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A Study to Investigate the Effect of Food on Oral LBH589 Absorption in Patients With Advanced Solid Tumors
This study is ongoing, but not recruiting participants.
Sponsored by: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00570284
  Purpose

The primary purpose of this study is to evaluate the effect of food on oral LBH589 in adult patients with advanced solid tumors. This study will also evaluate the safety and efficacy of LBH589 in adult patients with advanced solid tumors


Condition Intervention Phase
Cancer
Drug: LBH589
Phase I

MedlinePlus related topics: Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Pharmacokinetics Study
Official Title: A Phase Ib Open-Label, Multicenter Cross-Over Study to Investigate the Effect of Food on the Rate and Extent of Oral LBH589 Absorption in Patients With Advanced Solid Tumors

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Levels of LBH589 in the blood every week for the first 3 weeks

Secondary Outcome Measures:
  • Safety and tolerability throughout study to 28 days after last treatment Efficacy throughout study

Estimated Enrollment: 36
Study Start Date: November 2007
  Eligibility

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

Inclusion criteria

  • Patients with advanced solid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists
  • Age ≥ 18 years old
  • Patients must have adequate laboratory values
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  • Ability to swallow capsules or tablets

Exclusion criteria

  • Patients with active central nervous system (CNS) disease or brain metastases except those who have been previously treated and have been stable for at least 3 months.
  • Patients with a second primary malignancy that is currently clinically significant or requiring active intervention
  • Impaired heart function or clinically significant heart disease
  • Impairment of gastrointestinal (GI) function, or GI disease that may significantly alter the absorption of LBH589
  • Ongoing diarrhea
  • Liver or renal disease with impaired hepatic or renal functions
  • Concomitant use of any anti-cancer therapy or certain drugs
  • Female patients who are pregnant or breast feeding
  • Patients not willing to use an effective method of birth control

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00570284

Locations
United States, California
Los Angeles, California, United States
United States, Connecticut
Norwalk, Connecticut, United States
United States, Maryland
Rockville, Maryland, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, New Hampshire
Lebanon, New Hampshire, United States
United States, New York
New York, New York, United States
United States, Wisconsin
Madison, Wisconsin, United States
Sweden
Stokholm, Sweden
Switzerland
Zurich, Switzerland
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Novartis
  More Information

Responsible Party: Novartis ( External Affairs )
Study ID Numbers: CLBH589B2111
Study First Received: December 7, 2007
Last Updated: July 30, 2008
ClinicalTrials.gov Identifier: NCT00570284  
Health Authority: Sweden: Regional Ethical Review Board;   Switzerland: Swissmedic;   United States: Food and Drug Administration

Keywords provided by Novartis:
Cancer
solid tumor
food effect
HDAC inhibitor
oral
LBH589

ClinicalTrials.gov processed this record on January 13, 2009