Description:
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.
Title
- Brief Title: Andecaliximab With mFOLFOX6 as First Line Treatment for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
- 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
Clinical Trial IDs
- ORG STUDY ID:
GS-US-296-1080
- SECONDARY ID:
2015-001526-42
- NCT ID:
NCT02545504
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| Andecaliximab | GS-5745 | Andecaliximab |
| Placebo | | Placebo |
| Leucovorin | LV | Andecaliximab |
| 5-fluorouracil | 5-FU | Andecaliximab |
| Oxaliplatin | OXA | Andecaliximab |
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Andecaliximab | Experimental | Andecaliximab plus mFOLFOX6 (LV+5-FU+OXA) during Cycles 1-6, followed by andecaliximab plus LV+5-FU during subsequent cycles | - Andecaliximab
- Leucovorin
- 5-fluorouracil
- Oxaliplatin
|
| Placebo | Placebo Comparator | Placebo plus mFOLFOX6 (LV+5-FU+OXA) during Cycles 1-6, followed by placebo plus LV+5-FU during subsequent cycles | - Placebo
- Leucovorin
- 5-fluorouracil
- Oxaliplatin
|
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.
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Overall Survival (OS) |
| 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 |
| Safety Issue: | |
| Description: | OS was defined as the time interval from the date of randomization to death from any cause. |
Secondary Outcome Measures
| Measure: | Progression-free Survival (PFS) |
| 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 |
| Safety Issue: | |
| Description: | 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. |
| Measure: | Objective Response Rate (ORR) |
| Time Frame: | Up to 135.4 weeks at the time of final analysis |
| Safety Issue: | |
| Description: | 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. |
| Measure: | Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) |
| Time Frame: | First dose date up to the last dose date (maximum:161.7 weeks) plus 30 to 55 days |
| Safety Issue: | |
| Description: | 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. |
| Measure: | Percentage of Participants With Clinically Relevant Treatment-emergent Laboratory Abnormalities |
| Time Frame: | First dose date up to the last dose date (maximum: 161.7 weeks) plus 30 to 55 days |
| Safety Issue: | |
| Description: | 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. |
Details
| Phase: | Phase 3 |
| Primary Purpose: | Interventional |
| Overall Status: | Completed |
| Lead Sponsor: | Gilead Sciences |
Trial Keywords
- Gastroesophageal junction (GEJ)
- Stomach cancer
Last Updated
May 26, 2020
