Study Evaluating SOM230 in Patients With Metastatic Carcinoid Tumors

Study Overview
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Brief Summary
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Study evaluating SOM230 in patients with metastatic carcinoid tumors

Official Title
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An Open-label, Multicenter, Phase II Study Evaluating the Safety and Efficacy of Twice Daily Dosing of SOM230 in Patients With Metastatic Carcinoid Tumors

Conditions
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Carcinoid Tumors

Intervention / Treatment
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* Drug: Pasireotide (SOM230)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pasireotide<br> | Drug: Pasireotide (SOM230)<br>* 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.<br>* Other names: SOM230;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom Control (Diarrhea/Flushing) Using a Patient Symptom Diary | Complete Symptom Control: an average of ≤ 3 bowel movements per day for at least 15 consecutive days, with no more than 3 episodes on any given day, and no episodes of flushing over the time interval being studied. Partial Symptom Control: an average of < 4 bowel movements per day for at least 15 consecutive days, with no more than 6 episodes per given day, and an average of fewer than 2 daily flushing episodes over the same given time interval. Treatment failure: Failure to obtain partial or complete treatment success over a consecutive 15-day period at a constant dose level. | 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Complete Symptom Control (Days) by Dose Class | Complete symptom control: an average of three or less bowel movements per day for at least 15 consecutive days, with no more than three episodes on any given day, and no episodes of flushing over the time interval being studied. | 15 days | 
| Duration of Partial Symptom Control (Days) by Dose Class | Partial symptom control: an average of less than four bowel movements per day for at least 15 consecutive days, with no more than six episodes per any given day, and an average of less than two daily flushing episodes over the same given time interval. | up to 15 days | 
| The Number of Patients (Participants) With Overall Tumor Response | The disappearance of all lesions was considered a complete response and at least a 30% decrease in the diameter of lesions was considered a partial response (PR). Progressive disease (PD) required a 20% increase in the sum of the diameters of lesions and changes that did not qualify for PR or PD were considered stable disease. Progression not documented was defined as unknown. No more than a 10% increase in biochemical values, and no clinical signs of DP with complete or adequate control over symptoms were defined as complete treatment success and partial treatment success, respectively. | At least 15 days | 
| The Overall Safety and Tolerability of Pasireotide | Safety assessments consisted of recording all AEs and serious adverse events (SAEs), the regular monitoring of hematology, blood chemistry, vital signs, physical condition and body weight. | At least 15 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SOM230, Sandostatin, Carcinoid syndrome