A randomized, multi center, open label, two-treatment, two-period, two-sequence, multiple dose, crossover, pivotal steady state bioequivalence study of Everolimus 10 mg tablet, Manufactured by Teva Pharmaceuticals - Pliva Croatia Ltd., Prilaz baruna Filipovica 25, 10000 Zagreb Croatia vs. Afinitor®(Everolimus) 10 mg tablet of Novartis Pharmaceuticals Corporation, USA in advanced renal cell carcinoma (RCC) patients under fasting conditions.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 78
- 试验地点
- 36
- 主要终点
- To compare and evaluate the bioequivalence of Everolimus 10 mg tablet, Manufactured by Teva Pharmaceuticals - Pliva Croatia Ltd., Prilaz baruna Filipovica 25, 10000 Zagreb Croatia vs. Afinitor® (Everolimus) 10 mg tablet of Novartis Pharmaceuticals Corporation, USA in adult advanced renal cell carcinoma patients who are already receiving the drug at a stable dose of 10 mg once a day as their individual therapy.
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
- •Histologically or Cytologically confirmed diagnosis of advanced renal cell carcinoma.
- •Who are already receiving a stable dose of Everolimus tablets, 10 mg tablet once daily as per investigator’s discretion for at least 14 days at first dosing of study drug.
排除标准
- •Known hypersensitivity to rapamycin, everolimus or any excipient of everolimus.
- •Any prior treatment with everolimus resulting in unacceptable toxicity.
- •Receipt of any type of small molecule kinase inhibitors (i.e. axitinib, pazopanib, sorafenib, sunitinib etc) 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.
- •Known brain metastasis, spinal cord compression, or carcinomatous meningitis; or evidence of brain or leptomeningeal disease on screening computed tomography or magnetic resonance imaging scan.
- •(Unless adequately treated with radiotherapy and/or surgery and stable for at least 3 months before randomization and neurologically asymptomatic at check in).
- •Pregnant and lactating females.
- •Positive test for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV) 1 and 2 serological test at screening or has been previously treated for hepatitis B, hepatitis C, or HIV infection.
- •Participation in another clinical trial in the last 60 days.
- •9.History of noncompliance to medical regimens.
- •History of alcoholism / alcohol abuse.
- •History of difficulty with donating blood or difficulty in accessibility of veins.
- •Patients for whom oral administration of drug is not possible.
- •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 compare and evaluate the bioequivalence of Everolimus 10 mg tablet, Manufactured by Teva Pharmaceuticals - Pliva Croatia Ltd., Prilaz baruna Filipovica 25, 10000 Zagreb Croatia vs. Afinitor® (Everolimus) 10 mg tablet of Novartis Pharmaceuticals Corporation, USA in adult advanced renal cell carcinoma patients who are already receiving the drug at a stable dose of 10 mg once a day as their individual therapy.
时间窗: Total of 42 blood samples at time points, 3.0 ml at pre-dose blood sample(00.00) | within 5 minutes before dosing on Day 12, 13, 14, 26, 27 and 28 of the study. On day 14 & day 28 (the PK day), the post-dose blood samples of 3.0 mL each will be drawn at 0.25, | 0.50,0.75, 1.00, 1.25, 1.50, 1.75,2.00,2.25,2.50,3.00, 3.50, 4.00, 6.00, 8.00, 12.00, 16.00 and 24.00 hrs following drug administration.
次要结局
- To monitor the adverse events and to ensure the safety of patient.(NA)