QUILT-2.014: Gemcitabine and AMG 479 in Metastatic Adenocarcinoma of the Pancreas

Last updated: June 24, 2024
Sponsor: NantCell, Inc.
Overall Status: Completed

Phase

3

Condition

Bone Metastases

Pancreatic Disorders

Pancreatitis

Treatment

Placebo

gemcitabine

AMG 479

Clinical Study ID

NCT01231347
20060540
GAMMA
20060540
QUILT-2.014
  • Ages > 18
  • All Genders

Study Summary

AMG 479 is an investigational fully human monoclonal antibody that targets type 1 insulin-like growth factor receptor (IGF-1R). Signaling through IGF-1R plays an important role in the regulation of cell growth and survival. The primary purpose of the study is to determine if AMG 479 and gemcitabine improves overall survival as compared to placebo and gemcitabine.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Untreated metastatic adenocarcinoma of the pancreas

  • Adequate hematologic, renal and liver function

  • Eastern Cooperative Oncology Group (ECOG) 0 or 1

Exclusion

Exclusion Criteria:

  • Prior chemotherapy or radiotherapy for pancreatic cancer

  • Central nervous system metastases

  • External biliary drain

Study Design

Total Participants: 800
Treatment Group(s): 3
Primary Treatment: Placebo
Phase: 3
Study Start date:
April 07, 2011
Estimated Completion Date:
December 12, 2012

Connect with a study center

  • Research Site

    Kogarah, New South Wales 2217
    Australia

    Site Not Available

  • Research Site

    South Brisbane, Queensland 4101
    Australia

    Site Not Available

  • Research Site

    Kurralta Park, South Australia 5037
    Australia

    Site Not Available

  • Research Site

    Woodville South, South Australia 5011
    Australia

    Site Not Available

  • Research Site

    Bentleigh East, Victoria 3165
    Australia

    Site Not Available

  • Research Site

    Parkville, Victoria 3050
    Australia

    Site Not Available

  • Research Site

    Innsbruck, 6020
    Austria

    Site Not Available

  • Research Site

    Salzburg, 5020
    Austria

    Site Not Available

  • Research Site

    Steyr, 4400
    Austria

    Site Not Available

  • Research Site

    Wien, 1090
    Austria

    Site Not Available

  • Research Site

    Bruxelles, 1070
    Belgium

    Site Not Available

  • Research Site

    Charleroi, 6000
    Belgium

    Site Not Available

  • Research Site

    Edegem, 2650
    Belgium

    Site Not Available

  • Research Site

    Gent, 9000
    Belgium

    Site Not Available

  • Research Site

    Leuven, 3000
    Belgium

    Site Not Available

  • Research Site

    Libramont, 6800
    Belgium

    Site Not Available

  • Research Site

    Salvador, Bahia 40050-410
    Brazil

    Site Not Available

  • Research Site

    Curitba, Paraná 81520-060
    Brazil

    Site Not Available

  • Research Site

    Porto Alegre, Rio Grande Do Sul 90035-003
    Brazil

    Site Not Available

  • Research Site

    ItajaÃ-, Santa Cata 88301-220
    Brazil

    Site Not Available

  • Research Site

    ItajaÃ-, Santa Catarina 88301-220
    Brazil

    Site Not Available

  • Research Site

    Itajaí, Santa Catarina 88301-220
    Brazil

    Site Not Available

  • Research Site

    São Paulo, 01246-000
    Brazil

    Site Not Available

  • Research Site

    São Paulo, 01246-000
    Brazil

    Site Not Available

  • Research Site

    Sofia, 1606
    Bulgaria

    Site Not Available

  • Research Site

    Varna, 9010
    Bulgaria

    Site Not Available

  • Research Site

    Vancouver, British Columbia V5Z 4E6
    Canada

    Site Not Available

  • Research Site

    Oshawa, Ontario L1G 2B9
    Canada

    Site Not Available

  • Research Site

    Ottawa, Ontario K1H 8L6
    Canada

    Site Not Available

  • Research Site

    Toronto, Ontario M5G 2M9
    Canada

    Site Not Available

  • Research Site

    Quebec, G1R 2J6
    Canada

    Site Not Available

  • Research Site

    Brno, 656 53
    Czech Republic

    Site Not Available

  • Research Site

    Hradec Kralove, 500 05
    Czech Republic

    Site Not Available

  • Research Site

    Olomouc, 775 20
    Czech Republic

    Site Not Available

  • Research Site

    Praha 2, 128 08
    Czech Republic

    Site Not Available

  • Research Site

    Praha 5, 150 06
    Czech Republic

    Site Not Available

  • Research Site

    Brno, 656 53
    Czechia

    Site Not Available

  • Research Site

    Hradec Kralove, 500 05
    Czechia

    Site Not Available

  • Research Site

    Olomouc, 775 20
    Czechia

    Site Not Available

  • Research Site

    Praha 2, 128 08
    Czechia

    Site Not Available

  • Research Site

    Praha 5, 150 06
    Czechia

    Site Not Available

  • Research Site

    Aalborg, 9000
    Denmark

    Site Not Available

  • Research Site

    Herlev, 2730
    Denmark

    Site Not Available

  • Research Site

    Odense, 5000
    Denmark

    Site Not Available

  • Research Site

    HUS, 00029
    Finland

    Site Not Available

  • Research Site

    Lahti, 15850
    Finland

    Site Not Available

  • Research Site

    Tampere, 33521
    Finland

    Site Not Available

  • Research Site

    Turku, 20521
    Finland

    Site Not Available

  • Research Site

    Besançon Cedex, 25030
    France

    Site Not Available

  • Research Site

    Besançon Cedex, 25030
    France

    Site Not Available

  • Research Site

    Brest cedex, 29609
    France

    Site Not Available

  • Research Site

    Clermont Ferrand Cedex 1, 63003
    France

    Site Not Available

  • Research Site

    Pessac Cedex, 33604
    France

    Site Not Available

  • Research Site

    Berlin, 13353
    Germany

    Site Not Available

  • Research Site

    Dresden, 01307
    Germany

    Site Not Available

  • Research Site

    Halle (Saale), 06120
    Germany

    Site Not Available

  • Research Site

    Mainz, 55131
    Germany

    Site Not Available

  • Research Site

    Mannheim, 68167
    Germany

    Site Not Available

  • Research Site

    Marburg, 35043
    Germany

    Site Not Available

  • Research Site

    Münster, 48149
    Germany

    Site Not Available

  • Research Site

    Münster, 48149
    Germany

    Site Not Available

  • Research Site

    Villingen-Schwenningen, 78050
    Germany

    Site Not Available

  • Research Site

    Athens, 11527
    Greece

    Site Not Available

  • Research Site

    Heraklion, 71110
    Greece

    Site Not Available

  • Research Site

    Patra, 26500
    Greece

    Site Not Available

  • Research Site

    Thessaloniki, 56429
    Greece

    Site Not Available

  • Research Site

    Kowloon,
    Hong Kong

    Site Not Available

  • Research Site

    Sha Tin,
    Hong Kong

    Site Not Available

  • Research Site

    Tuen Mun,
    Hong Kong

    Site Not Available

  • Research Site

    Budapest, 1062
    Hungary

    Site Not Available

  • Research Site

    Debrecen, 4012
    Hungary

    Site Not Available

  • Research Site

    Gyor, 9023
    Hungary

    Site Not Available

  • Research Site

    Miskolc, 3526
    Hungary

    Site Not Available

  • Research Site

    Genova, 16132
    Italy

    Site Not Available

  • Research Site

    Messina, 98125
    Italy

    Site Not Available

  • Research Site

    Napoli, 80131
    Italy

    Site Not Available

  • Research Site

    San Giovanni Rotondo (FG),
    Italy

    Site Not Available

  • Research Site

    San Giovanni Rotondo FG, 71013
    Italy

    Site Not Available

  • Research Site

    Nagoya-city, Aichi 464-8681
    Japan

    Site Not Available

  • Research Site

    Kashiwa, Chiba 277-8577
    Japan

    Site Not Available

  • Research Site

    Yokohama-city, Kanagawa 241-0815
    Japan

    Site Not Available

  • Research Site

    Sunto-gun, Shizuoka 411-8777
    Japan

    Site Not Available

  • Research Site

    Mitaka-city, Tokyo 181-8611
    Japan

    Site Not Available

  • Research Site

    Tokyo, 104-0045
    Japan

    Site Not Available

  • Research Site

    Seoul, 110-744
    Korea, Republic of

    Site Not Available

  • Research Site

    Kaunas, 50009
    Lithuania

    Site Not Available

  • Research Site

    Vilnius, 08660
    Lithuania

    Site Not Available

  • Research Site

    Amsterdam, 1081 HV
    Netherlands

    Site Not Available

  • Research Site

    Eindhoven, 5623 EJ
    Netherlands

    Site Not Available

  • Research Site

    Groningen, 9713 GZ
    Netherlands

    Site Not Available

  • Research Site

    Leiden, 2333 ZA
    Netherlands

    Site Not Available

  • Research Site

    Gdansk, 80-952
    Poland

    Site Not Available

  • Research Site

    Konin, 62-500
    Poland

    Site Not Available

  • Research Site

    Lodz, 93-509
    Poland

    Site Not Available

  • Research Site

    Poznan, 61-485
    Poland

    Site Not Available

  • Research Site

    Warszawa, 04-125
    Poland

    Site Not Available

  • Research Site

    Barreiro, 2830-094
    Portugal

    Site Not Available

  • Research Site

    Lisboa, 1649-035
    Portugal

    Site Not Available

  • Research Site

    Porto, 4200-072
    Portugal

    Site Not Available

  • Research Site

    Bucharest, 022328
    Romania

    Site Not Available

  • Research Site

    Cluj Napoca, 400015
    Romania

    Site Not Available

  • Research Site

    Cluj-Napoca, 400015
    Romania

    Site Not Available

  • Research Site

    Sibiu, 550245
    Romania

    Site Not Available

  • Research Site

    Chelyabinsk, 454076
    Russian Federation

    Site Not Available

  • Research Site

    Moscow, 119992
    Russian Federation

    Site Not Available

  • Research Site

    Saint Petersburg, 191104
    Russian Federation

    Site Not Available

  • Research Site

    Samara,
    Russian Federation

    Site Not Available

  • Research Site

    Belgrade, 11080
    Serbia

    Site Not Available

  • Research Site

    Sremska Kamenica, 21204
    Serbia

    Site Not Available

  • Research Site

    Bardejov, 085 01
    Slovakia

    Site Not Available

  • Research Site

    Bratislava, 833 10
    Slovakia

    Site Not Available

  • Research Site

    Kosice, 041 91
    Slovakia

    Site Not Available

  • Research Site

    Nitra, 950 01
    Slovakia

    Site Not Available

  • Research Site

    Poprad, 058 01
    Slovakia

    Site Not Available

  • Research Site

    Ljubljana, 1000
    Slovenia

    Site Not Available

  • Research Site

    Santander, Cantabria 39008
    Spain

    Site Not Available

  • Research Site

    Badalona, Cataluña 08916
    Spain

    Site Not Available

  • Research Site

    Barcelona, Cataluña 08035
    Spain

    Site Not Available

  • Research Site

    Elche, Comunidad Valenciana 03203
    Spain

    Site Not Available

  • Research Site

    Valencia, Comunidad Valenciana 46010
    Spain

    Site Not Available

  • Research Site

    A Coruña, Galicia 15006
    Spain

    Site Not Available

  • Research Site

    A Coruña, Galicia 15006
    Spain

    Site Not Available

  • Research Site

    Madrid, 28034
    Spain

    Site Not Available

  • Research Site

    Eskilstuna, 631 88
    Sweden

    Site Not Available

  • Research Site

    Falun,
    Sweden

    Site Not Available

  • Research Site

    Linköping, 581 85
    Sweden

    Site Not Available

  • Research Site

    Linköping, 581 85
    Sweden

    Site Not Available

  • Research Site

    Uppsala, 751 85
    Sweden

    Site Not Available

  • Research Site

    Basel, 4031
    Switzerland

    Site Not Available

  • Research Site

    Geneva 14, 1211
    Switzerland

    Site Not Available

  • Research Site

    Winterthur, 8401
    Switzerland

    Site Not Available

  • Research Site

    Niaosong Township, Kaohsiung 83301
    Taiwan

    Site Not Available

  • Research Site

    Taipei City, Taipei 10002
    Taiwan

    Site Not Available

  • Research Site

    Gueishan Township, Taoyuan 33305
    Taiwan

    Site Not Available

  • Research Site

    Belfast, BT9 7AB
    United Kingdom

    Site Not Available

  • Research Site

    Birmingham, B9 5SS
    United Kingdom

    Site Not Available

  • Research Site

    Cottingham, HU16 5JQ
    United Kingdom

    Site Not Available

  • Research Site

    Hull,
    United Kingdom

    Site Not Available

  • Research Site

    Leicester, LE1 5WW
    United Kingdom

    Site Not Available

  • Research Site

    Manchester, M20 4BX
    United Kingdom

    Site Not Available

  • Research Site

    Northampton, NN1 5BD
    United Kingdom

    Site Not Available

  • Research Site

    Fullerton, California 92835
    United States

    Site Not Available

  • Research Site

    La Jolla, California 92093-0957
    United States

    Site Not Available

  • Research Site

    Los Angeles, California 90095
    United States

    Site Not Available

  • Research Site

    Rancho Mirage, California 92270
    United States

    Site Not Available

  • Research Site

    Redondo Beach, California 90277
    United States

    Site Not Available

  • Research Site

    Santa Maria, California 93454
    United States

    Site Not Available

  • Research Site

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Research Site

    Harvey, Illinois 60426
    United States

    Site Not Available

  • Research Site

    Quincy, Illinois 62301
    United States

    Site Not Available

  • Research Site

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Research Site

    Detroit, Michigan 48201
    United States

    Site Not Available

  • Research Site

    Grand Rapids, Michigan 49503
    United States

    Site Not Available

  • Research Site

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Research Site

    Bend, Oregon 97701
    United States

    Site Not Available

  • Research Site

    Providence, Rhode Island 02906
    United States

    Site Not Available

  • Research Site

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Research Site

    Knoxville, Tennessee 37909
    United States

    Site Not Available

  • Research Site

    Fort Worth, Texas 76177
    United States

    Site Not Available

  • Research Site

    Paris, Texas 75460-5004
    United States

    Site Not Available

  • Research Site

    Abingdon, Virginia 24211
    United States

    Site Not Available

  • Research Site

    Spokane Valley, Washington 99216
    United States

    Site Not Available

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