Study Evaluating SOM230 in Patients With Metastatic Carcinoid Tumors

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 evaluating SOM230 in patients with metastatic carcinoid tumors

Study Overview

• Status: Completed
• Conditions: Carcinoid Tumors
• Intervention / Treatment: Drug: Pasireotide (SOM230)

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center
  • Florida
    • Tampa, Florida, United States, 33612
      • H. Lee Moffitt Cancer Center and Research Institute
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Univ. Of Iowa Holden Cancer Center
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Louisiana State University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Pasireotide

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.; Other Names: SOM230

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: January 1, 2004
• Primary Completion (Actual): July 1, 2008
• Study Completion (Actual): July 1, 2008

Study Registration Dates

• First Submitted: July 30, 2004
• First Submitted That Met QC Criteria: July 30, 2004
• First Posted (Estimate): August 2, 2004

Study Record Updates

• Last Update Posted (Estimate): June 4, 2012
• Last Update Submitted That Met QC Criteria: May 29, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: Sandostatin; SOM230; Carcinoid syndrome
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Carcinoid Tumor; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pasireotide
• Other Study ID Numbers: CSOM230B2202