Status:
COMPLETED
Study Evaluating SOM230 in Patients With Metastatic Carcinoid Tumors
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Carcinoid Tumors
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
Study evaluating SOM230 in patients with metastatic carcinoid tumors
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00088595
Start Date
January 1 2004
End Date
July 1 2008
Last Update
June 4 2012
Active Locations (4)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
2
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
3
Univ. Of Iowa Holden Cancer Center
Iowa City, Iowa, United States, 52242
4
Louisiana State University Medical Center
New Orleans, Louisiana, United States, 70112