At a glance
ClinicalIndex Comparison Record- ✓Biopsy-proven metastatic carcinoid tumors
- ✓At least one measurable lesion (excluding bone)
- ✓Inadequately controlled on Sandostatin LAR with carcinoid syndrome symptoms: minimum 4 bowel movements/day or 2 flushing episodes/day
- ✕Major surgery within 1 month
- ✕Cytotoxic chemotherapy or interferon therapy within 2 months
- ✕Uncontrolled diabetes mellitus
- ✕Radiotherapy within 4 weeks
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label, Multicenter, Phase II Study Evaluating the Safety and Efficacy of Twice Daily Dosing of SOM230 in Patients With Metastatic Carcinoid Tumors
In Brief
A Phase 2 clinical trial evaluating Pasireotide (SOM230) for Carcinoid Tumors. Completed, enrolled 45 participants across 4 sites.
Detailed Summary
Study evaluating SOM230 in patients with metastatic carcinoid tumors
Study Details
Timeline
Interventions
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.