Comparative BE study of Everolimus 10 mg tablet OD manufactured by Par Pharmaceutical,NY 10977,USA with Afinitor10 mg tablet manufactured by Novartis Pharma Stein AG Stein, Switzerland in Advanced Renal Cell Carcinoma patients under fasting condition.

Completed

• Conditions: Advance Renal cell carcinoma

• Registration Number: CTRI/2014/02/004394
• Lead Sponsor: Par PharmaceuticalInc

Brief Summary

A Multicenter, randomized, open label, two treatment, two period, two sequence, multiple-dose, cross-over, bioequivalence study of Everolimus 10 mg tablet once daily manufactured by Par Pharmaceutical, Inc. 1 Ram Ridge Road, Spring Valley, NY 10977,USA with Afinitor (Everolimus)10 mg tablet  manufactured by: Novartis Pharma Stein AG Stein, Switzerland and Distributed by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936 in Advanced Renal Cell Carcinoma patients under fasting condition. Sufficient number of patients will be enrolled to have 48 evaluable patients in the study . Total expected duration of the study will be of at least 29 days from the day first IMP administration in Period I till collection of last PK blood sample in period II i.e. on day 29 of the study. There will be a no washout period of between  two periods. For each patient, a total of 34 PK samples will be collected during the study. Patient will also be provided with a patient diary card to enter the details of study drug consumption at his/her home. Patient will be provided with adequate instructions to complete the patient diary card at his/her home.  Compliance for dosing will be assessed by checking the patients diary for IMP consumption at home, pasting the duplicate label of dispensed container on the appropriate section of individual Case Report Form (CRF). Patients who complete the study and are withdrawn will have to go safety assessments immediately after the last IMP administration or last PK sample collection in period II. A telephonic safety follow up will be done for all the randomized patients till 30 days after the last IMP administration in the study.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02-17
• Last Update Posted: 2018-05-31

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• 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.Women of childbearing potential must have a negative serum pregnancy test in screening and negative urine pregnancy test on day 0 and must be using an adequate method of contraception.
• 5.Patients with advanced renal cell carcinoma and who are already receiving a stable dose of Everolimus tablets, 10 mg tablet once daily.
• 6.Adequate organ function, defined as the following: •Hemoglobin level ≥ 9 gm /dl •Total bilirubin < 1.5 x upper limit of normal (ULN) •SGOT and SGPT < 2.5 x ULN •Creatinine < 1.5 x ULN •Platelets > 100 x 10 raise to nine/L •Clinically non significant fasting blood glucose levels 7.No history of addiction to any recreational drug or drug dependence 8.No participation in any clinical study within the past 60 days prior to first dosing in the study.
• 9.ECOG performance status of ≤ 2 on the ECOG scale 10.Clinically acceptable ECG in opinion of the Investigator/Designee.

Exclusion Criteria

• 1.A history of allergic or adverse reactions to Everolimus or any other rapamycin derivative or any of its excipients 2.Patients with renal failure, or for whom the need for dose change during the study can be anticipated, should be excluded.
• 3.Patient with active infection and symptoms of Non-infectious pneumonitis (symptoms such as but not limited to hypoxia, pleural effusion, cough, or dyspnea, and in whom infectious, neoplastic, and other causes have been excluded by means of appropriate investigations) as judged by the investigator.
• 4.Concurrent use of other drugs known to suppress bone marrow function 5.Expected changes in concomitant medications during the period of study 6.Positive tests for drug of abuse at baseline.
• 7.History of alcoholism / alcohol abuse.
• 8.Patients who are: •Pregnant •Breast feeding •Of childbearing potential without a negative pregnancy test at baseline •Male or female of childbearing potential unwilling to use barrier contraceptive precautions throughout the trial and at least 8 week after ending study treatment.
• 9.Patient had major surgery within 4 weeks prior to study entry, or who have not recovered from prior major surgery 10.Patients with known positivity for human immunodeficiency virus (HIV), HBsAg and HCV.
• 11.Patients with any significant history of non-compliance to medical regimens 12.History of difficulty with donating blood or difficulty in accessibility of veins.
• 13.Patients for whom oral administration of drug is not possible.
• 14.An unusual or abnormal diet, for whatever reason e.g. religious fasting.
• 15.Patients having known brain metastasis 16.Donation of blood (1 unit or 350 ml) within 90 days prior to receiving the first dose of investigational medicinal product in the study.

Study & Design

• Study Type: BA/BE
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
•To compare and evaluate the multiple-dose oral bioavailability of Everolimus 10 mg tablet once daily manufactured by Par Pharmaceutical, Inc. 1 Ram Ridge Road, Spring Valley, NY 10977 USA, with Afinitor (Everolimus) 10 mg tablet manufactured by: Novartis Pharma Stein AG Stein, Switzerland and Distributed by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936 in Advanced renal cell carcinoma patients under fasting condition.	The pre-dose blood sample of 3.0 mL (00.00) will be collected within 5 minutes before dosing on Day 12 and 14 of both periods. On day 14, the post-dose blood samples of 3.0mL each will be drawn at 0.25, 0.5,0.75, 1.0,2.5, 3.0, 4.0, 8.0, 12.0 and 24.0 hrs following drug administration in each period.

Secondary Outcome Measures

Name	Time	Method
To monitor the adverse events and to ensure the safety of Patient	Not Applicable

Trial Locations

Locations (30)

Acharya Harihar Regional Cancer Centre ,; 🇮🇳 Cuttack, ORISSA, India

Aster Aadhar Hospital (Prerana Hospital Ltd.); 🇮🇳 Kolhapur, MAHARASHTRA, India

Axon Hospital; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

B. J .Government Medical College and Sassoon; 🇮🇳 Pune, MAHARASHTRA, India

BIBI General Hospital & Cancer center; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Bodyline Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Central India Cancer Research Institute; 🇮🇳 Nagpur, MAHARASHTRA, India

City Cancer centre; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Curie Manavata cancer centre; 🇮🇳 Nashik, MAHARASHTRA, India

Dr. G Vishwanathan Speciality Hospital; 🇮🇳 Tiruchirappalli, TAMIL NADU, India

Scroll for more (20 remaining)

Acharya Harihar Regional Cancer Centre ,

🇮🇳Cuttack, ORISSA, India

Dr Senapati Surendranath

Principal investigator

9437031718

snsenapati2007@gmail.com