Pharmacokinetic, Safety, and Efficacy Effects of Oral LBH589 on Dextromethorphan in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer or Malignant Pleural Mesothelioma
NCT ID: NCT00535951
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
18 participants
INTERVENTIONAL
2007-11-30
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
Eligibility Criteria
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Inclusion Criteria
2. Must have histologically or cytologically confirmed advanced or metastatic incurable solid tumor as documented by CT or MRI that has progressed on or following standard therapies
3. Must have failed prior standard systemic therapy
4. Must have at least one measurable and/or non-measurable lesion as defined by RECIST criteria
5. Baseline MUGA or ECHO must demonstrate LVEF ≥ the lower limit of the institutional normal.
6. Written informed consent obtained prior to any screening procedures
7. Willingness to have multiple blood draws
8. Ability to swallow capsules or tablets
Exclusion Criteria
2. Prior treatment with an HDAC inhibitor
3. Presence of clinically detectable third-space fluid collections (e.g., ascites or pleural effusions) that can not be controlled by drainage or other procedures prior to study entry
4. Concomitant use of any anti-cancer therapy, including radiation therapy
5. Significant cardiac disease
6. Concomitant use of drugs with a risk of causing torsades de pointes
7. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral LBH589
8. Previous use of monoamine oxidase inhibitors (e.g. clorgyline, iproniazid, isocarboxazid, moclobemide, sibutramine, phenelzine, tranylcypromine) within 14 days prior to the first dose of dextromethorphan
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 Pharmeceuticals
Locations
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Highlands Oncology Group
Fayetteville, Arkansas, United States
Medical College of Georgia
Augusta, Georgia, United States
RUSH Medical Center
Chicago, Illinois, United States
MD Anderson Cancer Center
Houston, Texas, United States
Novartis Investigative Site
Ontario, , Canada
Countries
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Related Links
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Results for CLBH589B2109 can be found on the Novartis Clinical Trial Results Website
Other Identifiers
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CLBH589B2109
Identifier Type: -
Identifier Source: org_study_id