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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/NCT02545504
Registration number
NCT02545504
Ethics application status
Date submitted
8/09/2015
Date registered
10/09/2015
Date last updated
26/05/2020
Titles & IDs
Public title
Andecaliximab With mFOLFOX6 as First Line Treatment for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
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Scientific title
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GS-5745 Combined With mFOLFOX6 as First Line Treatment in Patients With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
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Secondary ID [1]
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2015-001526-42
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Secondary ID [2]
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GS-US-296-1080
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Universal Trial Number (UTN)
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Trial acronym
GAMMA-1
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Gastric Adenocarcinoma
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Andecaliximab
Treatment: Drugs - Placebo
Treatment: Drugs - Leucovorin
Treatment: Drugs - 5-fluorouracil
Treatment: Drugs - Oxaliplatin
Experimental: Andecaliximab - Andecaliximab plus mFOLFOX6 (LV+5-FU+OXA) during Cycles 1-6, followed by andecaliximab plus LV+5-FU during subsequent cycles
Placebo Comparator: Placebo - Placebo plus mFOLFOX6 (LV+5-FU+OXA) during Cycles 1-6, followed by placebo plus LV+5-FU during subsequent cycles
Treatment: Drugs: Andecaliximab
800 mg administered intravenously on Days 1 and 15 of each 28-day treatment cycle
Treatment: Drugs: Placebo
Administered intravenously on Days 1 and 15 of each treatment cycle
Treatment: Drugs: Leucovorin
Administered intravenously per standard of care on Days 1 and 15 of each treatment cycle
Treatment: Drugs: 5-fluorouracil
Administered intravenously per standard of care on Days 1 and 15 of each treatment cycle
Treatment: Drugs: Oxaliplatin
Administered intravenously per standard of care on Days 1 and 15 of each treatment 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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Overall Survival (OS)
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Assessment method [1]
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OS was defined as the time interval from the date of randomization to death from any cause.
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Timepoint [1]
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Andecaliximab + mFOLFOX6 median follow-up at the time of final analysis: 19.43 months; Placebo + mFOLFOX6 median follow-up at the time of the final analysis: 19.45 months
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Secondary outcome [1]
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Progression-free Survival (PFS)
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Assessment method [1]
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PFS was defined as the interval of time from the date of randomization to the earlier of the first documentation of definitive disease progression or death from any cause.
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Timepoint [1]
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Andecaliximab + mFOLFOX6 median follow-up at the time of the final analysis: 18.64 months; Placebo + mFOLFOX6 median follow-up at the time of the final analysis: 18.74 months
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Secondary outcome [2]
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Objective Response Rate (ORR)
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Assessment method [2]
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ORR was defined as the percentage of participants who achieve a complete response (CR) or partial response (PR) as assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. CR was defined as the disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
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Timepoint [2]
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Up to 135.4 weeks at the time of final analysis
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Secondary outcome [3]
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Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
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Assessment method [3]
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An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal product, which does not necessarily have a causal relationship with the treatment. TEAEs are events in a given study period that meet any of the following criteria: Any AE with onset date of on or after andecalizimab/placebo start date and no later than 30 days after permanent discontinuation of all study treatment (andecaliximab/placebo and chemotherapy) or Any AEs with onset date of on or after the andecaliximab/placebo start date and no later than 55 days after permanent discontinuation of andecaliximab/placebo or AEs leading to discontinuation of andecaliximab/placebo.
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Timepoint [3]
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First dose date up to the last dose date (maximum:161.7 weeks) plus 30 to 55 days
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Secondary outcome [4]
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Percentage of Participants With Clinically Relevant Treatment-emergent Laboratory Abnormalities
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Assessment method [4]
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Treatment-emergent laboratory abnormalities were graded per Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03 where 0=None, 1=Mild, 2=Moderate, 3=Severe, 4=Potentially Life Threatening. Treatment-emergent laboratory abnormalities are defined as values that increase at least 1 toxicity grade from baseline at any post-baseline time point, up to 30 days after the last dose of all study treatment, or 55 days after the last dose of andecaliximab/placebo for participants who permanently discontinued all study treatments. If the relevant baseline laboratory value is missing, then any abnormality of at least Grade 1 was considered treatment-emergent.
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Timepoint [4]
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First dose date up to the last dose date (maximum: 161.7 weeks) plus 30 to 55 days
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Eligibility
Key inclusion criteria
Key
- Adults with histologically confirmed adenocarcinoma of the stomach or gastroesophageal
junction that is inoperable, locally advanced or metastatic and not amenable to
curative therapy
- Adequate hematologic, liver, coagulation and kidney function
- Eastern Cooperative Oncology Group (ECOG) = 1
- Evaluable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1
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Minimum age
18
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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
- Previous chemotherapy for locally advanced or metastatic gastric cancer.
- Human Epidermal Growth Factor Receptor 2 (HER2)-positive gastric cancer
- HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV) infection
- Pregnant or breast feeding women
- Individuals with known or suspected central nervous system metastases or individuals
requiring chronic daily treatment with oral corticosteroids
- Grade = 2 peripheral neuropathy
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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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 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
13/10/2015
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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
15/05/2019
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Sample size
Target
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Accrual to date
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Final
432
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC
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Recruitment hospital [1]
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The Canberra Hospital - Garran
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Chris O'Brien Lifehouse - Camperdown
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The Crown Princess Mary Cancer Centre - Westmead
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Princess Alexandra Hospital - Brisbane
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Ashford Cancer Centre - Kurralta Park
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Royal Hobart Hospital - Hobart
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Epworth Healthcare - Richmond
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Western Health Sunshine Hospital - St Albans
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The Tweed Hospital - Tweed Heads
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Sydney Adventist Hospital - Wahroonga
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- Garran
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- Camperdown
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- Westmead
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- Brisbane
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- Kurralta Park
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- Hobart
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- Richmond
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- St Albans
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2485 - Tweed Heads
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- Wahroonga
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Gilead Sciences
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Ethics approval
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Summary
Brief summary
The primary objective of this study is to compare the efficacy of andecaliximab (GS-5745)
versus placebo in combination with modified fluorouracil (5-FU), leucovorin (LV), and
oxaliplatin (OXA) (mFOLFOX6) as measured by overall survival.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02545504
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Trial related presentations / publications
Shah MA, Bodoky G, Starodub A, Cunningham D, Yip D, Wainberg ZA, Bendell J, Thai D, He J, Bhargava P, Ajani JA. Phase III Study to Evaluate Efficacy and Safety of Andecaliximab With mFOLFOX6 as First-Line Treatment in Patients With Advanced Gastric or GEJ Adenocarcinoma (GAMMA-1). J Clin Oncol. 2021 Mar 20;39(9):990-1000. doi: 10.1200/JCO.20.02755. Epub 2021 Feb 12.
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Public notes
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Contacts
Principal investigator
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Gilead Study Director
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Gilead Sciences
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02545504
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