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

Completed · Phase 1

Conditions studied: Non-Hodgkin Lymphoma, Neoplasms

In brief

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.

Key facts

Study ID

NCT00503451

Run by

Novartis Pharmaceuticals

People needed

14

Starts

2007-09-01

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 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

You may not qualify if…

• 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.

Where it is running

• Nevada Cancer Institute — Las Vegas, Nevada, United States
• Novartis Investigative Site — Rotterdam, Netherlands

Full record on ClinicalTrials.gov

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