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

December 16, 2020 updated by: Novartis Pharmaceuticals

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stokholm, Sweden
        • Novartis Investigative Site
  • Switzerland
      • Zurich, Switzerland
        • Novartis Investigative Site
  • United States
    • California
      • Los Angeles, California, United States
        • Novartis Investigative Site
    • Connecticut
      • Norwalk, Connecticut, United States
        • Novartis Investigative Site
    • Maryland
      • Rockville, Maryland, United States
        • Novartis Investigative Site
    • Massachusetts
      • Boston, Massachusetts, United States
        • Novartis Investigative Site
    • New Hampshire
      • Lebanon, New Hampshire, United States
        • Novartis Investigative Site
    • New York
      • New York, New York, United States
        • Novartis Investigative Site
    • Wisconsin
      • Madison, Wisconsin, United States
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Panobinostat

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Levels of LBH589 in the blood
Time Frame: every week for the first 3 weeks
every week for the first 3 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Efficacy, Safety and tolerability
Time Frame: throughout study to 28 days after last treatment
throughout study to 28 days after last treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (ACTUAL)

February 1, 2011

Study Completion (ACTUAL)

February 1, 2011

Study Registration Dates

First Submitted

December 7, 2007

First Submitted That Met QC Criteria

December 7, 2007

First Posted (ESTIMATE)

December 10, 2007

Study Record Updates

Last Update Posted (ACTUAL)

December 19, 2020

Last Update Submitted That Met QC Criteria

December 16, 2020

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLBH589B2111

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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