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

NCT ID: NCT00570284

Last Updated: 2020-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2011-02-28

Brief Summary

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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

Detailed Description

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Conditions

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Cancer

Keywords

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Cancer solid tumor food effect HDAC inhibitor oral LBH589

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LBH589

Group Type EXPERIMENTAL

LBH589

Intervention Type DRUG

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)

Interventions

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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)

Intervention Type DRUG

Other Intervention Names

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Panobinostat

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis

Role: STUDY_CHAIR

Novartis

Locations

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Novartis Investigative Site

Los Angeles, California, United States

Site Status

Novartis Investigative Site

Norwalk, Connecticut, United States

Site Status

Novartis Investigative Site

Rockville, Maryland, United States

Site Status

Novartis Investigative Site

Boston, Massachusetts, United States

Site Status

Novartis Investigative Site

Lebanon, New Hampshire, United States

Site Status

Novartis Investigative Site

New York, New York, United States

Site Status

Novartis Investigative Site

Madison, Wisconsin, United States

Site Status

Novartis Investigative Site

Stockholm, , Sweden

Site Status

Novartis Investigative Site

Zurich, , Switzerland

Site Status

Countries

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United States Sweden Switzerland

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=4924

Results for CLBH589B2111 on the Novartis Clinical Trials Website

Other Identifiers

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CLBH589B2111

Identifier Type: -

Identifier Source: org_study_id