CTRI

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CTRI Number

CTRI/2016/01/006540 [Registered on: 18/01/2016] Trial Registered Prospectively

Last Modified On:

17/02/2016

Post Graduate Thesis

Type of Trial

BA/BE

Type of Study

Study Design

Randomized, Crossover Trial

Public Title of Study
Modification(s)

Bioequivalence study of Everolimus 10mg in advanced renal cell carcinoma patients.

Scientific Title of Study

A randomized, multi center, open label, two-treatment, two-period, two-sequence, multiple dose, crossover, steady state bioequivalence study of Everolimus tablets, 10 mg of Biocon Limited, India vs. AfinitorÂ® (Everolimus) tablets, 10 mg of Novartis Pharmaceuticals Corporation, USA in advanced renal cell carcinoma (RCC) patients.

Trial Acronym

15-VIN-155

Secondary IDs if Any

Secondary ID	Identifier
15-VIN-155 Version 01 Date 20-Aug-2015	Protocol Number

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Ashoka Kumar Singh
Designation	Head Of the Department - Clinical Operations
Affiliation	Veeda Clinical Research Pvt. Ltd.
Address	Veeda Clinical Research Pvt. Ltd. Shivalik Plaza-A, Near IIM, Ambawadi, Ahmedabad NA Ahmadabad GUJARAT 380015 India
Phone	079-30013000
Fax
Email	Ashoka.Singh@veedacr.com

Details of Contact Person
Scientific Query

Name	Dr Yogesh Patel
Designation	Senior Manager-Clinical Operations
Affiliation	Veeda Clinical Research Pvt. Ltd.
Address	Veeda Clinical Research Pvt. Ltd. Shivalik Plaza-A, Near IIM, Ambawadi, Ahmedabad NA Ahmadabad GUJARAT 380015 India
Phone	079-30013000
Fax
Email	Yogesh.AP@veedacr.com

Details of Contact Person
Public Query

Name	Dr Ashoka Kumar Singh
Designation	Head Of the Department - Clinical Operations
Affiliation	Veeda Clinical Research Pvt. Ltd.
Address	Veeda Clinical Research Pvt. Ltd. Shivalik Plaza-A, Near IIM, Ambawadi, Ahmedabad NA Ahmadabad GUJARAT 380015 India
Phone	079-30013000
Fax
Email	Ashoka.Singh@veedacr.com

Source of Monetary or Material Support

Biocon Limited, India

Primary Sponsor

Name	Biocon Limited India
Address	SEZ Unit, Biocon Special Economic Zone, Plot No.2&3, Phase IV- B.I.A, Bommasandra-Jigani Link Road, Bangalore - 560099, India
Type of Sponsor	Pharmaceutical industry-Global

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 37
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Uday Pratap Singh	Sanjay Gandhi Post Graduate of Medical Sciences	Department of urology, Sanjay Gandhi Post Graduate of Medical Sciences , Raibareli road, Lucknow 226014 Lucknow UTTAR PRADESH	8004904811 5222668017 saurabhvashishtha@sgpgi.ac.in
Dr Surendranath Senapati	Acharya Harihar Regional Cancer Centre	Department of Radiation Oncology, Acharya Harihar Regional Cancer Centre,Medical road, Manjalabg , cuttack , odisha , 753007 , India. Cuttack ORISSA	9937031718 91-671-2305533 snsenapati2007@gmail.com
Dr Kaushal Patel	Apple Hospital	Apple Hospital , Udhna Darwaja, Ring Road, Surat Surat GUJARAT	9723431102 2616696078 drkaushalbpatel@gmail.com
Dr Jaiprakash Baraskar	Baraskar hospital & research centre	Baraskar hospital & research centre , 276, Crystal plaza, central Bazar road, Ramdas path , Nagpur , Maharashtra 440010. Nagpur MAHARASHTRA	9422108822 0712-2461479 jpcancercare@gmail.com
Dr Shailesh Shah	Bodyline Hospitals	Bodyline Hospitals , Opp. Annapurna Hall , New vikas gruh road, Paldi , Ahmedabad - 7 Gujarat 380007 Ahmadabad GUJARAT	9824035673 07926640558 Shaileshshahuro@yahoo.com
Dr Kim mammaen	Christian Medical College & Hospital	Department of Urology , Christian Medical College & Hospital , Ludhiyana , 14008 Ludhiana PUNJAB	9814034185 1615010909 kjmammen@gmail.com
Dr Ashutosh A Tondare	Curie Manavata cancer center	Curie Manavata cancer center, Opp, Mahamarg Bus stand, Mumbai Naka, Nashik-422004, Maharashtra. Nashik MAHARASHTRA	8552855111 253-2594866 dr.ashutosh.at@gmail.com
Dr KN Srinivasan	Dr G Viswanathan Speciality hospital	Dr G Viswanathan Speciality hospitals, No 27 BABU Road , Trichy , Tamilnadu , 620008 Tiruchirappalli TAMIL NADU	9443337230 kns68@yahoo.com
Dr Rajeev Sood	Dr. RML Hospital & PGIMER	Department of Urology, Dr. RML Hospital & PGIMER ,New Delhi , 11001. New Delhi DELHI	9810005182 1123360067 drsoodr@gmail.com
Dr C Sairam	Global Hospiotals	Global Hospiotals, Lakdi-ka-pool, Hyderabad, telangana-500004. Hyderabad ANDHRA PRADESH	9849032198 040-23233166 sureshattili@yahoo.com
Dr Dinesh Chandra Katiyar	HCG-SMH-Curie Cancer centre	HCG-SMH-Curie Cancer centre, 2, institutional Area, Vikas Marg extension, Karkardooma, Delhi-110092 East DELHI	9811555571 drdckatiyar@gmail.com
Dr Raghunath S K	Health care global enterprises ltd	Health care global enterprises ltd., HCG tower, #8, P.kalarga Rao Road, Sampang, Ram nagar, Bangalore-560027. Bangalore KARNATAKA	9731209671 080-40206059 drraghunathsk@yahoo.com
Dr Shibashish Bhattacharyya	Health point Multi-speciality hospital	Health point Multi-speciality hospital,21,prannath pandit street,opp Lansdowne padmapukur, Kolkata , west bengal 700025 Kolkata WEST BENGAL	9051837235 033-24557037 shibashishbhattacharya@ymail.com
Dr Bidisha Ghosh	I PGME & R/ SSKM Hospital	I PGME & R/ SSKM Hospital , Department of Radiology, # 244 AJC Bose road , Kolkata , West Bengal 700020. Kolkata WEST BENGAL	8420011311 anant@indoriv.com
Dr Ravindra Deshmukh	Jasleen Hospital & Kidney Centre	Jasleen Hospital & Kidney Centre , Opposite Big Bajar , Panchsheel Square Dhantoli , Nagpur 440012 Nagpur MAHARASHTRA	9823056120 dravi1962@gmail.com
Dr Rahul Janak Sinha	King George Medical University	Department of Urology King George Medical University, Lucknow, Uttar Pradesh,226003 Lucknow UTTAR PRADESH	9809211234 archit.deva@gmail.com
Dr Mahesh Kalloli	KLCS Dr Prashakar Kore Hospital	KLCS Dr Prashakar Kore Hospital and MRC Nehru nagar Belagavi-590010 , karnataka India Bangalore KARNATAKA	9945014996 590010 mahesh.kalloli@gmail.com
Dr Kunal Mangale	Kolhapur Cancer centre	Kolhapur Cancer centre pvt ltd, R.S 238 , opp Mayur Petrol Pump, Near Orange dhaba , gokul shirgaon , Maharashtra 416234 Kolhapur MAHARASHTRA	9987763508 dr.krunal.mangele@gmail.com
Dr Ramchandra Naniwadekar	Krisha Institute of Medical Sciences deemed University	Krisha Institute of Medical Sciences deemed University , Karad , Pune - Banglore Highway 4 Malkapur.Karad Dist - Satara - 415110 Pune MAHARASHTRA	9730475068 020-66434300 dr.rnaniwadekar@gmail.com
Dr Padhey D Damodar	Lifepoint Multispeciality Hospital	Lifepoint Multispeciality Hospital , 145/1 Mumbai Banglore High way , Near Hotel Sayaji , Bhumkar chowk Warad , pune - 411057 , Maharastra , India Pune MAHARASHTRA	9822495546 020-27298081 padhye.dev@gmail.com
Dr Guruprasad Bhatt	Mangala Hospital & Mangala Kidney Foundation	Mangala Hospital & Mangala Kidney Foundation , Vajra hills Kandri Road , Mangalore 575003 Bangalore KARNATAKA	9663560802 918244255925 guru02doc@yahoo.co.in
Dr Chandrashekhar Tamane	MGM Medical College & hospital	MGM Medical College & hospital, N-6 CIDCO Aurangabad 431003 Aurangabad MAHARASHTRA	9561707496 02402483404 MgMPharmacologydept@gmail.com
Dr Shekhar Takale	MMF , Joshi Hospitals	Maharashtra Medical Foundation , Joshi Hospitals, 778,Shivji naagar , opp.kamla nehru park , Pune 411004 Pune MAHARASHTRA	9225510913 dr.tshekhar7@gmail.com
Dr Arvind P Ganpule	Muljibhai Patel Urological Hospital	Muljibhai Patel Urological Hospital, Dr. Virendra Desai Road, Nadiad, Gujarat. Kheda GUJARAT	9824188685 912682520248 doctorarvind1@gmail.com
Dr Rakesh Suresh Neve	P.D.E.AS Ayurved Rugnalaya & Sterling multispeciality Hospital	P.D.E.AS Ayurved Rugnalaya & Sterling multispeciality Hospital Sector 27, near Bhel chowk, pradhikaran, Nigdi, pune, Maharashtra-411004 Pune MAHARASHTRA	9225510913 020-27332700 drrneve@gmail.com
Dr HS Shukla	Pragya Multispeciality Hospital & Research centre	Pragya Multispeciality Hospital & Research centre, Airport road , Mrahua , Varanasi-221002 U.P Varanasi UTTAR PRADESH	9415224400 harishukla@gmail.com
Dr Francis James	Regional Cancer Centre	Department of Radiation Oncology, Regional Cancer Centre, Medical college campus, Thiruvanthapuram 695011 Thiruvananthapuram KERALA	9847189270 04712448858 francisjames@hotmail.com
Dr Kartar Singh	RST Regional Cancer Hospital	RST Regional Cancer Hospital, Tukdoji sq., Morewada road, Maharashtra , Nagpur 440027 Nagpur MAHARASHTRA	9890354174 drkartarsingh@yahoo.co.in
Dr JK Singh	S .S Hospital And Research Centre	S .S Hospital And Research Centre Doctors colony , Malahipark chowk, Kankarbagh , Patna , 80020 , Bihar Patna BIHAR	9431021001 drjksingh147@hotmail.com
Dr Amit Jetani	Shree Giriraj Multispeciality Hospital	Shree Giriraj Multispeciality Hospital, 27 - Navjyot park corner, 150 feet ring road, Rajkot - 360005 Rajkot GUJARAT	9825713758 12812587222 dramitjetani@ymail.com
Dr Satish Srinivas	Shri Ramchandra Medical Centre	Shri Ramchandra Medical Centre No 1 Ramchandra Nagar , Porur Tamilnadu 600116 Thiruvallur TAMIL NADU	044459289008699 dr_satishsrinivas@rediffmail.com
Dr Sudhir khanna	Sir Ganga Ram Hospital	Sir Ganga Ram Hospital, rajinder nagar, New delhi-110060 New Delhi DELHI	9810195227 011-45041726 SK1957@gmail.com
Dr Vinay Tomar	SMS Medical college & Attached Hospital	Department of Urology , SMS Medical college & Attached Hospitals , J.I N Marg , Jaipur , 302004 , Rajasthan , India Jaipur RAJASTHAN	9414057088 0141-2518222 dr_v_tomar@yahoo.co.in
Dr Ghanshyam Biswas	Sparsh Hospitals & Critical Care	Sparsh Hospitals & Critical Care pvt ltd, Plot no A/407, Saheed Nagar, Bhuvneshwar 751007 Khordha ORISSA	9937500878 0674-254860 drgbiswas@gmail.com
Dr Lokesh KN	Sri Venkateshwara hospital	Sri Venkateshwara hospital, # 86 hosar main road , Madiwala, Banglore-560068 Bangalore KARNATAKA	9164242782 8025630006 svhospital1997@gmail.com
Dr Haresh Thummar	Sterling Hospital	Sterling Hospital , Opp.INOX , Race Cource Circle (west), vadodara 39007. Vadodara GUJARAT	9825847478 Kpaneshgt@yahoo.co.in
Dr Ketan Shukla	Sterling hospital	Sterling Hospital Memnagar Road Ahmedabad , Gujarat, India 380052 Ahmadabad GUJARAT	9825097767 079-40011622 ketanshukla1968@gmail.com

Details of Ethics Committee

No of Ethics Committees= 37
Name of Committee	Approval Status
Apple Hospital Ethics Committee	Submittted/Under Review
Bioethics Cell Ethics Committee	Submittted/Under Review
Bodyline Hospital Institutional Ethics Committee ,	Submittted/Under Review
Ethics Committee KLES University	Submittted/Under Review
Ethics Committee Sterling Hospital	Submittted/Under Review
HCG central ethics committee	Submittted/Under Review
HCG-SMH Institutional Ethics Committee	Submittted/Under Review
Health point ethics Committee	Submittted/Under Review
Health point ethics Committee	Submittted/Under Review
Hospital Ethics Committee Dr G Viswanathan Speciality hospital	Submittted/Under Review
Human Ethics committee Regional Cancer Centre	Submittted/Under Review
IEC RST Regional Cancer Hospital	Submittted/Under Review
Institutional Ethics Committee Acharya Harihar Regional Cancer Centre	Submittted/Under Review
Institutional Ethics Committee Jasleen Hospital	Submittted/Under Review
Institutional Ethics Committee Christian Medical College & Hospital	Submittted/Under Review
Institutional Ethics Committee Global Hospitals	Submittted/Under Review
Institutional Ethics Committee Maharashtra medical research society	Submittted/Under Review
Institutional Ethics Committee Muljibhai Patel Urological Hospital	Submittted/Under Review
Institutional Ethics Committee of Krisha Institute of Medical Sciences	Submittted/Under Review
Institutional Ethics Committee Research cell KGMU	Submittted/Under Review
Institutional Ethics Committee S .S Hospital And Research Centre	Submittted/Under Review
Institutional Ethics Committee Shri Ramchandra University	Submittted/Under Review
Institutional Ethics Committee Sparsh Hospitals & Critical Care pvt ltd	Submittted/Under Review
Institutional Ethics Committee, Dr Ram Manohar lohiya hospital	Submittted/Under Review
Jasleen hospitals ethics committee	Submittted/Under Review
Kolhapur Cancer centre Institutional Ethics Committee	Submittted/Under Review
LPR Ethics committee	Submittted/Under Review
Manavata Clinical Research Institute Ethics Committee	Submittted/Under Review
Mangala Institutional Ethics Committee	Submittted/Under Review
MGM ECRHS Ethics Committee	Submittted/Under Review
pragya Ethics committee	Submittted/Under Review
Shree Giriraj Hospital Research Ethics Committee	Approved
Sir Ganga Ram Hospital Ethics committee	Submittted/Under Review
SMS Medical college & Attached Hospitals	Submittted/Under Review
Sri Venkateshwara hospital Ethics committee	Submittted/Under Review
Sterling Ethics Committee	Submittted/Under Review
Sterling Hospital Ethics Committee	Submittted/Under Review

Regulatory Clearance Status from DCGI

Status

No Objection Certificate

Health Condition / Problems Studied

Health Type	Condition
Patients	Advanced renal cell carcinoma,

Intervention / Comparator Agent
Modification(s)

Type	Name	Details
Comparator Agent	AfinitorÂ® (Everolimus) tablets, 10 mg Manufactured by: Novartis Pharma Stein AG Stein, Switzerland and Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936.	As per the randomization schedule, either test [T] or [R] product will be administered orally to each patient (once daily) for 14 days in each period.
Intervention	Everolimus tablets, 10 mg of Biocon Limited,India.	As per the randomization schedule, either test [T] or [R] product will be administered orally to each patient (once daily) for 14 days in each period.

Inclusion Criteria
Modification(s)

Age From	18.00 Year(s)
Age To	65.00 Year(s)
Gender	Both
Details	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. Patients with confirmed diagnosis of advanced renal cell carcinoma who are candidates for everolimus therapy (10 mg once daily). 4. Patients already receiving a stable dose of Everolimus tablets.

ExclusionCriteria

Details

1. Known hypersensitivity or contraindication to everolimus, other rapamycin derivatives or any excipient of everolimus tablets.
2. Any prior treatment with everolimus resulting in unacceptable toxicity.
3. Receipt of any type of small molecule kinase inhibitor within 2 weeks before randomization.
4. Patients with renal failure, Hepatic failure or for whom the need for dose change during the study can be anticipated, should be excluded.
5. Patients who are on active treatment with drugs that are known to interact with Everolimus.
6. Known brain metastasis, spinal cord compression, or carcinomatous meningitis.
7. Uncontrolled, significant intercurrent or recent illness.
8. History of administration of live vaccines within the past 4 weeks or need to administer a live vaccine within 4 weeks after the last dose of the study drug.
9. Pregnant and lactating females.
10. Patients with any factor preventing orally consuming tablet.
11. Any difficulty inaccessibility of forearm veins for cannulation or blood sampling.
12. Positive test for hepatitis B surface antigen, hepatitis C antibody, or humanimmunodeficiency virus (HIV) 1 and 2 serological test at screening or has been previously treated for hepatitis B, hepatitis C, or HIV infection.
13. Participation in another clinical trial in the last 60 days.
14. Positive tests for drug of abuse at baseline.
15. Donation of blood (1 unit or 350 ml) within 90 days prior to receiving the first dose of investigational medicinal product in the study.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Other

Blinding/Masking

Open Label

Primary Outcome
Modification(s)

Outcome	TimePoints
To demonstrate the bioequivalence of Everolimus tablet, 10 mg of Biocon Limited, India vs. AfinitorÂ® (Everolimus) tablets, 10 mg of Novartis Pharmaceuticals Corporation, USA in adult advanced renal cell carcinoma patients who are already receiving everolimus at a stable dose of 10 mg once a day as their individual therapy.	Total 44 blood samples will be collected during the study for PK analysis.

Secondary Outcome

Outcome	TimePoints
To monitor the safety and tolerability profile of the study formulations.	NA

Target Sample Size

Total Sample Size="62"
Sample Size from India="62"
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)
Modification(s)

25/02/2016

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="1"
Months="0"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Not Applicable

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Brief Summary
Modification(s)

Patients with confirmed diagnosis of advanced renal cell carcinoma who are candidates for everolimus therapy (10 mg once daily) and who fulfill the inclusion and exclusion criteria will be randomized in study. As per randomization schedule, patient will be administered either Test or Reference orally once daily for 14 days in the following treatment sequence i.e. either R & T or T & R in each period crossed over without washout period.