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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
432
800 mg administered intravenously on Days 1 and 15 of each 28-day treatment cycle
Administered intravenously on Days 1 and 15 of each treatment cycle
Administered intravenously per standard of care on Days 1 and 15 of each treatment cycle
Overall Survival (OS)
OS was defined as the time interval from the date of randomization to death from any cause.
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
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.
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
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.
Time frame: Up to 135.4 weeks at the time of final analysis
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.
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Administered intravenously per standard of care on Days 1 and 15 of each treatment cycle
Administered intravenously per standard of care on Days 1 and 15 of each treatment cycle
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
...and 124 more locations
Time frame: First dose date up to the last dose date (maximum:161.7 weeks) plus 30 to 55 days
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.
Time frame: First dose date up to the last dose date (maximum: 161.7 weeks) plus 30 to 55 days