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

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 - SAVE ONCO

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2008/091/000277

Enrollment

3200

Registered

2008-12-17

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Venous Thromboembolism

Interventions

Intervention1: 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 concentra

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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)Timepoint: 7 Months	—

Measure

Time frame

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)Timepoint: 7 Months

—

Secondary

Measure	Time frame
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.Timepoint: 7 months	—

Countries

India, Indonesia

Contacts

Public ContactMalar Selvaraj

Malar.Selvaraj@iconplc.com914443902972

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026