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LBH589 in Adult Patients With Advanced Solid Tumors or Cutaneous T-cell Lymphoma
This study is ongoing, but not recruiting participants.
Study NCT00412997   Information provided by Novartis
First Received: December 18, 2006   Last Updated: November 18, 2009   History of Changes

December 18, 2006
November 18, 2009
November 2006
 
To determine the maximum-tolerated dose of LBH589
Same as current
Complete list of historical versions of study NCT00412997 on ClinicalTrials.gov Archive Site
  • Safety and tolerability assessed by AEs, SAEs and laboratory values.
  • To characterize the pharmacokinetic (PK) profile of LBH589
  • To assess antitumor activity of LBH589
Same as current
 
LBH589 in Adult Patients With Advanced Solid Tumors or Cutaneous T-cell Lymphoma
A Phase I Dose-escalation Study of LBH589 Administered Orally in Adult Patients With Advanced Solid Tumors or Cutaneous T-cell Lymphoma

The phase I study will evaluate the safety, efficacy and pharmacokinetics of LBH589B in adult patients with advanced solid tumors or Cutaneous T-cell lymphoma

 
Phase I
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
  • Tumors
  • Cutaneous T-Cell Lymphoma
Drug: LBH589
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
18
 
 

Inclusion Criteria:

  • Patients with either a) histologically-confirmed, advanced solid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists, or b) cytopathologically confirmed cutaneous T-cell lymphoma (CTCL) whose disease has progressed despite standard therapy or for whom no standard therapy exists. Inclusion is irrespective of stage of disease or extent of prior therapy.
  • World Health Organization (WHO) Performance Status of ≤ 2
  • Patients must have the adequate laboratory values

Exclusion Criteria:

  • Patients with a history of primary CNS tumors
  • Patients with any history of brain metastases
  • Patients with any peripheral neuropathy ≥ CTCAE grade 2
  • Patients with unresolved diarrhea ≥ CTCAE grade 2
  • Impairment of cardiac function
  • Impairment of gastrointestinal (GI) function or GI disease
  • Liver or renal disease

Other protocol-defined inclusion/exclusion criteria may apply

Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00412997
External Affairs, Novartis Pharmaceuticals
CLBH589B1101
Novartis
 
Study Chair: Novartis Novartis
Novartis
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP