drugset / Trial / NCT01084863

Evaluate Safety, Efficacy and Pharmacokinetics

NCT01084863

Phase 1/2 Completed 143 enrolled Celltrion
RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of the study is to demonstrate equivalent pharmacokinetics (PK)

Timeline

Start
2010-02
Primary completion
2011-12
Completion
2023-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Trastuzumab Monoclonal antibody 6 mg/kg Intravenous
Background Paclitaxel Small molecule 175 mg/m2 Intravenous

Indications