Study Evaluating SOM230 in Patients With Metastatic Carcinoid Tumors

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Study evaluating SOM230 in patients with metastatic carcinoid tumors

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Pasireotide

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