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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Panobinostat

Criteria

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.