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

Completed · Phase 1

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

In brief

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.

Key facts

Study ID

NCT00472368

Run by

Novartis Pharmaceuticals

People needed

4

Starts

2007-05-01

Last updated by the study team

2012-05-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Novartis Investigative Site — Buffalo, New York, United States

Full record on ClinicalTrials.gov

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