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

January 14, 2013 updated by: Sanofi

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

3212

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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".
From randomization up to 3 days after last study drug injection
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.
From randomization up to 3 days after last study drug injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From randomization up to 3 days after last study drug injection
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).
From first study drug injection up to 3 days after last study drug injection
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.
From randomization up to 1 year after randomization or 7 months following randomization of the last participant, whichever came first

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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;
From first study drug injection up to 3 days after last study drug injection
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.
From first study drug injection up to 3 days after last study drug injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

  • Principal Investigator: Giancarlo Agnelli, MD, University of Perugia, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

May 7, 2008

First Submitted That Met QC Criteria

June 6, 2008

First Posted (Estimate)

June 10, 2008

Study Record Updates

Last Update Posted (Estimate)

January 23, 2013

Last Update Submitted That Met QC Criteria

January 14, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFC6521
  • 2007-007943-29 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe