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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00503451

Collaborator

(none)

Enrollment

Locations

Arm

Patients Per Site

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Non-Hodgkin Lymphoma Neoplasms	Drug: LBH589	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

14 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Sep 1, 2007

Actual Primary Completion Date :

Apr 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LBH589	Drug: LBH589 Other Names: Panobinostat

Arm

Intervention/Treatment

Experimental: LBH589

Drug: LBH589

Other Names:

Panobinostat

Outcome Measures

Primary Outcome Measures

Levels of LBH589 in the blood on days 1, 5, 8, 9 and 10 of first cycle [2 weeks]

Secondary Outcome Measures

Safety, tolerability and efficacy of oral LBH589 throughout the study [at least every 2 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.