A Study to Investigate the Effect of Food on Oral LBH589 Absorption in Patients With Advanced Solid Tumors

Novartis

Status and phase

Completed

Phase 1

Conditions

Cancer

Treatments

Drug: LBH589

Study type

Interventional

Funder types

Industry

Identifiers

NCT00570284

CLBH589B2111

Details and patient eligibility

About

The primary purpose of this study is to evaluate the effect of food on oral LBH589 in adult patients with advanced solid tumors. This study will also evaluate the safety and efficacy of LBH589 in adult patients with advanced solid tumors

Enrollment

36 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with advanced solid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists
Age ≥ 18 years old
Patients must have adequate laboratory values
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Ability to swallow capsules or tablets

Exclusion criteria

Patients with active central nervous system (CNS) disease or brain metastases except those who have been previously treated and have been stable for at least 3 months.
Patients with a second primary malignancy that is currently clinically significant or requiring active intervention
Impaired heart function or clinically significant heart disease
Impairment of gastrointestinal (GI) function, or GI disease that may significantly alter the absorption of LBH589
Ongoing diarrhea
Liver or renal disease with impaired hepatic or renal functions
Concomitant use of any anti-cancer therapy or certain drugs
Female patients who are pregnant or breast feeding
Patients not willing to use an effective method of birth control

Other protocol-defined inclusion/exclusion criteria may apply