Evaluation of AVE5026 in the Prevention of Venous Thromboembolism in Cancer Patients Undergoing Chemotherapy

Phase 3

Completed

Conditions: Venous Thromboembolism
Cancer

Interventions: Drug: Placebo (for semuloparin)
Drug: Semuloparin sodium

Registration Number: NCT00694382

Lead Sponsor: Sanofi

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.

Detailed Description: Randomization had to take place just prior to the first study drug injection (randomization ratio 1:1).

The study period per participant was variable depending on the duration of chemotherapy. It included:

* a screening period up to 3 weeks,

* a double-blind treatment period,

* a follow-up period of 1 month.

Study end date was at the latest 7 months following the randomization of the last participant (6 months treatment and 1 month follow-up).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 3212

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

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

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo (for semuloparin)	Placebo (for semuloparin) once daily until change in chemotherapy regimen
Semuloparin	Semuloparin sodium	Semuloparin sodium 20 mg once daily until change in chemotherapy regimen

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Experienced Venous Thromboembolism Event [VTE] or VTE-related Death	From randomization up to 3 days after last study drug injection	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".
Time-to-first Occurrence of VTE or VTE-related Death (Cumulative Incidence Function)	From randomization up to 3 days after last study drug injection	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants who required the initiation of curative anticoagulant or thrombolytic treatment after VTE assessment	From randomization up to 3 days after last study drug injection	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.
Percentage of Participants Who Experienced Clinically Relevant Bleedings	From first study drug injection up to 3 days after last study drug injection	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).
Overall survival [OS]	From randomization up to 1 year after randomization or 7 months following randomization of the last participant, whichever came first	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.

Trial Locations

Locations (411): Investigational Site Number 840006
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Birmingham, Alabama, United States
Investigational Site Number 840007
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Casa Grande, Arizona, United States
Investigational Site Number 840060
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Tucson, Arizona, United States
Investigational Site Number 840050
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Fountain Valley, California, United States
Investigational Site Number 840072
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Fullerton, California, United States
Investigational Site Number 840037
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Indian Wells, California, United States
Investigational Site Number 840069
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La Verne, California, United States
Investigational Site Number 840009
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Long Beach, California, United States
Investigational Site Number 840001
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Oceanside, California, United States
Investigational Site Number 840011
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Rancho Mirage, California, United States
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Investigational Site Number 840006
🇺🇸Birmingham, Alabama, United States