Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Stomach Neoplasms

Adenocarcinoma

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Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Stomach Cancer

Micronutrients

All Drugs and Chemicals

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Hematinics

Vitamins

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Fluorouracil

Oxaliplatin

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Folate

Vitamin B9

Andecaliximab plus mFOLFOX6 (LV+5-FU+OXA) during Cycles 1-6, followed by andecaliximab plus LV+5-FU during subsequent cycles

Placebo plus mFOLFOX6 (LV+5-FU+OXA) during Cycles 1-6, followed by placebo plus LV+5-FU during subsequent cycles

800 mg administered intravenously on Days 1 and 15 of each 28-day treatment cycle

Andecaliximab

Administered intravenously on Days 1 and 15 of each treatment cycle

Placebo

Administered intravenously per standard of care on Days 1 and 15 of each treatment cycle

5-fluorouracil

Gilead Study Director

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.

Andecaliximab With mFOLFOX6 as First Line Treatment for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

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

OS was defined as the time interval from the date of randomization to death from any cause.

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.

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.

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.

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.

Gilead Sciences

All-Cause Mortality:The Intent-to-Treat Analysis Set included all randomized participants.Serious Adverse Events and Other Adverse Events: The Safety Analysis Set included all participants who received at least one dose of andecaliximab/placebo.

Participants received andecaliximab 800 mg IV plus mFOLFOX6 (LV+5-FU+OXA) IV as per standard of care on Days 1 and 15 of each 28-day treatment cycle during Cycles 1-6, followed by andecaliximab 800 mg IV plus LV+5-FU on Days 1 and 15 during subsequent cycles until disease progression, unacceptable toxicity, consent withdrawal, or the participant's refusal of treatment for up to 161.7 weeks.

Andecaliximab + mFOLFOX6

Participants received placebo IV plus mFOLFOX6 (LV+5-FU+OXA) as per standard of care on Days 1 and 15 of each 28-day treatment cycle during Cycles 1-6, followed by placebo IV plus LV+5-FU on Days 1 and 15 during subsequent cycles until disease progression, unacceptable toxicity, consent withdrawal, or the participant's refusal of treatment for up to 112.3 weeks.

Placebo + mFOLFOX6

Participants were randomized to receive andecaliximab 800 mg IV plus mFOLFOX6 (LV+5-FU+OXA) IV as per standard of care on Days 1 and 15 of each 28-day treatment cycle during Cycles 1-6, followed by andecaliximab 800 mg IV plus LV+5-FU on Days 1 and 15 during subsequent cycles until disease progression, unacceptable toxicity, consent withdrawal, or the participant's refusal of treatment for up to 161.7 weeks.

Participants were randomized to receive placebo IV plus mFOLFOX6 (LV+5-FU+OXA) as per standard of care on Days 1 and 15 of each 28-day treatment cycle during Cycles 1-6, followed by placebo IV plus LV+5-FU on Days 1 and 15 during subsequent cycles until disease progression, unacceptable toxicity, consent withdrawal, or the participant's refusal of treatment for up to 112.3 weeks.

Total

Age, Continuous

Sex: Female, Male

Race

Not Permitted = local regulators did not allow collection of race or ethnicity information.

Race/Ethnicity, Customized

Ethnicity

Colombia

Romania

Hungary

United States

Czechia

United Kingdom

Spain

Turkey

Belgium

Poland

Italy

Australia

Chile

France

Peru

Germany

Region of Enrollment

Type of Cancer

The Intent-to-Treat (ITT) Analysis Set included all randomized participants.

Gilead Clinical Study Information Center

The primary and secondary endpoints were tested sequentially in the following gate-keeping order: the primary OS endpoint, then the secondary PFS endpoint, and finally the secondary ORR endpoint.

Participants were randomized to receive andecaliximab 800 mg IV plus mFOLFOX6 (LV+5-FU+OXA) IV as per standard of care on Days 1 and 15 of each 28-day treatment cycle during Cycles 1-6, followed by andecaliximab 800 mg IV plus LV+5-FU on Days 1 and 15 during subsequent cycles until disease progression, unacceptable toxicity, consent withdrawal, or the participant's refusal of treatment for up to 135.4 weeks at the time of final analysis.

Participants were randomized to receive placebo IV plus mFOLFOX6 (LV+5-FU+OXA) as per standard of care on Days 1 and 15 of each 28-day treatment cycle during Cycles 1-6, followed by placebo IV plus LV+5-FU on Days 1 and 15 during subsequent cycles until disease progression, unacceptable toxicity, consent withdrawal, or the participant's refusal of treatment for up to 99.7 weeks at the time of final analysis.

Overall Survival (OS)

The primary and secondary endpoints were tested sequentially in the following gate-keeping order: the primary OS endpoint, then the secondary PFS endpoint, and finally the secondary ORR endpoint. PFS was tested only if OS was significant. The P-value is for display only.

Participants in the ITT Analysis Set were analyzed.

Progression-free Survival (PFS)

The primary and secondary endpoints were tested sequentially in the following gate-keeping order: the primary OS endpoint, then the secondary PFS endpoint, and finally the secondary ORR endpoint. ORR was tested only if OS and PFS were significant.The P-value is for display only.

The primary and secondary endpoints were tested sequentially in the following gate-keeping order: the primary OS endpoint, then the secondary PFS endpoint, and finally the secondary ORR endpoint. ORR was tested only if OS and PFS were significant.

Participants were randomized to receive andecaliximab 800 mg IV plus mFOLFOX6 (LV+5-FU+OXA) IV as per standard of care on Days 1 and 15 of each 28-day treatment cycle during Cycles 1-6, followed by andecaliximab 800 mg IV plus LV+5-FU on Days 1 and 15 during subsequent cycles until disease progression, unacceptable toxicity, consent withdrawal, or the participant's refusal of treatment for up to 135.4 weeks at the time of the final analysis.

Participants were randomized to receive placebo IV plus mFOLFOX6 (LV+5-FU+OXA) as per standard of care on Days 1 and 15 of each 28-day treatment cycle during Cycles 1-6, followed by placebo IV plus LV+5-FU on Days 1 and 15 during subsequent cycles until disease progression, unacceptable toxicity, consent withdrawal, or the participant's refusal of treatment for up to 99.7 weeks at the time of the final analysis.

Objective Response Rate (ORR)

The Safety Analysis Set included all participants who received at least one dose of andecaliximab/placebo.

Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

Hematology

Serum Chemistry

Coagulation

Participants in the Safety Analysis Set were analyzed.

Percentage of Participants With Clinically Relevant Treatment-emergent Laboratory Abnormalities

Participants were randomized to receive andecaliximab 800 mg intravenous (IV) plus mFOLFOX6 \[leucovorin (LV)+5-fluorouracil (5-FU) + oxaliplatin (OXA)\] IV as per standard of care on Days 1 and 15 of each 28-day treatment cycle during Cycles 1-6, followed by andecaliximab 800 mg IV plus LV+5-FU on Days 1 and 15 during subsequent cycles until disease progression, unacceptable toxicity, consent withdrawal, or the participant's refusal of treatment for up to 161.7 weeks.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Andecaliximab With mFOLFOX6 as First Line Treatment for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma	NCT02545504	Gastric Adenoca...	Andecaliximab Placebo Leucovorin 5-fluorouracil Oxaliplatin	18 Years -	Gilead Sciences
Andecaliximab With mFOLFOX6 as First Line Treatment for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma	NCT02545504	Gastric Adenoca...	Andecaliximab Placebo Leucovorin 5-fluorouracil Oxaliplatin	18 Years -	Gilead Sciences
Andecaliximab With mFOLFOX6 as First Line Treatment for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma	NCT02545504	Gastric Adenoca...	Andecaliximab Placebo Leucovorin 5-fluorouracil Oxaliplatin	18 Years -	Gilead Sciences
Andecaliximab With mFOLFOX6 as First Line Treatment for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma	NCT02545504	Gastric Adenoca...	Andecaliximab Placebo Leucovorin 5-fluorouracil Oxaliplatin	18 Years -	Gilead Sciences

Spots Global Cancer Trial Database for gastroesophageal junction (gej)