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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00694382




Registration number
NCT00694382
Ethics application status
Date submitted
7/05/2008
Date registered
10/06/2008
Date last updated
23/01/2013

Titles & IDs
Public title
Evaluation of AVE5026 in the Prevention of Venous Thromboembolism in Cancer Patients Undergoing Chemotherapy
Scientific title
A Multinational, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AVE5026 in the Prevention of Venous Thromboembolism (VTE) in Cancer Patients at High Risk for VTE and Who Are Undergoing Chemotherapy
Secondary ID [1] 0 0
2007-007943-29
Secondary ID [2] 0 0
EFC6521
Universal Trial Number (UTN)
Trial acronym
SAVE-ONCO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Venous Thromboembolism 0 0
Cancer 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 0 0 0 0
Clotting disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Semuloparin sodium
Treatment: Drugs - Placebo (for semuloparin)

Experimental: Semuloparin - Semuloparin sodium 20 mg once daily until change in chemotherapy regimen

Placebo Comparator: Placebo - Placebo (for semuloparin) once daily until change in chemotherapy regimen


Treatment: Drugs: Semuloparin sodium
0.4 mL solution in ready-to-use 0.5 ml pre-filled syringe
Subcutaneous injection

Treatment: Drugs: Placebo (for semuloparin)
0.4 mL solution in ready-to-use 0.5 ml prefilled syringe strictly identical in appearance but without active component
Subcutaneous injection

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Who Experienced Venous Thromboembolism Event [VTE] or VTE-related Death - VTE included any symptomatic Deep Vein Thrombosis [DVT] of lower or upper limbs and any non-fatal Pulmonary Embolism [PE] as confirmed by a Central Independent Adjudication Committee [CIAC] after review of compression ultrasound or venography for DVT, ventilation/perfusion lung scan, pulmonary angiogram or spiral computer tomography lung scan for PE.
VTE-related death included fatal PE and unexplained deaths without confirmatory autopsy. Any sudden death could be classified as fatal PE by the CIAC unless diagnostic test results strongly indicated an alternative diagnosis".
Timepoint [1] 0 0
From randomization up to 3 days after last study drug injection
Primary outcome [2] 0 0
Time-to-first Occurrence of VTE or VTE-related Death (Cumulative Incidence Function) - Participants alive and not having experienced VTE were right censored at last study drug injection plus 3 days. In order to correct for competing risks (Deaths other than VTE-related death), a model of cause-specific hazards was used to estimate the Cumulative incidence Function with Prentice non-parametric estimator.
Timepoint [2] 0 0
From randomization up to 3 days after last study drug injection
Secondary outcome [1] 0 0
Percentage of Participants who required the initiation of curative anticoagulant or thrombolytic treatment after VTE assessment - Initiation of curative anticoagulant or thrombolytic treatment after VTE assessment was defined from investigator's answer to the question "was the subject treated for VTE?" asked after diagnostic tests for suspected VTE and after lung imaging test for tumor evaluation.
Timepoint [1] 0 0
From randomization up to 3 days after last study drug injection
Secondary outcome [2] 0 0
Percentage of Participants Who Experienced Clinically Relevant Bleedings - Clinically Relevant Bleedings included overt bleedings classified by the CIAC as:
"major" (fatal, in a critical area/organ, causing a drop in hemoglobin =2 g/dL or requiring transfusion =2 units of blood)
"clinically relevant non-major" (requiring medical intervention and not meeting criteria for major bleeding).
Timepoint [2] 0 0
From first study drug injection up to 3 days after last study drug injection
Secondary outcome [3] 0 0
Overall survival [OS] - Survival status was collected for all participants either one year after randomization, or at the study end date, (ie, 7 months following randomization of the last patient), whichever came first.
OS was defined as the time from date of randomization to date of death due to any cause. Participants alive were censored at last date of contact that they were known to be alive.
Timepoint [3] 0 0
From randomization up to 1 year after randomization or 7 months following randomization of the last participant, whichever came first

Eligibility
Key inclusion criteria
Cancer patient 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Required systematic venous thromboprophylaxis or curative treatment with
anti-coagulant or thrombolytic;

- High risk of bleeding;

- Severe renal impairment (estimated creatinine clearance <30 mL/min);

- ECOG (Eastern Cooperative Oncology Group) performance status 3 & 4;

- Major surgery within 4 weeks before randomization;

- Known hypersensitivity to unfractionated heparin [UFH] or low molecular weight heparin
[LMWH].

The above information is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Investigational Site Number 036004 - Adelaide
Recruitment hospital [2] 0 0
Investigational Site Number 036002 - Bedford Park
Recruitment hospital [3] 0 0
Investigational Site Number 036001 - Box Hill
Recruitment hospital [4] 0 0
Investigational Site Number 036009 - Lismore
Recruitment hospital [5] 0 0
Investigational Site Number 036007 - Perth
Recruitment hospital [6] 0 0
Investigational Site Number 036006 - Ringwood East
Recruitment hospital [7] 0 0
Investigational Site Number 036008 - Westmead
Recruitment hospital [8] 0 0
Investigational Site Number 036003 - Woodville
Recruitment hospital [9] 0 0
Investigational Site Number 036005 - Woolloongabba
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
5042 - Bedford Park
Recruitment postcode(s) [3] 0 0
3128 - Box Hill
Recruitment postcode(s) [4] 0 0
2480 - Lismore
Recruitment postcode(s) [5] 0 0
6000 - Perth
Recruitment postcode(s) [6] 0 0
3135 - Ringwood East
Recruitment postcode(s) [7] 0 0
2145 - Westmead
Recruitment postcode(s) [8] 0 0
5011 - Woodville
Recruitment postcode(s) [9] 0 0
4102 - Woolloongabba
Recruitment outside Australia
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Wirral

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective was to compare the efficacy of once daily subcutaneous injections of
Semuloparin sodium (AVE5026) with placebo in the prevention of venous thromboembolism [VTE]
in cancer patients at high risk for VTE and who were undergoing chemotherapy.

The secondary objectives were to evaluate the safety of Semuloparin sodium (AVE5026), to
document Semuloparin sodium (AVE5026) exposures, to try identifying a metagene predictor of
VTE and to assess the survival status at one year in this population.
Trial website
https://clinicaltrials.gov/show/NCT00694382
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Alexander Turpie, MD
Address 0 0
HHS-General Hospital, Hamilton, Canada
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications