Comparison of two Everolimus 10 mg tablets in the patients with Advanced Renal Cell Carcinoma
- Conditions
- Health Condition 1: C649- Malignant neoplasm of unspecifiedkidney, except renal pelvis
- Registration Number
- CTRI/2013/09/004006
- Lead Sponsor
- ROXANE LABORATORIES INC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 46
•Patients willing to give written informed consent for participation in the trial.
•Patients must have an ECOG performance status of 0-2.
•Patients with diagnosis of advanced renal cell carcinoma (RCC).
•Patients should be able to comply with study procedures in the opinion of the investigator.
•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.
•Patients willing to avoid use of any recreational drugs/tobacco products/alcohol during the study (from screening to end of the study)
•Known hyper-sensitivity to Everolimus or to other Rapamycin derivatives or any of its excipients.
•Patients with human immunodeficiency virus (HIV) infection.
•A positive hepatitis screen including hepatitis B surface antigen, HCV and HAV antibodies.
•Use of any recreational drugs or history of drug addiction.
•Any other condition or abnormal baseline findings that, in the investigatorâ??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.
•Female patients who are lactating.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To characterize the pharmacokinetic profile of the sponsorâ??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.Timepoint: A total of 40 venous PK blood samples will be collected per patient.
- Secondary Outcome Measures
Name Time Method To monitor the safety of the patients exposed to the Investigational Medicinal Products.Timepoint: NI