CTRI/2013/09/004006 [Registered on: 20/09/2013] Trial Registered Prospectively
Last Modified On:
22/11/2018
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
Study Design
Randomized, Crossover Trial
Public Title of Study
Comparison of two Everolimus 10 mg tablets in the patients with Advanced Renal Cell Carcinoma
Scientific Title of Study
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.
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
208-13_Version 1 Dated 07/06/2013
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Mr Priyajeet Parekh
Designation
Project Manager
Affiliation
Lambda Therapeutic Research Ltd
Address
Plot No. 38,
Near Silver Oak Club, S. G. Highway, Gota,
Ahmadabad GUJARAT 380061 India
Phone
07940202057
Fax
07940202022
Email
priyajeetparekh@lambda-cro.com
Details of Contact Person Scientific Query
Name
Dr Ankit Ranpura
Designation
Assistant Manager
Affiliation
Lambda Therapeutic Research Ltd
Address
Plot No. 38,
Near Silver Oak Club, S. G. Highway, Gota,
Ahmadabad GUJARAT 380061 India
Phone
07940202074
Fax
07940202022
Email
ankitranpura@lambda-cro.com
Details of Contact Person Public Query
Name
Dr Praveen Shetty
Designation
Manager
Affiliation
Lambda Therapeutic Research Ltd
Address
Plot No.38,
Near Silver Oak Club, S. G. Highway, Gota,
Ahmadabad GUJARAT 380061 India
Phone
07940202098
Fax
07940202022
Email
praveenshetty@lambda-cro.com
Source of Monetary or Material Support
ROXANE LABORATORIES INC.
Primary Sponsor
Name
ROXANE LABORATORIES INC
Address
Wilson Road, Columbus, Ohio- 43228 USA
Type of Sponsor
Pharmaceutical industry-Global
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 14
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Ketan Shukla
Aarogyam Speciality Hospital
SHOM-1, Nr Darpan Sixs Road, Navrangpura, Ahmedabad-380014, Gujarat, India Ahmadabad GUJARAT
9825097767
ketanshukla1968@gmail.com
Dr Senapati Surendra Nath
Acharya Harilal Regional Cancer Centre
Dept of Radiation Oncology, Medical road, Mangalabag, Cuttack - 753007, Odisha, India Cuttack ORISSA
9437031718
snsenapati2007@gmail.com
Dr V Satya Suresh Attili
Bibi General Hospital and Cancer centre
16-3-991/1/C, Government printing press road, Malakpet, Hyderabad- 500024, Andhra Pradesh, India. Hyderabad ANDHRA PRADESH
9246243034
sureshattili@yahoo.com
Dr Smita Gupte
Cancer Clinic & Nursing Home
208, Shreewardhan complex, Wardha road, Ramdapeth and Block 4B, Hyatt Medicare, Plot No.12/2, Dr N.B.Khare Marg, Dhantoli, Nagpur – 440012, Maharastra, India Nagpur MAHARASHTRA
9373107176
smita_gupte@rediffmail.com
Dr Ajay Mehta
Centre India Cancer Research Institute
11 Shankar Nagar, west High Court Road, Nagpur – 440010, Maharashtra, India Nagpur MAHARASHTRA
9823190192
ajayonco@hotmail.com
Dr Rajnish Vasant Nagarkar
Curie Manavata Cancer Centre
Opp Mahamarg bus stand, Mumbai Naka, Nashik – 422004, Maharashtra, India. Nashik MAHARASHTRA
9823061929
drraj@manavatacancercentre.com
Dr Kartar Singh
Green City hospital
Near Dhantoli Police Station, Mehadia square, Nagpur - 440012, Maharashtra, India. Nagpur MAHARASHTRA
9890354174
drkartarsingh@yahoo.co.in
Dr Minish Jain
KEM Hospital Research Centre
3rd Floor, Day Care Centre, Banoo Koyaji Building, Rasta Peth, Sardar Moodliar Road, Pune – 411011, Maharashtra, India Pune MAHARASHTRA
9823133390
drminishjain@yahoo.co.in
Dr S P Srivastav
Lions cancer detection centre & Life Research Centre
New Civil Hospital campus, Majuragate, Surat-395004, Gujarat, India. Surat GUJARAT
9824196710
liononco@gmail.com
Dr Chiramana Haritha
M. S. Patel Cancer Centre, Shree Krishna Hospital & Medical Research Centre
Gokal Nagar, Karamsad - 388325, Gujarat, India Anand GUJARAT
9427042969
ritu80@rediffmail.com
Dr Kirushna kumar Kosanam Subramanian
Meenakshi Mission Hospital & Research Centre
Lake Area, Melur Road, Madurai-625107, Tamilnadu, India. Madurai TAMIL NADU
9842113003
drkskk@yahoo.com
Dr Rakesh Neve
Nandadeep Multispeciality Hospital
1195/1, F.C. Road, Shivajinagar, Pune – 411005, Maharashtra, India Pune MAHARASHTRA
(1) ICD-10 Condition: C649||Malignant neoplasm of unspecifiedkidney, except renal pelvis,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
AFINITOR® 10 mg tablet
10 mg tablets will be
administered orally once daily for 14 days
Intervention
Everolimus 10 mg tablets
10 mg tablets will be
administered orally once daily for 14 days
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
•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)
ExclusionCriteria
Details
•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 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.
•Female patients who are lactating.
Method of Generating Random Sequence
Other
Method of Concealment
Other
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
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.
A total of 40 venous PK blood samples will be collected per patient.
Secondary Outcome
Outcome
TimePoints
To monitor the safety of the patients exposed to the Investigational Medicinal Products.
NIL
Target Sample Size
Total Sample Size="46" Sample Size from India="46" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
N/A
Date of First Enrollment (India)
15/10/2013
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="0" Months="10" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
NIL
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
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.