A Study to Investigate the Effects of Ketoconazole on LBH589 in Patients With Advanced Solid Tumors
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.
1 other identifier
interventional
14
2 countries
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 17, 2007
CompletedFirst Posted
Study publicly available on registry
July 18, 2007
CompletedStudy Start
First participant enrolled
September 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedDecember 19, 2020
November 1, 2012
2.6 years
July 17, 2007
December 16, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Levels of LBH589 in the blood on days 1, 5, 8, 9 and 10 of first cycle
2 weeks
Secondary Outcomes (1)
Safety, tolerability and efficacy of oral LBH589 throughout the study
at least every 2 months
Study Arms (1)
LBH589
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Nevada Cancer Institute
Las Vegas, Nevada, 89135, United States
Novartis Investigative Site
Rotterdam, Netherlands
Related Publications (1)
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.
PMID: 21706316DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2007
First Posted
July 18, 2007
Study Start
September 1, 2007
Primary Completion
April 1, 2010
Last Updated
December 19, 2020
Record last verified: 2012-11