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Clinical Trial Summary

One promising approach to the treatment of cancer is inhibition or modulating the crucial signal transduction pathway of PI3K-Akt-mTOR. Several PI3K inhibitors are being tested in the clinical trials for cancer treatment but not for the head and neck cancer yet. BYL719 is an alpha specific I PI3K inhibitor. It showed significant, concentration dependent cell growth inhibition and induction of apoptosis. We suggest multicenter single arm phase II study to determine anti-tumor effects of BYL719 in patients with recurrent and/or metastatic SCCHN who failed to prior chemotherapy regimens. Enrollment will be done in 5 or more clinical trial centers in Korea. Primary objective is to evaluate disease control rate (DCR) at 8 weeks of BYL719, and the efficacy will be evaluated by the investigators analysis based on RECIST version 1.1.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT02145312
Study type Interventional
Source Yonsei University
Contact Byung Chul Cho
Phone +82 (2) 2228-0880
Email CBC1971@yuhs.ac
Status Recruiting
Phase Phase 2
Start date October 1, 2016
Completion date May 2019

See also
  Status Clinical Trial Phase
Recruiting NCT04868162 - A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck Phase 2