Andecaliximab With mFOLFOX6 as First Line Treatment for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/20/2019 |
| Start Date: | October 13, 2015 |
| End Date: | May 2019 |
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
The primary objective of this study is to compare the efficacy of andecaliximab (formerly
GS-5745) versus placebo in combination with modified fluorouracil (5-FU), leucovorin (LV),
and oxaliplatin (OXA) (mFOLFOX6) as measured by overall survival.
GS-5745) versus placebo in combination with modified fluorouracil (5-FU), leucovorin (LV),
and oxaliplatin (OXA) (mFOLFOX6) as measured by overall survival.
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.
We found this trial at
31
sites
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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University of Southern California The University of Southern California is one of the world’s leading...
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University of Rochester The University of Rochester is one of the country's top-tier research universities....
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Oncology Hematology Care Our more than 60 physicians and advanced practice providers throughout neighborhood offices...
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Duke Cancer Institute Leading-edge cancer care and research have been a hallmark of Duke Medicine...
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1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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Scott & White Memorial Hospital When Arthur C. Scott, MD, and Raleigh R. White Jr.,...
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