Study Evaluating SOM230 in Patients With Metastatic Carcinoid Tumors

Carcinoid Tumors Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00088595
• Other study ID #: CSOM230B2202
• Status: Completed
• Phase: Phase 2
• First received: July 30, 2004
• Last updated: May 29, 2012
• Start date: January 2004
• Est. completion date: July 2008

Study information

• Verified date: May 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Study evaluating SOM230 in patients with metastatic carcinoid tumors

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoid Tumor
• Carcinoid Tumors
• Neuroendocrine Tumors

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Univ. Of Iowa Holden Cancer Center	Iowa City	Iowa
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Louisiana State University Medical Center	New Orleans	Louisiana
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes