Phase II Study of Above-Label Octreotide-LAR in Patients With Insufficiently Controlled Carcinoid Syndrome
The study population will consist of patients with advanced (metastatic or unresectable)
neuroendocrine tumors with suboptimally controlled carcinoid syndrome. While the majority of
patients will have primary tumors of the ileocecum (midgut), any serotonin-producing
neuroendocrine tumors will be eligible (including pancreatic, lung and unknown primary).
All patients will be followed for adverse events and serious adverse events for 28 days
following the last dose of above-label octreotide, or until resolution or stabilization of
the event, whichever comes first.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Frequency of Symptoms
The frequencies of flushing, diarrhea, and carcinoid syndrome control rating (scale 1-5) will be measured and compared. These measurements will be compared using two-sided non-parametric paired Wilcoxon signed-rank test controlling type I error at 0.05 based on 2000 Monte Carlo simulations.
Up to 5 years
Jonathan Strosberg, M.D.
H. Lee Moffitt Cancer Center and Research Institute
United States: Food and Drug Administration
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|