A Phase I/II Study of Daily Oral Dosing With Temozolomide and Sunitinib Malate for 6 Weeks of an 8-Week Cycle in Patients With Metastatic and Unresectable Locally-Advanced Malignant Melanoma
- Assess the maximum tolerated dose of sunitinib malate when administered concurrently
with temozolomide in patients with stage IIIC or IV malignant melanoma. (Phase I)
- Assess the overall safety of this regimen in these patients. (Phase I)
- Determine the response rate in patients treated with this regimen. (Phase II)
- Determine the response rate in patients treated with this regimen. (Phase I)
- Determine the safety and tolerability of this regimen in these patients. (Phase II)
- Determine the progression-free survival of patients treated with this regimen.
- Determine the overall survival of patients treated with this regimen.
OUTLINE: This is a phase I, dose-escalation study of sunitinib malate followed by a phase II
Patients receive oral sunitinib malate once daily and oral temozolomide once daily on days
1-42. Treatment repeats every 56 days for up to 1 year in the absence of disease progression
or unacceptable toxicity.
After completion of study therapy, patients are followed up very 6 months for up to 5 years.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose of sunitinib malate when administered concurrently with temozolomide (Phase I)
Bartosz Chmielowski, MD
University of California, Los Angeles
United States: Food and Drug Administration
|University of California Los Angeles (UCLA)||Los Angeles, California 90095|