CTRI/2025/07/090599招募中不适用
A multi-centre, open label, balanced, randomized, two-treatment, four-period, two-sequence, full-replicate, multiple-dose, steady state, pharmacokinetic endpoint bioequivalence study of Niraparib tablets 200 mg of Sandoz (test formulation) against ZEJULA (niraparib) tablet 200 mg of GlaxoSmithKline (reference product) under fasting conditions in female participants with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with positive homologous recombination deficiency (HRD).
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 34
- 试验地点
- 15
- 主要终点
- To establish the bioequivalence between Niraparib tablets 200 mg of Sandoz (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 whose cancer is associated with positive homologous recombination deficiency (HRD)
研究概览
简要总结
This is a four-period, full-replicate bioequivalence study of test formulation against reference product in female patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer.
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 99.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Non-pregnant, non-lactating female participants with age of greater than, equal to 18 years and BMI range of 18.5 to 28 kg/m
- •both inclusive. 2.Participants with confirmed diagnosis 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 whose cancer is associated with positive homologous recombination deficiency (HRD) and are eligible to receive Niraparib as maintenance therapy. 3.Participants weighing more than 48 kg that is 106 lb and less than 77 kg that is 170 lbs or with a platelet count of more than or equal to 100,000 per uL and less than 150,000 per uL 4.Participants meeting either one of the following criteria: a.Participants with HRD-positive advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer that will be initiating treatment with Niraparib tablets 200 mg. Or b.Participants with HRD-positive advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer that are already receiving a stable dose of 200 mg of Niraparib for at least 12 days. 5.Participants that are non-smokers and ex-smoker.
- •stopped using nicotine products for at least 90 days prior to study. 6.Participants that provide written informed consent for participation in the study. 7.Acceptable adequate organ and bone marrow function at screening and randomization 8.Able to take oral medication without crushing, dissolving, or chewing tablets. 9.Participants must have a life expectancy of greater than or equal to 6 months. 10.If Participants have received prior radiation therapy or surgery at least 28 days must have elapsed since completion. 11.Participants who are willing and able to comply with the protocol. 12.ECOG performance status of 0-2, both inclusive. 13.12-lead ECG with no clinically significant findings at screening. 14.Women of non-childbearing potential or Women of child bearing potential must have negative pregnancy test at screening visit and before randomization.
排除标准
- •1.Pregnant, lactating or actively breastfeeding female 2.Participants requiring dosage modification or changes in concomitant medications that may affect the pharmacokinetics of niraparib. 3.Participants who are not on stable dose of Niraparib 200 mg, evaluated based on clinical and laboratory parameters after completion of at least 12 days of dose stabilization 4.Participants with known hypersensitivity or intolerance to niraparib. 5.History of other malignancies in the last 05 years. 6.Known CNS metastasis or previously treated brain metastases that required local treatment. 7.Participants has significant pleural effusion or ascites that is expected to require drainage during the pharmacokinetic phase of study. 8.If Participants has not recovered to Grade 0 or 1 toxicity from previous anticancer treatments or investigational agents. Exceptions are alopecia, Hemoglobin greater than equal to 9.0 g per dL, fatigue – less than equal to Grade 2, and peripheral neuropathy.
- •stable less than or equal to Grade 2 9.Participants with galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption or gastrointestinal resection that is likely to interfere with drug absorption. 10.Participants taking CYP3A4 inducers or inhibitors. 11.History or current diagnosis of myelodysplastic syndrome, MDS or acute myeloid leukemia , AML. 12.Participants who have had a transfusion of-platelets or red blood cells , bone marrow suppression or Major surgery 28 days prior to first dosing in Period I. 13.Blood loss of 1 unit or 350 ml within 90 days prior to first dosing. 14.History of difficulty in accessibility of veins or intolerance to direct venipuncture. 15.History or presence of alcoholism or drug abuse. 16.Participants with psychiatric illness. 17.Receipt of an IMP within 3 months or 5 half-lives prior to dosing. 18.Participants found positive for HIV, VDRL or RPR, Hep B or Hep C at screening. 19.Severe bone injury caused by tumor occurred in the last 6 months or expected to occur in the near future. 20.Participants with moderate or severe hepatic impairment.
- •Child Pugh Class B and C. 21.Participants with history of pulmonary embolism or venous thrombosis, arrhythmia, hypokalemia or hemorrhage. 22.Participants with history of Posterior reversible encephalopathy syndrome. 23.Participants with uncontrolled diabetes mellitus, HbA1c greater than 9 percentage. 24.Participants with uncontrolled hypertension. 25.Participants positive on Breath alcohol analyzer test. 26.Participants positive on urine test for drugs of abuse. 27.Difficulty in swallowing tablets. 28.Problems with fasting. 29.Any other medical condition or serious inter-current illness.
结局指标
主要结局
To establish the bioequivalence between Niraparib tablets 200 mg of Sandoz (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 whose cancer is associated with positive homologous recombination deficiency (HRD)
时间窗: Pre dose blood samples of 03 ml will be collected on day 1, day 7, 8 & 9 of Period I and day 17, 18 & 19 of Period III. | Post dose blood samples will be collected at on- Period I - Day 9, Period II - Day 10, Period III - Day 19 and Period IV - Day 20.
次要结局
- To assess the safety and tolerability of the test product compared to reference product by monitoring adverse events.(Safety & tolerability of the test or reference)
研究者
Dr Rakesh Patel
Veeda Clinical research Limited
研究点 (15)
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