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

June 24, 2024 updated by: NantCell, Inc.

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. 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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

800

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

  • 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
    • Bahia
      • Salvador, Bahia, Brazil, 40050-410
        • Research Site
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-003
        • 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
  • Czechia
      • Brno, Czechia, 656 53
        • Research Site
      • Brno, Czechia, 656 91
        • Research Site
      • Hradec Kralove, Czechia, 500 05
        • Research Site
      • Olomouc, Czechia, 775 20
        • Research Site
      • Praha 2, Czechia, 128 08
        • Research Site
      • Praha 5, Czechia, 150 06
        • Research Site
  • Denmark
      • Aalborg, Denmark, 9000
        • Research Site
      • Herlev, Denmark, 2730
        • Research Site
      • Odense, Denmark, 5000
        • Research Site
  • Finland
      • Lahti, Finland, 15850
        • Research Site
      • Tampere, Finland, 33521
        • Research Site
      • Turku, Finland, 20521
        • Research Site
  • France
      • 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
      • 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
  • 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
    • 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
  • Sweden
      • Eskilstuna, Sweden, 631 88
        • 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
    • Taipei
      • Taipei City, Taipei, Taiwan, 10002
        • 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

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

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

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Experimental: 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
Experimental: 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
Measure Description
Time Frame
Determine if the Treatment of AMG 479 at 12 mg/kg and/or 20 mg/kg in Combination With Gemcitabine Improves Overall Survival as Compared With Placebo in Combination With Gemcitabine in Subjects With Metastatic Adenocarcinoma of the Pancreas
Time Frame: From randomization up to 20 months
The primary endpoint of the study was OS, defined as the time from randomization to death.
From randomization up to 20 months

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

NantCell, Inc.

Collaborators

Takeda

Investigators

  • Principal Investigator: NantKWest Clinical Review Team, ImmunityBio, Inc.

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

Helpful Links

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 (Actual)

April 7, 2011

Primary Completion (Actual)

December 12, 2012

Study Completion (Actual)

December 12, 2012

Study Registration Dates

First Submitted

October 14, 2010

First Submitted That Met QC Criteria

October 28, 2010

First Posted (Estimated)

November 1, 2010

Study Record Updates

Last Update Posted (Actual)

July 16, 2024

Last Update Submitted That Met QC Criteria

June 24, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20060540
  • GAMMA
  • QUILT-2.014 (Other Identifier: NantCell, Inc.)

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.

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