A multicentre, randomized, open label, two treatment, two period, two-sequence, crossover, multiple dose, steady state bioequivalence study under fasting conditions comparing Everolimus tablets 10 mg (Manufactured by: ROXANE LABORATORIES, INC., Wilson Road, Columbus, Ohio 43228) to the reference listed drug AFINITOR® 10 mg tablets (Manufactured by: Novartis Pharma Stein AG Stein, Switzerland and Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936) in patients of Advanced Renal Cell Carcinoma stabilized on Everolimus 10 mg.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 46
- 试验地点
- 14
- 主要终点
- To characterize the pharmacokinetic profile of the sponsor’s test formulation (Everolimus 10 mg tablets) relative to that of the reference formulation AFINITOR® 10 mg tablets (Everolimus 10 mg tablets) in Advanced Renal Cell Carcinoma and to assess bioequivalence at steady state under fasting conditions.
研究概览
简要总结
Everolimus is an inhibitor of mammalian target of rapamycin (mTOR), a serine-threonine kinase, which ultimately reduces cell proliferation, angiogenesis, and glucose uptake. This study is being conducted to compare & characterize the relative bioavailability & pharmacokinetic profile of the sponsor’s formulation (Everolimus 10 mg tablets) with respect to the reference formulation (AFINITOR® Everolimus 10 mg tablets). This study will be carried out on adult Advanced Renal Cell Carcinoma patients. Treatment may be continued as long as there is no evidence of progressive disease or unacceptable toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 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
- •â€¢Patients willing to give written informed consent for participation in the trial.
- •â€¢Patients must have an ECOG performance status of 0-
- •â€¢Patients with diagnosis of advanced renal cell carcinoma (RCC).
- •â€¢Patients should be able to comply with study procedures in the opinion of the investigator.
- •â€¢In the case of female patients, the serum pregnancy test at the screening visit and the urine pregnancy test at Day 1 (before dosing) must be negative.
- •â€¢Patients willing to avoid use of any recreational drugs/tobacco products/alcohol during the study (from screening to end of the study).
排除标准
- •â€¢Known hyper-sensitivity to Everolimus or to other Rapamycin derivatives or any of its excipients.
- •â€¢Patients with human immunodeficiency virus (HIV) infection.
- •â€¢A positive hepatitis screen including hepatitis B surface antigen, HCV and HAV antibodies.
- •â€¢Use of any recreational drugs or history of drug addiction.
- •â€¢Any other condition or abnormal baseline findings that, in the investigator’s judgement, might increase the risk to the patient or decrease the chance of obtaining satisfactory data •Patients with a history of difficulty in donating blood or difficulty in accessibility of veins.
- •â€¢Female patients who are lactating.
结局指标
主要结局
To characterize the pharmacokinetic profile of the sponsor’s test formulation (Everolimus 10 mg tablets) relative to that of the reference formulation AFINITOR® 10 mg tablets (Everolimus 10 mg tablets) in Advanced Renal Cell Carcinoma and to assess bioequivalence at steady state under fasting conditions.
时间窗: A total of 40 venous PK blood samples will be collected per patient.
次要结局
- To monitor the safety of the patients exposed to the Investigational Medicinal Products.(NIL)