NEWS - The Journal of Clinical Endocrinology & Metabolism

SOM230 (pasireotide): Our next generation in somatostatin analogue therapy
Now Enrolling Adult Patients in a
Phase III Clinical Trial for Cushing’s Disease
Protocol No. CSOM230B2305
SIG-CUSHINGS Study Title:
A randomized, double-blind study to assess the safety and effi cacy of different dose levels of Pasireotide (SOM230) s.c.
over a 6 month treatment period in patients with de novo, persistent or recurrent Cushing’s disease
Study Design:
Screening/
washout
Randomization
600 µg pasireotide bid
900 µg pasireotide bid
Primary End Point:
Assess the effi cacy in terms of response to pasireotide 600 µg SC bid and 900 µg SC bid independently in intent-to-treat
patients with Cushing’s disease, as measured by mean UFC ≤1.0 x ULN from baseline after 6 months of treatment
Key Inclusion Criteria*:
Diagnosis of ACTH-dependent Cushing’s disease as defi ned by:
a. Mean UFC of four 24-hour urine samples collected within 2 weeks, at least 1.5 times the ULN
b. Morning plasma ACTH within the normal or above normal range
c. Either MRI confi rmation of pituitary macroadenoma (≥1 cm), or inferior petrosal sinus gradient >3 after
CRH stimulation for those patients with a microadenoma (tumor