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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00472368
First received: May 10, 2007
Last updated: April 27, 2012
Last verified: April 2012
  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: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: 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:

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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00472368     History of Changes
Other Study ID Numbers: CLBH589B2108
Study First Received: May 10, 2007
Last Updated: April 27, 2012
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Neoplasms
Lymphoma
Hematologic Neoplasms
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms by Site
Hematologic Diseases
Panobinostat
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014