A Study to Determine the Absorption, Distribution, Metabolism, and Excretion of LBH589
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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 or disease
Cancer Patients With Advanced Solid Tumors Including Lymphoma or Chronic Hematological Malignancies
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
Study Start Date
Actual Primary Completion Date
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes 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.