Chemo-refractory Melanoma Clinical Trial
Official title:
An Open-label, Uncontrolled Phase II Trial of Single Agent Sunitinib (SU 11248) for Patients With Chemo-refractory Metastatic Melanoma
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.
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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment