An Open-label, Multicenter, Phase II Study Evaluating the Safety and Efficacy of Twice Daily Dosing of SOM230 in Patients With Metastatic Carcinoid Tumors
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Symptom Control (Diarrhea/Flushing) Using a Patient Symptom Diary
Complete Symptom Control: an average of ≤ 3 bowel movements per day for at least 15 consecutive days, with no more than 3 episodes on any given day, and no episodes of flushing over the time interval being studied. Partial Symptom Control: an average of < 4 bowel movements per day for at least 15 consecutive days, with no more than 6 episodes per given day, and an average of fewer than 2 daily flushing episodes over the same given time interval. Treatment failure: Failure to obtain partial or complete treatment success over a consecutive 15-day period at a constant dose level.
15 days
No
Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals
United States: Food and Drug Administration
CSOM230B2202
NCT00088595
January 2004
July 2008
Name | Location |
---|---|
H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
Cedars-Sinai Medical Center | Los Angeles, California 90048 |
Louisiana State University Medical Center | Lafayette, Louisiana 70502-4016 |
Univ. Of Iowa Holden Cancer Center | Iowa City, Iowa 52242 |