Trial of Single Agent Sunitinib 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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-label, Uncontrolled Phase II Trial of Single Agent Sunitinib (SU 11248) for Patients With Chemo-refractory Metastatic Melanoma|
- clinical benefit rate cycle 1-3 [ Time Frame: tumor assessment every 6 weeks ] [ Designated as safety issue: No ]clinical benefit rate defined as a CR + PR + SD > 4 months duration
- clinical benefit rate cycle 4 and more [ Time Frame: tumor assessment every 12 weeks ] [ Designated as safety issue: No ]clinical benefit rate defined as a CR + PR + SD > 4 months duration
- response rate cycle 1-3 [ Time Frame: tumor assessment every 6 weeks ] [ Designated as safety issue: No ]response rate defined as CR+PR
- progression free survival [ Time Frame: follow-up one year ] [ Designated as safety issue: No ]
- overall survival [ Time Frame: follow-up for one year ] [ Designated as safety issue: No ]
- response rate cycle 4 and more [ Time Frame: every 12 weeks ] [ Designated as safety issue: No ]response rate defined as CR+PR
|Study Start Date:||March 2009|
|Study Completion Date:||May 2013|
|Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
50 mg Sunitinib daily for 4 weeks, then 2 weeks without treatment
50 mg oral, daily, for 4 weeks, then 2 weeks without treatment, repeat at d43
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01216657
|Frankfurt/Main, Germany, 60488|
|Principal Investigator:||Elke Jäger, Prof. Dr.||Krankenhaus Nordwest|