drugset
drugset / Trial / NCT01355302

E7050 in Combination With Cisplatin and Capecitabine Versus Cisplatin and Capecitabine Alone in Patients With Advanced or Metastatic Solid Tumors and Previously Untreated Gastric Cancer

NCT01355302 ↗

Phase 1/2 Terminated 7 enrolled Eisai Inc. Quintiles, Inc. · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to determine the following: 1. Find the maximum tolerated dose of E7050 when given in combination with cisplatin and capecitabine in patients with advance or metastatic solid tumors, and 2) Whether E7050 in combination with cisplatin and capecitabine is more effective in patients with previously untreated gastric cancer versus cisplatin and capecitabine alone.

Timeline

Start
2011-11
Primary completion
2013-04
Completion
2013-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Golvatinib Small molecule 200 mg Oral
Subject Golvatinib Small molecule 300 mg Oral
Subject Golvatinib Small molecule 400 mg Oral
Background Capecitabine Small molecule 1000 mg/m2 Oral
Background Cisplatin Other / unclassified 80 mg/m2 Intravenous

Indications

No indication recorded.