Health Condition 1: C569- Malignant neoplasm of unspecifiedovary
Conditions
Interventions
Intervention1: Niraparib tablets 2x100 mg: Two tablet of Investigational product will be given to the patient for 10 days in the morning with 240 ml drinking water.
Control Intervention1: Zejula (nira
Sponsors
NATCO Pharma Limited
Veeda Clinical Research Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Non-pregnant, non-lactating female participants with age greater than and equal to 18 years and less than equal to 65 years with BMI ranging from 18.5 to 28 kg/m2 (Both inclusive). 2. Participants with confirmed diagnosis - documented evidence of histopathological/ cytological confirmed of advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy and are eligible to receive niraparib as maintenance therapy and participants having weight criteria of greater than 48 kg (106 lb) and less than 77 kg (170 lbs). 3. Participants must have undergone a CT scan within 6 weeks prior to screening in the study. 4. Participants meeting either one of the following criteria: Participants with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer that will be initiating treatment with niraparib tablets 2x100 mg as per the independent clinical judgement of the investigator. Or Participants with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are already receiving niraparib 2x100 mg are also eligible. 5. Participants who are non-smokers and ex-smoker (an ex-smoker is defined as someone who has completely stopped using nicotine products for at least 90 days prior to study drug administration). 6. Participants who provide written informed consent for participation in the study. 7. Acceptable adequate organ and bone marrow function at screening and randomisation defined by: -Bone marrow function & haematology a) Haemoglobin greater than and equal to 9.0 g/dL b) Neutrophil count greater than and equal to 1,500 /uL c) Platelet count greater than and equal to 150,000/uL -Renal function Creatinine Clearance greater than and equal to 30 mL/min - calculated based on Cockcroft-Gault formula -Hepatic function Total Bilirubin less than 1.5 times ULN SGOT (AST) less than 2.5 times ULN SGPT (ALT) less than 2.5 times ULN 8. Able to take oral medication without crushing, dissolving, or chewing tablets. 9. Participants must have a life expectancy of greater than and equal to 6 months. 10. Participants who received prior radiation therapy or underwent surgery, at least 28 days must have elapsed since completion of radiation therapy or surgery and participant must have recovered from all side effects at the time of screening (e.g., back to baseline or grade 1). 11. Participants who are willing and able to comply with the protocol for the duration of the study including undergoing treatment, scheduled visits and examinations including follow up to implement safety precautions and monitoring including complete blood count during treatment. 12. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (both inclusive). 13. 12-lead ECG with no clinically significant findings at screening, as determined by the Investigator. 14. Women of non-childbearing potential with documented evidence of surgical sterility at least 6 months prior to IMP administration) or postmenopausal (defined as 12 consecutive months of spontaneous amenorrhea without other medical explanation) for at least one year. OR Women of child bearing potential must have negative pregnancy test at screening visit and before randomization and practicin
Exclusion criteria
Exclusion criteria: 1. Female participants who are pregnant, lactating, or actively breastfeeding 2. Participants who require dosage modification or with expected changes in concomitant medications that may potentially affect the pharmacokinetics of niraparib during the study. 3. Participants with known hypersensitivity/ intolerance to study drug or any other component of the drug or intolerance to niraparib. 4. History of other malignancies in the last 05 years (except in situ cancer or basal or squamous cell skin cancer). 5. Known CNS metastasis (screened by contrast brain MRI) or history of previously treated brain metastases that required local treatment. 6. Participant has significant pleural effusion or ascites that is expected to require drainage during the pharmacokinetic phase of study. 7. If participant has not recovered to Grade 0 or 1 toxicity from previous anticancer treatments or previous investigational agents. 8. Participants with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption or presence of a gastrointestinal condition (significant gastrointestinal resection) that is likely to interfere with drug absorption. 9. Participants taking strong and/or moderate CYP3A4 inducers or strong and/or moderate CYP3A4 inhibitors within 30 days of screening and throughout the study. 10. History or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML). 11. Participants who have had the following less than or equal to 28 days prior to first dosing in Period I: a. A transfusion (platelets or red blood cells) b. A myelosuppression or bone marrow suppression c. Major surgery 12. Blood loss (1 unit or 350 ml) within 90 days prior to first dosing in Period I for the current study 13. History of difficulty with donating blood or difficulty in accessibility of veins or intolerance to direct venipuncture. 14. History or presence of alcoholism or drug abuse. 15. Participants with psychiatric illness/social situations that would limit compliance with study requirements. 16. Receipt of any investigational medicinal product or participation in another drug research study involving IMP administration within 3 months/ 5 half-lives (whichever is longer) prior to first dosing in Period I for the current study. 17. Participants found positive for HIV, VDRL or RPR (for syphilis), Hepatitis B surface antigen or Hepatitis C antibody at screening. 18. Severe bone injury caused by tumour bone metastases as judged by the Investigator, including severe bone pain due to poor control, pathological fracture of important parts or spinal cord compression occurred in the last 6 months or expected to occur in the near future. 19. Participants with moderate or severe hepatic impairment (Child Pugh Class B and C) in screening. 20. Participants with a prior history of pulmonary embolism or venous thrombosis, arrhythmia, hypokalaemia or haemorrhage. 21. Participants with history of Posterior reversible encephalopathy syndrome (PRES) or at risk of developing Posterior reversible encephalopathy syndrome (PRES) as per the discretion of the Investigator. 22. Participants with uncontrolled diabetes mellitus and hypertension judged by investigator. 23. Participants positive on Breath alcohol analyzer test during screening and at the ti
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety & tolerability of the test product compared to reference product by monitoring adverse events.Timepoint: safety & tolerability of the test or reference product evaluable up to day 28 during the study | — |
Primary
| Measure | Time frame |
|---|---|
| To establish the bioequivalence between Niraparib tablets 200mg of Natco Pharma - test formulation and ZEJULA â??niraparib tablet 200 mg of GlaxoSmithKline - reference productunder fasting conditions in female patients with advancedepithelial ovarian, fallopian tube, or primary peritoneal cancerwho are in a complete or partial response to first-lineplatinum-based chemotherapy.Timepoint: To establish the bioequivalence between Niraparib tablets 200mg of Natco Pharma - test formulation and ZEJULA â??niraparib tablet 200 mg of GlaxoSmithKline - reference productunder fasting conditions in female patients with advancedepithelial ovarian, fallopian tube, or primary peritoneal cancerwho are in a complete or partial response to first-lineplatinum-based chemotherapy. | — |
Countries
India
Contacts
Public ContactDr Ravi Alamchandani
Veeda Clinical research Limited
Outcome results
None listed