A Study Comparing CO-1.01 With Gemcitabine as First Line Therapy in Patients With Metastatic Pancreatic Adenocarcinoma (LEAP)

PHASE2CompletedINTERVENTIONAL
Enrollment

367

Participants

Timeline

Start Date

May 31, 2010

Primary Completion Date

November 30, 2012

Study Completion Date

June 30, 2013

Conditions
Metastatic Pancreatic Adenocarcinoma
Interventions
DRUG

CO-1.01

1250 mg/m2 intravenous infusion weekly for 3 weeks every 4 weeks

DRUG

Gemcitabine

1000 mg/m2 intravenous infusion weekly for 7 weeks followed by 1 week rest, then weekly for 3 weeks every 4 weeks

Trial Locations (95)

1200

Cliniques Universitaires Saint Luc, Brussels

2305

Newcastle Private Hospital, New Lambton Heights

2444

Port Macquarie Base Hospital, Port Macquarie

2500

Southern Medical Day Oncology Care Centre, Wollongong

2650

Universitair Ziekenhuis Antwerpen, Edegem

3065

Saint Vincent's Hospital, Fitzroy

3690

Border Medical Oncology, Murray Valley Private Hospital, Wodonga

4604

Sørlandet sykehus HF, Kristiansand

5042

Flinders Medical Centre, Bedford Park

7100

Centre Hospitalier de Jolimont-Lobbes, Haine-Saint-Paul

11042

Arena Oncology Associates, PC, Lake Success

13353

Charité Universitätsmedizin Berlin, Berlin

17210

Fundacao Hospital, Jaú

17475

Klinikum der Ernst-Moritz-Arndt-Universität, Greifswald

20132

Fondazione San Raffaele del Monte Tabor, Milan

20231

Instituto Nacional do Cancer, Rio de Janeiro

21401

Annapolis Oncology Center, Annapolis

29605

Cancer Center of the Carolinas, Greenville

33000

Hôpital Saint André, Service d'Oncologie Médicale, Bordeaux

34295

Centre Hospitalier Régional Universitaire Hôpital Saint Eloi, Montpellier

34298

Centre Regional de Lutte contre le Cancer Val d'Aurelle, Montpellier

35128

Instituto Oncologico Veneto, Oncologia Medica 1, Padua

37134

Centro Ricerche Cliniche di Verona, Verona

39120

Klinik der Otto-Von-Guericke-Universität Magdeburg, Magdeburg

40138

Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi, Bologna

44805

Centre René Gauducheau, Saint-Herblain

44892

Knappschaftskrankenhaus Bochum-Langendreer, Bochum

49102

Dnipropetrovsk City Multispecialty Clinical Hospital #4, Department of Chemotherapy, Dnipropetrovsk State Medical Academy, Department of Oncology and Medical Radiology, Dnipropetrovsk

53226

Medical College of Wisconsin, Milwaukee

54044

Mykolayiv Regional Oncology Center, Surgery Department #1, Mykolayiv

55407

Virginia Piper Cancer Institute, Minneapolis

60020

Ospedali Riuniti di Ancona, Torrette Di Ancona

61070

"Public Healthcare Institution Kharkiv Regional Clinical Oncology Center, Abdominal Department", Kharkiv

64109

Centre Hospitalier de la Cote Basque, Bayonne

69032

"Clinical Facility: Public Institution Zaporizhya City Clinical Hospital #3, Regional Center of Hepatic, Biliary Tract and Pancreatic Surgery, Surgery Department #1", Zaporizhya

70840

Hospital Universitario, Brasília

78229

South Texas Oncology and Hematology, PA, San Antonio

78412

Cancer Specialists of South Texas, P.A., Corpus Christi

78550

Valley Cancer Associates, Harlingen

79031

State Regional Diagnostics and Treatment Oncology Center, Chemotherapy Department, Lviv

80218

Rocky Mountain Cancer Centers, Denver

81377

Ludwig-Maximilians-Universität, Medizinische Klinik und Poliklinikversität München, München

83092

"Public Clinical Treatment and Prophylaxis Institution Donetsk Regional Antitumor Center, Oncosurgery Department #6", Donetsk

85306

Arizona Center for Hematology Oncology, Glendale

87039

Clinique François Chénieux, Limoges

87109

New Mexico Cancer Care Alliance, Albuquerque

88014

Zakarpatya Regional Clinical Oncology Center, Chemotherapy Department, Uzhhorod

89081

Medizinische Universitätsklinik Ulm, Abt. Innere Medizin I, Ulm

90020

Irmandade da Santa, Porto Alegre

90033

White Memorial Medical Center, Los Angeles

90036

Cancer Care Institute, Los Angeles

92123

Sharp Clinical Oncology Research, San Diego

92660

Newport Cancer Care Medical, Newport Beach

92879

Wilshire Oncology Medical Group, Inc., Corona

94609

Hematology Oncology Associates, Oakland

94805

Institut Gustave-Roussy - Centre de Lutte Contre le Cancer, Villejuif

97701

Bend Memorial Clinic, Bend

115478

Blokhin Cancer Research Center, Moscow

150040

Regional Clinical Oncology Hospital, Yaroslavl

194291

Leningrad Regional Clinical Hospital, Saint Petersburg

195067

Mechnikov St. Petersburg State Medical Academy, Saint Petersburg

197785

St. Petersburg City Oncology Center, Saint Petersburg

300053

Tula Regional Oncology Center, Tula

305035

Kursk Regional Oncology Center, Kursk

350040

Clinical Oncology Center #1, Krasnodar

392013

Tambov Regional Oncology Center, Tambov

426067

Republic Clinical Oncology Center, Izhevsk

620036

Sverdlovsk Regional Oncology Center, Yekaterinburg

630047

Novosibirsk, City Clinical Hospital #1, Novosibirsk

664035

Regional Oncology Center, Irkutsk

06102

Hartford Hospital Clinical Research, Hartford

06611

Oncology Associates of Bridgeport, Trumbull

08901

The Cancer Institute of New Jersey, New Brunswick

B8000FJI

Policlínica Privada Instituto de Medicina Nuclear, Buenos Aires

C1426ANZ

Instituto Especializado Alexander Fleming, Cuidad Autónoma de Buenos Aires

B1657BHD

Hospital de Gastroenterología, Loma Hermosa

X5004FHP

Clínica Universitaria Reina Fabiola, Córdoba

S3000FFU

ISIS Centro Especializado, Santa Fe

60430-230

Santa Casa de Misericordia de Belo Horizonte, Belo Horizonte

90610-000

Hospital São Lucas - PUCRS, Porto Alegre

88034-000

CEPON-Centro de pesquisas Oncologicas, Florianópolis

14784-400

Hospital do Cancer de Barretos, Barretos

09060-650

Faculdade de Medicina do ABC, Santo André

T6G 1Z2

Cross Cancer Institute, Edmonton

07740

Universitätsklinikum Jena, Jena

01307

Universitätsklinikum Carl Gustav Carus, Dresden

1081 HV

Vrije Universiteit Medisch Centrum, Amsterdam

0407

Oslo Universitetssykehus, Ullevål, Oslo

551 85

Lanssjukhuset Ryhov, Jönköping

581 85

Linköping University Hospital, Linköping

351 85

Växjö Centrallasarettet, Vaxjo

03022

National Cancer Institute, Department of Tumors of Abdominal Cavity and Retroperitoneum, Kiev

W12 0HS

Hammersmith Hospital, London

M20 4BX

Christie Hospital, Manchester

G12 0YN

Beatson West of Scotland Cancer Centre, Cancer Research UK Clinical Trials Unit (CTU), Glasgow

Sponsors
All Listed Sponsors
lead

Clovis Oncology, Inc.

INDUSTRY