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

Completed · Phase 1

Conditions studied: Cancer

In brief

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

Key facts

Study ID

NCT00570284

Run by

Novartis Pharmaceuticals

People needed

36

Starts

2007-11-01

Expected to finish

2011-02-01

Last updated by the study team

2020-12-19

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Novartis Investigative Site — Los Angeles, California, United States
• Novartis Investigative Site — Norwalk, Connecticut, United States
• Novartis Investigative Site — Rockville, Maryland, United States
• Novartis Investigative Site — Boston, Massachusetts, United States
• Novartis Investigative Site — Lebanon, New Hampshire, United States
• Novartis Investigative Site — New York, New York, United States
• Novartis Investigative Site — Madison, Wisconsin, United States
• Novartis Investigative Site — Stockholm, Sweden
• Novartis Investigative Site — Zurich, Switzerland

Full record on ClinicalTrials.gov

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