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

This study has been completed.

First Received on July 17, 2007. Last Updated on April 12, 2011 History of Changes

Sponsor:	Novartis Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00503451

Purpose

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	Intervention	Phase
Non-Hodgkin Lymphoma Neoplasms	Drug: LBH589	Phase I

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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.

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lymphoma

Drug Information available for: Ketoconazole Fungarest LBH589

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Levels of LBH589 in the blood on days 1, 5, 8, 9 and 10 of first cycle [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety, tolerability and efficacy of oral LBH589 throughout the study [ Time Frame: at least every 2 months ] [ Designated as safety issue: No ]

Enrollment:	14
Study Start Date:	September 2007
Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: LBH589	Drug: LBH589 Other Name: Panobinostat

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00503451

Locations

United States, Nevada
Nevada Cancer Institute
Las Vegas, Nevada, United States, 89135
Netherlands
Novartis Investigative Site
Rotterdam, Netherlands

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Hamberg P, Woo MM, Chen LC, Verweij J, Porro MG, Zhao L, Li W, van der Biessen D, Sharma S, Hengelage T, de Jonge M. Effect of ketoconazole-mediated CYP3A4 inhibition on clinical pharmacokinetics of panobinostat (LBH589), an orally active histone deacetylase inhibitor. Cancer Chemother Pharmacol. 2011 Sep;68(3):805-13. Epub 2011 Jun 26.

Responsible Party:	External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00503451 History of Changes
Other Study ID Numbers:	CLBH589B2110
Study First Received:	July 17, 2007
Last Updated:	April 12, 2011
Health Authority:	United States: Food and Drug Administration; Netherlands: Centrale Commissie Mensgebonden Onderzoek

Keywords provided by Novartis:

Advanced cancer
solid tumors
lymphoma
HDAC

LBH589
adults
non-Hodgkin's lymphoma

Additional relevant MeSH terms:

Neoplasms
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

Ketoconazole
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012