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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Experiencing Grade 3 or Higher Toxicity | The proportion of participants experiencing any grade or grade 3 or higher adverse events, and serious adverse events (SAEs) will be reported, regardless of treatment attribution. Adverse events (AEs) or serious adverse event (SAEs) leading to treatment discontinuation, dose reduction, dose interruption, or death will also be reported. Adverse events will be assessed using the National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE) version 5.0. |
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Inclusion Criteria:
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
1.5-3.0 × ULN may be included with appropriate starting dose adjustment to 200 mg daily.
Creatinine <1.5 × ULN or estimated glomerular filtration rate (eGFR) ≥50 mL/min by Cockcroft-Gault
Patients with known human immunodeficiency virus (HIV) are allowed if they meet all the following criteria:
A female participant is eligible to participate if she is not pregnant or breastfeeding and at least one of the following conditions applies:
Note: The Investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
Participant must agree to complete HRQoL and patient reported outcomes (PRO) measures throughout the study period.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matthew Schlumbrecht, MD, MPH | Contact | 305-243-2233 | mschlumbrecht@med.miami.edu |
| Name | Affiliation | Role |
|---|---|---|
| Matthew Schlumbrecht, MD | University of Miami | Principal Investigator |
| Sophia HL George, PhD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Broward Health | Recruiting | Fort Lauderdale | Florida | 33316 | United States |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| C545685 | niraparib |
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|
| Up to 3 years |
| Proportion of Participants Experiencing Grade 3 or Higher Treatment-Related Adverse Event | The proportion of participants experiencing any grade or grade 3 or higher treatment-related adverse event (TRAE) will be reported. Adverse events will be assessed using the National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE) version 5.0. | Up to 3 years |
| Recurrence-Free Survival | Recurrence-free survival (RFS) among participants will be reported. RFS is defined as the elapsed time from the start date of study therapy to the date of recurrence as measured by cancer-antigen 125 (CA-125) levels in the blood and by computed tomography (CT) imaging utilizing Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria; or until date of death from any cause. | Up to 3 years |
| Change in Health-Related Quality of Life (HRQOL) as Measured by FACT-GP5 | Change in health-related quality of life among participants will be reported as measured by score on the Functional Assessment of Cancer Therapy-Item GP5 (FACT-GP5). FACT-GP5 is a single item, GP5, from the Functional Assessment of Cancer Therapy questionnaire, scored using a five-point Likert-type scale ranging from 0 to 4. A higher score indicates worsening health-related quality of life. | Up to 3 years |
| Change in Health-Related Quality of Life (HRQOL) as Measured by FOSI | Change in health-related quality of life among participants will be reported as measured by scores on the Functional Assessment of Cancer Therapy-Ovarian (FACT-O) Symptom Index (FOSI). FOSI is a subset of the Functional Assessment of Cancer Therapy Ovarian Cancer containing eight items. Each item is scored using a five-point Likert-type scale ranging from 0 to 4 with higher scores indicating worsening health-related quality of life. | Up to 3 years |
| Pharmacokinetics of Niraparib Measured By Cmax | The pharmacokinetics (PK) of niraparib among participants will be reported, measured as the maximal serum concentration (CMax). | Up to 22 months |
| Pharmacokinetics of Niraparib Measured by AUC | The pharmacokinetics (PK) of niraparib among participants will be reported, measured as the area under the concentration curve (AUC). | Up to 22 months |
| University of Florida Jacksonville | Recruiting | Jacksonville | Florida | 32209 | United States |
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| University of Miami | Recruiting | Miami | Florida | 33136 | United States |
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| Ahmadu Bello University Teaching Hospital (ABUTH) | Recruiting | Zaria | Kaduna State | Nigeria |
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| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |