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Trial record 1 of 1 for:    GS-US-296-1080
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Andecaliximab With mFOLFOX6 as First Line Treatment for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (GAMMA-1)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT02545504
First received: September 8, 2015
Last updated: June 7, 2017
Last verified: June 2017
  Purpose
The primary objective of this study is to compare the efficacy of andecaliximab (formerly GS-5745) versus placebo in combination with modified fluorouracil (5-FU), leucovorin (LV), and oxaliplatin (OXA) (mFOLFOX6) as measured by overall survival.

Condition Intervention Phase
Gastric Adenocarcinoma Drug: Andecaliximab Drug: Placebo Drug: Leucovorin Drug: 5-fluorouracil Drug: Oxaliplatin Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Overall survival [ Time Frame: Up to 8 years ]
    Overall survival is defined as the interval from the date of randomization to death from any cause.


Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: Up to 8 years ]
    Progression-free survival (PFS) is defined as the interval from the date of randomization to the earlier of the first documentation of definitive disease progression or death from any cause.

  • Objective response rate [ Time Frame: Up to 8 years ]
    The objective response rate (ORR) is defined as the proportion of subjects who achieve a complete response (CR) or partial response (PR) as assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.

  • Overall safety profile of GS-5745, including incidence of adverse events and clinically relevant changes in laboratory values and vital signs. [ Time Frame: Up to 8 years ]

Enrollment: 432
Actual Study Start Date: October 13, 2015
Estimated Study Completion Date: December 2023
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Cycles 1 to 6
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 Cycles 1 to 6
Other Name: OXA

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02545504

  Show 132 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Gilead Study Director Gilead Sciences
  More Information

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02545504     History of Changes
Other Study ID Numbers: GS-US-296-1080
2015-001526-42 ( EudraCT Number )
Study First Received: September 8, 2015
Last Updated: June 7, 2017

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:
Adenocarcinoma
Esophageal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Oxaliplatin
Fluorouracil
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 21, 2017