drugset / Trial / NCT01646125

An Open-label, Randomized Phase II Study to Evaluate the Efficacy of AUY922 vs Pemetrexed or Docetaxel in NSCLC Patients With EGFR Mutations

NCT01646125

Phase 2 Terminated 59 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study was to determine if AUY922 had superior efficacy when compared to chemotherapy agents docetaxel or pemetrexed in patients whose tumor had EGFR mutations. The primary purpose of this study was to compare the efficacy of AUY922, when administered i.v. on a once-weekly schedule at 70 mg/m2, versus docetaxel or pemetrexed in adult patients with advanced NSCLC, whose tumors harbored EGFR activating mutations, and had developed resistance to EGFR TKI.

Timeline

Start
2012-11-23
Primary completion
2015-11-04
Completion
2015-11-04

Drugs

EvaluationDrugModalityDoseRoute
Subject AUY922 Small molecule 70 mg/m2 Intravenous
Comparator Docetaxel Small molecule 75 mg/m2 Intravenous
Comparator Pemetrexed Small molecule 500 mg/m2