Study Evaluating SOM230 in Patients With Metastatic Carcinoid Tumors

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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

Brief Summary

      Study evaluating SOM230 in patients with metastatic carcinoid tumors
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 Duration of Complete Symptom Control (Days) by Dose Class

Condition

Carcinoid Tumors

Intervention

Pasireotide (SOM230)

Study Arms / Comparison Groups

 Pasireotide
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

45

Start Date

January 2004

Completion Date

July 2008

Primary Completion Date

July 2008

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
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Novartis Pharmaceuticals, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00088595

Organization ID

CSOM230B2202


Responsible Party

Sponsor

Study Sponsor

Novartis Pharmaceuticals


Study Sponsor

Novartis Pharmaceuticals, Study Director, Novartis Pharmaceuticals


Verification Date

May 2012