| CTRI Number |
CTRI/2008/091/000277 [Registered on: 17/12/2008] |
| Last Modified On: |
26/02/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
Modification(s)
|
A Multinational Randomized Double Blind, Placebo-controlled study to evaluate the efficacy and safety of AVE5026 in the prevention of Venous Thromembolism(VTE) in cancer patients at high risk for VTE and who are undergoing chemotherapy |
Scientific Title of Study
Modification(s)
|
A Multinational Randomized Double Blind, Placebo-controlled study to evaluate the efficacy and safety of AVE5026 in the prevention of Venous Thromembolism(VTE) in cancer patients at high risk for VTE and who are undergoing chemotherapy
|
| Trial Acronym |
SAVE ONCO |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| EFC6521 |
Protocol Number |
| NCT00694382 |
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 |
Malar Selvaraj |
| Designation |
Regional Project Manager |
| Affiliation |
|
| Address |
Icon clinical research
R M Z Millenia Business Park
Bangalore
KARNATAKA
600096
India |
| Phone |
914443902972 |
| Fax |
914443902801 |
| Email |
Malar.Selvaraj@iconplc.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Malar Selvaraj |
| Designation |
Regional Project Manager |
| Affiliation |
|
| Address |
Icon clinical research
RMZ Millenia Business Park
Not Applicable
N/A
600096
India |
| Phone |
914443902972 |
| Fax |
914443902801 |
| Email |
Malar.Selvaraj@iconplc.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Sanofi Synthelabo. 54/A, Sir Mathuradas Vasanji Road Andheri(E), Mumbai-400093, India. |
|
Primary Sponsor
Modification(s)
|
| Name |
Sanofi Synthelabo I Ltd |
| Address |
54/A, Sir Mathuradas Vasanji Road Andheri(E), Mumbai-400093, India. |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India
Indonesia |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrSH Advani |
Jaslok Hospital and Research Centre |
15, Dr.G. Deshmukh Marg,Peddar Road, -400 026
Mumbai
MAHARASHTRA |
02266573254
02223526833
shadvani2000@yahoo.com |
| Dr.Shyam Aggarwal |
Sri Ganga Ram Hospital |
Room 212 A,Department of medical oncology-110060
|
+91-11-25735205
+91-11-25861002
drshyam_aggarwal@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Ethics Committee, Jaslok Hospitals |
Approved |
| Ethics Committee, NewDelhi |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Venous Thromboembolism, Venous Thromboembolism in Cancer Patients undergoing Chemotherapy, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
AVE5026 |
20 mg of AVE5026 in a 0.5 mL pre-filled syringe containing 0.4 mL of a sterile, isotonic solution with sodium chloride 0.9% and water for injection corresponding to a concentration of 50mg/mL.
|
| Comparator Agent |
NIL |
NIL |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Cancer patients with metastatic or locally advanced solid tumor of lung, pancreas, stomach, colon/rectum, bladder or ovary
initiating a (new) course of chemotherapy with a minimum intent of 3 months therapy
|
|
| ExclusionCriteria |
| Details |
Subject requiring systematic venous thromboprophylaxis or curative treatment with anti-coagulant or thrombolytic
Patients at high risk of bleeding
Severe renal impairment (estimated creatinine clearance < 30 mL/min)
ECOG (Eastern Cooperative Oncology Group) performance status 3 & 4
Known hypersensitivity to UFH or LMWH
|
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Centralized |
Blinding/Masking
Modification(s)
|
Outcome Assessor Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| The primary efficacy endpoint is the time-to-first occurrence of any component of the composite endpoint of the following documented outcome results, confirmed by a blinded Adjudication Committee, occurring from randomization up to 3 calendar days after last study drug injection: - Any symptomatic DVT of the lower limbs - Any symptomatic DVT of the upper limbs (including CVC-related thrombosis) - Any non fatal PE - VTE-related deaths (fatal PE or unexplained deaths) |
7 Months |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
Other efficacy outcomes include each component of the primary
efficacy endpoint, from randomization up to 3 calendar days after last
study drug and the initiation of curative anticoagulant or thrombolytic
treatment by the investigator after local VTE assessment. |
7 months |
|
Target Sample Size
Modification(s)
|
Total Sample Size="3200"
Sample Size from India="316"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
14/10/2008 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
04/06/2008 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Clinical Study Report Summary |
|
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 46 countries all over the world.
|