drugset / Trial / NCT01839773

Phase 3 Study to Compare Efficacy and Safety of DHP107 vs. Taxol® in Patients With Metastatic or Recurrent Gastric Cancer

NCT01839773 ↗

Phase 3 Completed 238 enrolled Daehwa Pharmaceutical Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

Summary

The objective of this study is to evaluate the efficacy and safety of DHP107 (Oral paclitaxel) in comparison to Taxol®(IV paclitaxel) in Patients With Metastatic or Recurrent Gastric Cancer After Failure of 1st Line Chemotherapy With Fluoropyrimidine +/- Platinum.

Timeline

Start
2013-03
Primary completion
2015-08
Completion
2015-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Paclitaxel Small molecule 175 mg/m2 Oral
Comparator Paclitaxel Small molecule 200 mg/m2 Oral

Indications