A Study to Investigate the Effect of Food on Oral LBH589 Absorption in Patients With Advanced Solid Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00570284
First received: December 7, 2007
Last updated: November 26, 2012
Last verified: November 2012
  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 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Levels of LBH589 in the blood [ Time Frame: every week for the first 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy, Safety and tolerability [ Time Frame: throughout study to 28 days after last treatment ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: November 2007
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LBH589 Drug: LBH589
orally administered panobinostat at 20 mg twice weekly (core phase); orally administered panobinostat 45 mg twice weekly if 20 mg twice weekly was tolerated in Cycle 1 (extension phase)
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 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
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, see Learn About Clinical Studies.

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

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

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00570284     History of Changes
Other Study ID Numbers: CLBH589B2111
Study First Received: December 7, 2007
Last Updated: November 26, 2012
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

Additional relevant MeSH terms:
Panobinostat
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 19, 2014