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A Study to Determine the Absorption, Distribution, Metabolism, and Excretion of LBH589

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00472368
First Posted: May 11, 2007
Last Update Posted: May 1, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
This single center study will help determine the absorption, metabolism, and excretion of LBH589 and to assess the safety and efficacy of LBH589 in advanced cancer patients for whom no standard therapy exists.

Condition Intervention Phase
Cancer Patients With Advanced Solid Tumors Including Lymphoma or Chronic Hematological Malignancies Drug: LBH589 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Single Center, Study to Determine the Absorption, Distribution, Metabolism, and Excretion (ADME) of LBH589 After a Single Oral Administration of 20 mg (14C) LBH589 in Advanced Cancer Patients

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Rates and routes of excretion of LBH589 and its metabolites in urine and feces following administration of a single oral dose of [14C] LBH589 [ Time Frame: during the first 8 days on study ]
    oral dose of [14C] LBH589


Secondary Outcome Measures:
  • Safety Efficacy

Enrollment: 4
Study Start Date: May 2007
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LBH589 Drug: LBH589
Other Name: Panobinostat

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  • Histologically or cytologically confirmed cancer patients including solid tumors, lymphoma, or chronic hematological malignancies with progression on prior standard therapies.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of < 2
  • Normal renal and hepatic function

Exclusion criteria

  • Patients with central nervous system (CNS) involvement or brain metastases
  • Patients who have received chemotherapy, any investigational drug, undergone major surgery, or received wide field radiotherapy less than 4 weeks ago
  • Patients with congenital long QT syndrome or uncontrolled hypertension
  • Patients with a myocardial infarction or unstable angina within 6 months
  • Congestive heart failure
  • Impairment of gastrointestinal (GI) function
  • Use of any anti-cancer therapy
  • Female patients who are pregnant or breast feeding

Other protocol inclusion/exclusion criteria may apply.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00472368


Locations
United States, New York
Novartis Investigative Site
Buffalo, New York, United States, 14263
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00472368     History of Changes
Other Study ID Numbers: CLBH589B2108
First Submitted: May 10, 2007
First Posted: May 11, 2007
Last Update Posted: May 1, 2012
Last Verified: April 2012

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Advanced cancer
lymphoma
chronic hematological malignancies
adult

Additional relevant MeSH terms:
Neoplasms
Panobinostat
Antineoplastic Agents
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action