CTRI/2016/01/006540尚未招募未知
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. - 15-VIN-155
Biocon Limited India0 个研究点目标入组 62 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 62
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Ba/be
入排标准
入选标准
- •1. Men and Women, of age in between 18 years to 65 years(both inclusive).
- •2. Ability to provide informed consent prior to participation in the study
- •3. Patients with confirmed diagnosis of advanced renal cell carcinoma who are candidates for everolimus therapy (10 mg once daily).
- •4. Patients already receiving a stable dose of Everolimus tablets.
排除标准
- •1. Known hypersensitivity or contraindication to everolimus, other rapamycin derivatives or any excipient of everolimus tablets.
- •2. Any prior treatment with everolimus resulting in unacceptable toxicity.
- •3. Receipt of any type of small molecule kinase inhibitor within 2 weeks before randomization.
- •4. Patients with renal failure, Hepatic failure or for whom the need for dose change during the study can be anticipated, should be excluded.
- •5. Patients who are on active treatment with drugs that are known to interact with Everolimus.
- •6. Known brain metastasis, spinal cord compression, or carcinomatous meningitis.
- •7. Uncontrolled, significant intercurrent or recent illness.
- •8. 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.
- •9. Pregnant and lactating females.
- •10. Patients with any factor preventing orally consuming tablet.
- •11. Any difficulty inaccessibility of forearm veins for cannulation or blood sampling.
- •12. 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.
- •13. Participation in another clinical trial in the last 60 days.
- •14. Positive tests for drug of abuse at baseline.
- •15. Donation of blood (1 unit or 350 ml) within 90 days prior to receiving the first dose of investigational medicinal product in the study.
研究者
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