| CTRI Number |
CTRI/2007/091/000039 [Registered on: 01/04/2008] |
| Last Modified On: |
|
| Post Graduate Thesis |
|
| Type of Trial |
|
|
Type of Study
|
|
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Phase II Study for Previously Untreated Subjects With Non Small Cell Lung Cancer (NSCLC) or Small Cell Lung Cancer (SCLC) |
|
Scientific Title of Study
|
A Randomized, Double Blind, Parallel, Three Arm Trial Evaluating the Efficacy and Safety of Ipilimumab (BMS-734016) in Combination With Paclitaxel/Carboplatin Compared to Paclitaxel/Carboplatin Alone in Previously
Untreated Subjects With Lung Cancer |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NCT00527735 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
|
| Affiliation |
|
| Address |
Not Applicable
N/A
India |
| Phone |
|
| Fax |
|
| Email |
|
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manish Mistry |
| Designation |
|
| Affiliation |
Medical Director |
| Address |
Bristol-Myers Squibb India Pvt Ltd
A-Shiv Sagar Estate, A.B.A-Shiv Sagar Estate, A.B. Road, Worli
Mumbai
MAHARASHTRA
400018
India |
| Phone |
+912266534208 |
| Fax |
+912266614378 |
| Email |
manish.mistry@bms.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manishkumar D |
| Designation |
|
| Affiliation |
|
| Address |
Bristol-Myers Squibb India Pvt Ltd
A-Shiv Sagar Estate, A.B. Road, Worli
Mumbai
MAHARASHTRA
400018
India |
| Phone |
+912266534245 |
| Fax |
+912266614378 |
| Email |
manishkumar.shah@bms.com |
|
|
Source of Monetary or Material Support
|
| The Pharmaceutical Company Sponsoring This Study Is Bristol-Myers Squibb |
|
|
Primary Sponsor
|
| Name |
The pharmaceutical company sponsoring this study is Bristol-Myers
Squibb |
| Address |
|
| Type of Sponsor |
|
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. D.Raghunadharao |
Department of Medical Oncology Nizam's Institute of Medical Sciences |
,-500082
Hyderabad
ANDHRA PRADESH |
+91 40 23371747
+91 40 66669049
telerama@rediffmail.com |
| Dr. Joseph Thomas |
Dept. of Medical Oncology Shirdi Sai Baba Cancer Hospital KMC, Manipal |
,-576104
|
+ 91 820 2922348
+ 91 820 2571651
Josephthomas2@gmail.com |
| Dr Raju Chacko |
Dept. of Medical Oncology Christian Medical College Vellore |
Dept. of Medical Oncology Christian Medical College Vellore,-632004
Vellore
TAMIL NADU |
+91 416 2283040
+91 416 4203200
rchacko@cmcvellore.ac.in |
| Dr. Jayaprakash Madhavan |
GI and Lung Cancer Division Regional Cancer Institute |
,-695 011
|
+91 471 2442541
+91 471 2443498
jpmadhavan@hotmail.com |
| Dr. Chirag Desai |
Haemato-Oncology Clinic |
Vedanta, Near Samved Hospital,Commerce College Road-380 009
Ahmadabad
GUJARAT |
+91 79 40042223
+91 79 40042225
cdesai.oncology@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Ethics Committee of the Heart Care Clinic, Ahmedabad 380054 |
Approved |
| HUMAN Ethics Committee, RCC, Trivendrum, 695011 |
Approved |
| Institutional Ethics Committee, Nizam's Institute of Medical Sciences, Panjagutta Hyderabad-500082 Andra Pradesh, India |
Approved |
| Institutional Review Board (Ethics Committee), Christian Medical College Vellore-632002 |
Approved |
| Manipal Univerysity Ethics Committee, Manipal, Karnataka |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Lung Cancer
Small Cell Lung Cancer
Carcinoma, Non-Small-Cell Lung, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
A:EXPERIMENTAL |
Drug: Ipilimumab and Taxol and Paraplatin (concurrent)
Intravenous Solution, Intravenous, Ipilimumab -
10mg/kg (4 active + 2 placebo), Taxol - 175 mg/m2,
Paraplatin - AUC = 6, Every 3 weeks, up to 4 active
doses of ipilimumab and up to 6 doses of chemo, Until
disease progression, unacceptable toxicity or withdrawl
of consent |
| Intervention |
B:EXPERIMENTAL |
Drug: Ipilimumab and Taxol and Paraplatin (sequential)
Intravenous Solution, Intravenous, Ipilimumab -
10mg/kg ( 2 Placebo + 4 active), Taxol - 175 mg/m2,
Paraplatin - AUC = 6, every 3 weeks, up to 4 active
doses of ipilimumab and up to 6 doses of chemo, Until
disease progression, unacceptable toxicity or withdrawl
of consent |
| Comparator Agent |
C: Active COMPARATOR |
Drug: Ipilimumab placebo and Taxol and Paraplatin
Intravenous Solution, Intravenous, Ipilimumab -
10mg/kg (all placebo), Taxol - 175 mg/m2, Paraplatin -
AUC = 6, every 3 weeks, up to 6 placebo doses of
ipilimumab and up to 6 doses of chemo, Until disease
progression, unacceptable toxicity or withdrawl of
consent |
| Intervention |
ipilimumab, paclitaxel, carboplatin |
|
|
|
Inclusion Criteria
|
| Age From |
|
| Age To |
|
| Gender |
|
| Details |
Documented NSCLC or SCLC
ECOG of 0 or 1 |
|
| ExclusionCriteria |
| Details |
�� Brain metastases
�� Autoimmune disease
�� Known HIV, Hep B or Hep C infection
�� Peripheral neuropathy ≥ grade 2 |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary Outcome Measures:
EORTC-QLQ-30 questionnaire [ Time Frame: completed at every
visit ] |
[ Time Frame: completed at every
visit ] |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety evaluations in all study arms |
At defined timepoints per the protocol |
|
|
Target Sample Size
|
Total Sample Size="0"
Sample Size from India=""
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
11/04/2008 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years=""
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
|
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The trial is part of a global trial. In India it is proposed to recruit 22 patients from Indian sites. Globally trial has started recruitment. In India it is expected to begin on 11 April 20008. |