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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01231347
Registration number
NCT01231347
Ethics application status
Date submitted
14/10/2010
Date registered
1/11/2010
Date last updated
16/07/2024
Titles & IDs
Public title
QUILT-2.014: Gemcitabine and AMG 479 in Metastatic Adenocarcinoma of the Pancreas
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Scientific title
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
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Secondary ID [1]
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20060540
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Secondary ID [2]
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20060540
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Universal Trial Number (UTN)
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Trial acronym
GAMMA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Adenocarcinoma of the Pancreas
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Advanced Solid Tumors
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Cancer
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Cancer of Pancreas
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Cancer of the Pancreas
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Metastases
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Metastatic Cancer
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Metastatic Pancreatic Cancer
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Pancreas Cancer
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Pancreatic Cancer
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Bone Metastases
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Endocrine Cancer
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Oncology
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Oncology Patients
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Solid Tumors
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Advanced Malignancy
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Condition category
Condition code
Cancer
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Pancreatic
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Cancer
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Other cancer types
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Metabolic and Endocrine
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Other endocrine disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - AMG 479
Treatment: Drugs - Placebo
Treatment: Drugs - AMG 479
Treatment: Drugs - gemcitabine
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
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
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
Treatment: Drugs: AMG 479
AMG 479 12 mg/kg administered intravenously on days 1 and 15 of a 28 day cycle
Treatment: Drugs: Placebo
Placebo administered intravenously on days 1 and 15 of a 28 day cycle
Treatment: Drugs: AMG 479
AMG 479 20mg/kg administered intravenously on days 1 and 15 of a 28 day cycle
Treatment: Drugs: gemcitabine
gemcitabine 1000mg/m2 administered intravenously on days 1, 8 and 15 of a 28 day cycle
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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
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Assessment method [1]
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The primary endpoint of the study was OS, defined as the time from randomization to death.
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Timepoint [1]
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From randomization up to 20 months
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Eligibility
Key inclusion criteria
* Untreated metastatic adenocarcinoma of the pancreas
* Adequate hematologic, renal and liver function
* Eastern Cooperative Oncology Group (ECOG) 0 or 1
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Prior chemotherapy or radiotherapy for pancreatic cancer
* Central nervous system metastases
* External biliary drain
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
7/04/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
12/12/2012
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Sample size
Target
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Accrual to date
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Final
800
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Research Site - Kogarah
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Research Site - South Brisbane
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Research Site - Kurralta Park
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Research Site - Woodville South
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Research Site - Bentleigh East
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Research Site - Parkville
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2217 - Kogarah
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Recruitment postcode(s) [2]
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4101 - South Brisbane
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5037 - Kurralta Park
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5011 - Woodville South
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Recruitment postcode(s) [5]
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3165 - Bentleigh East
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Recruitment postcode(s) [6]
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3050 - Parkville
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Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
NantCell, Inc.
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Address
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Other collaborator category [1]
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Commercial sector/industry
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Takeda
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Ethics approval
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/study/NCT01231347
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Trial related presentations / 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.
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Public notes
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Contacts
Principal investigator
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NantKWest Clinical Review Team
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Address
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ImmunityBio, Inc.
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/47/NCT01231347/Prot_SAP_000.pdf
Statistical analysis plan
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/47/NCT01231347/Prot_SAP_000.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01231347
Download to PDF