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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00472368

Enrollment

Registered

2007-05-11

Start date

2007-05-31

Completion date

Unknown

Last updated

2012-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer Patients With Advanced Solid Tumors Including Lymphoma or Chronic Hematological Malignancies

Keywords

Advanced cancer, lymphoma, chronic hematological malignancies, adult

Brief summary

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.

Interventions

DRUGLBH589

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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/

Design outcomes

Primary

Measure	Time frame	Description
Rates and routes of excretion of LBH589 and its metabolites in urine and feces following administration of a single oral dose of [14C] LBH589	during the first 8 days on study	oral dose of \[14C\] LBH589

Secondary

Measure	Time frame
Safety Efficacy	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026