Study Evaluating SOM230 in Patients With Metastatic Carcinoid Tumors

PHASE2CompletedINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

January 31, 2004

Primary Completion Date

July 31, 2008

Study Completion Date

July 31, 2008

Conditions
Carcinoid Tumors
Interventions
DRUG

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.

Trial Locations (4)

33612

H. Lee Moffitt Cancer Center and Research Institute, Tampa

52242

Univ. Of Iowa Holden Cancer Center, Iowa City

70112

Louisiana State University Medical Center, New Orleans

90048

Cedars-Sinai Medical Center, Los Angeles

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY