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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01231347




Registration number
NCT01231347
Ethics application status
Date submitted
14/10/2010
Date registered
1/11/2010
Date last updated
27/10/2016

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

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

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

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


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
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
Timepoint [1] 0 0
After 825 subjects randomized + 24 months
Secondary outcome [1] 0 0
Progression free survival
Timepoint [1] 0 0
After 825 subjects randomized + 24 months
Secondary outcome [2] 0 0
Objective response rate
Timepoint [2] 0 0
After 825 subjects randomized + 24 months
Secondary outcome [3] 0 0
Time to disease progression
Timepoint [3] 0 0
After 825 subjects randomized + 24 months
Secondary outcome [4] 0 0
Disease control rate
Timepoint [4] 0 0
After 825 subjects randomized + 24 months
Secondary outcome [5] 0 0
Number of subjects with adverse events
Timepoint [5] 0 0
After 825 subjects randomized + 24 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
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2012
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
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United States of America
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Steyr
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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
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01231347
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.
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01231347