NCT00088595

Study Evaluating SOM230 in Patients With Metastatic Carcinoid Tumors

An Open-label, Multicenter, Phase II Study Evaluating the Safety and Efficacy of Twice Daily Dosing of SOM230 in Patients With Metastatic Carcinoid Tumors

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Study evaluating SOM230 in patients with metastatic carcinoid tumors

Conditions

• Carcinoid Tumors

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2004-01-01
• Primary completion: 2008-07-01
• Completion: 2008-07-01
• First posted: 2004-08-02
• Last updated: 2012-06-04
• Results posted: 2011-05-06

Locations

4 sites across 1 country: United States