| CTRI Number |
CTRI/2008/091/000042 [Registered on: 28/04/2008] |
| Last Modified On: |
30/10/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Other |
Public Title of Study
Modification(s)
|
Aflibercept Compared to Placebo in Term of Efficacy in Patients Treated With Gemcitabine for Metastatic Pancreatic Cancer
|
Scientific Title of Study
Modification(s)
|
A Multinational, Randomized, Double-Blind Study, Comparing the Efficacy of Aflibercept Once Every 2 Weeks versus Placebo in Patients Treated with Gemcitabine for Metastatic Pancreatic Cancer
|
| Trial Acronym |
VANILLA |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| EFC10547 |
Protocol Number |
| NCT00574275 |
ClinicalTrials.gov |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
|
| Designation |
|
| Affiliation |
|
| Address |
|
| Phone |
|
| Fax |
|
| Email |
|
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Salini James |
| Designation |
Sr Clinical Project Leader |
| Affiliation |
Sanofi-Synthelabo (India) Limited |
| Address |
54/A, Sir Mathuradas Vasanji Rd.
Andheri (East)
Mumbai
MAHARASHTRA
400093
India |
| Phone |
912230707820 |
| Fax |
|
| Email |
salini.james@sanofi.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Salini James |
| Designation |
Sr Clinical Project Leader |
| Affiliation |
Sanofi-Synthelabo (India) Limited |
| Address |
54/A, Sir Mathuradas Vasanji Rd.
Andheri (East)
Mumbai
MAHARASHTRA
400093
India |
| Phone |
912230707820 |
| Fax |
|
| Email |
salini.james@sanofi.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Sanofi-Synthelabo (India) Limited 54/A, Sir Mathuradas Vasanji Road, Andheri (E), Mumbai 400093
|
|
Primary Sponsor
Modification(s)
|
| Name |
SanofiSynthelabo India Limited |
| Address |
54/A, Sir Mathuradas Vasanji Road, Andheri East, Mumbai |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India
Belgium
Canada
Germany |
|
Sites of Study
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| 001 |
Bhagwan Mahavir Cancer Hospital |
,-
|
|
| 002 |
Department of Medical Oncology, Christian Medical College, Vellore |
,-
|
|
| 004 |
Indo-American Institute of Oncology |
,-
|
|
| 003 |
Rajalakshmi Multispeciality Hospital, Dept. of Medical Oncology, |
,-
|
|
| 005 |
Tata Memorial Hospital, Medical Oncology, |
,-
|
|
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| CMC Vellore Ethics committee |
Submittted/Under Review |
| Ethics Committee Bhagwan Mahavir Cancer Hospital |
Approved |
| Ethics Committee, Indo-American Institute & Research Centre |
Submittted/Under Review |
| Rajalakshmi Ethics Committee |
Submittted/Under Review |
| Tata Memorial Center Ethics Committee |
Submittted/Under Review |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C259||Malignant neoplasm of pancreas, unspecified, Pancreatic Neoplasm
, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Aflibercept (AVE0005 - VEGF Trap) |
Aflibercept 4 mg/kg over 1 hour I.V. every 2 weeks. |
| Comparator Agent |
Gemcitabine |
Gemcitabine 1000 mg/m2 IV administered over 30 minutes. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
"1.Cytologically or histologically confirmed evidence of epithelial cancer (adenocarninoma) of the exocrine pancreas
2.Metastatic disease
3.No prior chemotherapy for pancreatic disease
4.ECOG performance status (PS) 0, 1 or 2
5.Adequate renal, liver and bone marrow functions
"
|
|
| ExclusionCriteria |
| Details |
"1. Less than 42 days elapsed from prior major surgery (28 days from other orior surgery) to the time of randomization
2. Prior treatment with anti-VEGF or VEGF-Receptor-inhibitors
3. Uncontrolled hypertension
4. Pregnancy or breastfeeding
5. Patient with reproductive potential (M/F) without effective method of contraception
"
|
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Centralized |
Blinding/Masking
Modification(s)
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Overall Survival (OS) |
From the first randomization until the end of study data cutoff date (approximately 2 years) |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
Secondary objectives include response to treatment, progression free survival, safety, documentation of potential immunogenicity of aflibercept and, in selected centers the pharmacokinetics of aflibercept.
|
From the first randomization until the end of study data cutoff date (approximately 2 years) |
|
Target Sample Size
Modification(s)
|
Total Sample Size="630"
Sample Size from India="25"
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
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
18/09/2008 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
03/12/2007 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
Modification(s)
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Other (Terminated) |
| Recruitment Status of Trial (India) |
Other (Terminated) |
Publication Details
Modification(s)
|
CSR to be published after study is over. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Trial will be conducted in 24 countries all over the world The Indian target - 25 patients Indian status - No patients randomized till date Planned date of first enrolment - April 2008 |