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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
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
Secondary ID [1] 0 0
20060540
Secondary ID [2] 0 0
20060540
Universal Trial Number (UTN)
Trial acronym
GAMMA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adenocarcinoma of the Pancreas 0 0
Advanced Solid Tumors 0 0
Cancer 0 0
Cancer of Pancreas 0 0
Cancer of the Pancreas 0 0
Metastases 0 0
Metastatic Cancer 0 0
Metastatic Pancreatic Cancer 0 0
Pancreas Cancer 0 0
Pancreatic Cancer 0 0
Bone Metastases 0 0
Endocrine Cancer 0 0
Oncology 0 0
Oncology Patients 0 0
Solid Tumors 0 0
Advanced Malignancy 0 0
Condition category
Condition code
Cancer 0 0 0 0
Pancreatic
Cancer 0 0 0 0
Other cancer types
Metabolic and Endocrine 0 0 0 0
Other endocrine disorders

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
From randomization up to 20 months

Eligibility
Key inclusion criteria
* Untreated metastatic adenocarcinoma of the pancreas
* Adequate hematologic, renal and liver function
* Eastern Cooperative Oncology Group (ECOG) 0 or 1
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior chemotherapy or radiotherapy for pancreatic cancer
* Central nervous system metastases
* External biliary drain

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/04/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/12/2012
Sample size
Target
Accrual to date
Final
800
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Research Site - Kogarah
Recruitment hospital [2] 0 0
Research Site - South Brisbane
Recruitment hospital [3] 0 0
Research Site - Kurralta Park
Recruitment hospital [4] 0 0
Research Site - Woodville South
Recruitment hospital [5] 0 0
Research Site - Bentleigh East
Recruitment hospital [6] 0 0
Research Site - Parkville
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane
Recruitment postcode(s) [3] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [4] 0 0
5011 - Woodville South
Recruitment postcode(s) [5] 0 0
3165 - Bentleigh East
Recruitment postcode(s) [6] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
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California
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United States of America
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Illinois
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Massachusetts
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Michigan
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North Carolina
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United States of America
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Oregon
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Rhode Island
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United States of America
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South Carolina
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Tennessee
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Texas
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Virginia
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United States of America
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Washington
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Austria
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Innsbruck
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Austria
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Salzburg
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Austria
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Steyr
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Austria
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Wien
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Belgium
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Bruxelles
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Belgium
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Charleroi
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Belgium
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Edegem
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Belgium
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Gent
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Belgium
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Leuven
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Belgium
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Libramont
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Brazil
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Bahia
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Brazil
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Rio Grande Do Sul
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Sofia
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Varna
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Brno
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Hradec Kralove
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Olomouc
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Praha 2
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Praha 5
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Aalborg
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Herlev
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Odense
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Finland
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Lahti
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Finland
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Tampere
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Turku
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France
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Brest cedex
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France
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Clermont Ferrand Cedex 1
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France
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Pessac Cedex
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Germany
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Berlin
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Germany
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Dresden
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Germany
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Halle (Saale)
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Mainz
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Mannheim
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Marburg
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Germany
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Villingen-Schwenningen
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Gyor
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Messina
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Napoli
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Aichi
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Vilnius
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Eindhoven
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Cluj Napoca
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Moscow
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Saint Petersburg
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Serbia
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Belgrade
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Serbia
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Sremska Kamenica
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Slovakia
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Bardejov
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Bratislava
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Kosice
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Nitra
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Poprad
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Slovenia
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Ljubljana
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Cataluña
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Comunidad Valenciana
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Madrid
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Sweden
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Eskilstuna
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Uppsala
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Switzerland
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Basel
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Winterthur
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Taipei
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Belfast
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Birmingham
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United Kingdom
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Cottingham
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Leicester
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United Kingdom
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Manchester
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United Kingdom
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Northampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
NantCell, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Takeda
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
NantKWest Clinical Review Team
Address 0 0
ImmunityBio, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01231347