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

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. Identifier: NCT00503451
Recruitment Status : Completed
First Posted : July 18, 2007
Last Update Posted : November 27, 2012
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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

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Study Type : Interventional  (Clinical Trial)
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 : September 2007
Actual Primary Completion Date : April 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: LBH589 Drug: LBH589
Other Name: Panobinostat

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT00503451

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United States, Nevada
Nevada Cancer Institute
Las Vegas, Nevada, United States, 89135
Novartis Investigative Site
Rotterdam, Netherlands
Sponsors and Collaborators
Novartis Pharmaceuticals
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Novartis Pharmaceuticals Identifier: NCT00503451    
Other Study ID Numbers: CLBH589B2110
First Posted: July 18, 2007    Key Record Dates
Last Update Posted: November 27, 2012
Last Verified: November 2012
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Advanced cancer
solid tumors
non-Hodgkin's lymphoma
Additional relevant MeSH terms:
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Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action