A Study to Investigate the Effects of Ketoconazole on LBH589 in Patients With Advanced Solid Tumors

Novartis

Status and phase

Completed

Phase 1

Conditions

Neoplasms

Non-Hodgkin Lymphoma

Treatments

Drug: LBH589

Study type

Interventional

Funder types

Industry

Identifiers

NCT00503451

CLBH589B2110

Details and patient eligibility

About

The primary purpose of this open-label study is to investigate the interaction of ketoconazole, a liver enzyme inhibitor, on oral LBH589 in adult patients with advanced solid tumors. The extension phase of the study will evaluate the safety and efficacy of LBH589 in patients with advanced solid tumors.

Enrollment

14 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with histologically confirmed solid tumors or non-Hodgkin's lymphoma with progression on prior standard therapies.
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
Adequate kidney function and laboratory values

Exclusion criteria

Patients who have received chemotherapy, any investigational drug, undergone major surgery, or received wide field radiotherapy less than 4 weeks ago
Patients who had a heart attack or have unstable angina within past 6 months
Heart disease including congestive heart failure and uncontrolled high blood pressure
Liver disease, abnormal gastrointestinal (GI) function or ongoing diarrhea
Use of any anti-cancer therapy, including radiation therapy, or certain drugs while on study
Female patients who are pregnant or breast feeding.

Other protocol inclusion/exclusion criteria may apply.