A Study to Investigate the Effects of Ketoconazole on LBH589 in Patients With Advanced Solid Tumors
NCT ID: NCT00503451
Last Updated: 2020-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
14 participants
INTERVENTIONAL
2007-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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LBH589
LBH589
Interventions
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LBH589
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
* Adequate kidney function and laboratory values
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Nevada Cancer Institute
Las Vegas, Nevada, United States
Novartis Investigative Site
Rotterdam, , Netherlands
Countries
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References
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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.
Related Links
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Results for CLBH589B2110 can be found on the Novartis Clinical Trial Results Website
Other Identifiers
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CLBH589B2110
Identifier Type: -
Identifier Source: org_study_id