A Study to Determine the Absorption, Distribution, Metabolism, and Excretion of LBH589
This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
First received: May 10, 2007
Last updated: April 27, 2012
Last verified: April 2012
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.
Cancer Patients With Advanced Solid Tumors Including Lymphoma or Chronic Hematological Malignancies
||Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
Primary Outcome Measures:
Secondary Outcome Measures:
| Study Start Date:
| Primary Completion Date:
||June 2008 (Final data collection date for primary outcome measure)
Other Name: Panobinostat
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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.
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
|Novartis Investigative Site
|Buffalo, New York, United States, 14263 |
No publications provided
||Novartis ( Novartis Pharmaceuticals )
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 10, 2007
||April 27, 2012
||United States: Food and Drug Administration
Keywords provided by Novartis:
chronic hematological malignancies
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 21, 2015
Histone Deacetylase Inhibitors
Molecular Mechanisms of Pharmacological Action