Study Evaluating SOM230 in Patients With Metastatic Carcinoid Tumors
Condition: Carcinoid Tumors
MeSH terms: Carcinoid Tumor
Intervention: Pasireotide (SOM230)
Intervention description: 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.
Intervention MeSH terms: Pasireotide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: SOM230; Sandostatin; Carcinoid syndrome

Summary:

      Study evaluating SOM230 in patients with metastatic carcinoid tumors
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with biopsy-proven metastatic carcinoid tumors

          -  Patients with at least one measurable lesion (excluding bone)

          -  Patients must be considered inadequately controlled while on Sandostatin LAR therapy
             based on the symptoms of carcinoid syndrome (diarrhea and/or flushing) as defined as
             experiencing a minimum average of at least four bowel movements per day or a minimum
             average of at least two episodes of flushing per day

        Exclusion Criteria:

          -  Patients who have been previously treated with certain medications may be required to
             be without certain medications prior to entering the study

          -  Patients who have undergone major recent surgery / surgical therapy for any cause
             within 1 month

          -  Patients on any cytotoxic chemotherapy or interferon therapy within the last 2 months

          -  Patients with uncontrolled diabetes mellitus

          -  Patients who had received radiotherapy for any reason within the last 4 weeks must
             have recovered from any side effects of radiotherapy

          -  Patients who have congestive heart failure unstable angina, cardiac arrhythmia or a
             history of acute myocardial infarction within the three months preceding enrollment

          -  Patients with chronic liver disease

          -  Female patients who are pregnant or lactating, or are of childbearing potential and
             not practicing a medically acceptable method for birth control.

          -  History of immunocompromise, including a positive HIV test result

          -  Patients who have a history of alcohol or drug abuse in the 6 month period prior to
             receiving SOM230

          -  Patients who have given a blood donation (of 400 mL or more) within 2 months before
             receiving SOM230

          -  Patients who have participated in any clinical investigation with an investigational
             drug within 1 month prior to dosing

          -  Patients with additional active malignant disease within the last five years