Back to resultsA Study to Investigate the Effects of Ketoconazole on LBH589 in Patients With Advanced Solid Tumors
Primary Purpose
Non-Hodgkin Lymphoma, Neoplasms
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
LBH589
Sponsored by
About this trial
This is an interventional treatment trial for Non-Hodgkin Lymphoma focused on measuring Advanced cancer, solid tumors, lymphoma, HDAC, LBH589, adults, non-Hodgkin's lymphoma
Eligibility Criteria
Inclusion criteria:
- Patients with histologically confirmed solid tumors or non-Hodgkin's lymphoma with progression on prior standard therapies.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
- Adequate kidney function and laboratory values
Exclusion criteria:
- Patients who have received chemotherapy, any investigational drug, undergone major surgery, or received wide field radiotherapy less than 4 weeks ago
- Patients who had a heart attack or have unstable angina within past 6 months
- Heart disease including congestive heart failure and uncontrolled high blood pressure
- Liver disease, abnormal gastrointestinal (GI) function or ongoing diarrhea
- Use of any anti-cancer therapy, including radiation therapy, or certain drugs while on study
- Female patients who are pregnant or breast feeding.
Other protocol inclusion/exclusion criteria may apply.
Sites / Locations
- Nevada Cancer Institute
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
LBH589
Arm Description
Outcomes
Primary Outcome Measures
Levels of LBH589 in the blood on days 1, 5, 8, 9 and 10 of first cycle
Secondary Outcome Measures
Safety, tolerability and efficacy of oral LBH589 throughout the study
Full Information
NCT ID
NCT00503451
First Posted
July 17, 2007
Last Updated
December 16, 2020
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00503451
Brief Title
A Study to Investigate the Effects of Ketoconazole on LBH589 in Patients With Advanced Solid Tumors
Official Title
A Phase IB, Study to Investigate the Effect of Ketoconazole, a CYP3A4 Inhibitor, on Oral LBH589 and to Assess the Efficacy and Safety of Oral LBH589 in Patients With Advanced Solid Tumors.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
5. Study Description
Brief Summary
The primary purpose of this open-label study is to investigate the interaction of ketoconazole, a liver enzyme inhibitor, on oral LBH589 in adult patients with advanced solid tumors. The extension phase of the study will evaluate the safety and efficacy of LBH589 in patients with advanced solid tumors.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin Lymphoma, Neoplasms
Keywords
Advanced cancer, solid tumors, lymphoma, HDAC, LBH589, adults, non-Hodgkin's lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LBH589
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
LBH589
Other Intervention Name(s)
Panobinostat
Primary Outcome Measure Information:
Title
Levels of LBH589 in the blood on days 1, 5, 8, 9 and 10 of first cycle
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Safety, tolerability and efficacy of oral LBH589 throughout the study
Time Frame
at least every 2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Patients with histologically confirmed solid tumors or non-Hodgkin's lymphoma with progression on prior standard therapies.
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
Adequate kidney function and laboratory values
Exclusion criteria:
Patients who have received chemotherapy, any investigational drug, undergone major surgery, or received wide field radiotherapy less than 4 weeks ago
Patients who had a heart attack or have unstable angina within past 6 months
Heart disease including congestive heart failure and uncontrolled high blood pressure
Liver disease, abnormal gastrointestinal (GI) function or ongoing diarrhea
Use of any anti-cancer therapy, including radiation therapy, or certain drugs while on study
Female patients who are pregnant or breast feeding.
Other protocol inclusion/exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Nevada Cancer Institute
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89135
Country
United States
Facility Name
Novartis Investigative Site
City
Rotterdam
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
21706316
Citation
Hamberg P, Woo MM, Chen LC, Verweij J, Porro MG, Zhao L, Li W, van der Biessen D, Sharma S, Hengelage T, de Jonge M. Effect of ketoconazole-mediated CYP3A4 inhibition on clinical pharmacokinetics of panobinostat (LBH589), an orally active histone deacetylase inhibitor. Cancer Chemother Pharmacol. 2011 Sep;68(3):805-13. doi: 10.1007/s00280-011-1693-x. Epub 2011 Jun 26.
Results Reference
derived
Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=4102
Description
Results for CLBH589B2110 can be found on the Novartis Clinical Trial Results Website
Learn more about this trial
A Study to Investigate the Effects of Ketoconazole on LBH589 in Patients With Advanced Solid Tumors
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