CTRI/2016/02/006674招募中未知
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
- 未知
- 状态
- 招募中
- 入组人数
- 78
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. Histologically or Cytologically confirmed diagnosis of advanced renal cell carcinoma.
- •4. Who are already receiving a stable dose of Everolimus tablets, 10 mg tablet once daily as per investigatorâ??s discretion for at least 14 days at first dosing of study drug.
排除标准
- •1. Known hypersensitivity to rapamycin, everolimus or any excipient of everolimus.
- •2. Any prior treatment with everolimus resulting in unacceptable toxicity.
- •3. Receipt of any type of small molecule kinase inhibitors (i.e. axitinib, pazopanib, sorafenib, sunitinib etc) 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.
- •5. 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).
- •6. Pregnant and lactating females.
- •7. 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.
- •8. Participation in another clinical trial in the last 60 days.
- •9.History of noncompliance to medical regimens.
- •10. History of alcoholism / alcohol abuse.
- •11. History of difficulty with donating blood or difficulty in accessibility of veins.
- •12. Patients for whom oral administration of drug is not possible.
- •13. 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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