A Study to Determine the Absorption, Distribution, Metabolism, and Excretion of LBH589

NCT ID: NCT00472368

Last Updated: 2012-05-01

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

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Brief Summary

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This single center study will help determine the absorption, metabolism, and excretion of LBH589 and to assess the safety and efficacy of LBH589 in advanced cancer patients for whom no standard therapy exists.

Detailed Description

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Conditions

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Cancer Patients With Advanced Solid Tumors Including Lymphoma or Chronic Hematological Malignancies

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

Interventions

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LBH589

Intervention Type DRUG

Other Intervention Names

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Panobinostat

Eligibility Criteria

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Inclusion Criteria

* Histologically or cytologically confirmed cancer patients including solid tumors, lymphoma, or chronic hematological malignancies with progression on prior standard therapies.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of \< 2
* Normal renal and hepatic function

Exclusion Criteria

* Patients with central nervous system (CNS) involvement or brain metastases
* Patients who have received chemotherapy, any investigational drug, undergone major surgery, or received wide field radiotherapy less than 4 weeks ago
* Patients with congenital long QT syndrome or uncontrolled hypertension
* Patients with a myocardial infarction or unstable angina within 6 months
* Congestive heart failure
* Impairment of gastrointestinal (GI) function
* Use of any anti-cancer therapy
* Female patients who are pregnant or breast feeding
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 Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Buffalo, New York, United States

Site Status

Countries

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United States

Other Identifiers

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CLBH589B2108

Identifier Type: -

Identifier Source: org_study_id

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