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

Sponsored by:Novartis Pharmaceuticals
Information provided:Novartis
ClinicalTrials.gov Identifier:NCT00535951

Purpose:

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

Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
Mesothelioma
Drug: LBH589
Phase 1

Eligibility

Study Design: Allocation: Non-Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Official Title: A Phase IB, Open-Label, Multicenter Study to Investigate the Effect of Oral LBH589 on Dextromethorphan, a CYP2D6 Substrate, and to Assess the Efficacy and Safety of Oral LBH589 in Patients With Advanced Solid Tumors

Enrollment Size: Both

Gender: 18 Years

Min. Age: N/A

Max. Age: No

Location and Contact Information

United States, Arkansas
Highlands Oncology Group, Fayetteville, Arkansas, 72703, United States
Status:

United States, Georgia
Medical College of Georgia, Augusta, Georgia, 30912, United States
Status:

United States, Illinois
RUSH Medical Center, Chicago, Illinois, 60612, United States
Status:

United States, Texas
MD Anderson Cancer Center, Houston, Texas, 77030, United States
Status:

, Canada
Novartis Investigative Site, Ontario, Canada, ,
Status:

Last modified: July 29 2010.