Study Evaluating SOM230 in Patients With Metastatic Carcinoid Tumors

Novartis

Status and phase: Completed; Phase 2

Conditions: Carcinoid Tumors

Treatments: Drug: Pasireotide (SOM230)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00088595

CSOM230B2202

Details and patient eligibility

About

Study evaluating SOM230 in patients with metastatic carcinoid tumors

Enrollment: 45 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

45 participants in 1 patient group

Pasireotide

Experimental group

Treatment:

Drug: Pasireotide (SOM230)