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Study of Panobinostat in Patients With Neuroendocrine Tumors

This study has been terminated.
(Study did not meet statistical requirements to continue.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00985946
First Posted: September 29, 2009
Last Update Posted: July 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
University of Wisconsin, Madison
Results First Submitted: March 17, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Neuroendocrine Tumors
Intervention: Drug: panobinostat (LBH589)

  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
This study actively recruited from April 2010 through May 2011 at a large cancer center in Wisconsin.

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
Panobinostat Adult patients with histologically confirmed, metastatic, low-grade NETs and an Eastern Cooperative Oncology Group (ECOG) performance status of ≤2 were treated with oral panobinostat 20 mg once daily three times per week. Treatment was continued until patients experienced unacceptable toxicities or disease progression. The study was stopped at planned interim analysis based on a Simon two-stage design.

Participant Flow:   Overall Study
    Panobinostat
STARTED   15 [1] 
COMPLETED   8 
NOT COMPLETED   7 
Lost to Follow-up                6 
Withdrawal by Subject                1 
[1] Eighty-seven percent (n=13) were evaluable for response.



  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
Panobinostat Adult patients with histologically confirmed, metastatic, low-grade NETs and an Eastern Cooperative Oncology Group (ECOG) performance status of ≤2 were treated with oral panobinostat 20 mg once daily three times per week. Treatment was continued until patients experienced unacceptable toxicities or disease progression. The study was stopped at planned interim analysis based on a Simon two-stage design.

Baseline Measures
   Panobinostat 
Overall Participants Analyzed 
[Units: Participants]
 15 
Age, Customized 
[Units: Participants]
 
40-49 years of age   3 
50-59 years of age   5 
60-69 years of age   4 
70-79 years of age   2 
>= 80 years of age   1 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      5  33.3% 
Male      10  66.7% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      0   0.0% 
Not Hispanic or Latino      13  86.7% 
Unknown or Not Reported      2  13.3% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      0   0.0% 
White      15 100.0% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   15 


  Outcome Measures
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1.  Primary:   Tumor Response Rate of Patients With Gastrointestinal Neuroendocrine Tumors Using Response Evaluation Criteria in Solid Tumors (RECIST) Criteria.   [ Time Frame: every 8 weeks, up to 5 years ]

2.  Secondary:   Number of Participants With Toxicities   [ Time Frame: up to 5 years ]

3.  Secondary:   Evaluate the Time to Progression for Patients With Gastrointestinal Neuroendocrine Tumors Treated With Panobinostat   [ Time Frame: Up to 5 years ]

4.  Secondary:   Delineate the Expression of Notch 1 in Neuroendocrine Tumor Samples Before and During Treatment With Panobinostat   [ Time Frame: Pre-treatment and up to week 12 ]

5.  Secondary:   Evaluate the Overall Survival of Patients With Gastrointestinal Neuroendocrine Tumors Treated With Panobinostat   [ Time Frame: Up to 5 years ]


  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
This study was terminated early because of the use of objective response rate as the primary outcome measure, which is a shortcoming of this study.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Noelle LoConte
Organization: University of Wisconsin Carbone Cancer Center
phone: 608-265-5883
e-mail: ns3@medicine.wisc.edu



Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00985946     History of Changes
Other Study ID Numbers: 2010-0050 (CO08209)
CLBH589BUS38T
First Submitted: September 25, 2009
First Posted: September 29, 2009
Results First Submitted: March 17, 2017
Results First Posted: July 17, 2017
Last Update Posted: July 17, 2017