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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00503451
First Posted: July 18, 2007
Last Update Posted: November 27, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  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 1

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Levels of LBH589 in the blood on days 1, 5, 8, 9 and 10 of first cycle [ Time Frame: 2 weeks ]

Secondary Outcome Measures:
  • Safety, tolerability and efficacy of oral LBH589 throughout the study [ Time Frame: at least every 2 months ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Novartis Pharmaceuticals
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00503451     History of Changes
Other Study ID Numbers: CLBH589B2110
First Submitted: July 17, 2007
First Posted: July 18, 2007
Last Update Posted: November 27, 2012
Last Verified: November 2012

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Advanced cancer
solid tumors
lymphoma
HDAC
LBH589
adults
non-Hodgkin's lymphoma

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Ketoconazole
Panobinostat
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors
Antineoplastic Agents
Histone Deacetylase Inhibitors