Study Evaluating SOM230 in Patients With Metastatic Carcinoid Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00088595
First received: July 30, 2004
Last updated: May 29, 2012
Last verified: May 2012
Results First Received: January 21, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Carcinoid Tumors
Intervention: Drug: Pasireotide (SOM230)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Pasireotide (Any Dose) SOM230 (Pasireotide), 150µg twice daily dose titration up to 1200µg twice daily, subcutaneous injection.

Participant Flow:   Overall Study
    Pasireotide (Any Dose)  
STARTED     45  
COMPLETED     17  
NOT COMPLETED     28  
Adverse Event                 11  
Withdrawal by Subject                 8  
Ongoing (After Core)                 7  
New Cancer Therapy                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Pasireotide (Any Dose) SOM230 (Pasireotide), 150µg twice daily dose titration up to 1200µg twice daily, subcutaneous injection.

Baseline Measures
    Pasireotide (Any Dose)  
Number of Participants  
[units: participants]
  45  
Age  
[units: years]
Mean ± Standard Deviation
  61.0  ± 8.72  
Gender  
[units: participants]
 
Female     20  
Male     25  
Region of Enrollment  
[units: participants]
 
United States     24  
Sweden     5  
Germany     11  
Netherlands     4  
France     1  



  Outcome Measures
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1.  Primary:   Symptom Control (Diarrhea/Flushing) Using a Patient Symptom Diary   [ Time Frame: 15 days ]

2.  Secondary:   Duration of Complete Symptom Control (Days) by Dose Class   [ Time Frame: 15 days ]

3.  Secondary:   Duration of Partial Symptom Control (Days) by Dose Class   [ Time Frame: up to 15 days ]

4.  Secondary:   The Number of Patients (Participants) With Overall Tumor Response   [ Time Frame: At least 15 days ]

5.  Secondary:   The Overall Safety and Tolerability of Pasireotide   [ Time Frame: At least 15 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300


No publications provided


Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00088595     History of Changes
Other Study ID Numbers: CSOM230B2202
Study First Received: July 30, 2004
Results First Received: January 21, 2011
Last Updated: May 29, 2012
Health Authority: United States: Food and Drug Administration