Study Evaluating Safety, Tolerability, and Metabolism of Niraparib
- Conditions
- Ovarian Cancer
- Registration Number
- NCT06412120
- Lead Sponsor
- University of Miami
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- Female
- Target Recruitment
- 70
Inclusion Criteria:<br><br> 1. Participant must be female =18 years of age, able to understand study procedures,<br> and agree to participate in the study by providing written informed consent.<br><br> 2. Self-identify as Black. Please note that individuals who identify as Latino are<br> eligible to participate so long as they also self-identify as Black.<br><br> 3. Participant has completed adjuvant treatment for newly diagnosed stage III or IV<br> ovarian, fallopian tube, or primary peritoneal cancer according to the International<br> Federation of Gynecology and Obstetrics staging criteria.<br><br> 4. Participant must have high-grade serous or high-grade endometrioid histology.<br><br> 5. Participant must provide saliva and/or blood specimens for assessment of germline<br> mutation(s) in the Fanconi Anemia pathway.<br><br> 6. Participant must provide formalin-fixed, paraffin-embedded (FFPE) or fresh tumor<br> specimen from initial cytoreductive surgery (primary debulking) or initial<br> pre-treatment core biopsy (if neoadjuvant chemotherapy (NACT) received; tumor<br> obtained from interval cytoreduction acceptable if pre-treatment biopsy not<br> obtained).<br><br> 7. Participant must have had a complete or partial clinical response to adjuvant<br> treatment as confirmed by CT scan within 8 weeks after completion of the last dose<br> of platinum-based chemotherapy.<br><br> 8. Participant must have recovered to = Grade 1 in terms of toxicity from prior<br> treatments.<br><br> 9. Participant must not have any known contraindication or hypersensitivity to<br> niraparib or any of its excipients.<br><br> 10. Participants must be considered candidates for maintenance niraparib therapy by<br> their treating physician.<br><br> 11. Participants should have adequate organ function as defined below:<br><br> - Platelets = 100 platelets × 10^9/L<br><br> - Hemoglobin = 9 g/dL or 5.6 mmol/L<br><br> - Aspartate transaminase (AST) and alanine transaminase (ALT) =2.5 × upper limit<br> of normal (ULN), <5× in patients with known liver metastases<br><br> - Serum total bilirubin = 1.5 × ULN<br><br> - 1.5-3.0 × ULN may be included with appropriate starting dose adjustment to 200<br> mg daily.<br><br> - Creatinine <1.5 × ULN or estimated glomerular filtration rate (eGFR) =50 mL/min<br> by Cockcroft-Gault<br><br> - Depending on scenario, glomerular filtration rate (GFR) 30-49 mL/min can<br> be permissible.<br><br> 12. Patients with known human immunodeficiency virus (HIV) are allowed if they meet all<br> the following criteria:<br><br> - Cluster of differentiation 4 (CD4) =350/µL and viral load <400 copies/mL<br><br> - No history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic<br> infections within 12 months before enrollment<br><br> - No history of HIV-associated malignancy for the past 5 years. Concurrent<br> antiretroviral therapy as per the most current National Institutes of Health<br> (NIH) Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents<br> with HIV started >4 weeks before study enrollment.<br><br> 13. A female participant is eligible to participate if she is not pregnant or<br> breastfeeding and at least one of the following conditions applies:<br><br> - Is not a woman of childbearing potential (WOCBP), or<br><br> - Is a WOCBP and using a contraceptive method that is highly effective (with a<br> failure rate of <1% per year) from the Screening Visit through at least 180<br> days after the last dose of study treatment and agrees not to donate eggs (ova,<br> oocytes) for the purpose of reproduction during this period. The Investigator<br> should evaluate the effectiveness of the contraceptive method in relationship<br> to the first dose of study treatment, and<br><br> - A WOCBP must have a negative test result from a highly sensitive pregnancy test<br> (urine or serum, as required by local regulations) within 72 hours before<br> treatment. Additional periodic testing should be carried out according to the<br> protocol.<br><br> Note: The Investigator is responsible for review of medical history, menstrual<br> history, and recent sexual activity to decrease the risk for inclusion of a woman<br> with an early undetected pregnancy.<br><br> 14. Participant must agree to complete HRQoL and patient reported outcomes (PRO)<br> measures throughout the study period.<br><br>Exclusion Criteria:<br><br> 1. Any of the following histologies: low-grade serous carcinoma, grade 1 or 2<br> endometrioid adenocarcinoma, clear cell, mucinous, transitional cell,<br> carcinosarcoma, undifferentiated, dedifferentiated<br><br> 2. Any known history or current diagnosis of myelodysplastic syndrome (MDS) or acute<br> myeloid leukemia (AML)<br><br> 3. Primary progressive, platinum-refractory disease<br><br> 4. Participant is at an increased risk of bleeding due to concurrent conditions (eg,<br> major injuries or major surgery within the past 28 days before start of study<br> treatment).<br><br> 5. Current diagnosis of platelet disorder (eg, thrombotic thrombocytopenic purpura<br> (TTP), immune thrombocytopenia (ITP))<br><br> 6. Inability to swallow orally administered medication or has a gastrointestinal<br> disorder likely to interfere with absorption of the study medication<br><br> 7. Participants that have systolic blood pressure (SBP])>140 mmHg or diastolic blood<br> pressure (DBP)>90 mmHg that has not been adequately treated or controlled.<br><br> 8. Active second primary malignancy<br><br> 9. Participant is pregnant, currently breastfeeding an infant, or expecting to conceive<br> children while receiving study treatment and/or for up to 180 days after the last<br> dose of study treatment.<br><br> 10. Participant has received a live vaccine within 30 days of planned start of study<br> therapy. Coronavirus disease 2019 (COVID-19) vaccines that do not contain live<br> viruses are allowed.<br><br> 11. Participant has received a transfusion (platelets or red blood cells) or<br> colony-stimulating factors (eg, granulocyte macrophage colony-stimulating factor or<br> recombinant erythropoietin) within 4 weeks before the first dose of study treatment.<br><br> 12. Participant has had radiotherapy encompassing >20% of the bone marrow within 2 weeks<br> or any radiation therapy within 1 week before Day 1 of protocol therapy.<br><br> 13. Participant has leptomeningeal disease, carcinomatous meningitis, symptomatic brain<br> metastasis, or radiographic signs of central nervous system hemorrhage.<br><br> 14. Participant has current active pneumonitis or any history of pneumonitis requiring<br> steroids (any dose) or immunomodulatory treatment within 90 days of planned start of<br> the study.<br><br> 15. Participants with active hepatitis B or C infection.<br><br> 16. Patient with prior history of posterior reversible encephalopathy syndrome (PRES).<br><br> 17. Patients with impaired decision-making capacity.<br><br> 18. Participants have high medical risk due to a serious, uncontrolled medical disorder;<br> non malignant systemic disease; or active, uncontrolled infection. Examples include,<br> but are not limited to, uncontrolled ventricular arrhythmia, recent (within 90 days)<br> myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord<br> compression, superior vena cava syndrome, active uncontrolled coagulopathy, bleeding<br> disorder, or any psychiatric
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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).
- Secondary Outcome Measures
Name Time Method Proportion of Participants Experiencing Grade 3 or Higher Toxicity;Proportion of Participants Experiencing Grade 3 or Higher Treatment-Related Adverse Event;Recurrence-Free Survival;Change in Health-Related Quality of Life (HRQOL) as Measured by FACT-GP5;Change in Health-Related Quality of Life (HRQOL) as Measured by FOSI;Pharmacokinetics of Niraparib Measured By Cmax;Pharmacokinetics of Niraparib Measured by AUC