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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.

Sponsored by: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00412997
  Purpose

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


Condition Intervention Phase
Tumors
Cutaneous T-Cell Lymphoma
Drug: LBH589
Phase I

MedlinePlus related topics:   Cancer    Lymphoma   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:   A Phase I Dose-Escalation Study of LBH589 Administered Orally in Adult Patients With Advanced Solid Tumors or Cutaneous T-Cell Lymphoma

Further study details as provided by Novartis:

Primary Outcome Measures:
  • To determine the maximum-tolerated dose of LBH589

Secondary Outcome Measures:
  • Safety and tolerability assessed by AEs, SAEs and laboratory values.
  • To characterize the pharmacokinetic (PK) profile of LBH589
  • To assess antitumor activity of LBH589

Estimated Enrollment:   18
Study Start Date:   November 2006

  Eligibility
Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00412997

Locations
Japan
      Tokyo, Japan

Sponsors and Collaborators
Novartis

Investigators
Study Chair:     Novartis     Novartis    
  More Information

Study ID Numbers:   CLBH589B1101
First Received:   December 18, 2006
Last Updated:   January 25, 2008
ClinicalTrials.gov Identifier:   NCT00412997
Health Authority:   Japan: Ministry of Health, Labor and Welfare

Keywords provided by Novartis:
Solid tumor  
Cutaneous T-cell lymphoma  
Phase I  
HDAC inhibitor  
Adult patients with advanced solid tumors or cutaneous T-cell lymphoma whose disease has progressed  

Study placed in the following topic categories:
Lymphatic Diseases
Mycoses
Sezary syndrome
Immunoproliferative Disorders
Cutaneous T-cell lymphoma
Lymphoma, T-Cell
Sezary Syndrome
Mycosis Fungoides
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Lymphoma, T-Cell, Cutaneous

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on September 05, 2008




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