Epithelial Ovarian Cancer
Conditions
Interventions
Niraparib 200mg capsules administered orally once daily continuously. Drug suspension, dose reduction, and prescription discontinuation will be carried out according to the package insert.
Sponsors
Hyogo Cancer Center
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. At least 20 years old 2. Patients who understand that consent can be withdrawn at any time without penalizing future treatment and give written consent. 3. Patients histologically diagnosed with ovarian, fallopian tube or primary peritoneal cancer 4. Patients receiving maintenance therapy, including olaparib. (Including patients who received maintenance therapy with bevacizumab at the time of initial treatment) 5. Patients who have completed 2 or more lines of chemotherapy containing platinum Note: The last platinum regimen does not have to follow directly to the penultimate platinum regimen line, if all the selection criteria are met. a. Patients who showed platinum susceptibility to the penultimate line of platinum regimens prior to enrollment. b. Patients who meet both of the following b-1 to b-2 in the last platinum regimen before enrollment: b-1. Patients who have received at least 4 cycles of platinum regimen b-2. Patients who have achieved CR or PR and can maintain Niraparib oral administration c. Patients within 12 weeks of enrollment in this study after the last dose of platinum. 6. Eastern Cooperative Oncology Group performance status of 1 or less 7. Patients with proper organ function and laboratory test values that meet the following criteria: a. Absolute number of neutrophils: 1,500/microL or more b. Platelet count: 100,000 /microL or more c. Hemoglobin value: 9 g / dL or more (allows red blood cell transfusion before the start of treatment) d. Serum creatinine level is 1.5 times or less than ULN, or Cockcroft-Gault estimation formula creatinine clearance value is 50 mL / min or more. e. Total bilirubin value is 1.5 times or less of ULN, or direct bilirubin value is ULN or less f. AST and ALT: 2.5 times or less of ULN, 5 times or less of ULN if having liver metastasis 8. Patients who can orally administer the study drug 9. Non-pregnant woman
Exclusion criteria
Exclusion criteria: 1. Patients with persistent Grade 3 or higher toxicity from previous chemotherapy 2. Patients with untreated double cancer 3. Patients with brain metastases or pial meningeal metastases 4. Patients who have undergone ascites drainage since the start of the last two cycles of chemotherapy 5. Patients who are hypersensitive to the components of the study drug or its related compounds 6. Patients who have previously received PARP inhibitors for the treatment of other diseases 7. Patients who underwent major surgery (at the discretion of the investigator) within 3 weeks before the first dose. The patient must have recovered from all the effects of major surgery. 8. Patients at high medical risk due to uncontrolled serious illness, non-malignant systemic illness, or uncontrolled active infection. 9. Patients with any disease, treatment or laboratory abnormalities that affect the test results [myelosuppression with poor control (anemia, leukocyte depletion, neutropenia or thrombocytopenia), etc.] 10. Women who are pregnant, planning to become pregnant, or breastfeeding. However, if a lactating woman stops breastfeeding, she can register. 11. Immunosuppressed patients (patients undergoing splenectomy are acceptable) 12. Patients known to be positive for human immunodeficiency virus (HIV) 13. Patients with known or suspected hepatitis B virus surface antigen (HBsAg) positive or active hepatitis C virus (HCV) infection Note: Patients with hepatitis B core antibody (HBcAb) or hepatitis B surface antibody (HBsAb) can be enrolled, but hepatitis B virus (HBV) must be below the detection limit. Patients who are positive for hepatitis C virus antibody (HCVAb) must have HCV below the detection limit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| treatment completion proportion | — |
Countries
Japan
Contacts
Public ContactHiroshi Nakazawa
Hyogo Cancer Center Gynecologic Oncology
Outcome results
None listed