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| Sponsor: | Novartis Pharmaceuticals |
|---|---|
| Information provided by (Responsible Party): | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT00425555 |
Purpose
This study will evaluate the safety and efficacy of LBH489B in adult patients with refractory Cutaneous T-Cell Lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Cutaneous T-Cell Lymphoma |
Drug: Panobinostat |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Oral LBH589 in Adult Patients With Refractory Cutaneous T-Cell Lymphoma |
| Estimated Enrollment: | 118 |
| Study Start Date: | December 2006 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Previously treated with oral bexarotene |
Drug: Panobinostat
Other Name: LBH589
|
| Experimental: No prior oral bexarotene treatmemt |
Drug: Panobinostat
Other Name: LBH589
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Contacts and Locations
Show 50 Study Locations| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT00425555 History of Changes |
| Other Study ID Numbers: | CLBH589B2201 |
| Study First Received: | January 22, 2007 |
| Last Updated: | November 2, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Cutaneous T-Cell Lymphoma, adults Mycosis Fungoides Sézary Syndrome CTCL |
|
Lymphoma Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin |