Evaluation of AVE5026 in the Prevention of Venous Thromboembolism in Cancer Patients Undergoing Chemotherapy (SAVE-ONCO)

Sanofi

Status and phase: Completed; Phase 3

Conditions: Venous Thromboembolism; Cancer

Treatments: Drug: Semuloparin sodium; Drug: Placebo (for semuloparin)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00694382

EFC6521

2007-007943-29 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 3,212 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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3,212 participants in 2 patient groups, including a placebo group

Semuloparin

Experimental group

Description:

Semuloparin sodium 20 mg once daily until change in chemotherapy regimen

Treatment:

Drug: Semuloparin sodium

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo (for semuloparin)