Clinical trial · Interventional
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
NCT00472368CI-TRIAL-00006820completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Patients With Advanced Solid Tumors Including Lymphoma or Chronic Hematological Malignancies | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LBH589 | Drug | Panobinostat | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LBH589
- interventionNames
- Drug: LBH589
Primary outcomes (1)
- measure
- Rates and routes of excretion of LBH589 and its metabolites in urine and feces following administration of a single oral dose of [14C] LBH589
- timeFrame
- during the first 8 days on study
- description
- oral dose of \[14C\] LBH589
Secondary outcomes (1)
- measure
- Safety Efficacy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.