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

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ClinicalTrials.gov Identifier: NCT00694382
Recruitment Status : Completed
First Posted : June 10, 2008
Last Update Posted : January 23, 2013
Sponsor:
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date  ICMJE May 7, 2008
First Posted Date  ICMJE June 10, 2008
Last Update Posted Date January 23, 2013
Study Start Date  ICMJE June 2008
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 14, 2013)
  • Percentage of Participants Who Experienced Venous Thromboembolism Event [VTE] or VTE-related Death [ Time Frame: 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) [ Time Frame: 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.
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 History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 14, 2013)
  • Percentage of Participants who required the initiation of curative anticoagulant or thrombolytic treatment after VTE assessment [ Time Frame: 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 [ Time Frame: 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] [ Time Frame: 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.
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 ]
Current Other Pre-specified Outcome Measures
 (submitted: January 14, 2013)
  • Platelets Count: Percentage of Participants With Potentially Clinically Significant Abnormalities [PCSA] [ Time Frame: From first study drug injection up to 3 days after last study drug injection ]
    PCSA are abnormal values considered medically important by the Sponsor according to predefined criteria based on literature review. Thresholds for platelet counts were defined as follows:
    • Platelets count <50 Giga/L;
    • Platelets count ≥50 and <100 Giga/L;
  • Liver Function: Percentage of Participants With Potentially Clinically Significant Abnormalities [PCSA] [ Time Frame: From first study drug injection up to 3 days after last study drug injection ]
    Thresholds were defined as follows:
    • Alanine Aminotransferase [ALAT] >3 Upper Normal Limit [ULN];
    • Total Bilirubin [TB] >2 ULN;
    • ALAT >3 ULN and TB >2 ULN;
    Cases with ALAT >3 ULN and TB >2 ULN (not necessarily concomitant) were evaluated by blinded independent adjudicator to determine if they met Hy's law criteria.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of AVE5026 in the Prevention of Venous Thromboembolism in Cancer Patients Undergoing Chemotherapy
Official Title  ICMJE 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
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Venous Thromboembolism
  • Cancer
Intervention  ICMJE
  • Drug: Semuloparin sodium

    0.4 mL solution in ready-to-use 0.5 ml pre-filled syringe

    Subcutaneous injection

    Other Name: AVE5026
  • Drug: Placebo (for semuloparin)

    0.4 mL solution in ready-to-use 0.5 ml prefilled syringe strictly identical in appearance but without active component

    Subcutaneous injection

Study Arms  ICMJE
  • Experimental: Semuloparin
    Semuloparin sodium 20 mg once daily until change in chemotherapy regimen
    Intervention: Drug: Semuloparin sodium
  • Placebo Comparator: Placebo
    Placebo (for semuloparin) once daily until change in chemotherapy regimen
    Intervention: Drug: Placebo (for semuloparin)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 5, 2011)
3212
Original Estimated Enrollment  ICMJE
 (submitted: June 6, 2008)
3200
Actual Study Completion Date  ICMJE November 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belarus,   Belgium,   Brazil,   Bulgaria,   Canada,   Chile,   China,   Colombia,   Croatia,   Czech Republic,   Denmark,   Estonia,   Finland,   France,   Germany,   Greece,   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,   Taiwan,   Ukraine,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00694382
Other Study ID Numbers  ICMJE EFC6521
2007-007943-29 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Alexander Turpie, MD HHS-General Hospital, Hamilton, Canada
Principal Investigator: Giancarlo Agnelli, MD University of Perugia, Italy
PRS Account Sanofi
Verification Date January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP