Back to resultsStudy Evaluating SOM230 in Patients With Metastatic Carcinoid Tumors
Primary Purpose
Carcinoid Tumors
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pasireotide (SOM230)
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoid Tumors focused on measuring SOM230, Sandostatin, Carcinoid syndrome
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
Sites / Locations
- Cedars-Sinai Medical Center
- H. Lee Moffitt Cancer Center and Research Institute
- Univ. Of Iowa Holden Cancer Center
- Louisiana State University Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pasireotide
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00088595
Brief Title
Study Evaluating SOM230 in Patients With Metastatic Carcinoid Tumors
Official Title
An Open-label, Multicenter, Phase II Study Evaluating the Safety and Efficacy of Twice Daily Dosing of SOM230 in Patients With Metastatic Carcinoid Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Study evaluating SOM230 in patients with metastatic carcinoid tumors
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoid Tumors
Keywords
SOM230, Sandostatin, Carcinoid syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pasireotide
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Pasireotide (SOM230)
Other Intervention Name(s)
SOM230
Intervention Description
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.
Primary Outcome Measure Information:
Title
Symptom Control (Diarrhea/Flushing) Using a Patient Symptom Diary
Description
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.
Time Frame
15 days
Secondary Outcome Measure Information:
Title
Duration of Complete Symptom Control (Days) by Dose Class
Description
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.
Time Frame
15 days
Title
Duration of Partial Symptom Control (Days) by Dose Class
Description
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.
Time Frame
up to 15 days
Title
The Number of Patients (Participants) With Overall Tumor Response
Description
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.
Time Frame
At least 15 days
Title
The Overall Safety and Tolerability of Pasireotide
Description
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.
Time Frame
At least 15 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Univ. Of Iowa Holden Cancer Center
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Louisiana State University Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
12. IPD Sharing Statement
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Study Evaluating SOM230 in Patients With Metastatic Carcinoid Tumors
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