| CTRI Number |
CTRI/2009/091/000276 [Registered on: 24/11/2010] |
| Last Modified On: |
16/07/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
BRISK - FL |
Scientific Title of Study
Modification(s)
|
A Randomized, Double-blind, Multi-center Phase III Study of Brivanib versus Sorafenib as First-line Treatment in Patients with Advanced Hepatocellular Carcinoma |
| Trial Acronym |
CA182-033 |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| CA182-033 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr T Raja |
| Designation |
Investigator |
| Affiliation |
|
| Address |
Appolo Speciality Hospital.
320 Mount Road,
Chennai
TAMIL NADU
600035
India |
| Phone |
914424355003 |
| Fax |
|
| Email |
rajatraj@yahoo.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Poonam Rohira |
| Designation |
Disease Area Head |
| Affiliation |
|
| Address |
Bristol Myers Squibb India Pvt. Ltd.
The Indiabulls Finance Centre, 6th Floor , Tower 01 ,
Senapati Bapat Marg, Elphinstone ( W ) , Mumbai
Mumbai
MAHARASHTRA
400013
India |
| Phone |
|
| Fax |
|
| Email |
poonam.rohira@bms.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
MsShivkumar Subashri |
| Designation |
Hub Unit Director |
| Affiliation |
|
| Address |
Bristol Myers Squibb India Pvt Ltd
The Indiabulls Finance Centre
Tower 01 6th Floor
Senapati Bapat Marg
Elphinstone
Mumbai
MAHARASHTRA
400013
India |
| Phone |
912266534245 |
| Fax |
|
| Email |
subashri.shivkumar@bms.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Bristol Myers Squibb India Pvt. Ltd.
Mumbai , India |
|
Primary Sponsor
Modification(s)
|
| Name |
Bristol Myers Squibb India Pvt Ltd |
| Address |
The Indiabulls Finance Centre Tower 01 6th Floor
Senapati Bapat Road Elphinstone W Mumbai 400013 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
Modification(s)
|
India
Argentina
Australia
Belgium
Brazil
Canada
China
Czech Republic
France
Germany
Greece
Hong Kong
Italy
Japan
Mexico
Poland
Russian Federation
South Africa
Spain
Sweden
Taiwan
Thailand
Turkey
United Kingdom
United States of America |
Sites of Study
Modification(s)
|
| No of Sites = 12 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr.Samir.R.Shah |
303, Doctor House, Opposite Jaslok |
303, Doctor House, Opposite Jaslok,-400 026
Mumbai
MAHARASHTRA |
|
| Dr.M.K Goenka |
Apollo Gleaneagles Hospitals |
58, Canal Circular Road,-700054
Kolkata
WEST BENGAL |
|
| Dr T Raja |
Apollo Speciality Hospital, 320 Mount Road, Badma Complex, Chennai ? 600035 |
,-600035
Chennai
TAMIL NADU |
914424355003
rajatraj@yahoo.com |
| Dr.P.N.Rao |
Asian Institute of Gastroenterology |
6-3-661 Somajiguda,-500082
Hyderabad
ANDHRA PRADESH |
|
| Dr Chanchal Goswami |
B. P. Poddar Hospital & Medical Research Limited |
71/1, Humayun Kabir Sarani,,New Alipore, Block G,(Near Durgapur Bridge)-7000053
Kolkata
WEST BENGAL |
00919830055035
drcgoswami@gmail.com |
| Dr AVS Suresh |
Bibi General Hospital and Cancer Center |
16-3-991/1/C , Govt printing Press Road , Malakapet , Hyderabad ,
Andra Pradesh -500024
Hyderabad
ANDHRA PRADESH |
04024528122
sureshattili@yahoo.com |
| Dr Abraham Koshy |
Department of Gastroenterology, Lakeshore Hospital & Research Centre |
NH-47,Bypass, Maradu,,-682304
|
00914842701032
koshyabe@yahoo.com |
| Dr. B Sivanesan |
G Kuppuswamy Naidu Memorial hospital |
Valavadi Narayanaswamy Cancer Centre,Post Box No. 6327, Pappanaickenpalayam-641037
Coimbatore
TAMIL NADU |
|
| Dr.S.K.Sarin |
ILBS |
Sector D-1,,Vasant Kunj,-100070
New Delhi
DELHI |
|
| Dr Shona Nag |
Jehangir Clinical Development Centre |
Jehangir Clinical Development Center (JCDC) Jehangir Hospital, ,Sassoon Road,-411001
Pune
MAHARASHTRA |
|
| Shyam Agarwal |
Sir Ganga Ram Hospital. |
Haematologist and Medical Oncologist,-110060
New Delhi
DELHI |
drshyam_aggarwal@yahoo.com |
| Dr. Shaesta Mehta |
Tata memorial Hospital |
Dr. E Borges Road, Parel,-400012
Mumbai
MAHARASHTRA |
|
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 14 |
| Name of Committee |
Approval Status |
| Asian Institute of Gastroenterology, |
Approved |
| B.P.Poddar Hospital & Medical research |
Approved |
| Bibi General Hospital & Cancer Center, IEC |
Approved |
| Ethics Committee Apollo Hospitals Enterprise Limited |
Approved |
| Ethics Committee of CIMS |
Approved |
| Ethics Committee,ILBS |
Approved |
| Ethics Committee,Sir Ganga RaM Hospital |
Approved |
| HUMAN ETHICS COMMITTEE |
Approved |
| INDEPENDENT ETHICS COMMITTEE, MUMBAI |
Approved |
| Institutional Ethichs Committee,Appolo Gleneagles |
Approved |
| Institutional Ethics Committee,Coimbatore |
Approved |
| Jehangir clinical development center |
Approved |
| Lakeshore Ethics Committee |
Approved |
| Regional Cancer Center, IRB |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Advanced Hepatocellular Carcinoma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Brivanib : Active Comparator |
Drug: Brivanib
Tablets, Oral, 800 mg, Once Daily, Until disease progression or unacceptable toxicity
Drug: Placebo
Capsules, Oral, twice Daily, Until disease progression or unacceptable toxicity |
| Comparator Agent |
Placebo |
800mg |
| Comparator Agent |
Sorafenib : Active Comparator |
Drug: Sorafenib
Capsules, Oral, 800 mg, twice daily, Until disease progression or unacceptable toxicity
Drug: Placebo
Tablets, Oral, Once Daily, Until disease progression or unacceptable toxicity |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Histologic or cytologic confirmed diagnosis of HCC. Advanced HCC
Disease not eligible for surgical and / or locoregional therapies
Progressive disease after surgical and / or locoregional therapies
Child-Pugh Class A
ECOG performance status 0-1
Adequate hematologic, hepatic, and renal function
|
|
| ExclusionCriteria |
| Details |
Prior use of any systemic anti-cancer chemotherapy, immunotherapy or molecular targeted agents for HCC
History of active cardiac disease
Thrombotic or embolic events within the past 6 months
Any other hemorrhage/bleeding event >= CTCAE Grade 3 within 4 weeks except for esophageal or gastric varices
Inability to swallow tablets or untreated malabsorption syndrome
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the overall survival of brivanib versus sorafenib in subjects with advanced HCC who have not received prior systemic treatment
|
Time Frame: Survival will be assessed continuously Designated as safety issue: No
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the time to progression (TTP) (investigator assessed using modified RECIST criteria
To compare the investigator assessed objective response rate (ORR) and disease control rate (DCR) using modified RECIST criteria
To determine duration of response, duration of disease control, and time to response (TTR)
To assess the safety profile of brivanib and sorafenib
To explore PK and exposure-response in the study population
To compare time to symptomatic progression
To compare health-related quality of life
|
Time frame for every secondary outcome is 6 weeks.
Designated as safety issue: No
|
|
Target Sample Size
Modification(s)
|
Total Sample Size="1714"
Sample Size from India="115"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
31/08/2009 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The purpose of this study is to compare the overall survival of brivanib versus sorafenib in subjects with advanced HCC who have not received prior systemic therapy.
Number of patients to be recruited from India :- 72
Patient recruitment started on 31st AUG 2009 |