Health Condition 1: C569- Malignant neoplasm of unspecifiedovary Health Condition 2: C569- Malignant neoplasm of unspecifiedovary
Conditions
Interventions
Intervention1: Test Product (T):
Niraparib Tablets 200mg: One tablet of Niraparib 200 mg to be taken daily for total of 12 days, manufactured by of Sun Pharmaceutical Industries Limited, India
Contro
Sponsors
Sun Pharmaceutical Industries Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Female patients of 18 to 75 years (both inclusive) at the time of signing the informed consent form. 2. Patients with documented advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. 3. Patients must have received their most recent platinum-containing regimen within 12 weeks prior to initiating Niraparib treatment. 4. Patients with weight of less than 77 Kg (less than 170 lbs) or with a platelet count less than 150,000/µL at the time of screening. 5. Patients with Eastern Cooperation Oncology Group (ECOG) performance status of 0-2 at screening 6. Patients with adequate organ function with the following laboratory criteria during screening. ? Absolute neutrophil count more than equal to 1500 per µL ? Platelets count more than equal to 100,000 per µL ? Haemoglobin more than equal to 9 g per dL ? Serum creatinine less than equal to 1.5 × ULN ? Serum total bilirubin less than equal to 1.5 × ULN ? Serum aspartate aminotransferase and alanine aminotransferase more than equal to 2.5 × ULN; more than equal to 5 × ULN in patients with liver infiltration 7. Patients with a negative test for Human Immunodeficiency Virus type I/II antibodies, Hepatitis B surface antigen, and Hepatitis C virus antibodies at screening. 8. Patients of childbearing age (defined as women physiologically capable of becoming pregnant) who agree to use effective contraception and not to donate eggs starting from the date of signing the informed consent form and for at least 6 months after the last dose of Niraparib. Acceptable methods of contraception include: ? Intrauterine device or intrauterine system ? Double barrier method of contraception (Condom and occlusive cap or condom and spermicidal agent) ? Hormonal contraception ? Female sterilization (surgical bilateral oophorectomy) or tubal ligation within at least 6 weeks prior to study participation ? Male sterilization (at least 6 months prior to the screening, should be the sole male partner for that patient) plus one additional contraception method. 9. Female patients of non-childbearing potential or female patients who have attained or achieved menopause which is defined as females with consecutive 12 months of spontaneous amenorrhea (not amenorrhea induced by a medical condition or medical therapy) or have bilateral absence of the ovaries. 10. Non-lactating patients 11. Patients of childbearing potential with a negative serum pregnancy test at Screening Part I and II, a negative urine pregnancy test at baseline/randomization visit (Day 0) and on the day of check-in of all the periods. 12. Patients with a life expectancy of more than 90 days. 13. Patients with no history of addiction to any recreational drug or drug dependence or alcohol addiction. 14. Patients who are preferably non-smokers or mild/moderate smokers with not more than 10 bidis/cigarettes/pipes per day, and willing to abstain from smoking or chewing any tobacco-containing products at least 48.00 hours prior to first check-in until the last sample collection in each study period. 15. Patients who are willing to abstain from caffeine/xanthine-containing food and beverages (chocolates, tea, coffee or cola drinks) for at least 48.00 hours (2 days) prior to first chec
Exclusion criteria
Exclusion criteria: 1. Patient with contraindications or hypersensitivity to Niraparib or related other PARP-1 and PARP-2 {Poly (ADP-ribose) polymerase} inhibitors such as Olaparib, Rucaparib etc. 2. Patients with a history of persistent toxicity (more than grade 2) from prior cancer therapy. 3. If patients require dose modification (other than Niraparib 200 mg daily dose) or with expected changes in concomitant medications. 4. Patients who have received palliative radiotherapy within 1 week of screening (encompassing more than 20% of the bone marrow). 5. Patients with known symptomatic, uncontrolled brain or leptomeningeal metastases. 6. Patients who have undergone any major surgery within 3 weeks before initiation of the study. 7. Patients who are receiving prohibited medications such as Anti-coagulants or drugs that reduce thrombocyte counts during the study period. 8. Patients with an active or history of cerebrovascular diseases, such as stroke, or cerebral hemorrhage within 6 months before the screening. 9. Patients who are unable to swallow orally administered drugs; or have gastric, gastro-esophageal, or esophageal cancer or any other gastrointestinal-related disorders that are likely to interfere with the absorption of investigational products. 10. Patients with a history of myelodysplastic syndrome or acute myeloid leukemia. 11. Patients who are pregnant, breastfeeding, or planning to become pregnant during this study period. 12. Patients with psychiatric or neurological disorders. 13. Patients with positive tests for urine drugs of abuse and alcohol breath test on the day of Screening Part I, Randomization Day and every check-in day. 14. Patients who consume grapefruit within 48 hours prior to first check-in and for the entire period of study. 15. Ingestion of any alcoholic beverage within the 48 hours prior to first check-in until the last PK sample collection in each study period. 16. Alcohol or substance abuse, dependence, or intoxication within the past 6 months of screening. 17. Patients with a history of difficulty in donating blood or difficulty in accessibility of veins. 18. Patients who have participated in drug research within the past 3 months before the first administration of the investigational product. 19. Patients who have donated/lost blood (more than 350 ml/1 unit) in the past 3 months before screening. 20. Patients with any condition for which, in the opinion of the investigator, it would not be in the best interest of the patient and may compromise the well-being or that could prevent, limit, or confound the protocol-specified assessments.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax,ss, AUC0-tTimepoint: Day 36 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. PK endpoints: Cmin,ss, Cavg,ss, Degree of Fluctuation, Swing, Cpd,, Tmax,ss 2. Safety endpoint: Incidence of TEAEs (Treatment-Emergent Adverse Events) Timepoint: At day 36 | — |
Countries
India
Contacts
Public ContactDr Sudarshan Kumar
Sun Pharmaceutical Industries Limited
Outcome results
None listed