Ignite Creation Date:
2024-05-06 @ 7:32 AM
Last Modification Date:
2024-10-26 @ 11:49 AM
Study NCT ID:
NCT02558387
Status:
UNKNOWN
Last Update Posted:
2015-11-20
First Post:
2015-09-22
Brief Title:
Trial of BIBF1120 Nintedanib in Patients With Recurrent or Metastatic Salivary Gland Cancer of the Head and Neck
Sponsor:
Samsung Medical Center
Organization:
Samsung Medical Center
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2015-11
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Recently sorafenib which can target VEGFR and PDGFR demonstrated 13-16 of response rate in patients with recurrentmetastatic 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 50-100mgkg 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
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 50-100mgkg 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None