Clinical trial · Interventional
Evaluation of AVE5026 in the Prevention of Venous Thromboembolism in Cancer Patients Undergoing Chemotherapy
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Venous Thromboembolism | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo (for semuloparin) | Drug | — | UNRESOLVED |
| Semuloparin sodium | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Semuloparin
- description
- Semuloparin sodium 20 mg once daily until change in chemotherapy regimen
- interventionNames
- Drug: Semuloparin sodium
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo (for semuloparin) once daily until change in chemotherapy regimen
- interventionNames
- Drug: Placebo (for semuloparin)
Primary outcomes (2)
- measure
- Percentage of Participants Who Experienced Venous Thromboembolism Event [VTE] or VTE-related Death
- timeFrame
- From randomization up to 3 days after last study drug injection
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- RESULTAgnelli G, George DJ, Kakkar AK, Fisher W, Lassen MR, Mismetti P, Mouret P, Chaudhari U, Lawson F, Turpie AG; SAVE-ONCO Investigators. Semuloparin for thromboprophylaxis in patients receiving chemotherapy for cancer. N Engl J Med. 2012 Feb 16;366(7):601-9. doi: 10.1056/NEJMoa1108898. PMID 22335737
- DERIVEDRutjes AW, Porreca E, Candeloro M, Valeriani E, Di Nisio M. Primary prophylaxis for venous thromboembolism in ambulatory cancer patients receiving chemotherapy. Cochrane Database Syst Rev. 2020 Dec 18;12(12):CD008500. doi: 10.1002/14651858.CD008500.pub5. PMID 33337539