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

Novartis

Status and phase

Completed

Phase 1

Conditions

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

Treatments

Drug: LBH589

Study type

Interventional

Funder types

Industry

Identifiers

NCT00472368

CLBH589B2108

Details and patient eligibility

About

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.

Enrollment

4 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.