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

Completed · Phase 1

Conditions studied: Carcinoma, Non-Small-Cell Lung, Mesothelioma

In brief

This study will investigate the effect of oral LBH589 on dextromethorphan, a CYP2D6 substrate, and to assess safety and efficacy of oral LBH589 when used with this co-medication in advanced stage NSCLC or malignant pleural mesothelioma patients

Key facts

Study ID

NCT00535951

Run by

Novartis Pharmaceuticals

People needed

18

Starts

2007-11-01

Last updated by the study team

2020-12-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years
• 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
• Must have failed prior standard systemic therapy
• Must have at least one measurable and/or non-measurable lesion as defined by RECIST criteria
• Baseline MUGA or ECHO must demonstrate LVEF ≥ the lower limit of the institutional normal.
• Written informed consent obtained prior to any screening procedures
• Willingness to have multiple blood draws
• Ability to swallow capsules or tablets

You may not qualify if…

• Uncontrolled brain metastases
• Prior treatment with an HDAC inhibitor
• 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
• Concomitant use of any anti-cancer therapy, including radiation therapy
• Significant cardiac disease
• Concomitant use of drugs with a risk of causing torsades de pointes
• Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral LBH589
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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