NCT01216657

Trial of Single Agent Sunitinib for Patients With Chemo-refractory Metastatic Melanoma

An Open-label, Uncontrolled Phase II Trial of Single Agent Sunitinib (SU 11248) for Patients With Chemo-refractory Metastatic Melanoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Krankenhaus Nordwest · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Sunitinib is a novel small molecule receptor tyrosine kinase inhibitor with direct antitumor effects as well as antiangiogenetic activity. Preclinical and clinical data for Sunitinib and data about angiogenesis and growth regulation in melanoma suggest the activity of Sunitinib in melanoma. This study will investigate the efficacy, safety and tolerability of Sunitinib as palliative treatment in chemo-refractory metastatic melanoma.

Detailed description

This is a single agent 2-step phase 2 study with a one-year follow-up to evaluate the antitumor activity of Sunitinib administered in treatment cycles of 6 weeks duration (4 weeks treatment and 2 weeks rest) in patients with chemo-refractory melanoma. If the first step shows sufficient efficacy and tolerability the study will continue to step 2. Treatment will continue for 9 months or until disease progression or until intolerable adverse events occur. Subsequently the patients will be followed up for 1 year. Tumor assessment will be performed at baseline, at the end of cycle 1,2,3 and subsequently at the end of every uneven cycle (5,7,9,…). A total of 40 patients will be enrolled in this trial.

Conditions

• Chemo-refractory Melanoma

Interventions

Type	Name	Description
DRUG	Sunitinib	50 mg oral, daily, for 4 weeks, then 2 weeks without treatment, repeat at d43

Timeline

• Start date: 2009-03-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2010-10-07
• Last updated: 2013-06-04

Locations

1 site across 1 country: Germany