Study Evaluating SOM230 in Patients With Metastatic Carcinoid Tumors

NCT00088595 | Completed Phase 2 Results DMC

• 1 other identifier: CSOM230B2202
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 4

Brief Summary

Study evaluating SOM230 in patients with metastatic carcinoid tumors

Conditions

Carcinoid Tumors

Keywords

SOM230; Sandostatin; Carcinoid syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Duration of Complete Symptom Control (Days) by Dose Class

  15 days

• Duration of Partial Symptom Control (Days) by Dose Class

  up to 15 days

• The Number of Patients (Participants) With Overall Tumor Response

  At least 15 days

• The Overall Safety and Tolerability of Pasireotide

  At least 15 days

Study Arms (1)

Pasireotide

EXPERIMENTAL

Drug: Pasireotide (SOM230)

Interventions

Pasireotide (SOM230) DRUG

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.

Also known as: SOM230

Pasireotide

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (4)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Univ. Of Iowa Holden Cancer Center

Iowa City, Iowa, 52242, United States

Location

Louisiana State University Medical Center

New Orleans, Louisiana, 70112, United States

Location

MeSH Terms

Conditions

Carcinoid Tumor; Serotonin Syndrome

Interventions

pasireotide

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Limitations and Caveats

No formal statistical comparisons were performed for this study. Summary statistics were provided to compare the different doses administered for the primary and secondary endpoints.

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2004
• First Posted: August 2, 2004
• Study Start: January 1, 2004
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: June 4, 2012
• Results First Posted: May 6, 2011

Record last verified: 2012-05

Locations

US (4)