- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00985946
Study of Panobinostat in Patients With Neuroendocrine Tumors
November 19, 2019 updated by: University of Wisconsin, Madison
A Phase II Trial of Panobinostat in Patients With Neuroendocrine Tumors
This summary will use Panobinostat (LBH589) in patients with neuroendocrine tumors to see how the patient's tumor responds to panobinostat.
Additionally, this study will examine how long it takes neuroendocrine tumor patient's cancer to progress while taking the drug and examine the overall survival of patients using panobinostat.
Also, the study will examine the toxicity and tolerability of panobinostat in the patient population.
Finally, this study will look at the effect of panobinostat on Notch 1 signaling before and after treatment with panobinostat.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Wisconsin
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Madison, Wisconsin, United States, 53792
- University of Wisconsin, Madison
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Histologically confirmed, metastatic, low grade neuroendocrine neoplasms. Small cell lung cancers, paragangliomas, and pheochromocytomas are excluded
- Must have measurable disease as defined by RECIST
- 4 weeks from completion of major surgery, chemotherapy, or other systemic therapy or local liver therapy to study registration. Concurrent octreotide is allowed.
- Not allowed to be on concurrent chemotherapy or radiation
- 18 years of age or older
- ECOG Performance status of equal to or less than 2
- Able to sign and date a written informed consent prior to participation in the study
- Baseline MUGA or ECHO must demonstrate LVEF greater than or equal to the lower limit of the institutional normal
- Must have the following laboratory criteria: Neutrophil count greater than 1500/mm3, platelet count greater than 100,000/mm3L, hemoglobin greater than or equal to 9 g/dL, AST/SGOT and ALT/SGPT less than or equal to 2.5 x ULN, serum bilirubin less than or equal to 1.5 x ULN, serum creatinine less than or equal to 1.5 x ULN, total serum calcium greater than or equal to LLN, serum potassium greater than or equal to LLN, serum sodium greater than or equal to LLN, serum albumin greater than or equal to LLN or 3g/dl,
- Women of child bearing potential must have a negative urine pregnancy test within 72 hours of first administration of study treatment and must be willing to use two methods of contraception
- Patients with a history of hypertension must be well controlled (to less than 150/90 mmHg) on a stable regimen of anti-hypertensive therapy
Exclusion Criteria:
- Prior HDAC, DAC, HSP90 inhibitors or valproic acid for the treatment of cancer
- Patients who will need valproic acid for any medical condition during the study or within 5 days prior to the first panobinostat treatment
- Impaired cardiac function including any of the following: Screening ECG with a QTc greater than 450 msec, patients with congenital long QT syndrome, history of unsustained ventricular tachycardia, any history of ventricular fibrillation or torsades de pointes, bradycardia defined as heart rate less than 50 beats per minutes, patients with a myocardial infarction or unstable angina within 6 months of study entry, congestive heart failure, right bundle branch block or left anterior hemiblock
- Uncontrolled hypertension
- Unresolved diarrhea greater than CTCAE grade 1
- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral panobinostat
- Other concurrent sever and/or uncontrolled medical conditions
- Patients with a history of another primary malignancy that, in the opinion of the investigator, would interfere with the assessment of the primary endpoint of the study
- Patients with known positivity for human immunodeficiency virus (HIV) or hepatitis C, baseline testing is not required
- Any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent
- Any medication which may cause QTc prolongation or inducing torsades de pointes
- Use of concomitant medications that may interact with panobinostat
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: panobinostat
This is a single arm trial.
All patients will take panobinostat
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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.
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every 8 weeks, up to 5 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Toxicities
Time Frame: up to 5 years
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Evaluate the toxicity and tolerability of panobinostat in the patient population
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up to 5 years
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Evaluate the Time to Progression for Patients With Gastrointestinal Neuroendocrine Tumors Treated With Panobinostat
Time Frame: Up to 5 years
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Up to 5 years
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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
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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.
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Pre-treatment and up to week 12
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Evaluate the Overall Survival of Patients With Gastrointestinal Neuroendocrine Tumors Treated With Panobinostat
Time Frame: Up to 5 years
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Up to 5 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Noelle LoConte, MD, University of Wisconsin, Madison
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2010
Primary Completion (Actual)
April 1, 2015
Study Completion (Actual)
April 1, 2015
Study Registration Dates
First Submitted
September 25, 2009
First Submitted That Met QC Criteria
September 28, 2009
First Posted (Estimate)
September 29, 2009
Study Record Updates
Last Update Posted (Actual)
December 9, 2019
Last Update Submitted That Met QC Criteria
November 19, 2019
Last Verified
June 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CO08209
- A534260 (Other Identifier: UW Madison)
- SMPH\MEDICINE\HEM-ONC (Other Identifier: UW Madison)
- CLBH589BUS38T (Other Grant/Funding Number: Novartis)
- 2010-0050 (Other Identifier: Institutional Review Board)
- 2014-1298 (Other Identifier: Institutional Review Board)
- NCI-2011-00320 (Registry Identifier: NCI Trial ID)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neuroendocrine Tumors
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Jiangsu HengRui Medicine Co., Ltd.RecruitingAdvanced Gastroenteropancreatic Neuroendocrine TumorChina
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Jiangsu HengRui Medicine Co., Ltd.Not yet recruitingAdvanced Gastroenteropancreatic Neuroendocrine Tumor
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Amr Mohamed MDNovatek PharmaceuticalsActive, not recruitingNeuroendocrine Carcinoma | Gastroenteropancreatic Neuroendocrine Tumor | Gastroenteropancreatic Neuroendocrine Neoplasm | Mixed Neuroendocrine-Non Neuroendocrine NeoplasmUnited States
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Francesco De CobelliCompleted
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Grupo Espanol de Tumores NeuroendocrinosActive, not recruitingNeuroendocrine Tumors | Neuroendocrine Neoplasm | Gastroenteropancreatic Neuroendocrine TumorSpain
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Centre Leon BerardCompleted
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NovartisCompletedCutaneous T-Cell Lymphoma | TumorsJapan
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Novartis PharmaceuticalsCompletedAdvanced Solid TumorsSwitzerland, Netherlands, United States, United Kingdom
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Duke UniversityNovartisWithdrawn
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SCRI Development Innovations, LLCNovartis; Onyx Therapeutics, Inc.CompletedMultiple MyelomaUnited States
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Peter MacCallum Cancer Centre, AustraliaCompletedMultiple Myeloma | Nodal Lymphoma | Lymphoma With Cutaneous Involvement | Lymphoma in Leukemic Phase | Marrow Involvement With LymphomaAustralia