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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
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) - OS was defined as the time interval from the date of randomization to death from any cause.
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) - 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.
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) - 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.
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) - 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.
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 - 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.
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Recruitment postcode(s) [2] 0 0
- Camperdown
Recruitment postcode(s) [3] 0 0
- Westmead
Recruitment postcode(s) [4] 0 0
- Brisbane
Recruitment postcode(s) [5] 0 0
- Kurralta Park
Recruitment postcode(s) [6] 0 0
- Hobart
Recruitment postcode(s) [7] 0 0
- Richmond
Recruitment postcode(s) [8] 0 0
- 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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Manchester

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/show/NCT02545504
Trial related presentations / publications
Shah et al A phase III, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of andecaliximab combined with mFOLFOX6 as first-line treatment in patients with advanced gastric or gastroesophageal junction adenocarcinoma (GAMMA-1)
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
Other publications