AzTrials
AzTrials

Venous ThromboembolismPhase 3SAVE-ONCONCT00694382

Evaluation of AVE5026 in the Prevention of Venous Thromboembolism in Cancer Patients Undergoing Chemotherapy

A Phase 3 study testing Semuloparin sodium in people with Venous Thromboembolism and Cancer, run by Sanofi at 411 sites in 49 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Venous Thromboembolism, Cancer
What is being tested?
Semuloparin sodium
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
3,212 participants
Where
411 sitesin 49 countries
Study dates
Jun 2008to Nov 2010
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

411 sites in 49 countries.

411 sites in 49 countries

United States48 sites

  • Investigational Site Number 840067

    Beaumont, Texas, 77701

  • Investigational Site Number 840042

    Bethesda, Maryland, 20817

  • Investigational Site Number 840006

    Birmingham, Alabama, 35211

  • Investigational Site Number 840046

    Bismarck, North Dakota, 58501

  • Investigational Site Number 840007

    Casa Grande, Arizona, 85222

  • Investigational Site Number 840074

    Clearwater, Florida, 33756

  • Investigational Site Number 840020

    Durham, North Carolina, 27710

  • Investigational Site Number 840021

    Durham, North Carolina, 27710

  • Investigational Site Number 840075

    East Providence, Rhode Island, 02915

  • Investigational Site Number 840066

    Easton, Maryland, 21601

  • Investigational Site Number 840004

    El Paso, Texas, 79915

  • Investigational Site Number 840050

    Fountain Valley, California, 92708

  • Investigational Site Number 840072

    Fullerton, California, 92835

  • Investigational Site Number 840033

    Goshen, Indiana, 46526

  • Investigational Site Number 840026

    High Point, North Carolina, 27262

  • Investigational Site Number 840034

    Houston, Texas, 77030

  • Investigational Site Number 840037

    Indian Wells, California, 92210

  • Investigational Site Number 840010

    Indianapolis, Indiana, 46237

  • Investigational Site Number 840019

    Jacksonville, Florida, 32207

  • Investigational Site Number 840063

    Kennewick, Washington, 99336

  • Investigational Site Number 840069

    La Verne, California, 91750

  • Investigational Site Number 840009

    Long Beach, California, 90806

  • Investigational Site Number 840014

    Louisville, Kentucky, 40202

  • Investigational Site Number 840047

    Metairie, Louisiana, 70056

  • Investigational Site Number 840003

    Middletown, Ohio, 45042

  • Investigational Site Number 840048

    Mount Sterling, Kentucky, 40353

  • Investigational Site Number 840005

    Norwich, Connecticut, 06360

  • Investigational Site Number 840001

    Oceanside, California, 92056

  • Investigational Site Number 840016

    Park Ridge, Illinois, 60068

  • Investigational Site Number 840028

    Quincy, Illinois, 62301

  • Investigational Site Number 840011

    Rancho Mirage, California, 92270

  • Investigational Site Number 840024

    Rochester, New York, 14642

  • Investigational Site Number 840051

    Rockledge, Florida, 32955

  • Investigational Site Number 840070

    Roswell, Georgia, 30076

  • Investigational Site Number 840032

    Ruston, Louisiana, 71270

  • Investigational Site Number 840073

    Sarasota, Florida, 34239

  • Investigational Site Number 840008

    Skokie, Illinois, 60077

  • Investigational Site Number 840035

    Sugar Land, Texas, 77055

  • Investigational Site Number 840022

    Sylvania, Ohio, 43560

  • Investigational Site Number 840031

    Syracuse, New York, 13210

  • Investigational Site Number 840018

    Tacoma, Washington, 98431

  • Investigational Site Number 840064

    Torrington, Connecticut, 06790

  • Investigational Site Number 840060

    Tucson, Arizona, 85704

  • Investigational Site Number 840059

    Tupelo, Mississippi, 38801

  • Investigational Site Number 840052

    Washington D.C., District of Columbia, 20010

  • Investigational Site Number 840025

    Washington D.C., District of Columbia, 20017

  • Investigational Site Number 840029

    West Covina, California, 91790

  • Investigational Site Number 840038

    Woodbridge, Connecticut, 06525

Other trials in United States

Germany31 sites

  • Investigational Site Number 276012

    Augsburg, 86150

  • Investigational Site Number 276025

    Berlin, 10117

  • Investigational Site Number 276016

    Berlin, 13125

  • Investigational Site Number 276002

    Berlin, 13353

  • Investigational Site Number 276029

    Berlin, 13585

  • Investigational Site Number 276004

    Bochum, 44791

  • Investigational Site Number 276006

    Cologne, 51109

  • Investigational Site Number 276014

    Dresden, 01219

  • Investigational Site Number 276009

    Dresden, 01307

  • Investigational Site Number 276030

    Essen, 45136

  • Investigational Site Number 276005

    Frankfurt am Main, 65929

  • Investigational Site Number 276032

    Gauting, 82131

  • Investigational Site Number 276034

    Halle, 06120

  • Investigational Site Number 276038

    Halle, 06120

  • Investigational Site Number 276037

    Hamburg, 22457

  • Investigational Site Number 276007

    Hanover, 30625

  • Investigational Site Number 276020

    Leer, 26789

  • Investigational Site Number 276010

    Leipzig, 04207

  • Investigational Site Number 276017

    Magdeburg, 39104

  • Investigational Site Number 276011

    Mannheim, 68167

  • Investigational Site Number 276003

    Minden, 32427

  • Investigational Site Number 276021

    München, 81377

  • Investigational Site Number 276019

    München, 81545

  • Investigational Site Number 276015

    München, 81737

  • Investigational Site Number 276013

    Neumünster, 24634

  • Investigational Site Number 276022

    Oldenburg, 26121

  • Investigational Site Number 276035

    Paderborn, 33098

  • Investigational Site Number 276031

    Passau, 94032

  • Investigational Site Number 276023

    Rosenheim, 83022

  • Investigational Site Number 276008

    Singen, 78224

  • Investigational Site Number 276024

    Westerstede, 26655

Other trials in Germany

Brazil22 sites

  • Investigational Site Number 076002

    Belo Horizonte, 30150-221

  • Investigational Site Number 076022

    Curitiba, 80730 170

  • Investigational Site Number 076015

    Curitiba, 81520-060

  • Investigational Site Number 076012

    Florianópolis, 88015-240

  • Investigational Site Number 076001

    Fortaleza, 60336-550

  • Investigational Site Number 076009

    Goiânia, 74070-040

  • Investigational Site Number 076007

    Goiânia, 74605-070

  • Investigational Site Number 076016

    Goiânia, 74605-070

  • Investigational Site Number 076024

    Ijuí, 98700 000

  • Investigational Site Number 076003

    Joinville, 89202-000

  • Investigational Site Number 076010

    Londrina, 86050-190

  • Investigational Site Number 076026

    Passo Fundo, 99010-080

  • Investigational Site Number 076027

    Passo Fundo, 99010-260

  • Investigational Site Number 076023

    Porto Alegre, 90020-090

  • Investigational Site Number 076020

    Porto Alegre, 90430-090

  • Investigational Site Number 076014

    Salvador, 40050-410

  • Investigational Site Number 076018

    Salvador, 41825-010

  • Investigational Site Number 076011

    Santo André, 09090-780

  • Investigational Site Number 076006

    São José dos Campos, 12245-750

  • Investigational Site Number 076008

    São Paulo, 04039-901

  • Investigational Site Number 076017

    São Paulo, 04122 000

  • Investigational Site Number 076004

    Taguatinga, 72115-700

Other trials in Brazil

Russia22 sites

  • Investigational Site Number 643024

    Berdsk, 633190

  • Investigational Site Number 643006

    Chelyabinsk, 454087

  • Investigational Site Number 643001

    Kazan', 420111

  • Investigational Site Number 643004

    Krasnoyarsk, 660113

  • Investigational Site Number 643010

    Obninsk, 249036

  • Investigational Site Number 643005

    Omsk, 644013

  • Investigational Site Number 643022

    Pyatigorsk, 357502

  • Investigational Site Number 643023

    Rostov-on-Don, 344037

  • Investigational Site Number 643009

    Saint Petersburg, 196084

  • Investigational Site Number 643014

    Saint Petersburg, 197089

  • Investigational Site Number 643015

    Saint Petersburg, 197089

  • Investigational Site Number 643011

    Saint Petersburg, 197758

  • Investigational Site Number 643020

    Saratov, 410004

  • Investigational Site Number 643019

    Smolensk, 214000

  • Investigational Site Number 643021

    Sochi, 354057

  • Investigational Site Number 643008

    Tomsk, 634050

  • Investigational Site Number 643016

    Tula, 300053

  • Investigational Site Number 643018

    Tyumen, 625023

  • Investigational Site Number 643012

    Ufa, 450054

  • Investigational Site Number 643007

    Vladivostok, 690105

  • Investigational Site Number 643017

    Voronezh, 394000

  • Investigational Site Number 643003

    Yaroslavl, 150040

Other trials in Russia

India21 sites

  • Investigational Site Number 356006

    Bangalore, 560029

  • Investigational Site Number 356008

    Bangalore

  • Investigational Site Number 356009

    Bhopal, 462 001 (M.P)

  • Investigational Site Number 356018

    Chennai

  • Investigational Site Number 356020

    Chennai

  • Investigational Site Number 356019

    Coimbatore, 641037

  • Investigational Site Number 356015

    Hyderabad, 500004

  • Investigational Site Number 356025

    Hyderabad, 500004

  • Investigational Site Number 356011

    Jaipur

  • Investigational Site Number 356014

    Kochi

  • Investigational Site Number 356003

    Kolkata, 700026

  • Investigational Site Number 356013

    Kolkata

  • Investigational Site Number 356017

    Kolkata

  • Investigational Site Number 356005

    Madurai

  • Investigational Site Number 356016

    Miraj

  • Investigational Site Number 356001

    Mumbai, 400026

  • Investigational Site Number 356023

    Nagpur

  • Investigational Site Number 356002

    New Delhi, 110060

  • Investigational Site Number 356004

    Pune, 411001

  • Investigational Site Number 356024

    Pune, 411004

  • Investigational Site Number 356012

    Visakhapatnam, 530002

Other trials in India

China20 sites

  • Investigational Site Number 156014

    Beijing, 100029

  • Investigational Site Number 156008

    Beijing, 100071

  • Investigational Site Number 156022

    Beijing, 101149

  • Investigational Site Number 156031

    Changchun, 130021

  • Investigational Site Number 156021

    Chengdu, 610083

  • Investigational Site Number 156019

    Chongqing, 400037

  • Investigational Site Number 156003

    Dalian, 116011

  • Investigational Site Number 156025

    Guangzhou, 510405

  • Investigational Site Number 156026

    Hangzhou, 310016

  • Investigational Site Number 156030

    Nanning, 530021

  • Investigational Site Number 156029

    Qingdao, 266003

  • Investigational Site Number 156024

    Shanghai, 200032

  • Investigational Site Number 156028

    Shanghai, 200072

  • Investigational Site Number 156020

    Shanghai, 200233

  • Investigational Site Number 156011

    Shanghai, 200433

  • Investigational Site Number 156013

    Shantou, 515041

  • Investigational Site Number 156012

    Suzhou, 215004

  • Investigational Site Number 156004

    Xi'an, 710032

  • Investigational Site Number 156009

    Xi'an, 710038

  • Investigational Site Number 156027

    Yinchuan, 750004

Other trials in China

Italy18 sites

  • Investigational Site Number 380005

    Castellanza, 21053

  • Investigational Site Number 380014

    Cattolica, 47861

  • Investigational Site Number 380007

    Cesena, 47023

  • Investigational Site Number 380015

    Cremona, 26100

  • Investigational Site Number 380009

    Faenza, 48018

  • Investigational Site Number 380012

    Lecce, 73100

  • Investigational Site Number 380006

    Lugo, 48022

  • Investigational Site Number 380001

    Meldola, 47014

  • Investigational Site Number 380011

    Parma, 43100

  • Investigational Site Number 380020

    Perugia, 06128

  • Investigational Site Number 380013

    Ravenna, 48121

  • Investigational Site Number 380016

    Rimini, 47900

  • Investigational Site Number 380004

    Sondrio, 23100

  • Investigational Site Number 380010

    Sora, 03039

  • Investigational Site Number 380008

    Taormina, 98039

  • Investigational Site Number 380019

    Terni, 05100

  • Investigational Site Number 380003

    Treviglio, 24047

  • Investigational Site Number 380017

    Udine, 33100

Other trials in Italy

France16 sites

  • Investigational Site Number 250002

    Antibes, 06606

  • Investigational Site Number 250010

    Colmar, 68024

  • Investigational Site Number 250020

    Gap, 5007

  • Investigational Site Number 250005

    Lille, 59020

  • Investigational Site Number 250025

    Lille, 59020

  • Investigational Site Number 250012

    Lille, 59037

  • Investigational Site Number 250003

    Lyon, 69003

  • Investigational Site Number 250001

    Marseille, 13273

  • Investigational Site Number 250024

    Montpellier, 34094

  • Investigational Site Number 250006

    Paris, 75475

  • Investigational Site Number 250027

    Paris, 75475

  • Investigational Site Number 250004

    Paris, 75674

  • Investigational Site Number 250021

    Reims, 51100

  • Investigational Site Number 250019

    Rouen, 76031

  • Investigational Site Number 250017

    Saint-Grégoire, 35570

  • Investigational Site Number 250014

    Vandœuvre-lès-Nancy, 54500

Other trials in France

Poland15 sites

  • Investigational Site Number 616009

    Bialystok, 15-069

  • Investigational Site Number 616008

    Bielsko-Biala, 43-300

  • Investigational Site Number 616006

    Gliwice, 44-101

  • Investigational Site Number 616004

    Krakow, 31-826

  • Investigational Site Number 616003

    Lubin, 59-300

  • Investigational Site Number 616019

    Olsztyn, 10-228

  • Investigational Site Number 616021

    Otwock, 05-400

  • Investigational Site Number 616010

    Poznan, 60-569

  • Investigational Site Number 616001

    Prabuty, 82-550

  • Investigational Site Number 616014

    Rybnik, 44-200

  • Investigational Site Number 616005

    Rzeszów, 35-021

  • Investigational Site Number 616013

    Torun, 87-100

  • Investigational Site Number 616018

    Warsaw, 00-416

  • Investigational Site Number 616002

    Warsaw, 02-097

  • Investigational Site Number 616015

    Wroclaw, 53-439

Other trials in Poland

United Kingdom13 sites

  • Investigational Site Number 826016

    Bangor, LL57 2PW

  • Investigational Site Number 826010

    Brighton, BN2 5BE

  • Investigational Site Number 826015

    Coventry, CV2 2DX

  • Investigational Site Number 826013

    Dundee, DD1 9SY

  • Investigational Site Number 826007

    Hull, HU8 9HE

  • Investigational Site Number 826002

    Lincoln, LN2 5QY

  • Investigational Site Number 826017

    Lincoln, LN2 5QY

  • Investigational Site Number 826005

    Manchester, M20 4BX

  • Investigational Site Number 826014

    Metropolitan Borough of Wirral, CH63 4JY

  • Investigational Site Number 826004

    Norwich, NR4 7UY

  • Investigational Site Number 826009

    Peterborough, PE3 6DA

  • Investigational Site Number 826011

    Portsmouth, PO3 6AD

  • Investigational Site Number 826001

    Shrewsbury, SY3 8XQ

Other trials in United Kingdom

Peru12 sites

  • Investigational Site Number 604012

    Arequipa

  • Investigational Site Number 604004

    Callao, CALLAO 02

  • Investigational Site Number 604011

    Callao, CALLAO 02

  • Investigational Site Number 604001

    Cercado

  • Investigational Site Number 604002

    Chiclayo

  • Investigational Site Number 604008

    Lima, LIMA 11

  • Investigational Site Number 604007

    Lima, LIMA 13

  • Investigational Site Number 604009

    Lima, LIMA 13

  • Investigational Site Number 604005

    Lima, LIMA 34

  • Investigational Site Number 604006

    Lima, LIMA 34

  • Investigational Site Number 604010

    Lima, LIMA 34

  • Investigational Site Number 604003

    Lima

Other trials in Peru

Spain12 sites

  • Investigational Site Number 724008

    Barakaldo, 48903

  • Investigational Site Number 724010

    Barakaldo, 48903

  • Investigational Site Number 724004

    Barcelona, 08036

  • Investigational Site Number 724006

    Islas Baleares, 07014

  • Investigational Site Number 724011

    Lleida, 25198

  • Investigational Site Number 724001

    Madrid, 28034

  • Investigational Site Number 724007

    Madrid, 28034

  • Investigational Site Number 724013

    Madrid, 28035

  • Investigational Site Number 724012

    Madrid, 28040

  • Investigational Site Number 724005

    Ourense, 32005

  • Investigational Site Number 724003

    Port de Sagunt, 46520

  • Investigational Site Number 724002

    Valencia, 46017

Other trials in Spain

Canada11 sites

  • Investigational Site Number 124008

    Greenfield Park, J4V 2H1

  • Investigational Site Number 124007

    Kelowna

  • Investigational Site Number 124010

    Moncton, E1C 8X3

  • Investigational Site Number 124003

    Montreal, H3T 1E2

  • Investigational Site Number 124002

    Ottawa, K1Y 4E9

  • Investigational Site Number 124009

    Owen Sound, N4K 2J1

  • Investigational Site Number 124006

    Rimouski, G5L 5T1

  • Investigational Site Number 124013

    Saint John, E2L 4L2

  • Investigational Site Number 124001

    Sherbrooke, J1H 5N4

  • Investigational Site Number 124012

    Victoria, V8R 6V5

  • Investigational Site Number 124011

    Weston, M9N 1N8

Other trials in Canada

Hungary11 sites

  • Investigational Site Number 348005

    Budapest, 1076

  • Investigational Site Number 348006

    Budapest, 1106

  • Investigational Site Number 348009

    Budapest, 1121

  • Investigational Site Number 348004

    Budapest, 1125

  • Investigational Site Number 348010

    Farkasgyepű, 8582

  • Investigational Site Number 348001

    Gyula, 5700

  • Investigational Site Number 348012

    Mátraháza, 3233

  • Investigational Site Number 348003

    Sopron, 9700

  • Investigational Site Number 348008

    Szikszó, 3800

  • Investigational Site Number 348011

    Szolnok, 5000

  • Investigational Site Number 348007

    Zalaegerszeg, 8900

Other trials in Hungary

Belgium10 sites

  • Investigational Site Number 056008

    Bonheiden, 2820

  • Investigational Site Number 056011

    Brussels, 1020

  • Investigational Site Number 056005

    Ghent, 9000

  • Investigational Site Number 056010

    Haine-Saint-Paul, 7100

  • Investigational Site Number 056006

    Kortrijk, 8500

  • Investigational Site Number 056009

    Liège, 4000

  • Investigational Site Number 056004

    Merksem, 2170

  • Investigational Site Number 056003

    Ostend

  • Investigational Site Number 056012

    Ottignies, 1340

  • Investigational Site Number 056002

    Sint-Niklaas

Other trials in Belgium

Australia9 sites

  • Investigational Site Number 036004

    Adelaide, 5000

  • Investigational Site Number 036002

    Bedford Park, 5042

  • Investigational Site Number 036001

    Box Hill, 3128

  • Investigational Site Number 036009

    Lismore, 2480

  • Investigational Site Number 036007

    Perth, 6000

  • Investigational Site Number 036006

    Ringwood East, 3135

  • Investigational Site Number 036008

    Westmead, 2145

  • Investigational Site Number 036003

    Woodville, 5011

  • Investigational Site Number 036005

    Woolloongabba, 4102

Other trials in Australia

South Korea9 sites

  • Investigational Site Number 410008

    Daegu, 700-712

  • Investigational Site Number 410007

    Seoul, 110-744

  • Investigational Site Number 410001

    Seoul, 120-752

  • Investigational Site Number 410002

    Seoul, 120-752

  • Investigational Site Number 410006

    Seoul, 135-710

  • Investigational Site Number 410005

    Seoul, 136-705

  • Investigational Site Number 410003

    Seoul, 137-701

  • Investigational Site Number 410009

    Seoul, 152-703

  • Investigational Site Number 410004

    Suwon, 442-060

Other trials in South Korea

Ukraine9 sites

  • Investigational Site Number 804008

    Cherkasy, 18009

  • Investigational Site Number 804009

    Chernivtsi, 58001

  • Investigational Site Number 804002

    Dnipropetrovsk, 49102

  • Investigational Site Number 804006

    Donetsk, 83092

  • Investigational Site Number 804005

    Kryvyi Rih, 50048

  • Investigational Site Number 804001

    Lutsk, 43018

  • Investigational Site Number 804010

    Lviv, 79031

  • Investigational Site Number 804011

    Sumy, 40005

  • Investigational Site Number 804004

    Ternopil, 46023

Other trials in Ukraine

Colombia7 sites

  • Investigational Site Number 170010

    Bogotá

  • Investigational Site Number 170005

    Manizales

  • Investigational Site Number 170002

    Medellín

  • Investigational Site Number 170006

    Medellín

  • Investigational Site Number 170007

    Medellín

  • Investigational Site Number 170008

    Montería

  • Investigational Site Number 170004

    Pereira

Other trials in Colombia

Croatia7 sites

  • Investigational Site Number 191006

    Pula, 52100

  • Investigational Site Number 191005

    Rijeka, 51000

  • Investigational Site Number 191007

    Varaždin, 42000

  • Investigational Site Number 191003

    Zadar, 23000

  • Investigational Site Number 191008

    Zagreb, 10000

  • Investigational Site Number 191001

    Zagreb

  • Investigational Site Number 191004

    Zagreb

Other trials in Croatia

Mexico7 sites

  • Investigational Site Number 484002

    Acapulco, 39670

  • Investigational Site Number 484006

    Aguascalientes, 20230

  • Investigational Site Number 484007

    Durango, 34260

  • Investigational Site Number 484008

    Mérida, 97000

  • Investigational Site Number 484012

    Puebla City, 72550

  • Investigational Site Number 484003

    Toluca, 50120

  • Investigational Site Number 484010

    Xalapa, 91130

Other trials in Mexico

Romania7 sites

  • Investigational Site Number 642004

    Brasov, 500117

  • Investigational Site Number 642002

    Bucharest, 022328

  • Investigational Site Number 642001

    Cluj-Napoca, 400015

  • Investigational Site Number 642006

    Cluj-Napoca, 400015

  • Investigational Site Number 642010

    Iași, 700106

  • Investigational Site Number 642003

    Suceava, 720237

  • Investigational Site Number 642008

    Timișoara, 300041

Other trials in Romania

Portugal6 sites

  • Investigational Site Number 620003

    Aveiro, 3814-501

  • Investigational Site Number 620009

    Guimarães, 4835-044

  • Investigational Site Number 620004

    Lisbon, 1070

  • Investigational Site Number 620008

    Matosinhos Municipality, 4454-509

  • Investigational Site Number 620007

    Porto, 4200-072

  • Investigational Site Number 620002

    Setúbal, 2910-446

Other trials in Portugal

Argentina5 sites

  • Investigational Site Number 032006

    Buenos Aires, 1425

  • Investigational Site Number 032003

    Capital Federal, 1264

  • Investigational Site Number 032004

    Rosario, S200PBJ

  • Investigational Site Number 032007

    San Miguel de Tucumán, T4000IAK

  • Investigational Site Number 032005

    San Miguel de Tucumán, T4000NIL

Other trials in Argentina

Israel5 sites

  • Investigational Site Number 376003

    Jerusalem, 91031

  • Investigational Site Number 376004

    Kfar Saba, 44281

  • Investigational Site Number 376001

    Nahariya, 22100

  • Investigational Site Number 376006

    Petah Tikva, 49100

  • Investigational Site Number 376007

    Tzrifin, 70300

Other trials in Israel

Netherlands5 sites

  • Investigational Site Number 528004

    Groningen, 9728 NT

  • Investigational Site Number 528005

    Helmond, 5707 HA

  • Investigational Site Number 528001

    Hoofddorp, 2134 TM

  • Investigational Site Number 528003

    Rotterdam, 3083 AN

  • Investigational Site Number 528006

    The Hague, 2545 CH

Other trials in Netherlands

Belarus4 sites

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About this study

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

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.

Read the 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).

Being tested
Semuloparin sodium, Placebo (for semuloparin)
Keywords
chemotherapy
Medical subject headings
Venous Thromboembolism, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Semuloparin sodiumDrug

    Also called AVE5026

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

    Subcutaneous injection

  • Placebo (for semuloparin)Drug

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

    Subcutaneous injection

Study groups in NCT00694382
Study groupRoleWhat they receive
SemuloparinExperimentalSemuloparin sodium 20 mg once daily until change in chemotherapy regimen
Receives: Drug: Semuloparin sodium
PlaceboPlacebo comparatorPlacebo (for semuloparin) once daily until change in chemotherapy regimen
Receives: Drug: Placebo (for semuloparin)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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".

    Measured: From randomization up to 3 days after last study drug injection

  2. Time-to-first Occurrence of VTE or VTE-related Death (Cumulative Incidence Function)

    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.

    Measured: From randomization up to 3 days after last study drug injection

Secondary outcomes (3)

  1. Percentage of Participants who required the initiation of curative anticoagulant or thrombolytic treatment after VTE assessment

    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.

    Measured: From randomization up to 3 days after last study drug injection

  2. Percentage of Participants Who Experienced Clinically Relevant Bleedings

    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).

    Measured: From first study drug injection up to 3 days after last study drug injection

  3. Overall survival [OS]

    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.

    Measured: From randomization up to 1 year after randomization or 7 months following randomization of the last participant, whichever came first

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2008 (estimated)
  2. Study startJun 2008
  3. Primary completionNov 2010
  4. Study completionNov 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
3,212 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00694382
Sponsor's protocol ID
EFC6521
Other IDs
2007-007943-29
Acronym
SAVE-ONCO
Status last verified
Jan 2013
First submitted
7 May 2008
Last updated
23 Jan 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Agnelli G, George DJ, Kakkar AK, Fisher W, Lassen MR, Mismetti P, Mouret P, Chaudhari U, Lawson F, Turpie AG; SAVE-ONCO Investigators. Semuloparin for thromboprophylaxis in patients receiving chemotherapy for cancer. N Engl J Med. 2012 Feb 16;366(7):601-9. doi: 10.1056/NEJMoa1108898.

    PubMed 22335737

  • Rutjes AW, Porreca E, Candeloro M, Valeriani E, Di Nisio M. Primary prophylaxis for venous thromboembolism in ambulatory cancer patients receiving chemotherapy. Cochrane Database Syst Rev. 2020 Dec 18;12(12):CD008500. doi: 10.1002/14651858.CD008500.pub5.

    PubMed 33337539

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Semuloparin sodium in people with Venous Thromboembolism and Cancer, run by Sanofi at 411 sites in 49 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 411 sites in United States, Germany, Brazil, Russia, India and 44 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00694382, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2013.

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