Safety of LBH589 Alone and in Combination With Intravenous Docetaxel and Prednisone

NCT ID: NCT00419536

Last Updated: 2010-04-08

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

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Brief Summary

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This 2-arm study is designed to determine the maximum tolerated dose of LBH589 as a single agent and in combination with docetaxel and prednisone 5 mg twice daily (second arm) and to characterize the safety, tolerability, biologic activity and pharmacokinetic profile.

Detailed Description

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Conditions

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Hormone Refractory Prostate Cancer Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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LBH589

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with hormone refractory prostate cancer
* Patients must have metastatic disease with at least 1 measurable soft tissue lesion that can be assessed by CT or MRI and/or detectable lesion(s) on bone scintigraphy scan. Patients with only elevated PSA levels are not eligible for entry.
* Patients must be able to provide written informed consent

Exclusion Criteria

* Patients with prior or concurrent brain metastases
* Impaired cardiac, gastrointestinal, kidney or liver function
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Novartis Pharmaceuticals

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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CLBH589A2105

Identifier Type: -

Identifier Source: org_study_id

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