    Given PO

  • Questionnaire AdministrationOther

    Ancillary studies

  • SeleniumDietary supplement

    Also called Se

    Given IV

Study groups in NCT05672095
Study groupRoleWhat they receive
Treatment (selenium, niraparib)ExperimentalPatients receive selenium IV and niraparib PO on study. Patients also undergo CT, MRI, biopsy, and collection of blood samples throughout the trial.
Receives: Procedure: Biopsy; Procedure: Biospecimen Collection; Drug: Niraparib; Other: Questionnaire Administration; Dietary Supplement: Selenium

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 3 years

  2. Progression-free Survival (PFS) (Phase II)

    PFS will be estimated using the Kaplan-Meier product limit method.

    Measured: From start of selenium treatment until date of death, relapse/progression, or last contact date, whichever comes first, assessed up to 3 years

  3. Tolerability (Phase II)

    Tolerability will be assessed using the CTCAE 5.0. Reduction in percentage of patients experiencing nausea and fatigue.

    Measured: Up to 3 years

Secondary outcomes (6)

  1. 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.

    Measured: Up to 3 years

  2. 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.

    Measured: Up to 3 years

  3. Overall Survival (OS)

    OS will be calculated using the Kaplan-Meier product limit method.

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

  4. Response Duration

    Defined as the time from date of first documented response to documented disease relapse, progression or death whichever comes first.

    Measured: Up to 3 years

  5. Time to Progression

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

  6. 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.

    Measured: Up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2023
  2. Study start18 Apr 2025 (estimated)
  3. Primary completion27 Nov 2026 (estimated)
  4. Study completion27 Nov 2026 (estimated)

Why it stopped: Abandoned

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05672095
Sponsor's protocol ID
23231
Other IDs
NCI-2022-10203, 20530, P30CA033572
Status last verified
May 2025
First submitted
3 Jan 2023
Last updated
23 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Biopsy, Biospecimen Collection and Niraparib in people with Platinum-Resistant Fallopian Tube Carcinoma and Platinum-Resistant Ovarian Carcinoma, run by City of Hope Medical Center.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose Limiting Toxicity (Phase I) (time frame: Up to 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05672095.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025.

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