A Study to Investigate the Effects of Ketoconazole on LBH589 in Patients With Advanced Solid Tumors
Information source: Novartis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Non-Hodgkin Lymphoma; Neoplasms
Intervention: LBH589 (Drug)
Phase: Phase 1
Status: Active, not recruiting
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Novartis, Study Chair, Affiliation: Novartis
Summary
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.
Clinical Details
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.
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Levels of LBH589 in the blood on days 1, 5, 8, 9 and 10 of first cycle
Secondary outcome: Safety, tolerability and efficacy of oral LBH589 throughout the study
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Rotterdam, Netherlands
Las Vegas, Nevada 89135, United States
Additional Information
Starting date: July 2007
Last updated: June 12, 2008
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