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


Tracking Information

Start Date  ICMJEJune 2008
Estimated Primary Completion DateSeptember 2010   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: August 11, 2008)		Time-to-first occurrence of symptomatic Deep Venous Thrombosis of lower or upper limbs, non fatal Pulmonary embolism, and VTE-related deaths [ Time Frame: From randomization up to 3 calendar days after last study drug injection ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJE 
 (submitted: June 6, 2008)		Time-to-first occurrence of symptomatic Deep Venous Thrombosis of lower or upper limbs, non fatal Pulmonary embolism, and VTE-related deaths [ Time Frame: From randomization up to 3 calendar days after last study drug injection ]
Change HistoryComplete list of historical versions of study NCT00694382 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: July 31, 2008)
  • Efficacy: individual components of the primary outcome measure [ Time Frame: From randomization up to 3 calendar days after last study drug injection ] [ Designated as safety issue: No ]
  • Safety: bleedings, transfusions, laboratory data, adverse events, deaths [ Time Frame: Study period ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures  ICMJE 
 (submitted: June 6, 2008)
  • Efficacy: individual components of the primary outcome measure [ Time Frame: From randomization up to 3 calendar days after last study drug injection ]
  • Safety: bleedings, transfusions, laboratory data, adverse events, deaths [ Time Frame: Study period ]

Descriptive Information

Brief Title  ICMJEEvaluation of AVE5026 in the Prevention of Venous Thromboembolism in Cancer Patients Undergoing Chemotherapy
Official Title  ICMJEA 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
Brief Summary

The primary objective is to compare the efficacy of once daily (q.d.) subcutaneous (s.c.) injections of AVE5026 with placebo in the prevention of venous thromboembolism (VTE) in cancer patients at high risk for VTE and who are undergoing chemotherapy.

The secondary objectives are to evaluate the safety of AVE5026, to document AVE5026 exposures, to try identifying a metagene predictor of VTE and to assess the survival status at one year in this population.

Detailed Description

The study treatment duration is variable depending on the duration of chemotherapy.

Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJEPrevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Condition  ICMJE
  • Prevention of Venous Thromboembolism
  • Cancer
Intervention  ICMJE
  • Drug: AVE5026
    once daily subcutaneous injection
  • Drug: Placebo
    once daily subcutaneous injection
Study Arms / Comparison Groups
  • 1: Experimental
    Intervention: Drug: AVE5026
  • 2: Placebo Comparator
    Intervention: Drug: Placebo

Recruitment Information

Estimated Enrollment  ICMJE3200
Estimated Completion DateSeptember 2010
Estimated Primary Completion DateSeptember 2010   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

  • 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

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

GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Public Registry ICDGV-Contact-us@sanofi-aventis.com
Location Countries  ICMJEUnited States,   Argentina,   Australia,   Austria,   Belarus,   Belgium,   Brazil,   Bulgaria,   Canada,   Chile,   China,   Colombia,   Croatia,   Czech Republic,   Denmark,   Estonia,   Finland,   France,   Germany,   Hong Kong,   Hungary,   India,   Indonesia,   Ireland,   Israel,   Italy,   Korea, Republic of,   Latvia,   Lithuania,   Malaysia,   Mexico,   Netherlands,   Norway,   Peru,   Poland,   Portugal,   Romania,   Russian Federation,   Serbia,   Slovakia,   Slovenia,   South Africa,   Spain,   Sweden,   Switzerland,   Ukraine,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00694382
Responsible PartyICD Study Director, Sanofi-aventis
Study ID Numbers  ICMJEEFC6521, EudraCT 2007-007943-29
Study Sponsor  ICMJESanofi-Aventis
Collaborators  ICMJE 
Investigators  ICMJE
Study Chair:Alexander Turpie, MDHHS-General Hospital, Hamilton, Canada
Principal Investigator:Giancarlo Agnelli, MDUniversity of Perugia, Italy
Information Provided BySanofi-Aventis