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Andecaliximab With mFOLFOX6 as First Line Treatment for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (GAMMA-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02545504
Recruitment Status : Completed
First Posted : September 10, 2015
Results First Posted : April 28, 2020
Last Update Posted : April 28, 2020
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

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.

Condition or disease Intervention/treatment Phase
Gastric Adenocarcinoma Drug: Andecaliximab Drug: Placebo Drug: Leucovorin Drug: 5-fluorouracil Drug: Oxaliplatin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 432 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : October 13, 2015
Actual Primary Completion Date : May 15, 2019
Actual Study Completion Date : May 15, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Andecaliximab
Andecaliximab plus mFOLFOX6 (LV+5-FU+OXA) during Cycles 1-6, followed by andecaliximab plus LV+5-FU during subsequent cycles
Drug: Andecaliximab
800 mg administered intravenously on Days 1 and 15 of each 28-day treatment cycle
Other Name: GS-5745

Drug: Leucovorin
Administered intravenously per standard of care on Days 1 and 15 of each treatment cycle
Other Name: LV

Drug: 5-fluorouracil
Administered intravenously per standard of care on Days 1 and 15 of each treatment cycle
Other Name: 5-FU

Drug: Oxaliplatin
Administered intravenously per standard of care on Days 1 and 15 of each treatment cycle
Other Name: OXA

Placebo Comparator: Placebo
Placebo plus mFOLFOX6 (LV+5-FU+OXA) during Cycles 1-6, followed by placebo plus LV+5-FU during subsequent cycles
Drug: Placebo
Administered intravenously on Days 1 and 15 of each treatment cycle

Drug: Leucovorin
Administered intravenously per standard of care on Days 1 and 15 of each treatment cycle
Other Name: LV

Drug: 5-fluorouracil
Administered intravenously per standard of care on Days 1 and 15 of each treatment cycle
Other Name: 5-FU

Drug: Oxaliplatin
Administered intravenously per standard of care on Days 1 and 15 of each treatment cycle
Other Name: OXA




Primary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: 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 ]
    OS was defined as the time interval from the date of randomization to death from any cause.


Secondary Outcome Measures :
  1. Progression-free Survival (PFS) [ Time Frame: 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 ]
    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.

  2. Objective Response Rate (ORR) [ Time Frame: Up to 135.4 weeks at the time of final analysis ]
    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.

  3. Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) [ Time Frame: First dose date up to the last dose date (maximum:161.7 weeks) plus 30 to 55 days ]
    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.

  4. Percentage of Participants With Clinically Relevant Treatment-emergent Laboratory Abnormalities [ Time Frame: First dose date up to the last dose date (maximum: 161.7 weeks) plus 30 to 55 days ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • 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 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02545504


Locations
Show Show 134 study locations
Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences
  Study Documents (Full-Text)

Documents provided by Gilead Sciences:
Study Protocol  [PDF] March 6, 2017
Statistical Analysis Plan  [PDF] October 3, 2018


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)

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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02545504    
Other Study ID Numbers: GS-US-296-1080
2015-001526-42 ( EudraCT Number )
First Posted: September 10, 2015    Key Record Dates
Results First Posted: April 28, 2020
Last Update Posted: April 28, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gilead Sciences:
Gastroesophageal junction (GEJ)
Stomach cancer
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Leucovorin
Fluorouracil
Oxaliplatin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antidotes
Protective Agents
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances