NCT00886132

A Study of Sunitinib in Recurrent and/or Metastatic Adenoid Cystic Carcinoma of the Salivary Glands

A Phase 2 Study of Sunitinib in Recurrent and/or Metastatic Adenoid Cystic Carcinoma of the Salivary Glands

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a phase II study to evaluate the effectiveness of study drug sunitinib malate in patients with recurrent and/or metastatic adenoid cystic carcinomas of the salivary gland. There currently is not standard of care for this type of cancer and it has hoped that sunitinib will have antitumor effects on patients with this type of cancer.

Detailed description

This is an open-label phase II study of sunitinib malate in patients with recurrent and/or metastatic adenoid cystic carcinomas (ACC) of major or minor salivary gland origin. Sunitinib is a novel, multi-targeted small molecule inhibitor of the receptor tyrosine kinases (RTKs), including vascular endothelial growth factor receptors (VEGFs), platelet derived growth factor receptors (PDGFRs) and stem cell factor receptor (KIT), that are involved in tumour proliferation and angiogenesis. VEGF expression has been associated clinically with disease prognosis in many different types of cancers and a number of studies have suggested that VEGF may play an important role in the pathogenicity of ACC. Sunitinib is expected to inhibit PDGF- and VEGF-driven angiogenesis and, as a consequence, limit solid tumour growth.This study will determine the anti-tumour activity of sunitinib in ACC of the salivary glands using objective response rates (partial and complete responses) as its primary objective.

Conditions

• Adenoid Cystic Carcinoma
• Salivary Gland Cancer

Interventions

Type	Name	Description
DRUG	Sunitinib	37.5 mg taken orally, daily every 28-day cycles

Timeline

• Start date: 2007-01-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2009-04-22
• Last updated: 2015-07-23

Locations

1 site across 1 country: Canada