Health Condition 1: C569- Malignant neoplasm of unspecifiedovary
Conditions
Interventions
Intervention1: Niraparib tablets 200 mg: One tablet of Investigational product will be given to the patient for 10 days in the morning with 240 ml drinking water.
Control Intervention1: ZEJULA (nirap
Sponsors
NATCO Pharma Limited
Veeda Clinical Research Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Non-pregnant, non-lactating female patients with age of = 18 years and = 65 years with BMI ranging from 18.5 to 28 kg/m2 (both inclusive). 2. Patients with confirmed diagnosis - documented evidence of histopathological or 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. Not more than 12 weeks should have passed since their most recent platinum-based treatment regimen AND Patients having weight criteria of more than 48 kg -106 lb and less than 77 kg – less than 170 lbs. 3. Patients meeting either one of the following criteria: a. Patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer that will be initiating treatment with Niraparib tablets 200 mg as per the independent clinical judgement of the investigator. Or b. Patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are already receiving Niraparib 200 mg are also eligible. 4. Patients 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. 5. Patients who provide written informed consent for participation in the study. 6. Acceptable adequate organ and bone marrow function at screening and randomization defined by - Bone marrow function & hematology a) Hemoglobin more than or equal 9.0 g/dL b) Neutrophil count more than or equal 1,500 /uL c) Platelet count more than or equal 150,000/uL - Renal function Creatinine Clearance more than or equal 30 mL/min - calculated based on Cockcroft-Gault formula - Hepatic function Total Bilirubin less than 1.5 times ULN SGOT (AST) less than or equal 2.5 times ULN SGPT (ALT) less than or equal 2.5 times ULN 7. Able to take oral medication without crushing, dissolving, or chewing tablets. 8. Patients must have a life expectancy of more than or equal 6 months. 9. Patients who received prior radiation therapy or underwent surgery, at least 28 days must have elapsed since completion of radiation therapy or surgery and patient must have recovered from all side effects at the time of screening -e.g., back to baseline or grade 1. 10. Patients 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. 11. Eastern Cooperative Oncology Group – ECOG performance status of 0-2 - both inclusive. 12. 12-lead ECG with no clinically significant findings at screening, as determined by the Investigator. 13. Women of non-childbearing potential with documented evidence of hysterectomy or bilateral oophorectomy 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 practicing an acceptable method of birth control for the duration of the study as judged b
Exclusion criteria
Exclusion criteria: 1. Female patients who are pregnant, lactating or actively breastfeeding 2. Patients who require dosage modification or with expected changes in concomitant medications that may potentially affect the pharmacokinetics of niraparib during the study. 3. Patients with known hypersensitivity or 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. Patient has significant pleural effusion or ascites that is expected to require drainage during the pharmacokinetic phase of study. 7. If patient has not recovered to Grade 0 or 1 toxicity from previous anticancer treatments or previous investigational agents. Exceptions are alopecia-any grade is acceptable, Hemoglobin more than or equal 9.0 g/dL, fatigue – less than or equal Grade 2 is acceptable, and peripheral neuropathy -stable less than or equal Grade 2 is acceptable Per National Cancer Institute –NCI- Common Terminology Criteria for Adverse Events - CTCAE, V5.0. 8. Patients 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. Patients taking strong and/or moderate CYP3A4 inducers - e.g., carbamazepine, phenytoin, St. John’s Wort, rifampicin or strong and/or moderate CYP3A4 inhibitors - e.g., cimetidine, ciprofloxacin, grapefruit juice within 30 days of screening and throughout the study. 10. History or current diagnosis of myelodysplastic syndrome – MDS or acute myeloid leukemia -AML. 11. Patients who have had the following less than or equal 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 Note: All surgical procedures are considered Major, those are not minor surgical. A minor surgical procedure is one that neither penetrates or exposes a body cavity nor induces permanent impairment of physical or physiologic function. e.g. superficial vascular cut-down, abscess drain, laparoscopy, and percutaneous biopsy. 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. Patients with psychiatric illness or social situations that would limit compliance with study requirements. Receipt of any investigational medicinal product or participation in another drug research study involving IMP administration within 3 months or 5 half-lives - whichever is longer prior to first dosing in Period I for the current study. Note: Elimination half-life of the study drug should be taken into consideration for inclusion of the patient in the study. 17. Patients 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 tumor bone metastases as judged by
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To establish the bioequivalence between Niraparib tablets 200 mg of Natco Pharma - test formulation and ZEJULA – niraparib tablet 200 mg of GlaxoSmithKline - reference product under fasting conditions in female patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy.Timepoint: The pre-dose blood sample of 03 mL (0.00 hour) will be collected within 05 minutes prior dosing on day 8, day 9 & day 10 of Period I and day 18, day 19 & day 20 of Period-II On Day 10 of Period I and Day 20 of Period II, post dose samples will be collected at 0.500, 1.000, 1.500, 2.000, 2.333, 2.667, 3.000, 3.333, 3.667, 4.000, 4.500, 5.000, 6.000, 7.000, 8.000, 12.000, 16.000 and 24.000 hours following drug administration | — |
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 upto day 28 during the study | — |
Countries
India
Contacts
Public ContactDr Ravi Alamchandani
Veeda Clinical Research Limited
Outcome results
None listed