Recurrent or Metastatic Salivary Gland Cancer of the Head and Neck Clinical Trial
Official title:
Phase II Trial of BIBF1120 (Nintedanib) in Patients With Recurrent or Metastatic Salivary Gland Cancer of the Head and Neck : a Multicentre Phase II Study
Recently, sorafenib which can target VEGFR and PDGFR demonstrated 13-16% of response rate in
patients with recurrent/metastatic salivary gland cancers, suggesting that VEGFR and PDGFR
might be important role in salivary gland cancers. Accordingly, several trials with various
anti-angiogenic molecular targeted agents such as dasatinib, dovitinib, or sunitinib in
salivary gland cancer are ongoing.
Nintedanib (BIBF1120) is a potent small molecule triple receptor tyrosine kinase inhibitor
(PDGFR/ FGFR1-2 and VEGFR1-3). VEGFR-2 is considered to be the crucial receptor involved in
initiation of the formation as well as the maintenance of tumor vasculature. In vitro, the
target receptors are all inhibited by nintedanib in low nanomolar concentrations. In in vivo
nude mouse models, nintedanib showed good anti-tumor efficacy at doses of 50-100mg/kg,
leading to a substantial delay of tumor growth or even complete tumor stasis in xenografts
of a broad range of differing human tumors.
Based on this background, in this study, the investigators would like to conduct a phase II
study of Nintedanib (BIBF 1120) in patients with recurrent or metastatic salivary gland
cancer of the head and neck to evaluate efficacy and safety.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment