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Completed

NCT Number: NCT00472368

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

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.

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Key information

Conditions

Cancer Patients With Advanced Solid Tumors Including Lymphoma or Chronic Hematological Malignancies Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigative Site

Buffalo, New York, 14263, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LBH589

Drug

Other names: Panobinostat

Primary outcomes

  1. 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 outcomes

  1. Safety Efficacy

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
First posted
May 11, 2007
Registry last updated
May 1, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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