Study Evaluating Safety, Tolerability, and Metabolism of Niraparib

NCT06412120 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 20230316
• Study Type: interventional
• Target: 70
• Locations: 2 countries
• Sites: 4

Brief Summary

The purpose of this study is to identify the genetic characteristic(s), specifically degree of African ancestry, and environmental characteristic(s) that appear to be related to the effects, both good and bad, that the maintenance treatment has women with ovarian cancer. In this study, an investigational medication called niraparib is being tested for the treatment of ovarian cancer. Niraparib works by blocking the ability of cancer cells to fix their genes. Cancer cells with damaged genes have a harder time growing and spreading in the body and can even die.

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants Experiencing Any Grade or Grade 3 or Higher of the Most Common Adverse Events (AEs) Previously Reported in the PRIMA trial (NCT02655016).

  The proportion of participants in this study experiencing any grade or grade 3 or higher of the most common adverse events (AEs), of any treatment attribution, as those previously reported in the PRIMA Trial (NCT02655016). Adverse events will be assessed using the National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE) version 5.0. The most common adverse events previously reported include: Anemia, nausea, thrombocytopenia, constipation, fatigue, neutropenia, headache, insomnia, vomiting, abdominal pain, and hypertension.

  Up to 3 years

Secondary Outcomes (7)

• Proportion of Participants Experiencing Grade 3 or Higher Toxicity

  Up to 3 years

• Proportion of Participants Experiencing Grade 3 or Higher Treatment-Related Adverse Event

  Up to 3 years

• Recurrence-Free Survival

  Up to 3 years

• Change in Health-Related Quality of Life (HRQOL) as Measured by FACT-GP5

  Up to 3 years

• Change in Health-Related Quality of Life (HRQOL) as Measured by FOSI

  Up to 3 years

Study Arms (1)

Niraparib Maintenance Group

EXPERIMENTAL

Participants in this group will receive Niraparib maintenance therapy for up to 24 cycles, 28 days per cycle. Participants will be followed for up to one (1) year after completion of Niraparib therapy. Total participation is about three years.

Drug: Niraparib

Interventions

Niraparib DRUG

Niraparib will be administered orally (PO) daily as tablets at one of three possible dose levels, 100mg/day, 200mg/day or 300mg/day, based upon participant weight, platelet count, and certain drug combinations and conditions assessed at baseline.

Also known as: GSK3985771

Niraparib Maintenance Group

Eligibility Criteria

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

You may qualify if:

• Participant must be female ≥18 years of age, able to understand study procedures, and agree to participate in the study by providing written informed consent.
• Self-identify as Black. Please note that individuals who identify as Latino are eligible to participate so long as they also self-identify as Black.
• Participant has completed adjuvant treatment for newly diagnosed stage III or IV ovarian, fallopian tube, or primary peritoneal cancer according to the International Federation of Gynecology and Obstetrics staging criteria.
• Participant must have high-grade serous or high-grade endometrioid histology.
• Participant must provide saliva and/or blood specimens for assessment of germline mutation(s) in the Fanconi Anemia pathway.
• Participant must provide formalin-fixed, paraffin-embedded (FFPE) or fresh tumor specimen from initial cytoreductive surgery (primary debulking) or initial pre-treatment core biopsy (if neoadjuvant chemotherapy (NACT) received; tumor obtained from interval cytoreduction acceptable if pre-treatment biopsy not obtained).
• Participant must have had a complete or partial clinical response to adjuvant treatment as confirmed by CT scan within 8 weeks after completion of the last dose of platinum-based chemotherapy.
• Participant must have recovered to ≤ Grade 1 in terms of toxicity from prior treatments.
• Participant must not have any known contraindication or hypersensitivity to niraparib or any of its excipients.
• Participants must be considered candidates for maintenance niraparib therapy by their treating physician.
• Participants should have adequate organ function as defined below:
• Platelets ≥ 100 platelets × 10\^9/L
• Hemoglobin ≥ 9 g/dL or 5.6 mmol/L
• Aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 × upper limit of normal (ULN), \<5× in patients with known liver metastases
• Serum total bilirubin ≤ 1.5 × ULN

You may not qualify if:

• Any of the following histologies: low-grade serous carcinoma, grade 1 or 2 endometrioid adenocarcinoma, clear cell, mucinous, transitional cell, carcinosarcoma, undifferentiated, dedifferentiated
• Any known history or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)
• Primary progressive, platinum-refractory disease
• Participant is at an increased risk of bleeding due to concurrent conditions (eg, major injuries or major surgery within the past 28 days before start of study treatment).
• Current diagnosis of platelet disorder (eg, thrombotic thrombocytopenic purpura (TTP), immune thrombocytopenia (ITP))
• Inability to swallow orally administered medication or has a gastrointestinal disorder likely to interfere with absorption of the study medication
• Participants that have systolic blood pressure (SBP\])\>140 mmHg or diastolic blood pressure (DBP)\>90 mmHg that has not been adequately treated or controlled.
• Active second primary malignancy
• Participant is pregnant, currently breastfeeding an infant, or expecting to conceive children while receiving study treatment and/or for up to 180 days after the last dose of study treatment.
• Participant has received a live vaccine within 30 days of planned start of study therapy. Coronavirus disease 2019 (COVID-19) vaccines that do not contain live viruses are allowed.
• Participant has received a transfusion (platelets or red blood cells) or colony-stimulating factors (eg, granulocyte macrophage colony-stimulating factor or recombinant erythropoietin) within 4 weeks before the first dose of study treatment.
• Participant has had radiotherapy encompassing \>20% of the bone marrow within 2 weeks or any radiation therapy within 1 week before Day 1 of protocol therapy.
• Participant has leptomeningeal disease, carcinomatous meningitis, symptomatic brain metastasis, or radiographic signs of central nervous system hemorrhage.
• Participant has current active pneumonitis or any history of pneumonitis requiring steroids (any dose) or immunomodulatory treatment within 90 days of planned start of the study.
• Participants with active hepatitis B or C infection.

Sponsors & Collaborators

• University of Miami: lead
• GlaxoSmithKline: collaborator

Study Sites (4)

Broward Health

Fort Lauderdale, Florida, 33316, United States

RECRUITING

University of Florida Jacksonville

Jacksonville, Florida, 32209, United States

RECRUITING

University of Miami

Miami, Florida, 33136, United States

RECRUITING

Ahmadu Bello University Teaching Hospital (ABUTH)

Zaria, Kaduna State, Nigeria

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

niraparib

Condition Hierarchy (Ancestors)

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

Study Officials

• Matthew Schlumbrecht, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

• Sophia HL George, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew Schlumbrecht, MD, MPH

CONTACT

305-243-2233; mschlumbrecht@med.miami.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2024
• First Posted: May 14, 2024
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2031
• Last Updated: June 3, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3); NG (1)