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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
2015-001526-42
Secondary ID [2] 0 0
GS-US-296-1080
Universal Trial Number (UTN)
Trial acronym
GAMMA-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastric Adenocarcinoma 0 0
Condition category
Condition code

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

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
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
Secondary outcome [1] 0 0
Progression-free Survival (PFS)
Timepoint [1] 0 0
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
Secondary outcome [2] 0 0
Objective Response Rate (ORR)
Timepoint [2] 0 0
Up to 135.4 weeks at the time of final analysis
Secondary outcome [3] 0 0
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Timepoint [3] 0 0
First dose date up to the last dose date (maximum:161.7 weeks) plus 30 to 55 days
Secondary outcome [4] 0 0
Percentage of Participants With Clinically Relevant Treatment-emergent Laboratory Abnormalities
Timepoint [4] 0 0
First dose date up to the last dose date (maximum: 161.7 weeks) plus 30 to 55 days

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

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

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 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
13/10/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/05/2019
Sample size
Target
Accrual to date
Final
432
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC
Recruitment hospital [1] 0 0
The Canberra Hospital - Garran
Recruitment hospital [2] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [3] 0 0
The Crown Princess Mary Cancer Centre - Westmead
Recruitment hospital [4] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [5] 0 0
Ashford Cancer Centre - Kurralta Park
Recruitment hospital [6] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [7] 0 0
Epworth Healthcare - Richmond
Recruitment hospital [8] 0 0
Western Health Sunshine Hospital - St Albans
Recruitment hospital [9] 0 0
The Tweed Hospital - Tweed Heads
Recruitment hospital [10] 0 0
Sydney Adventist Hospital - Wahroonga
Recruitment postcode(s) [1] 0 0
- 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
Recruitment postcode(s) [9] 0 0
2485 - Tweed Heads
Recruitment postcode(s) [10] 0 0
- Wahroonga
Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Gilead Sciences
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT02545504
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.
Public notes

Contacts
Principal investigator
Name 0 0
Gilead Study Director
Address 0 0
Gilead Sciences
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/study/NCT02545504