drugset / Trial / NCT02448290

Single-arm Study of Selumetinib in Combination With Docetaxel, in Advanced Gastric Adenocarcinoma Patients With Low/High MEK Signature, RAS Mutation or RAS Amplification as a Second-line Chemotherapy

NCT02448290

Phase 2 Completed 25 enrolled Samsung Medical Center
NaSingle-groupOpen-labelTreatment

Summary

This study is a single-arm, phase II study of selumetinib in combination with docetaxel in patients with advanced gastric adenocarcinoma harboring MEK signature, RAS mutation or amplification as a second line chemotherapy. Selumetinib will be administered orally 75mg twice a day continuously. Docetaxel will be administered as an IV infusion over 1 hour at 60 mg/m2 every 3 week of a 21 days schedule.

Timeline

Start
2014-11-12
Primary completion
2018-05-17
Completion
2018-05-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Docetaxel Small molecule 60 mg/m2 Intravenous
Subject Selumetinib Small molecule 75 mg Oral