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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Venous Thromboembolism, Cancer

Thank you

Trial Information

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


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).


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

Percentage of Participants Who Experienced Venous Thromboembolism Event [VTE] or VTE-related Death

Outcome Description:

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".

Outcome Time Frame:

From randomization up to 3 days after last study drug injection

Safety Issue:

No

Principal Investigator

Alexander Turpie, MD

Investigator Role:

Study Chair

Investigator Affiliation:

HHS-General Hospital, Hamilton, Canada

Authority:

United States: Food and Drug Administration

Study ID:

EFC6521

NCT ID:

NCT00694382

Start Date:

June 2008

Completion Date:

November 2010

Related Keywords:

  • Venous Thromboembolism
  • Cancer
  • chemotherapy
  • Thromboembolism
  • Venous Thromboembolism
  • Venous Thrombosis

Name

Location

Investigational Site Number 840001Vallejo, California  94589
Investigational Site Number 840026Charlotte, North Carolina  28262
Investigational Site Number 840034Waco, Texas  76708
Investigational Site Number 840009Modesto, California  95355
Investigational Site Number 840019Jacksonville, Florida  32256
Investigational Site Number 840011Palo Alto, California  94301
Investigational Site Number 840004Houston, Texas  77030
Investigational Site Number 840006Birmingham, Alabama  35211
Investigational Site Number 840007Casa Grande, Arizona  85222
Investigational Site Number 840060Tucson, Arizona  85704
Investigational Site Number 840050Fountain Valley, California  92708
Investigational Site Number 840072Fullerton, California  92835
Investigational Site Number 840037Indian Wells, California  92210
Investigational Site Number 840069La Verne, California  91750
Investigational Site Number 840029West Covina, California  91790
Investigational Site Number 840005Norwich, Connecticut  06360
Investigational Site Number 840064Torrington, Connecticut  06790
Investigational Site Number 840038Woodbridge, Connecticut  06525
Investigational Site Number 840025Washington, District of Columbia  20017
Investigational Site Number 840052Washington, District of Columbia  20010
Investigational Site Number 840074Clearwater, Florida  33756
Investigational Site Number 840051Rockledge, Florida  32955
Investigational Site Number 840073Sarasota, Florida  34239
Investigational Site Number 840070Roswell, Georgia  30076
Investigational Site Number 840016Park Ridge, Illinois  60068
Investigational Site Number 840028Quincy, Illinois  62301
Investigational Site Number 840008Skokie, Illinois  60077
Investigational Site Number 840033Goshen, Indiana  46526
Investigational Site Number 840010Indianapolis, Indiana  46237
Investigational Site Number 840014Louisville, Kentucky  40202
Investigational Site Number 840048Mount Sterling, Kentucky  40353
Investigational Site Number 840047Metairie, Louisiana  70056
Investigational Site Number 840032Ruston, Louisiana  71270
Investigational Site Number 840042Bethesda, Maryland  20817
Investigational Site Number 840066Easton, Maryland  21601
Investigational Site Number 840059Tupelo, Mississippi  38801
Investigational Site Number 840024Rochester, New York  14642
Investigational Site Number 840031Syracuse, New York  13210
Investigational Site Number 840020Durham, North Carolina  27710
Investigational Site Number 840021Durham, North Carolina  27710
Investigational Site Number 840046Bismarck, North Dakota  58501
Investigational Site Number 840003Middletown, Ohio  45042
Investigational Site Number 840022Sylvania, Ohio  43560
Investigational Site Number 840075East Providence, Rhode Island  02915
Investigational Site Number 840067Beaumont, Texas  77701
Investigational Site Number 840035Sugar Land, Texas  77055
Investigational Site Number 840063Kennewick, Washington  99336
Investigational Site Number 840018Tacoma, Washington  98431