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Comparison of two Everolimus 10 mg tablets in the patients with Advanced Renal Cell Carcinoma

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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/09/004006
Enrollment
46
Registered
2013-09-20
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C649- Malignant neoplasm of unspecifiedkidney, except renal pelvis

Interventions

Intervention1: Everolimus 10 mg tablets: 10 mg tablets will be administered orally once daily for 14 days Control Intervention1: AFINITOR® 10 mg tablet: 10 mg tablets will be administered orally once

Sponsors

ROXANE LABORATORIES INC
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: •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)

Exclusion criteria

Exclusion criteria: •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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
To monitor the safety of the patients exposed to the Investigational Medicinal Products.Timepoint: NIL—

Countries

India

Contacts

Public ContactDr Praveen Shetty

Lambda Therapeutic Research Ltd

ankitranpura@lambda-cro.com07940202074

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026