Trial of BIBF1120 (Nintedanib) in Patients With Recurrent or Metastatic Salivary Gland Cancer of the Head and Neck
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|ClinicalTrials.gov Identifier: NCT02558387|
Recruitment Status : Unknown
Verified November 2015 by Myung-Ju Ahn, Samsung Medical Center.
Recruitment status was: Active, not recruiting
First Posted : September 24, 2015
Last Update Posted : November 20, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Recurrent or Metastatic Salivary Gland Cancer of the Head and Neck||Drug: BIBF1120||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||November 2014|
|Estimated Primary Completion Date :||July 2016|
|Estimated Study Completion Date :||January 2017|
Experimental: Nintedanib arm
Nintedanib has never been applied to salivary gland cancer. Nintedanib was given orally at a dose of 200mg twice daily (bid) until progression or unacceptable toxicity.
Nintedanib will be given orally at a dose of 200mg twice daily (bid) until progression or unacceptable toxicity.
Other Name: Nintedanib
- response rate [ Time Frame: 6months after patient enrollment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02558387
|Korea, Republic of|
|Samsung Medical Center|
|Seoul, Korea, Republic of, 135-710|
|Principal Investigator:||Myung-Ju Ahn, MD, PhD||Samsung Medical Center|