Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00503451
First received: July 17, 2007
Last updated: November 26, 2012
Last verified: November 2012
History of Changes
  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: 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
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 Novartis Pharmaceuticals
  More Information

No publications provided by Novartis

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

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00503451     History of Changes
Other Study ID Numbers: CLBH589B2110
Study First Received: July 17, 2007
Last Updated: November 26, 2012
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 May 21, 2013