drugset
drugset / Trial / NCT03051373

Phase 2 Trial of Nab-paclitaxel Plus S-1 vs Gemcitabine Plus Cisplatin as 1-line Chemotherapy of Patients With Local Advanced and/or Metastatic Transitional Cell Carcinoma of Urothelial Tract

NCT03051373 ↗

Phase 2 Completed 108 enrolled Chinese PLA General Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

Gemcitabine plus cisplatin have been the most studied and used anticancer agents in patients with local advanced and/or metastatic transitional cell carcinoma of urothelial tract even if clinical benefits and survival remains limited. The purpose of this study is to test in a randomized trial enrolling patients for comparing the efficacy and safety of nab-paclitaxel plus S-1 with Gemcitabine plus cisplatin, in order to determine the most promising agents as the first line treatment of advanced and/or metastatic transitional cell carcinoma of urothelial tract.

Timeline

Start
2017-04-01
Primary completion
2019-04-30
Completion
2020-04-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cisplatin Other / unclassified 75 mg/m2 Intravenous
Comparator Gemcitabine Small molecule 1000 mg/m2 Intravenous
Subject Nab-paclitaxel Small molecule 120 mg/m2 Intravenous
Subject S-1 Small molecule 40 mg Oral
Subject S-1 Small molecule 60 mg Oral

Indications

transitional cell carcinoma