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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


Phase 2
18 Years
80 Years
Not Enrolling
Both
Carcinoid Tumors

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Symptom Control (Diarrhea/Flushing) Using a Patient Symptom Diary

Outcome 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.

Outcome Time Frame:

15 days

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CSOM230B2202

NCT ID:

NCT00088595

Start Date:

January 2004

Completion Date:

July 2008

Related Keywords:

  • Carcinoid Tumors
  • SOM230
  • Sandostatin
  • Carcinoid syndrome
  • Carcinoid Tumor

Name

Location

H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Cedars-Sinai Medical CenterLos Angeles, California  90048
Louisiana State University Medical CenterLafayette, Louisiana  70502-4016
Univ. Of Iowa Holden Cancer CenterIowa City, Iowa  52242