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| Sponsor: | Novartis Pharmaceuticals |
|---|---|
| Information provided by: | 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 I |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
| 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: | 18 |
| Study Start Date: | November 2007 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| LBH589: Experimental | Drug: LBH589 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Inclusion criteria:
Contacts and Locations| United States, Arkansas | |
| Highlands Oncology Group | |
| Fayetteville, Arkansas, United States, 72703 | |
| United States, Georgia | |
| Medical College of Georgia | |
| Augusta, Georgia, United States, 30912 | |
| United States, Illinois | |
| RUSH Medical Center | |
| Chicago, Illinois, United States | |
| United States, Texas | |
| MD Anderson Cancer Center | |
| Houston, Texas, United States | |
| Canada | |
| Ontario, Canada | |
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmeceuticals |
More Information
| Responsible Party: | Novartis Pharmaceuticals ( External Affairs ) |
| Study ID Numbers: | CLBH589B2109 |
| Study First Received: | September 26, 2007 |
| Last Updated: | September 21, 2009 |
| ClinicalTrials.gov Identifier: | NCT00535951 History of Changes |
| Health Authority: | Canada: Health Canada (Sante Canada); United States: Food and Drug Administration |
|
Non-small cell lung cancer NSCLC lung cancer pleural mesothelioma malignant advanced stage mesothelioma |
phase I LBH589 dextromethorphan CYP2D6 oral Non-small Cell Lung Cancer Pleural Mesothelioma |
|
Thoracic Neoplasms Respiratory System Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Neoplasms, Mesothelial Physiological Effects of Drugs Excitatory Amino Acid Agents Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Excitatory Amino Acid Antagonists Respiratory Tract Neoplasms |
Neoplasms by Histologic Type Pharmacologic Actions Carcinoma Neoplasms Lung Diseases Dextromethorphan Mesothelioma Antitussive Agents Adenoma Carcinoma, Non-Small-Cell Lung Central Nervous System Agents Neoplasms, Glandular and Epithelial |