drugset / Trial / NCT01348009

Tesetaxel Plus Capecitabine and Cisplatin in Advanced Gastric Cancer

NCT01348009

Phase 1/2 Unknown 63 enrolled Genta Incorporated
NaSingle-groupOpen-labelTreatment

Summary

Cisplatin, an intravenously administered platinum agent, in combination with an intravenously administered taxane and capecitabine has been shown to improve time to disease progression and overall survival in previously untreated patients with gastric cancer. This study is being performed to evaluate an orally administered taxane (tesetaxel) in combination with cisplatin and capecitabine in previously untreated patients with gastric cancer.

Timeline

Start
2011-05
Primary completion
2013-10
Completion
2014-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Tesetaxel Small molecule 18 mg/m2 Oral
Subject Tesetaxel Small molecule 21 mg/m2 Oral
Subject Tesetaxel Small molecule 24 mg/m2 Oral
Subject Tesetaxel Small molecule 27 mg/m2 Oral
Background Capecitabine Small molecule 2000 mg/m2 Oral
Background Cisplatin Other / unclassified 60 mg/m2 Intravenous

Indications