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Sponsored by: |
Novartis Pharmaceuticals |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00739414 |
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.
Condition | Intervention | Phase |
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Cancer Advanced Solid Tumor |
Drug: LBH589 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | A Phase IA, Dose-Escalating Study of LBH589 Administered Intravenously in Adult Patients With Advanced Solid Tumors |
Estimated Enrollment: | 18 |
Study Start Date: | July 2008 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: LBH589
10, 15, 20 mg/m2, i.v. on day 1 and 8 of each 21 day cycle
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Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Novartis Pharmaceuticals | +81-3-3797-8748 |
Japan | |
Novartis Investigational Site | Recruiting |
Hokkaido, Japan | |
Novartis Investigational Site | Recruiting |
Aichi prefecture, Japan | |
Novartis Investigational Site | Recruiting |
Hyogo prefecture, Japan |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmeceuticals |
Responsible Party: | Novartis Pharmaceuticals ( External Affairs ) |
Study ID Numbers: | CLBH589A1101 |
Study First Received: | August 18, 2008 |
Last Updated: | May 26, 2009 |
ClinicalTrials.gov Identifier: | NCT00739414 History of Changes |
Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Histone Deacetylases HDAC inhibitor LBH589 Advanced solid tumor Adult |