A Study to Investigate the Effects of Ketoconazole on LBH589 in Patients With Advanced Solid Tumors
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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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.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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.