Andecaliximab With mFOLFOX6 as First Line Treatment for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
- Conditions
- Gastric Adenocarcinoma
- Interventions
- Registration Number
- NCT02545504
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 432
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo plus mFOLFOX6 (LV+5-FU+OXA) during Cycles 1-6, followed by placebo plus LV+5-FU during subsequent cycles Placebo 5-fluorouracil Placebo plus mFOLFOX6 (LV+5-FU+OXA) during Cycles 1-6, followed by placebo plus LV+5-FU during subsequent cycles Placebo Oxaliplatin Placebo plus mFOLFOX6 (LV+5-FU+OXA) during Cycles 1-6, followed by placebo plus LV+5-FU during subsequent cycles Andecaliximab Leucovorin Andecaliximab plus mFOLFOX6 (LV+5-FU+OXA) during Cycles 1-6, followed by andecaliximab plus LV+5-FU during subsequent cycles Andecaliximab 5-fluorouracil Andecaliximab plus mFOLFOX6 (LV+5-FU+OXA) during Cycles 1-6, followed by andecaliximab plus LV+5-FU during subsequent cycles Andecaliximab Oxaliplatin Andecaliximab plus mFOLFOX6 (LV+5-FU+OXA) during Cycles 1-6, followed by andecaliximab plus LV+5-FU during subsequent cycles Placebo Leucovorin Placebo plus mFOLFOX6 (LV+5-FU+OXA) during Cycles 1-6, followed by placebo plus LV+5-FU during subsequent cycles Andecaliximab Andecaliximab Andecaliximab plus mFOLFOX6 (LV+5-FU+OXA) during Cycles 1-6, followed by andecaliximab plus LV+5-FU during subsequent cycles
- Primary Outcome Measures
Name Time Method Overall Survival (OS) 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
Name Time Method Progression-free Survival (PFS) 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.
Objective Response Rate (ORR) 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.
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) 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.
Percentage of Participants With Clinically Relevant Treatment-emergent Laboratory Abnormalities 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.
Trial Locations
- Locations (134)
Scripps Green Hospital
🇺🇸La Jolla, California, United States
University of Southern California
🇺🇸Los Angeles, California, United States
UCLA Jonsson Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
Innovative Clinical Research Institute
🇺🇸Whittier, California, United States
Cancer Center of Central Connecticut
🇺🇸Plainville, Connecticut, United States
Omega Research Consultants LLC
🇺🇸DeBary, Florida, United States
Edward Hospital & Health Services
🇺🇸Naperville, Illinois, United States
Parkview Hospital
🇺🇸Fort Wayne, Indiana, United States
Indiana University Goshen Center for Cancer Care
🇺🇸Goshen, Indiana, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
Scroll for more (124 remaining)Scripps Green Hospital🇺🇸La Jolla, California, United States