Study Evaluating SOM230 in Patients With Metastatic Carcinoid Tumors

NCT ID: NCT00088595

Last Updated: 2012-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-01-31
• Study Completion Date: 2008-07-31

Brief Summary

Study evaluating SOM230 in patients with metastatic carcinoid tumors

Conditions

Carcinoid Tumors

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pasireotide

Group Type: EXPERIMENTAL

Pasireotide (SOM230)

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

SOM230

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Cedars-Sinai Medical Center

Los Angeles, California, United States

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Univ. Of Iowa Holden Cancer Center

Iowa City, Iowa, United States

Louisiana State University Medical Center

New Orleans, Louisiana, United States

Countries

United States

Other Identifiers

CSOM230B2202

Identifier Type: -

Identifier Source: org_study_id