Phase 3
N=432
Andecaliximab With mFOLFOX6 as First Line Treatment for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
Gastric Adenocarcinoma
Bottom Line
View on ClinicalTrials.gov: NCT02545504 ↗Enrolled (actual)
432
Serious AEs
49.5%
Results posted
Apr 2020
Primary outcome: Primary: Overall Survival (OS) — 12.52; 11.76 months — p=0.5625
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Andecaliximab (Drug); Placebo (Drug); Leucovorin (Drug); 5-fluorouracil (Drug); Oxaliplatin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Gilead Sciences
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (OS) |
12.52; 11.76 | 0.5625 |
| SECONDARY Progression-free Survival (PFS) |
7.46; 7.06 | 0.1031 |
| SECONDARY Objective Response Rate (ORR) |
50.5; 41.1 | 0.0493 sig |
| SECONDARY Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) |
99.1; 99.5 | — |
| SECONDARY Percentage of Participants With Clinically Relevant Treatment-emergent Laboratory Abnormalities |
94.4; 89.5; 91.7; 92.9; 7.4; 3.3 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02545504). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.