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| Sponsored by: |
Novartis |
| 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: LBH 589 |
Phase I |
| MedlinePlus related topics: | Cancer Lung Cancer Mesothelioma |
| Drug Information available for: | Dextromethorphan Dextromethorphan hydrobromide Levomethorphan Racemethorphan |
| 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 |
| Estimated Enrollment: | 24 |
| Study Start Date: | September 2007 |
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| Contact: Novartis U.S. | 800 340 6843 | |
| Contact: Novartis Basel | 41 61 324 1111 |
| United States, Arkansas | |||||
| Highlands Oncology Group | Recruiting | ||||
| Fayetteville, Arkansas, United States, 72703 | |||||
| Contact: Kim Davison 479-587-1700 ext 4171 kdavison@hogonc.com | |||||
| Principal Investigator: J. T. Beck, M.D | |||||
| United States, Georgia | |||||
| Medical College of Georgia | Not yet recruiting | ||||
| Augusta, Georgia, United States, 30912 | |||||
| Contact: Eileen Dickman 706-721-1599 edickman@mail.mcg.edu | |||||
| Principal Investigator: Asha Nayak, M.D. | |||||
| United States, Illinois | |||||
| RUSH Medical Center | Recruiting | ||||
| Chicago, Illinois, United States | |||||
| Contact: Robert Bonomi, M.D. | |||||
| United States, Texas | |||||
| MD Anderson Cancer Center | Recruiting | ||||
| Houston, Texas, United States | |||||
| Contact: Vali Papa, M.D. | |||||
| Canada | |||||
| Recruiting | |||||
| Ontario, Canada | |||||
| Novartis |
| Study Chair: | Novartis | Novartis |
More Information
| Study ID Numbers: | CLBH589B2109 |
| First Received: | September 26, 2007 |
| Last Updated: | July 7, 2008 |
| ClinicalTrials.gov Identifier: | NCT00535951 |
| Health Authority: | Canada: Health Canada (Sante Canada); United States: Food and Drug Administration |
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