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
- Registration Number
- NCT00535951
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description LBH589 LBH589 -
- Primary Outcome Measures
Name Time Method Pharmacokinetic (PK) parameters first 10 days
- Secondary Outcome Measures
Name Time Method Safety (until disease progression, unacceptable toxicity or study completion) assessed by duration of patient participation first 10 days, day 10 through end of treatment plus follow-up Response rate assessed by comparing tumor size via radiology scans (CTs or MRIs) day 10 through end of treatment Tolerability (until disease progression, unacceptable toxicity or study completion) assessed by duration of patient participation day 10 through end of treatment
Trial Locations
- Locations (5)
Highlands Oncology Group
🇺🇸Fayetteville, Arkansas, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Medical College of Georgia
🇺🇸Augusta, Georgia, United States
RUSH Medical Center
🇺🇸Chicago, Illinois, United States
Novartis Investigative Site
🇨🇦Ontario, Canada