Study of Panobinostat in Patients With Neuroendocrine Tumors
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|ClinicalTrials.gov Identifier: NCT00985946|
Recruitment Status : Terminated (Study did not meet statistical requirements to continue.)
First Posted : September 29, 2009
Results First Posted : July 17, 2017
Last Update Posted : July 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|Neuroendocrine Tumors||Drug: panobinostat (LBH589)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Panobinostat in Patients With Neuroendocrine Tumors|
|Study Start Date :||May 2010|
|Primary Completion Date :||April 2015|
|Study Completion Date :||April 2015|
This is a single arm trial. All patients will take panobinostat
Drug: panobinostat (LBH589)
Panobinostat will be taken once daily at 20 mg three times a week (every Monday, Wednesday, Friday). It will be taken as long as patients are benefiting from treatment.
- 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 ]Confirmed anti-tumor response rate will be validated by the Response Evaluation Criteria in Solid Tumors (RECIST). All participants included in the study will be assessed for response to the proposed panobinostat treatment, even if there are protocol treatment deviations. Each participant will be assigned one of the following categories: complete response, partial response, stable disease, progressive disease, early death from malignant disease, early death from toxicity, early death because of other cause, or unknown.
- Number of Participants With Toxicities [ Time Frame: up to 5 years ]Evaluate the toxicity and tolerability of panobinostat in the patient population
- Evaluate the Time to Progression for Patients With Gastrointestinal Neuroendocrine Tumors Treated With Panobinostat [ Time Frame: Up to 5 years ]
- 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 ]The expression of Notch 1 in neuroendocrine tumor samples will be evaluated prior to Cycle 1 Day 1 dose and at the end of Cycle 2 of treatment of treatment.
- Evaluate the Overall Survival of Patients With Gastrointestinal Neuroendocrine Tumors Treated With Panobinostat [ Time Frame: Up to 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00985946
|United States, Wisconsin|
|University of Wisconsin, Madison|
|Madison, Wisconsin, United States, 53792|
|Principal Investigator:||Noelle LoConte, MD||University of Wisconsin, Madison|