Ovarian cancer, Fallopian tube cancer, Primary peritoneal cancer
Conditions
Sponsors
Takeda Pharmaceutical Company Limited
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Japanese female participants aged 20 years or older on the day of signing informed consent. 2. Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care. 3. Participant must have a histologically diagnosed ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. 4. Participant must have a high-grade (or Grade 3) serous or high-grade predominantly serous histology or known to have germline breast cancer gene mutation (gBRCAmut). 5. Participants must have completed at least 2 previous lines of platinum-containing therapy (eg, carboplatin, oxaliplatin, or cisplatin): Note: The last platinum regimen did not necessarily have to immediately follow the next-to-last (penultimate) platinum regimen. For example, if a participant received a non-platinum regimen between the penultimate platinum regimen and last platinum regimen, she could have been eligible as long as she met all entry criteria. a. For the penultimate platinum-based chemotherapy prior to study enrollment, participants must have had platinum-sensitive disease after this treatment, defined as achieving a response (CR or PR) and disease progression >6 months after completion of her last dose of platinum therapy (documented 6 to 12 months or >12 months). Source documentation was required. b. For the last line of platinum-based chemotherapy prior to study enrollment: i. Participants must have received a platinum-containing regimen for a minimum of 4 cycles. ii. Participants must have achieved a partial or complete tumor response. iii. Following the last regimen, participants must have had either. 1. CA-125 in the normal range, OR 2. CA-125 decrease by more than 90% during the last platinum regimen, and which was stable for at least 7 days (ie, no increase >15%). iv. Following the last regimen, participants could not have had any measurable lesion >2 cm at the time of study enrollment. c. Participants must have been enrolled within 8 weeks after completion of their final dose of the platinum-containing regimen. 6. Participants must have performance status of ==1,500/microL. b. Platelet count >=100,000/microL. c. Hemoglobin >=9 g/dL. d. Serum creatinine ==50 mL/minute, using the Cockcroft-Gault equation. e. Total bilirubin =<1.5xULN OR direct bilirubin =<1xULN. f. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =<2.5xULN unless liver metastases were present, in which case they had to be =<5xULN. 8. Participants must be able to take oral medications. 9. Female participants of childbearing potential must be negative for pregnancy test (beta-human chorionic gonadotropin [beta-hCG]) within 7 days prior to receiving the first dose of study treatment. 10. Female participants who: a. Are postmenopausal for at least 1 year before the screening visit, OR b. Are surgically sterile, OR c. If they are of childbearing potential, agree to practice 1 highly effective method of contraception and 1 additional effective (barrier) method at the same time, from the time of signing the informe
Exclusion criteria
Exclusion criteria: 1. Participants who have had drainage of ascites during last 2 cycles of last chemotherapy. 2. Participants who have had palliative radiotherapy encompassing >20% of the bone marrow within 1 week of the first dose of study treatment. 3. Participants who have any persistent Grade >=3 toxicity from last cancer therapy. 4. Participants who have symptomatic, uncontrolled brain or leptomeningeal metastases. To be considered "controlled," central nervous system (CNS) disease must have undergone treatment (eg, radiation or chemotherapy) at least 1 month prior to study enrollment. The participant must not have had any new or progressive signs or symptoms related to the CNS disease and must have been taking a stable dose of steroids or no steroids (as long as these were started at least 4 weeks prior to enrollment] or no steroids). A scan to confirm the absence of brain metastases at baseline was not required. Participants with spinal cord compression might have been considered if they had received definitive treatment for this and evidence of clinically stable disease for 28 days. 5. Participants who have known hypersensitivity to the components of niraparib. 6. Participants who have had prior treatment with a known poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor. 7. Participant who have had treatment with any investigational products within 28 days or 5 half-lives (whichever was longer) before the first dose. 8. Participants who have had major surgery per Investigator judgment within 3 weeks of the first dose. Participant must have recovered from any effects of any major surgery. 9. Participants who have diagnosis, detection, or treatment of invasive second primary malignancy other than ovarian cancer =<24 months prior to study enrollment (except basal or squamous cell carcinoma of the skin that was definitively treated). Note: Participants must not have any known history or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML), irrespective of the time for disease history. 10. Participants who are considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease, or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 90 days of the first dose) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, small bowel obstruction or other serious gastrointestinal disorder, or any psychiatric disorder that prohibits obtaining informed consent. 11. Participants who have received a transfusion (platelets or red blood cells) within 4 weeks of the first dose of study treatment. 12. Participants who have received a live virus or bacterial vaccines within 4 weeks of the first dose of study treatment. 13. Participants who have a history or current evidence of any condition, therapy, or lab abnormality (including active or uncontrolled myelosuppression [ie, anemia, leukopenia, neutropenia, thrombocytopenia]) that might confound the results of the study, interfere with the participant's participation throughout the study period, or study participation is not in the best interest of the participant. 14. Participants who are regular user (including "recreational use") of any illicit drugs at the time of signing informed consent or have a recent history (within the past year) of drug or alcohol abuse. 15. Participan
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Safety: Number of Participants with Grade 3 or 4 Thrombocytopenia Occurring within 30 Days after Initial Administration of Niraparib Timeframe; Up to 30 days after the initial dose An adverse event of 'thrombocytopenia' was collected and graded as per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03. As per the NCI-CTCAE, Grade 1 scales as Mild; Grade 2 scales as Moderate; Grade 3 scales as severe or medically significant but not immediately life threatening; Grade 4 scales as life-threatening consequences; and Grade 5 scales as death related to Adverse Events (AE). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Safety: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) Timeframe; From the day of signing the informed consent form (ICF) until 30 days after last dose of study drug or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months). An AE is defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. 2.Safety: Number of Participants with Grade 3 or Higher TEAEs Timeframe; From the day of signing the ICF until 30 days after last dose of study drug or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months). A severity grade is defined by the NCI-CTCAE Version 4.03. Grade 1 scales as Mild; Grade 2 scales as Moderate; Grade 3 scales as severe or medically significant but not immediately life threatening; Grade 4 scales as life-threatening consequences; and Grade 5 scales as death related to AE. 3.Safety: Number of Participants with Serious Adverse Events (SAEs) Timeframe; From the day of signing the ICF until 30 days after last dose of study drug or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months). An SAE is any AE that results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event. 4.Safety: Number of Participants with TEAEs Leading to Drug Discontinuation Timeframe; From the day of signing the ICF until 30 days after last dose of study drug or beginning of subsequent anticancer therapy, whichever comes first (up to 48 months). 5.Safety: Number of Participants with TEAEs Leading to Dose Interruption Timeframe; From the day of signing the ICF until 30 days aft | — |
Countries
Japan
Outcome results
None listed