Health Condition 1: C569- Malignant neoplasm of unspecifiedovary
Conditions
Interventions
Intervention1: Niraparib 100 mg Tablet: Dose Formulation: Tablet
Route of Administration: Oral
Dosage Level(s):200/300mg once daily
Control Intervention1: Not Applicable: Not Applicable
Sponsors
GlaxosmithKline -
Eligibility
Inclusion criteria
Inclusion criteria: 1. Female Subjects with >= 18 years of age, able to understand the study procedures and agree to participate in the study by providing written informed consent. 2. Histologically confirmed epithelial ovarian cancer -Eligible for active study drug treatment according to the approved label â?? as monotherapy for the maintenance treatment of adult subjects with advanced epithelial (FIGO stage III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. - as monotherapy for the maintenance treatment of adult subjects with platinum-sensitive relapsed high grade serious epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy. 3. Laboratory CBC criteria -Absolute neutrophil count >=1,500/μL; -Platelets >=100,000/μL; -Hemoglobin >=9 g/dL; 4. Adequately controlled hypertension basis on investigatorâ??s discretion. 5. Women of childbearing potential must be ready to use contraceptive measures to avoid pregnancy during study period and until 180 days after the last dose.
Exclusion criteria
Exclusion criteria: 1. Subject is pregnant, breastfeeding, or expecting to conceive children while receiving study treatment and for up to 180 days after the last dose of study treatment. 2. Subject had known, active hepatic disease, known case of ESRD, known case of serious, uncontrolled medical disorder, any known history or current diagnosis of MDS or AML. 3. Any previous PARPi treatment. 4. Subjects with concomitant serious uncontrolled medical illness. 5. Patient is receiving niraparib for use that is not according to the approved label. 6. Subjects with either the history of hypersensitivity to excipients of the study drug or to drugs with a similar chemical structure or class to the study drug. 7. Patients with a previously or currently diagnosed MDS/ AML or pneumonitis. 8. Patients who have not recovered sufficiently from prior surgery or anticancer treatment. 9. Patients who have known history of hepatitis B or hepatitis C. 10. Patients with active infection such as TB Prior/concurrent clinical study experience. 11. Participation in another clinical study with a study drug administered in the last 3 months. 12. Judgment by the investigator that the subject should not participate in the study if the subject is unlikely to comply with study procedures, restrictions and requirements. 13. Previous enrolment in the present study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety will be evaluated by assessing the incidence of treatment emergent adverse events (TEAE).Timepoint: 15 Weeks (105 days) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Proportion of SAEs and possibly TEAEs leading to death, dose modification (reduction), treatment discontinuationTimepoint: 15 weeks (105 days) | — |
Countries
India
Contacts
Public ContactDr Gaurav Deshmukh
GSK
Outcome results
None listed