A randomized, multi center, open label, two-treatment, two-period, two-sequence, multiple dose, crossover, steady state bioequivalence study of Everolimus tablets, 10 mg of Biocon Limited, India vs. Afinitor® (Everolimus) tablets, 10 mg of Novartis Pharmaceuticals Corporation, USA in advanced renal cell carcinoma (RCC) patients.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 62
- 试验地点
- 37
- 主要终点
- To demonstrate the bioequivalence of Everolimus tablet, 10 mg of Biocon Limited, India vs. Afinitor® (Everolimus) tablets, 10 mg of Novartis Pharmaceuticals Corporation, USA in adult advanced renal cell carcinoma patients who are already receiving everolimus
研究概览
简要总结
Patients with confirmed diagnosis of advanced renal cell carcinoma who are candidates for everolimus therapy (10 mg once daily) and who fulfill the inclusion and exclusion criteria will be randomized in study. As per randomization schedule, patient will be administered either Test or Reference orally once daily for 14 days in the following treatment sequence i.e. either R & T or T & R in each period crossed over without washout period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Men and Women, of age in between 18 years to 65 years(both inclusive).
- •Ability to provide informed consent prior to participation in the study
- •Patients with confirmed diagnosis of advanced renal cell carcinoma who are candidates for everolimus therapy (10 mg once daily).
- •Patients already receiving a stable dose of Everolimus tablets.
排除标准
- •Known hypersensitivity or contraindication to everolimus, other rapamycin derivatives or any excipient of everolimus tablets.
- •Any prior treatment with everolimus resulting in unacceptable toxicity.
- •Receipt of any type of small molecule kinase inhibitor within 2 weeks before randomization.
- •Patients with renal failure, Hepatic failure or for whom the need for dose change during the study can be anticipated, should be excluded.
- •Known brain metastasis, spinal cord compression, or carcinomatous meningitis.
- •Uncontrolled, significant intercurrent or recent illness.
- •History of administration of live vaccines within the past 4 weeks or need to administer a live vaccine within 4 weeks after the last dose of the study drug.
- •Pregnant and lactating females.
- •Patients with any factor preventing orally consuming tablet.
- •Any difficulty inaccessibility of forearm veins for cannulation or blood sampling.
- •Positive test for hepatitis B surface antigen, hepatitis C antibody, or humanimmunodeficiency virus (HIV) 1 and 2 serological test at screening or has been previously treated for hepatitis B, hepatitis C, or HIV infection.
- •Positive tests for drug of abuse at baseline.
- •Donation of blood (1 unit or 350 ml) within 90 days prior to receiving the first dose of investigational medicinal product in the study.
结局指标
主要结局
To demonstrate the bioequivalence of Everolimus tablet, 10 mg of Biocon Limited, India vs. Afinitor® (Everolimus) tablets, 10 mg of Novartis Pharmaceuticals Corporation, USA in adult advanced renal cell carcinoma patients who are already receiving everolimus
时间窗: Total 44 blood samples will be collected during the study for PK analysis.
at a stable dose of 10 mg once a day as their individual therapy.
时间窗: Total 44 blood samples will be collected during the study for PK analysis.
次要结局
- To monitor the safety and tolerability profile of the study formulations.(NA)