45
Participants
Start Date
January 31, 2004
Primary Completion Date
July 31, 2008
Study Completion Date
July 31, 2008
Pasireotide (SOM230)
Open label. Patients received starting dose of 300 µg of study drug subcutaneously (s.c.) twice (total of 600 µg ) daily for three days, which could be increased in 150 µg increments up to 900 µg twice daily (total 1800 µg daily) if control of symptoms was not achieved. Prior sponsor agreement was required for a higher dose. A dose of 2400 µg/day was the maximum allowed. Dose reductions of 300 µg/day were allowed at any time if unacceptable toxicity occurred.
H. Lee Moffitt Cancer Center and Research Institute, Tampa
Univ. Of Iowa Holden Cancer Center, Iowa City
Louisiana State University Medical Center, New Orleans
Cedars-Sinai Medical Center, Los Angeles
Lead Sponsor
Novartis Pharmaceuticals
INDUSTRY