Clinical Trial: Study Evaluating SOM230 in Patients With Metastatic Carcinoid Tumors

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: Study evaluating SOM230 in patients with metastatic carcinoid tumors

Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome: Symptom Control (Diarrhea/Flushing) Using a Patient Symptom Diary [ Time Frame: 15 days ]

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.



Original Primary Outcome:

Current Secondary Outcome:

  • Duration of Complete Symptom Control (Days) by Dose Class [ Time Frame: 15 days ]
    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 ]
    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 ]
    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 ]
    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.


Original Secondary Outcome:

Information By: Novartis

Dates:
Date Received: July 30, 2004
Date Started: January 2004
Date Completion:
Last Updated: May 29, 2012
Last Verified: May 2012