drugset / Trial / NCT03130790

Varlitinib in Combination With mFOLFOX6 for Advanced or Metastatic Gastric Cancer (First Line)

NCT03130790

Phase 2/3 Completed 52 enrolled ASLAN Pharmaceuticals
RandomizedParallel-groupDouble-blindTreatment

Summary

This protocol for Varlitinib is developed for the treatment of Gastric Cancer. Varlitinib (also known as ASLAN001) is a small-molecule, adenosine triphosphate competitive inhibitor of the tyrosine kinases - epidermal growth factor receptor (EGFR), human epidermal growth factor receptor (HER)2, and HER4. Varlitinib may be beneficial to subjects with cancer by simultaneous inhibition of these receptors. The purpose of this study is to determine the safety and efficacy of Varlitinib in combination with mFOLFOX6 for the treatment of Gastric Cancer. Treatment groups are Varlitinib+mFOLFOX6 and Placebo+mFOLFOX6.

Timeline

Start
2017-08-31
Primary completion
2018-12-20
Completion
2019-02-22

Drugs

EvaluationDrugModalityDoseRoute
Subject Varlitinib Small molecule 300 mg Oral
Comparator Leucovorin Small molecule 400 mg/m2 Intravenous
Comparator Oxaliplatin Small molecule 85 mg/m2 Intravenous
Comparator fluorouracil Small molecule 400 mg/m2 Intravenous
Comparator fluorouracil Small molecule 2400 mg/m2 Intravenous

Indications