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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00694382
First received: May 7, 2008
Last updated: January 14, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Venous Thromboembolism
Cancer
Drug: Semuloparin sodium
Drug: Placebo (for semuloparin)
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: No ]

    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.



Other Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]

    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.



Enrollment: 3212
Study Start Date: June 2008
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Semuloparin
Semuloparin sodium 20 mg once daily until change in chemotherapy regimen
Drug: Semuloparin sodium

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

Subcutaneous injection

Other Name: AVE5026
Placebo Comparator: Placebo
Placebo (for semuloparin) once daily until change in chemotherapy regimen
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


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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00694382

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Locations
United States, Alabama
Investigational Site Number 840006
Birmingham, Alabama, United States, 35211
United States, Arizona
Investigational Site Number 840007
Casa Grande, Arizona, United States, 85222
Investigational Site Number 840060
Tucson, Arizona, United States, 85704
United States, California
Investigational Site Number 840050
Fountain Valley, California, United States, 92708
Investigational Site Number 840072
Fullerton, California, United States, 92835
Investigational Site Number 840037
Indian Wells, California, United States, 92210
Investigational Site Number 840069
La Verne, California, United States, 91750
Investigational Site Number 840009
Long Beach, California, United States, 90806
Investigational Site Number 840001
Oceanside, California, United States, 92056
Investigational Site Number 840011
Rancho Mirage, California, United States, 92270
Investigational Site Number 840029
West Covina, California, United States, 91790
United States, Connecticut
Investigational Site Number 840005
Norwich, Connecticut, United States, 06360
Investigational Site Number 840064
Torrington, Connecticut, United States, 06790
Investigational Site Number 840038
Woodbridge, Connecticut, United States, 06525
United States, District of Columbia
Investigational Site Number 840025
Washington, District of Columbia, United States, 20017
Investigational Site Number 840052
Washington, District of Columbia, United States, 20010
United States, Florida
Investigational Site Number 840074
Clearwater, Florida, United States, 33756
Investigational Site Number 840019
Jacksonville, Florida, United States, 32207
Investigational Site Number 840051
Rockledge, Florida, United States, 32955
Investigational Site Number 840073
Sarasota, Florida, United States, 34239
United States, Georgia
Investigational Site Number 840070
Roswell, Georgia, United States, 30076
United States, Illinois
Investigational Site Number 840016
Park Ridge, Illinois, United States, 60068
Investigational Site Number 840028
Quincy, Illinois, United States, 62301
Investigational Site Number 840008
Skokie, Illinois, United States, 60077
United States, Indiana
Investigational Site Number 840033
Goshen, Indiana, United States, 46526
Investigational Site Number 840010
Indianapolis, Indiana, United States, 46237
United States, Kentucky
Investigational Site Number 840014
Louisville, Kentucky, United States, 40202
Investigational Site Number 840048
Mount Sterling, Kentucky, United States, 40353
United States, Louisiana
Investigational Site Number 840047
Metairie, Louisiana, United States, 70056
Investigational Site Number 840032
Ruston, Louisiana, United States, 71270
United States, Maryland
Investigational Site Number 840042
Bethesda, Maryland, United States, 20817
Investigational Site Number 840066
Easton, Maryland, United States, 21601
United States, Mississippi
Investigational Site Number 840059
Tupelo, Mississippi, United States, 38801
United States, New York
Investigational Site Number 840024
Rochester, New York, United States, 14642
Investigational Site Number 840031
Syracuse, New York, United States, 13210
United States, North Carolina
Investigational Site Number 840020
Durham, North Carolina, United States, 27710
Investigational Site Number 840021
Durham, North Carolina, United States, 27710
Investigational Site Number 840026
High Point, North Carolina, United States, 27262
United States, North Dakota
Investigational Site Number 840046
Bismarck, North Dakota, United States, 58501
United States, Ohio
Investigational Site Number 840003
Middletown, Ohio, United States, 45042
Investigational Site Number 840022
Sylvania, Ohio, United States, 43560
United States, Rhode Island
Investigational Site Number 840075
East Providence, Rhode Island, United States, 02915
United States, Texas
Investigational Site Number 840067
Beaumont, Texas, United States, 77701
Investigational Site Number 840004
El Paso, Texas, United States, 79915
Investigational Site Number 840034
Houston, Texas, United States, 77030
Investigational Site Number 840035
Sugar Land, Texas, United States, 77055
United States, Washington
Investigational Site Number 840063
Kennewick, Washington, United States, 99336
Investigational Site Number 840018
Tacoma, Washington, United States, 98431
Argentina
Investigational Site Number 032006
Buenos Aires, Argentina, 1425
Investigational Site Number 032003
Capital Federal, Argentina, 1264
Investigational Site Number 032004
Rosario, Argentina, S200PBJ
Investigational Site Number 032005
San Miguel De Tucuman, Argentina, T4000NIL
Investigational Site Number 032007
Tucuman, Argentina, T4000IAK
Australia
Investigational Site Number 036004
Adelaide, Australia, 5000
Investigational Site Number 036002
Bedford Park, Australia, 5042
Investigational Site Number 036001
Box Hill, Australia, 3128
Investigational Site Number 036009
Lismore, Australia, 2480
Investigational Site Number 036007
Perth, Australia, 6000
Investigational Site Number 036006
Ringwood East, Australia, 3135
Investigational Site Number 036008
Westmead, Australia, 2145
Investigational Site Number 036003
Woodville, Australia, 5011
Investigational Site Number 036005
Woolloongabba, Australia, 4102
Austria
Investigational Site Number 040002
Graz, Austria, 8036
Investigational Site Number 040003
Wien, Austria, 1090
Investigational Site Number 040004
Wien, Austria, 1130
Belarus
Investigational Site Number 112002
Gomel, Belarus, 246012
Investigational Site Number 112001
Minsk, Belarus, 223040
Investigational Site Number 112003
Minsk, Belarus, 220013
Investigational Site Number 112004
Vitebsk, Belarus, 210603
Belgium
Investigational Site Number 056008
Bonheiden, Belgium, 2820
Investigational Site Number 056011
Brussels, Belgium, 1020
Investigational Site Number 056005
Gent, Belgium, 9000
Investigational Site Number 056010
Haine-Saint-Paul, Belgium, 7100
Investigational Site Number 056006
Kortrijk, Belgium, 8500
Investigational Site Number 056009
Liège, Belgium, 4000
Investigational Site Number 056004
Merksem, Belgium, 2170
Investigational Site Number 056003
Oostende, Belgium
Investigational Site Number 056012
Ottignies, Belgium, 1340
Investigational Site Number 056002
Sint Niklaas, Belgium
Brazil
Investigational Site Number 076002
Belo Horizonte, Brazil, 30150-221
Investigational Site Number 076022
Curitiba, Brazil, 80730 170
Investigational Site Number 076015
Curitiba, Brazil, 81520-060
Investigational Site Number 076012
Florianopolis, Brazil, 88015-240
Investigational Site Number 076001
Fortaleza, Brazil, 60336-550
Investigational Site Number 076009
Goiania, Brazil, 74070-040
Investigational Site Number 076016
Goiania, Brazil, 74605-070
Investigational Site Number 076007
Goiania, Brazil, 74605-070
Investigational Site Number 076024
Ijui, Brazil, 98700 000
Investigational Site Number 076003
Joinville, Brazil, 89202-000
Investigational Site Number 076010
Londrina, Brazil, 86050-190
Investigational Site Number 076026
Passo Fundo, Brazil, 99010-080
Investigational Site Number 076027
Passo Fundo, Brazil, 99010-260
Investigational Site Number 076023
Porto Alegre, Brazil, 90020-090
Investigational Site Number 076020
Porto Alegre, Brazil, 90430-090
Investigational Site Number 076014
Salvador, Brazil, 40050-410
Investigational Site Number 076018
Salvador, Brazil, 41825-010
Investigational Site Number 076011
Santo Andre, Brazil, 09090-780
Investigational Site Number 076006
Sao Jose Dos Campos, Brazil, 12245-750
Investigational Site Number 076017
Sao Paulo, Brazil, 04122 000
Investigational Site Number 076008
Sao Paulo, Brazil, 04039-901
Investigational Site Number 076004
Taguatinga, Brazil, 72115-700
Bulgaria
Investigational Site Number 100001
Rousse, Bulgaria, 7002
Investigational Site Number 100003
Varna, Bulgaria, 9010
Canada
Investigational Site Number 124008
Greenfield Park, Canada, J4V 2H1
Investigational Site Number 124007
Kelowna, Canada
Investigational Site Number 124010
Moncton, Canada, E1C 8X3
Investigational Site Number 124003
Montreal, Canada, H3T 1E2
Investigational Site Number 124002
Ottawa, Canada, K1Y 4E9
Investigational Site Number 124009
Owen Sound, Canada, N4K 2J1
Investigational Site Number 124006
Rimouski, Canada, G5L 5T1
Investigational Site Number 124013
Saint John, Canada, E2L 4L2
Investigational Site Number 124001
Sherbrooke, Canada, J1H 5N4
Investigational Site Number 124012
Victoria, Canada, V8R 6V5
Investigational Site Number 124011
Weston, Canada, M9N 1N8
Chile
Investigational Site Number 152002
Temuco, Chile, 4810469
China
Investigational Site Number 156022
Beijing, China, 101149
Investigational Site Number 156014
Beijing, China, 100029
Investigational Site Number 156008
Beijing, China, 100071
Investigational Site Number 156031
Changchun, China, 130021
Investigational Site Number 156021
Chengdu, China, 610083
Investigational Site Number 156019
Chongqing, China, 400037
Investigational Site Number 156003
Dalian, China, 116011
Investigational Site Number 156025
Guangzhou, China, 510405
Investigational Site Number 156026
Hangzhou, China, 310016
Investigational Site Number 156030
Nanning, China, 530021
Investigational Site Number 156029
Qingdao, China, 266003
Investigational Site Number 156011
Shanghai, China, 200433
Investigational Site Number 156020
Shanghai, China, 200233
Investigational Site Number 156024
Shanghai, China, 200032
Investigational Site Number 156028
Shanghai, China, 200072
Investigational Site Number 156013
Shantou, China, 515041
Investigational Site Number 156012
Suzhou, China, 215004
Investigational Site Number 156009
Xi'An, China, 710038
Investigational Site Number 156004
Xi'An, China, 710032
Investigational Site Number 156027
Yinchuan, China, 750004
Colombia
Investigational Site Number 170010
Bogota, Colombia
Investigational Site Number 170005
Manizales, Colombia
Investigational Site Number 170002
Medellin, Colombia
Investigational Site Number 170006
Medellin, Colombia
Investigational Site Number 170007
Medellín, Colombia
Investigational Site Number 170008
Monteria, Colombia
Investigational Site Number 170004
Pereira, Colombia
Croatia
Investigational Site Number 191006
Pula, Croatia, 52100
Investigational Site Number 191005
Rijeka, Croatia, 51000
Investigational Site Number 191007
Varazdin, Croatia, 42000
Investigational Site Number 191003
Zadar, Croatia, 23000
Investigational Site Number 191001
Zagreb, Croatia
Investigational Site Number 191004
Zagreb, Croatia
Investigational Site Number 191008
Zagreb, Croatia, 10000
Czech Republic
Investigational Site Number 203004
Hradec Kralove, Czech Republic, 50005
Investigational Site Number 203008
Kolin, Czech Republic, 28020
Investigational Site Number 203007
Nova Ves Pod Plesi, Czech Republic, 26202
Investigational Site Number 203003
Praha 5, Czech Republic, 15006
Denmark
Investigational Site Number 208001
Herlev, Denmark, 2730
Estonia
Investigational Site Number 233001
Tallinn, Estonia, 10167
Finland
Investigational Site Number 246001
Turku, Finland, FIN-20520
France
Investigational Site Number 250002
Antibes, France, 06606
Investigational Site Number 250010
Colmar, France, 68024
Investigational Site Number 250020
Gap, France, 5007
Investigational Site Number 250012
Lille Cedex, France, 59037
Investigational Site Number 250005
Lille Cedex, France, 59020
Investigational Site Number 250025
Lille Cedex, France, 59020
Investigational Site Number 250003
Lyon, France, 69003
Investigational Site Number 250001
Marseille, France, 13273
Investigational Site Number 250024
Montpellier Cedex, France, 34094
Investigational Site Number 250006
Paris Cedex 10, France, 75475
Investigational Site Number 250027
Paris Cedex 10, France, 75475
Investigational Site Number 250004
Paris Cedex 14, France, 75674
Investigational Site Number 250021
Reims, France, 51100
Investigational Site Number 250019
Rouen, France, 76031
Investigational Site Number 250017
Saint Gregoire, France, 35570
Investigational Site Number 250014
Vandoeuvre Les Nancy, France, 54500
Germany
Investigational Site Number 276012
Augsburg, Germany, 86150
Investigational Site Number 276016
Berlin, Germany, 13125
Investigational Site Number 276002
Berlin, Germany, 13353
Investigational Site Number 276025
Berlin, Germany, 10117
Investigational Site Number 276029
Berlin, Germany, 13585
Investigational Site Number 276004
Bochum, Germany, 44791
Investigational Site Number 276014
Dresden, Germany, 01219
Investigational Site Number 276009
Dresden, Germany, 01307
Investigational Site Number 276030
Essen, Germany, 45136
Investigational Site Number 276005
Frankfurt Am Main, Germany, 65929
Investigational Site Number 276032
Gauting, Germany, 82131
Investigational Site Number 276034
Halle, Germany, 06120
Investigational Site Number 276038
Halle/Saale, Germany, 06120
Investigational Site Number 276037
Hamburg, Germany, 22457
Investigational Site Number 276007
Hannover, Germany, 30625
Investigational Site Number 276006
Köln, Germany, 51109
Investigational Site Number 276020
Leer, Germany, 26789
Investigational Site Number 276010
Leipzig, Germany, 04207
Investigational Site Number 276017
Magdeburg, Germany, 39104
Investigational Site Number 276011
Mannheim, Germany, 68167
Investigational Site Number 276003
Minden, Germany, 32427
Investigational Site Number 276019
München, Germany, 81545
Investigational Site Number 276021
München, Germany, 81377
Investigational Site Number 276015
München, Germany, 81737
Investigational Site Number 276013
Neumünster, Germany, 24634
Investigational Site Number 276022
Oldenburg, Germany, 26121
Investigational Site Number 276035
Paderborn, Germany, 33098
Investigational Site Number 276031
Passau, Germany, 94032
Investigational Site Number 276023
Rosenheim, Germany, 83022
Investigational Site Number 276008
Singen, Germany, 78224
Investigational Site Number 276024
Westerstede, Germany, 26655
Greece
Investigational Site Number 300004
Athens, Greece, 11527
Investigational Site Number 300003
Heraklion, Greece, 71110
Investigational Site Number 300002
Thessaloniki, Greece, 54629
Hong Kong
Investigational Site Number 344001
Hong Kong, Hong Kong
Hungary
Investigational Site Number 348009
Budapest, Hungary, 1121
Investigational Site Number 348005
Budapest, Hungary, 1076
Investigational Site Number 348004
Budapest, Hungary, 1125
Investigational Site Number 348006
Budapest, Hungary, 1106
Investigational Site Number 348010
Farkasgyepu, Hungary, 8582
Investigational Site Number 348001
Gyula, Hungary, 5700
Investigational Site Number 348012
Mátraháza, Hungary, 3233
Investigational Site Number 348003
Sopron, Hungary, 9700
Investigational Site Number 348008
Szikszó, Hungary, 3800
Investigational Site Number 348011
Szolnok, Hungary, 5000
Investigational Site Number 348007
Zalaegerszeg, Hungary, 8900
India
Investigational Site Number 356008
Bangalore, India
Investigational Site Number 356006
Bangalore, India, 560029
Investigational Site Number 356009
Bhopal, India, 462 001 (M.P)
Investigational Site Number 356018
Chennai, India
Investigational Site Number 356020
Chennai, India
Investigational Site Number 356019
Coimbatore, India, 641037
Investigational Site Number 356015
Hyderabad, India, 500004
Investigational Site Number 356025
Hyderabad, India, 500004
Investigational Site Number 356011
Jaipur, India
Investigational Site Number 356014
Kochi, India
Investigational Site Number 356013
Kolkata, India
Investigational Site Number 356003
Kolkata, India, 700026
Investigational Site Number 356017
Kolkata, India
Investigational Site Number 356005
Madurai, India
Investigational Site Number 356016
Miraj, India
Investigational Site Number 356001
Mumbai, India, 400026
Investigational Site Number 356023
Nagpur, India
Investigational Site Number 356002
New Delhi, India, 110060
Investigational Site Number 356024
Pune, India, 411004
Investigational Site Number 356004
Pune, India, 411001
Investigational Site Number 356012
Vishakhapatnam, India, 530002
Indonesia
Investigational Site Number 360002
Bandung, Indonesia, 40161
Investigational Site Number 360001
Denpasar, Indonesia, 80114
Investigational Site Number 360004
Medan, Indonesia, 20136
Ireland
Investigational Site Number 372003
Dublin, Ireland, D24
Investigational Site Number 372002
Dublin, Ireland, D9
Investigational Site Number 372004
Dublin 7, Ireland
Israel
Investigational Site Number 376003
Jerusalem, Israel, 91031
Investigational Site Number 376004
Kfar Saba, Israel, 44281
Investigational Site Number 376001
Nahariya, Israel, 22100
Investigational Site Number 376006
Petah-Tikva, Israel, 49100
Investigational Site Number 376007
Tzrifin, Israel, 70300
Italy
Investigational Site Number 380005
Castellanza, Italy, 21053
Investigational Site Number 380014
Cattolica, Italy, 47861
Investigational Site Number 380007
Cesena, Italy, 47023
Investigational Site Number 380015
Cremona, Italy, 26100
Investigational Site Number 380009
Faenza, Italy, 48018
Investigational Site Number 380012
Lecce, Italy, 73100
Investigational Site Number 380006
Lugo, Italy, 48022
Investigational Site Number 380001
Meldola, Italy, 47014
Investigational Site Number 380011
Parma, Italy, 43100
Investigational Site Number 380020
Perugia, Italy, 06128
Investigational Site Number 380013
Ravenna, Italy, 48121
Investigational Site Number 380016
Rimini, Italy, 47900
Investigational Site Number 380004
Sondrio, Italy, 23100
Investigational Site Number 380010
Sora, Italy, 03039
Investigational Site Number 380008
Taormina, Italy, 98039
Investigational Site Number 380019
Terni, Italy, 05100
Investigational Site Number 380003
Treviglio, Italy, 24047
Investigational Site Number 380017
Udine, Italy, 33100
Korea, Republic of
Investigational Site Number 410008
Daegu, Korea, Republic of, 700-712
Investigational Site Number 410006
Seoul, Korea, Republic of, 135-710
Investigational Site Number 410007
Seoul, Korea, Republic of, 110-744
Investigational Site Number 410001
Seoul, Korea, Republic of, 120-752
Investigational Site Number 410002
Seoul, Korea, Republic of, 120-752
Investigational Site Number 410005
Seoul, Korea, Republic of, 136-705
Investigational Site Number 410003
Seoul, Korea, Republic of, 137-701
Investigational Site Number 410009
Seoul, Korea, Republic of, 152-703
Investigational Site Number 410004
Suwon, Korea, Republic of, 442-060
Latvia
Investigational Site Number 428002
Liepaja, Latvia, 3401
Investigational Site Number 428001
Riga, Latvia, LV-1002
Investigational Site Number 428003
Riga, Latvia, 1079
Lithuania
Investigational Site Number 440001
Kaunas, Lithuania, 06080
Investigational Site Number 440002
Vilnius, Lithuania, LT-08661
Malaysia
Investigational Site Number 458001
Kota Kinabalu, Malaysia, 88996
Investigational Site Number 458003
Kuala Lumpur, Malaysia, 50603
Investigational Site Number 458005
Penang, Malaysia, 11900
Investigational Site Number 458004
Penang, Malaysia, 11900
Mexico
Investigational Site Number 484002
Acapulco, Mexico, 39670
Investigational Site Number 484006
Aguascalientes, Mexico, 20230
Investigational Site Number 484007
Durango, Mexico, 34260
Investigational Site Number 484008
Mérida, Mexico, 97000
Investigational Site Number 484012
Puebla, Mexico, 72550
Investigational Site Number 484003
Toluca, Mexico, 50120
Investigational Site Number 484010
Xalapa, Mexico, 91130
Netherlands
Investigational Site Number 528006
Den Haag, Netherlands, 2545 CH
Investigational Site Number 528004
Groningen, Netherlands, 9728 NT
Investigational Site Number 528005
Helmond, Netherlands, 5707 HA
Investigational Site Number 528001
Hoofddorp, Netherlands, 2134 TM
Investigational Site Number 528003
Rotterdam, Netherlands, 3083 AN
Norway
Investigational Site Number 578001
Oslo, Norway, 0407
Peru
Investigational Site Number 604012
Arequipa, Peru
Investigational Site Number 604011
Callao, Peru, CALLAO 02
Investigational Site Number 604004
Callao, Peru, CALLAO 02
Investigational Site Number 604001
Cercado, Peru
Investigational Site Number 604002
Chiclayo, Peru
Investigational Site Number 604003
Lima, Peru
Investigational Site Number 604007
Lima, Peru, LIMA 13
Investigational Site Number 604008
Lima, Peru, LIMA 11
Investigational Site Number 604009
Lima, Peru, LIMA 13
Investigational Site Number 604006
Lima, Peru, LIMA 34
Investigational Site Number 604005
Lima, Peru, LIMA 34
Investigational Site Number 604010
Lima, Peru, LIMA 34
Poland
Investigational Site Number 616009
Bialystok, Poland, 15-069
Investigational Site Number 616008
Bielsko-Biala, Poland, 43-300
Investigational Site Number 616006
Gliwice, Poland, 44-101
Investigational Site Number 616004
Krakow, Poland, 31-826
Investigational Site Number 616003
Lubin, Poland, 59-300
Investigational Site Number 616019
Olsztyn, Poland, 10-228
Investigational Site Number 616021
Otwock, Poland, 05-400
Investigational Site Number 616010
Poznan, Poland, 60-569
Investigational Site Number 616001
Prabuty, Poland, 82-550
Investigational Site Number 616014
Rybnik, Poland, 44-200
Investigational Site Number 616005
Rzeszow, Poland, 35-021
Investigational Site Number 616013
Torun, Poland, 87-100
Investigational Site Number 616002
Warszawa, Poland, 02-097
Investigational Site Number 616018
Warszawa, Poland, 00-416
Investigational Site Number 616015
Wroclaw, Poland, 53-439
Portugal
Investigational Site Number 620003
Aveiro, Portugal, 3814-501
Investigational Site Number 620009
Guimarães, Portugal, 4835-044
Investigational Site Number 620004
Lisboa, Portugal, 1070
Investigational Site Number 620008
Matosinhos, Portugal, 4454-509
Investigational Site Number 620007
Porto, Portugal, 4200-072
Investigational Site Number 620002
Setúbal, Portugal, 2910-446
Romania
Investigational Site Number 642004
Brasov, Romania, 500117
Investigational Site Number 642002
Bucuresti, Romania, 022328
Investigational Site Number 642001
Cluj Napoca, Romania, 400015
Investigational Site Number 642006
Cluj-Napoca, Romania, 400015
Investigational Site Number 642010
Iasi, Romania, 700106
Investigational Site Number 642003
Suceava, Romania, 720237
Investigational Site Number 642008
Timisoara, Romania, 300041
Russian Federation
Investigational Site Number 643024
Berdsk, Russian Federation, 633190
Investigational Site Number 643006
Chelyabinsk, Russian Federation, 454087
Investigational Site Number 643001
Kazan, Russian Federation, 420111
Investigational Site Number 643004
Krasnoyarsk, Russian Federation, 660113
Investigational Site Number 643010
Obninsk, Russian Federation, 249036
Investigational Site Number 643005
Omsk, Russian Federation, 644013
Investigational Site Number 643022
Pyatigorsk, Russian Federation, 357502
Investigational Site Number 643023
Rostov-On-Don, Russian Federation, 344037
Investigational Site Number 643020
Saratov, Russian Federation, 410004
Investigational Site Number 643019
Smolensk, Russian Federation, 214000
Investigational Site Number 643021
Sochi, Russian Federation, 354057
Investigational Site Number 643011
St-Petersburg, Russian Federation, 197758
Investigational Site Number 643014
St-Petersburg, Russian Federation, 197089
Investigational Site Number 643015
St-Petersburg, Russian Federation, 197089
Investigational Site Number 643009
St.Petersburg, Russian Federation, 196084
Investigational Site Number 643008
Tomsk, Russian Federation, 634050
Investigational Site Number 643016
Tula, Russian Federation, 300053
Investigational Site Number 643018
Tyumen, Russian Federation, 625023
Investigational Site Number 643012
Ufa, Russian Federation, 450054
Investigational Site Number 643007
Vladivostok, Russian Federation, 690105
Investigational Site Number 643017
Voronezh, Russian Federation, 394000
Investigational Site Number 643003
Yaroslavl, Russian Federation, 150040
Serbia
Investigational Site Number 688002
Belgrade, Serbia, 11000
Investigational Site Number 688004
Belgrade, Serbia, 11080
Investigational Site Number 688007
Kragujevac, Serbia, 34000
Investigational Site Number 688005
Nis, Serbia, 18000
Slovakia
Investigational Site Number 703003
Trnava, Slovakia, 91775
Slovenia
Investigational Site Number 705003
Golnik, Slovenia, 4204
Investigational Site Number 705002
Maribor, Slovenia, 2000
South Africa
Investigational Site Number 710002
Durban, South Africa, 4091
Investigational Site Number 710003
Durban, South Africa, 400
Spain
Investigational Site Number 724010
Barakaldo, Spain, 48903
Investigational Site Number 724008
Barakaldo, Spain, 48903
Investigational Site Number 724004
Barcelona, Spain, 08036
Investigational Site Number 724006
Islas Baleares, Spain, 07014
Investigational Site Number 724011
Lérida, Spain, 25198
Investigational Site Number 724013
Madrid, Spain, 28035
Investigational Site Number 724001
Madrid, Spain, 28034
Investigational Site Number 724007
Madrid, Spain, 28034
Investigational Site Number 724012
Madrid, Spain, 28040
Investigational Site Number 724005
Orense, Spain, 32005
Investigational Site Number 724003
Puerto De Sagunto, Spain, 46520
Investigational Site Number 724002
Valencia, Spain, 46017
Sweden
Investigational Site Number 752003
Göteborg, Sweden, 416 85
Investigational Site Number 752005
Mora, Sweden, 792 85
Investigational Site Number 752002
Uppsala, Sweden, 751 85
Investigational Site Number 752001
Växjö, Sweden, 351 85
Switzerland
Investigational Site Number 756006
Aarau, Switzerland, 5001
Investigational Site Number 756004
Winterthur, Switzerland, 8401
Taiwan
Investigational Site Number 158004
Changhua, Taiwan, 500
Ukraine
Investigational Site Number 804008
Cherkasy, Ukraine, 18009
Investigational Site Number 804009
Chernivtsi, Ukraine, 58001
Investigational Site Number 804002
Dnipropetrovsk, Ukraine, 49102
Investigational Site Number 804006
Donetsk, Ukraine, 83092
Investigational Site Number 804005
Krivoy Rog, Ukraine, 50048
Investigational Site Number 804001
Lutsk, Ukraine, 43018
Investigational Site Number 804010
Lviv, Ukraine, 79031
Investigational Site Number 804011
Sumy, Ukraine, 40005
Investigational Site Number 804004
Ternopil, Ukraine, 46023
United Kingdom
Investigational Site Number 826016
Bangor, United Kingdom, LL57 2PW
Investigational Site Number 826010
Brighton, United Kingdom, BN2 5BE
Investigational Site Number 826015
Coventry, United Kingdom, CV2 2DX
Investigational Site Number 826013
Dundee, United Kingdom, DD1 9SY
Investigational Site Number 826007
Hull, United Kingdom, HU8 9HE
Investigational Site Number 826002
Lincoln, United Kingdom, LN2 5QY
Investigational Site Number 826017
Lincoln, United Kingdom, LN2 5QY
Investigational Site Number 826005
Manchester, United Kingdom, M20 4BX
Investigational Site Number 826004
Norwich, United Kingdom, NR4 7UY
Investigational Site Number 826009
Peterborough, United Kingdom, PE3 6DA
Investigational Site Number 826011
Portsmouth, United Kingdom, PO3 6AD
Investigational Site Number 826001
Shrewsbury, United Kingdom, SY3 8XQ
Investigational Site Number 826014
Wirral, United Kingdom, CH63 4JY
Sponsors and Collaborators
Sanofi
Investigators
Study Chair: Alexander Turpie, MD HHS-General Hospital, Hamilton, Canada
Principal Investigator: Giancarlo Agnelli, MD University of Perugia, Italy
  More Information

Publications:
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00694382     History of Changes
Other Study ID Numbers: EFC6521, 2007-007943-29
Study First Received: May 7, 2008
Last Updated: January 14, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
chemotherapy

Additional relevant MeSH terms:
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis
Heparin, Low-Molecular-Weight
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 22, 2014