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

Official Title: “A Phase IB, Study to Investigate the Effect of Ketoconazole, a CYP3A4 Inhibitor, on Oral LBH589 and to Assess the Efficacy and Safety of Oral LBH589 in Patients With Advanced Solid Tumors.”

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.

Intervention(s) in this Clinical Trial

• Drug: LBH589

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: LBH589

Primary Measures

• Levels of LBH589 in the blood on days 1, 5, 8, 9 and 10 of first cycle
  • Time Frame: 2 weeks
    Safety Issue?: No

Secondary Measures

• Safety, tolerability and efficacy of oral LBH589 throughout the study
  • Time Frame: at least every 2 months
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Novartis Pharmaceuticals Industry

Overall Clinical Trial Officials and Contacts

Novartis Pharmaceuticals Study Director Novartis Pharmaceuticals  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00503451

Study ID Number: CLBH589B2110

ClinicalTrials.gov Identifier: NCT00503451

Health Authority: United States: Food and Drug Administration