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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00570284 |
The primary purpose of this study is to evaluate the effect of food on oral LBH589 in adult patients with advanced solid tumors. This study will also evaluate the safety and efficacy of LBH589 in adult patients with advanced solid tumors
Condition | Intervention | Phase |
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Cancer |
Drug: LBH589 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Pharmacokinetics Study |
Official Title: | A Phase Ib Open-Label, Multicenter Cross-Over Study to Investigate the Effect of Food on the Rate and Extent of Oral LBH589 Absorption in Patients With Advanced Solid Tumors |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria
Exclusion criteria
Other protocol-defined inclusion/exclusion criteria may apply
United States, California | |
Los Angeles, California, United States | |
United States, Connecticut | |
Norwalk, Connecticut, United States | |
United States, Maryland | |
Rockville, Maryland, United States | |
United States, Massachusetts | |
Boston, Massachusetts, United States | |
United States, New Hampshire | |
Lebanon, New Hampshire, United States | |
United States, New York | |
New York, New York, United States | |
United States, Wisconsin | |
Madison, Wisconsin, United States | |
Sweden | |
Stokholm, Sweden | |
Switzerland | |
Zurich, Switzerland |
Study Chair: | Novartis | Novartis |
Responsible Party: | Novartis ( External Affairs ) |
Study ID Numbers: | CLBH589B2111 |
Study First Received: | December 7, 2007 |
Last Updated: | July 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00570284 |
Health Authority: | Sweden: Regional Ethical Review Board; Switzerland: Swissmedic; United States: Food and Drug Administration |
Cancer solid tumor food effect |
HDAC inhibitor oral LBH589 |