Efficacy and Safety of Oral Octreolin™ in Patients With Acromegaly Who Are Currently Receiving Parenteral Somatostatin Analogs
Qualifying patients with acromegaly will receive treatment with Octreolin. Dose escalation
will proceed to identify the optimal dose for each patient. The optimal dose will be
continued as chronic therapy. Levels of GH and IGF-1 will be assessed during the study and
at end of treatment.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Efficacy will be assessed at the end of 7 months of study drug treatment. Age-normalized IGF-1 concentration is the treatment goal.
Completion of the treatment period
Shlomo Melmed, MD
Cedars-Sinai Medical Center
United States: Food and Drug Administration
|Cedars-Sinai Medical Center||Los Angeles, California 90048|