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

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled, Trial of AMG 479 or Placebo in Combination With Gemcitabine as First Line Therapy for Metastatic Adenocarcinoma of the Pancreas

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.

Gemcitabine is administered on days 1, 8 and 15 of a 28 day cycle, AMG 479 or placebo is administered on days 1 and 15 of the 28 day cycle, both are administered intravenously.

The primary purpose of the study is to determine if AMG 479 and gemcitabine improves overall survival as compared to placebo and gemcitabine.

Study Overview

• Status: Terminated
• Conditions: Cancer; Pancreatic Cancer; Advanced Solid Tumors; Metastatic Cancer; Bone Metastases; Solid Tumors; Pancreas Cancer; Adenocarcinoma of the Pancreas; Oncology; Cancer of Pancreas; Metastatic Pancreatic Cancer; Metastases; Cancer of the Pancreas; Advanced Malignancy; Oncology Patients; Endocrine Cancer
• Intervention / Treatment: Drug: AMG 479; Drug: AMG 479; Drug: gemcitabine; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 800
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Kogarah, New South Wales, Australia, 2217
      • Research Site
  • Queensland
    • South Brisbane, Queensland, Australia, 4101
      • Research Site
  • South Australia
    • Kurralta Park, South Australia, Australia, 5037
      • Research Site
    • Woodville South, South Australia, Australia, 5011
      • Research Site
  • Victoria
    • Bentleigh East, Victoria, Australia, 3165
      • Research Site
    • Parkville, Victoria, Australia, 3050
      • Research Site
• Austria
  • Innsbruck, Austria, 6020
    • Research Site
  • Salzburg, Austria, 5020
    • Research Site
  • Steyr, Austria, 4400
    • Research Site
  • Wien, Austria, 1090
    • Research Site
• Belgium
  • Bruxelles, Belgium, 1070
    • Research Site
  • Charleroi, Belgium, 6000
    • Research Site
  • Edegem, Belgium, 2650
    • Research Site
  • Gent, Belgium, 9000
    • Research Site
  • Leuven, Belgium, 3000
    • Research Site
  • Libramont, Belgium, 6800
    • Research Site
• Brazil
  • São Paulo, Brazil, 01246-000
    • Research Site
  • Bahia
    • Salvador, Bahia, Brazil, 40050-410
      • Research Site
  • Paraná
    • Curitba, Paraná, Brazil, 81520-060
      • Research Site
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90035-003
      • Research Site
  • Santa Catarina
    • ItajaÃ-, Santa Catarina, Brazil, 88301-220
      • Research Site
• Bulgaria
  • Sofia, Bulgaria, 1527
    • Research Site
  • Sofia, Bulgaria, 1756
    • Research Site
  • Sofia, Bulgaria, 1606
    • Research Site
  • Varna, Bulgaria, 9010
    • Research Site
• Canada
  • Quebec, Canada, G1R 2J6
    • Research Site
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E6
      • Research Site
  • Ontario
    • Oshawa, Ontario, Canada, L1G 2B9
      • Research Site
    • Ottawa, Ontario, Canada, K1H 8L6
      • Research Site
    • Toronto, Ontario, Canada, M5G 2M9
      • Research Site
• Czech Republic
  • Brno, Czech Republic, 656 53
    • Research Site
  • Brno, Czech Republic, 656 91
    • Research Site
  • Hradec Kralove, Czech Republic, 500 05
    • Research Site
  • Olomouc, Czech Republic, 775 20
    • Research Site
  • Praha 2, Czech Republic, 128 08
    • Research Site
  • Praha 5, Czech Republic, 150 06
    • Research Site
• Denmark
  • Aalborg, Denmark, 9000
    • Research Site
  • Herlev, Denmark, 2730
    • Research Site
  • Odense, Denmark, 5000
    • Research Site
• Finland
  • HUS, Finland, 00029
    • Research Site
  • Lahti, Finland, 15850
    • Research Site
  • Tampere, Finland, 33521
    • Research Site
  • Turku, Finland, 20521
    • Research Site
• France
  • Besançon Cedex, France, 25030
    • Research Site
  • Brest cedex, France, 29609
    • Research Site
  • Clermont Ferrand Cedex 1, France, 63003
    • Research Site
  • Pessac Cedex, France, 33604
    • Research Site
• Germany
  • Berlin, Germany, 13353
    • Research Site
  • Dresden, Germany, 01307
    • Research Site
  • Halle (Saale), Germany, 06120
    • Research Site
  • Mainz, Germany, 55131
    • Research Site
  • Mannheim, Germany, 68167
    • Research Site
  • Marburg, Germany, 35043
    • Research Site
  • Münster, Germany, 48149
    • Research Site
  • Villingen-Schwenningen, Germany, 78050
    • Research Site
• Greece
  • Athens, Greece, 11527
    • Research Site
  • Heraklion, Greece, 71110
    • Research Site
  • Patra, Greece, 26500
    • Research Site
  • Thessaloniki, Greece, 56429
    • Research Site
• Hong Kong
  • Kowloon, Hong Kong
    • Research Site
  • Sha Tin, Hong Kong
    • Research Site
  • Tuen Mun, Hong Kong
    • Research Site
• Hungary
  • Budapest, Hungary, 1062
    • Research Site
  • Budapest, Hungary, 1097
    • Research Site
  • Debrecen, Hungary, 4012
    • Research Site
  • Gyor, Hungary, 9023
    • Research Site
  • Miskolc, Hungary, 3526
    • Research Site
• Italy
  • Genova, Italy, 16132
    • Research Site
  • Messina, Italy, 98125
    • Research Site
  • Napoli, Italy, 80131
    • Research Site
  • San Giovanni Rotondo FG, Italy, 71013
    • Research Site
• Japan
  • Tokyo, Japan, 104-0045
    • Research Site
  • Aichi
    • Nagoya-city, Aichi, Japan, 464-8681
      • Research Site
  • Chiba
    • Kashiwa, Chiba, Japan, 277-8577
      • Research Site
  • Kanagawa
    • Yokohama-city, Kanagawa, Japan, 241-0815
      • Research Site
  • Shizuoka
    • Sunto-gun, Shizuoka, Japan, 411-8777
      • Research Site
  • Tokyo
    • Mitaka-city, Tokyo, Japan, 181-8611
      • Research Site
• Korea, Republic of
  • Seoul, Korea, Republic of, 135-710
    • Research Site
  • Seoul, Korea, Republic of, 120-752
    • Research Site
  • Seoul, Korea, Republic of, 138-736
    • Research Site
  • Seoul, Korea, Republic of, 110-744
    • Research Site
  • Seoul, Korea, Republic of, 152-703
    • Research Site
• Lithuania
  • Kaunas, Lithuania, 50009
    • Research Site
  • Vilnius, Lithuania, 08660
    • Research Site
• Netherlands
  • Amsterdam, Netherlands, 1081 HV
    • Research Site
  • Eindhoven, Netherlands, 5623 EJ
    • Research Site
  • Groningen, Netherlands, 9713 GZ
    • Research Site
  • Leiden, Netherlands, 2333 ZA
    • Research Site
• Poland
  • Gdansk, Poland, 80-952
    • Research Site
  • Konin, Poland, 62-500
    • Research Site
  • Lodz, Poland, 93-509
    • Research Site
  • Poznan, Poland, 61-485
    • Research Site
  • Warszawa, Poland, 04-141
    • Research Site
  • Warszawa, Poland, 02-097
    • Research Site
  • Warszawa, Poland, 04-125
    • Research Site
• Portugal
  • Barreiro, Portugal, 2830-094
    • Research Site
  • Lisboa, Portugal, 1649-035
    • Research Site
  • Lisboa, Portugal, 1099-023
    • Research Site
  • Porto, Portugal, 4200-319
    • Research Site
  • Porto, Portugal, 4200-072
    • Research Site
• Romania
  • Bucharest, Romania, 022328
    • Research Site
  • Cluj Napoca, Romania, 400015
    • Research Site
  • Cluj-Napoca, Romania, 400015
    • Research Site
  • Sibiu, Romania, 550245
    • Research Site
• Russian Federation
  • Moscow, Russian Federation, 115478
    • Research Site
  • Moscow, Russian Federation, 119992
    • Research Site
  • Saint Petersburg, Russian Federation, 191104
    • Research Site
• Serbia
  • Belgrade, Serbia, 11000
    • Research Site
  • Belgrade, Serbia, 11080
    • Research Site
  • Sremska Kamenica, Serbia, 21204
    • Research Site
• Slovakia
  • Bardejov, Slovakia, 085 01
    • Research Site
  • Bratislava, Slovakia, 833 10
    • Research Site
  • Kosice, Slovakia, 041 91
    • Research Site
  • Nitra, Slovakia, 950 01
    • Research Site
  • Poprad, Slovakia, 058 01
    • Research Site
• Slovenia
  • Ljubljana, Slovenia, 1000
    • Research Site
  • Ljubljana, Slovenia, 1525
    • Research Site
• Spain
  • Madrid, Spain, 28034
    • Research Site
  • Madrid, Spain, 28050
    • Research Site
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Research Site
  • Cataluña
    • Badalona, Cataluña, Spain, 08916
      • Research Site
    • Barcelona, Cataluña, Spain, 08035
      • Research Site
    • Barcelona, Cataluña, Spain, 08036
      • Research Site
  • Comunidad Valenciana
    • Elche, Comunidad Valenciana, Spain, 03203
      • Research Site
    • Valencia, Comunidad Valenciana, Spain, 46010
      • Research Site
  • Galicia
    • A Coruña, Galicia, Spain, 15006
      • Research Site
• Sweden
  • Eskilstuna, Sweden, 631 88
    • Research Site
  • Linköping, Sweden, 581 85
    • Research Site
  • Uppsala, Sweden, 751 85
    • Research Site
• Switzerland
  • Basel, Switzerland, 4031
    • Research Site
  • Geneva 14, Switzerland, 1211
    • Research Site
  • Winterthur, Switzerland, 8401
    • Research Site
• Taiwan
  • Kaohsiung
    • Niaosong Township, Kaohsiung, Taiwan, 83301
      • Research Site
  • Taipei
    • Taipei City, Taipei, Taiwan, 10002
      • Research Site
  • Taoyuan
    • Gueishan Township, Taoyuan, Taiwan, 33305
      • Research Site
• United Kingdom
  • Belfast, United Kingdom, BT9 7AB
    • Research Site
  • Birmingham, United Kingdom, B9 5SS
    • Research Site
  • Cottingham, United Kingdom, HU16 5JQ
    • Research Site
  • Leicester, United Kingdom, LE1 5WW
    • Research Site
  • Manchester, United Kingdom, M20 4BX
    • Research Site
  • Northampton, United Kingdom, NN1 5BD
    • Research Site
• United States
  • California
    • Fullerton, California, United States, 92835
      • Research Site
    • La Jolla, California, United States, 92093-0957
      • Research Site
    • Los Angeles, California, United States, 90095
      • Research Site
    • Los Angeles, California, United States, 90095-1772
      • Research Site
    • Rancho Mirage, California, United States, 92270
      • Research Site
    • Redondo Beach, California, United States, 90277
      • Research Site
    • Santa Maria, California, United States, 93454
      • Research Site
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Research Site
    • Harvey, Illinois, United States, 60426
      • Research Site
    • Quincy, Illinois, United States, 62301
      • Research Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Research Site
    • Boston, Massachusetts, United States, 02215
      • Research Site
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Research Site
    • Grand Rapids, Michigan, United States, 49503
      • Research Site
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Research Site
  • Oregon
    • Bend, Oregon, United States, 97701
      • Research Site
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Research Site
    • Providence, Rhode Island, United States, 02906
      • Research Site
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Research Site
  • Tennessee
    • Knoxville, Tennessee, United States, 37909
      • Research Site
  • Texas
    • Fort Worth, Texas, United States, 76177
      • Research Site
    • Paris, Texas, United States, 75460-5004
      • Research Site
  • Virginia
    • Abingdon, Virginia, United States, 24211
      • Research Site
  • Washington
    • Spokane Valley, Washington, United States, 99216
      • Research Site

Participation Criteria

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:

• Untreated metastatic adenocarcinoma of the pancreas
• Adequate hematologic, renal and liver function
• Eastern Cooperative Oncology Group (ECOG) 0 or 1

Exclusion Criteria:

• Prior chemotherapy or radiotherapy for pancreatic cancer
• Central nervous system metastases
• External biliary drain

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: AMG 479 12 mg/kg dose + gemcitabine; Arm 2: AMG 479 12 mg/kg IV days 1 and 15 plus gemcitabine 1000 mg/m2 IV days 1, 8, and 15 of a 28 day cycle	Drug: AMG 479; AMG 479 12 mg/kg administered intravenously on days 1 and 15 of a 28 day cycle; Drug: AMG 479; AMG 479 20mg/kg administered intravenously on days 1 and 15 of a 28 day cycle; Drug: gemcitabine; gemcitabine 1000mg/m2 administered intravenously on days 1, 8 and 15 of a 28 day cycle; Other Names: Gemzar
Placebo Comparator: Placebo + gemcitabine; Arm 1: AMG 479-placebo IV days 1 and 15 plus gemcitabine 1000 mg/m2 IV days 1, 8, and 15 of a 28 day cycle	Drug: gemcitabine; gemcitabine 1000mg/m2 administered intravenously on days 1, 8 and 15 of a 28 day cycle; Other Names: Gemzar; Drug: Placebo; Placebo administered intravenously on days 1 and 15 of a 28 day cycle
Active Comparator: AMG 479 20 mg/kg + gemcitabine; Arm 3: AMG 479 20 mg/kg IV days 1 and 15 plus gemcitabine 1000 mg/m2 IV days 1, 8, and 15 of a 28 day cycle	Drug: AMG 479; AMG 479 12 mg/kg administered intravenously on days 1 and 15 of a 28 day cycle; Drug: AMG 479; AMG 479 20mg/kg administered intravenously on days 1 and 15 of a 28 day cycle; Drug: gemcitabine; gemcitabine 1000mg/m2 administered intravenously on days 1, 8 and 15 of a 28 day cycle; Other Names: Gemzar

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To determine if AMG 479 in combination with gemcitabine improves overall survival as compared with placebo in combination with gemcitabine in subjects with metastatic adenocarcinoma of the pancreas	After 825 subjects randomized + 24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Progression free survival	After 825 subjects randomized + 24 months
Objective response rate	After 825 subjects randomized + 24 months
Time to disease progression	After 825 subjects randomized + 24 months
Disease control rate	After 825 subjects randomized + 24 months
Number of subjects with adverse events	After 825 subjects randomized + 24 months

Collaborators and Investigators

• Sponsor: NantCell, Inc.
• Collaborators: Takeda

Publications and helpful links

General Publications

• Fuchs CS, Azevedo S, Okusaka T, Van Laethem JL, Lipton LR, Riess H, Szczylik C, Moore MJ, Peeters M, Bodoky G, Ikeda M, Melichar B, Nemecek R, Ohkawa S, Swieboda-Sadlej A, Tjulandin SA, Van Cutsem E, Loberg R, Haddad V, Gansert JL, Bach BA, Carrato A. A phase 3 randomized, double-blind, placebo-controlled trial of ganitumab or placebo in combination with gemcitabine as first-line therapy for metastatic adenocarcinoma of the pancreas: the GAMMA trial. Ann Oncol. 2015 May;26(5):921-927. doi: 10.1093/annonc/mdv027. Epub 2015 Jan 21.

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: October 14, 2010
• First Submitted That Met QC Criteria: October 28, 2010
• First Posted (Estimate): November 1, 2010

Study Record Updates

• Last Update Posted (Estimate): October 27, 2016
• Last Update Submitted That Met QC Criteria: October 26, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: pancreas; metastatic; gemcitabine; jaundice
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms by Histologic Type; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Digestive System Neoplasms; Neoplastic Processes; Pancreatic Diseases; Neoplasms; Neoplasm Metastasis; Adenocarcinoma; Pancreatic Neoplasms; Endocrine Gland Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Gemcitabine; Antibodies, Monoclonal
• Other Study ID Numbers: 20060540; GAMMA; QUILT-2.014 (Other Identifier: NantCell, Inc.)