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...
Date First Received: July 17, 2007
Last Updated: June 12, 2008
Verified by: Novartis, June 2008
Clinical Trial Phase: Phase 1 | Start Date: July 2007
Overall Status: Active, not recruiting
Estimated Enrollment: 24
Brief Summary
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.”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: LBH589
Outcome Measures for this Clinical Trial
Primary Measures
- Levels of LBH589 in the blood on days 1, 5, 8, 9 and 10 of first cycle
Secondary Measures
- Safety, tolerability and efficacy of oral LBH589 throughout the study
Criteria for Participation in this Clinical Trial
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
Clinical Trial Sponsor Information
Lead Sponsor: Novartis
Overall Clinical Trial Officials and Contacts
Novartis Study Chair Novartis
Additional Information
Information obtained from ClinicalTrials.gov on November 20, 2008
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
Clinical Trials Authorship and Review
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