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

This study is ongoing, but not recruiting participants.

First Received: July 17, 2007 Last Updated: November 18, 2009 History of Changes

Sponsor:	Novartis
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:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Secondary Outcome Measures:

Safety, tolerability and efficacy of oral LBH589 throughout the study

Estimated Enrollment:	24
Study Start Date:	July 2007

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

Las Vegas, Nevada, United States, 89135
Netherlands

Rotterdam, Netherlands

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis

More Information

No publications provided

Responsible Party:	Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers:	CLBH589B2110
Study First Received:	July 17, 2007
Last Updated:	November 18, 2009
ClinicalTrials.gov Identifier:	NCT00503451 History of Changes
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
Cancer patients with advanced solid tumors including non-Hodgkin's lymphoma

Additional relevant MeSH terms:

Anti-Infective Agents
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Ketoconazole
Pharmacologic Actions
Lymphatic Diseases

Neoplasms
Antifungal Agents
Therapeutic Uses
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma

ClinicalTrials.gov processed this record on February 08, 2010