Study Evaluating SOM230 in Patients With Metastatic Carcinoid Tumors
Study evaluating SOM230 in patients with metastatic carcinoid tumors
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-label, Multicenter, Phase II Study Evaluating the Safety and Efficacy of Twice Daily Dosing of SOM230 in Patients With Metastatic Carcinoid Tumors|
- Symptom Control (Diarrhea/Flushing) Using a Patient Symptom Diary [ Time Frame: 15 days ] [ Designated as safety issue: No ]
Complete Symptom Control: an average of ≤ 3 bowel movements per day for at least 15 consecutive days, with no more than 3 episodes on any given day, and no episodes of flushing over the time interval being studied.
Partial Symptom Control: an average of < 4 bowel movements per day for at least 15 consecutive days, with no more than 6 episodes per given day, and an average of fewer than 2 daily flushing episodes over the same given time interval.
Treatment failure: Failure to obtain partial or complete treatment success over a consecutive 15-day period at a constant dose level.
- Duration of Complete Symptom Control (Days) by Dose Class [ Time Frame: 15 days ] [ Designated as safety issue: No ]Complete symptom control: an average of three or less bowel movements per day for at least 15 consecutive days, with no more than three episodes on any given day, and no episodes of flushing over the time interval being studied.
- Duration of Partial Symptom Control (Days) by Dose Class [ Time Frame: up to 15 days ] [ Designated as safety issue: No ]Partial symptom control: an average of less than four bowel movements per day for at least 15 consecutive days, with no more than six episodes per any given day, and an average of less than two daily flushing episodes over the same given time interval.
- The Number of Patients (Participants) With Overall Tumor Response [ Time Frame: At least 15 days ] [ Designated as safety issue: No ]The disappearance of all lesions was considered a complete response and at least a 30% decrease in the diameter of lesions was considered a partial response (PR). Progressive disease (PD) required a 20% increase in the sum of the diameters of lesions and changes that did not qualify for PR or PD were considered stable disease. Progression not documented was defined as unknown. No more than a 10% increase in biochemical values, and no clinical signs of DP with complete or adequate control over symptoms were defined as complete treatment success and partial treatment success, respectively.
- The Overall Safety and Tolerability of Pasireotide [ Time Frame: At least 15 days ] [ Designated as safety issue: Yes ]Safety assessments consisted of recording all AEs and serious adverse events (SAEs), the regular monitoring of hematology, blood chemistry, vital signs, physical condition and body weight.
|Study Start Date:||January 2004|
|Study Completion Date:||July 2008|
|Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
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.
Other Name: SOM230
|United States, California|
|Cedars-Sinai Medical Center|
|Los Angeles, California, United States, 90048|
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|United States, Iowa|
|Univ. Of Iowa Holden Cancer Center|
|Iowa City, Iowa, United States, 52242|
|United States, Louisiana|
|Louisiana State University Medical Center|
|New Orleans, Louisiana, United States, 70112|
|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|