drugset / Trial / NCT01199367

Safety, Tolerability, and Efficacy Study in Subjects With Advanced or Metastatic Breast Cancer

NCT01199367

NaSingle-groupOpen-labelTreatment

Summary

This study will determine the highest dose of KW-2450 in combination with lapatinib and letrozole that can be administered safely to subjects with advanced or metastatic breast cancer and to evaluate its effectiveness. This study was terminated in Phase 1 and never proceeded to the Phase 2 portion of the study.

Timeline

Start
2010-12
Primary completion
2012-12
Completion
2012-12

Publications

  • Results Dickson MA, P. LoRusso P, E. A. Sausville EA, Rao N, Kobayashi E, Kurman MR, Akinaga S, Schwartz GK. Open-label, sequential, ascending, multi-dose, phase I study of KW-2450 as monotherapy in subjects with previously treated advanced solid tumors. J Clin Oncol 29: 2011 (suppl; abstr 3078)

Drugs

EvaluationDrugModalityDoseRoute
Subject KW-2450 Small molecule Oral
Background Lapatinib Small molecule
Background Letrozole Other / unclassified

Indications