A Phase II Study of G3139 (Genasense ™) in Patients With Merkel Cell Carcinoma
I. Determine the overall response rate in patients with Merkel cell carcinoma treated with
I. Determine the time to progression in patients treated with this drug. II. Determine the
response duration in patients treated with this drug. III. Determine the safety and
tolerability of this drug in these patients. IV. Determine the pharmacodynamic effects of
this drug on bcl-2 expression and apoptosis in tumor biopsy specimens from these patients.
OUTLINE: This is an open-label, multicenter study.
Patients receive oblimersen IV continuously on days 1-14. Courses repeat every 21 days in
the absence of disease progression or unacceptable toxicity.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall response rate
Up to 3 years
Memorial Sloan-Kettering Cancer Center
United States: Food and Drug Administration
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|