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Tracking Information | |||||
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First Received Date † | August 18, 2008 | ||||
Last Updated Date | August 20, 2008 | ||||
Start Date † | July 2008 | ||||
Current Primary Outcome Measures † |
To characterize the safety and tolerability of LBH589, including acute and chronic toxicities in Japanese patients with advanced solid tumors. [ Time Frame: First cycle ] [ Designated as safety issue: Yes ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00739414 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Dose-Escalating Study of LBH589 in Adult Patients With Advanced Solid Tumors | ||||
Official Title † | A Phase IA, Dose-Escalating Study of LBH589 Administered Intravenously in Adult Patients With Advanced Solid Tumors | ||||
Brief Summary | This study will characterize the safety, tolerability, biological activity, and pharmacokinetics of LBH589 in Japanese patients with advanced solid tumors whose disease has progressed despite standard therapies, or for whom no standard therapy exists. |
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Detailed Description | |||||
Study Phase | Phase I | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study | ||||
Condition † |
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Intervention † | Drug: LBH589 | ||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Recruiting | ||||
Enrollment † | 18 | ||||
Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 20 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† |
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Location Countries † | Japan | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00739414 | ||||
Responsible Party | External Affairs, Novartis | ||||
Secondary IDs †† | |||||
Study Sponsor † | Novartis | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | Novartis | ||||
Verification Date | August 2008 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |