CTRI/2025/01/079290尚未招募不适用
A multi-centre, open label, balanced, randomized, two-treatment, two-period, two-sequence, two-way crossover, multiple-dose, steady state, pharmacokinetic endpoint bioequivalence study of Niraparib tablets 200 mg of Natco Pharma (test product) against 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.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 62
- 试验地点
- 18
- 主要终点
- 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.
研究概览
简要总结
between test and reference products 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 that are receiving market available products of Niraparib tablets 200 mg once daily or are eligible to receive Niraparib tablets 200 mg once daily.
The patients will undergo screening within 28 days prior to first dose administration.
Treatment Period: 20 days
The patients who are found eligible will participate in the study. Two consecutive steady state full PK profiles will be obtained after administration of each treatment -i.e., Test & Reference in this study
In period I -Day 1 to Day 10, patients will receive either Test product or Reference product and in period II -Day 11-20 alternate treatment arm will be received by the patient. Safety assessment: Day 21±2 or at the time of early discontinuation of the subject.
Safety follow-up / End of study assessment: Day 28 ± 2
Total 42 blood samples of 03 mL each will be collected during the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •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).
- •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.
- •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.
- •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.
- •Patients who provide written informed consent for participation in the study.
- •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
- •Able to take oral medication without crushing, dissolving, or chewing tablets.
- •Patients must have a life expectancy of more than or equal 6 months.
- •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
- •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.
- •Eastern Cooperative Oncology Group – ECOG performance status of 0-
- •both inclusive.
- •12-lead ECG with no clinically significant findings at screening, as determined by the Investigator.
- •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 by the investigator, such as condoms, foams, jellies, diaphragm, intrauterine device -IUD, or total abstinence-not the periodic abstinence for at least 4 weeks prior to study drug administration, during the study and for 6 months after the last dose of study drug administration.Cessation of birth control after this point should be discussed with a responsible physician.
- •Patients that can comply with the study procedures in the opinion of Investigator. Patient or caregiver must be able to communicate effectively with study personnel or investigator.
排除标准
- •Female patients who are pregnant, lactating or actively breastfeeding
- •Patients who require dosage modification or with expected changes in concomitant medications that may potentially affect the pharmacokinetics of niraparib during the study.
- •Patients with known hypersensitivity or intolerance to study drug or any other component of the drug or intolerance to niraparib.
- •History of other malignancies in the last 05 years -except in situ cancer or basal or squamous cell skin cancer.
- •Known CNS metastasis.
- •screened by contrast brain MRI or history of previously treated brain metastases that required local treatment.
- •Patient has significant pleural effusion or ascites that is expected to require drainage during the pharmacokinetic phase of study.
- •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.
- •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.
- •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.
- •History or current diagnosis of myelodysplastic syndrome – MDS or acute myeloid leukemia -AML.
- •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.
- •Blood loss -1 unit or 350 ml within 90 days prior to first dosing in Period I for the current study.
- •History of difficulty with donating blood or difficulty in accessibility of veins or intolerance to direct venipuncture.
- •History or presence of alcoholism or drug abuse.
- •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.
- •Patients found positive for HIV, VDRL or RPR -for syphilis, Hepatitis B surface antigen or Hepatitis C antibody at screening.
- •Severe bone injury caused by tumor 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.
- •Patients with moderate or severe hepatic impairment.
- •Child Pugh Class B and C.
- •Patients with a prior history of pulmonary embolism or venous thrombosis, arrhythmia, hypokalemia or hemorrhage.
- •Patients 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.
- •Patients with uncontrolled diabetes mellitus.
- •HbA1c less than 9%.
- •Patients with uncontrolled hypertension as per investigators discretion -however, patients with controlled blood pressure can be allowed as per Investigator’s judgment.
- •Patients positive on Breath alcohol analyzer test during screening and at the time of baseline/randomization visit.
- •Patients positive on urine test for drugs of abuse.
- •including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine during screening and at the time of baseline/randomization visit. Note: If the participant is taking any of the above drugs as a part of prescription medication under the guidance of her physician, then this participant will not be excluded from study.
- •Difficulty in swallowing tablets.
- •Problems with fasting.
- •Any other medical condition or serious inter-current illness.
- •e.g. uncontrolled hypertension, fluid retention, etc. that, in the opinion of the Investigator, may make it undesirable for the patient to participate in the study but not limited to cirrhosis or psychiatric illness/social situations or would limit adherence to study requirements.
结局指标
主要结局
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.
时间窗: 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
次要结局
- To assess the safety & tolerability of the test product compared to reference product by monitoring adverse events.(safety & tolerability of the test or reference product evaluable upto day 28 during the study)
研究者
Dr Rakesh Patel
Veeda Clinical Research Limited
研究点 (18)
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