NCT00859456

Sunitinib in Certain Subtypes of Soft Tissue Sarcomas

A Phase II, Open-label, Non-randomized Trial of Sunitinib in Certain Subtypes of Soft Tissue Sarcomas

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the clinical response rate (complete response and partial response) in patients with metastatic, locally advanced, or locally recurrent vascular soft tissue sarcoma treated with sunitinib.

Detailed description

Soft tissue sarcomas are rare tumors that arise from mesenchymal tissue from anywhere in the body. While surgical intervention can offer a cure for localized soft tissue sarcoma, treatment of unresectable and metastatic disease is particularly challenging. New treatment options are needed for patients with unresectable or metastatic disease if they progress or cannot tolerate conventional chemotherapy. This study will investigate sunitinib - a novel orally-administered multitargeted tyrosine kinase inhibitor with anti-tumor and antiangiogenic activities.

Conditions

• Sarcoma, Soft Tissue

Interventions

Type	Name	Description
DRUG	Sunitinib	Taken daily PO for a 42 day cycle. This cycle is repeated at least twice. A small molecule, multi-targeted receptor tyrosine kinase inhibitor that selectively targets and intracellularly blocks the signaling pathways of receptor tyrosine kinase (RTKs).

Timeline

• Start date: 2007-04-01
• Primary completion: 2012-11-01
• Completion: 2013-02-01
• First posted: 2009-03-11
• Last updated: 2019-11-04
• Results posted: 2019-11-04

Locations

1 site across 1 country: United States