drugset / Trial / NCT01613950

PI3K Inhibitor BYL719 in Combination With the HSP90 Inhibitor AUY922 in Patients With Advanced or Metastatic Gastric Cancer

NCT01613950

Phase 1 Completed 18 enrolled Novartis Pharmaceuticals
NaSingle-groupOpen-labelTreatment

Summary

The study is intended to investigate the safety of BYL719 and AUY922 in patients with advanced gastric cancer, and to determine the MTD and/or RDE of both drugs in combination. In addition, the preliminary efficacy of BYL719 in combination with AUY922, and the pharmacokinetics of both drugs will be assessed. Patients will be eligible for this study, if their tumors carry either a molecular alteration of PIK3CA, or an amplification of HER2. The study includes a dose escalation part followed by a safety expansion phase.

Timeline

Start
2012-12
Primary completion
2014-03
Completion
2014-03

Drugs

EvaluationDrugModalityDoseRoute
Subject AUY922 Small molecule Intravenous
Subject Alpelisib Small molecule Oral

Indications