Efficacy and Safety Study of Panobinostat in Participants With Metastatic Hormone Refractory Prostate Cancer

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-18

Study Completion Date

2010-11-05

Brief Summary

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This Phase II single dose study was designed to characterize the safety, tolerability, and efficacy of intravenous (i.v.) panobinostat as a single-agent treatment in participants with hormone refractory prostate cancer.

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Detailed Description

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Conditions

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Prostate Cancer

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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Panobinostat

Participants with metastatic hormone refractory prostate cancer received 20 milligrams per meter square (mg/m\^2) of panobinostat intravenously (i.v.) on Days 1 and 8 of a 21-day cycle. Treatment continued until disease progression as per investigator, intolerable toxicity, start of new cancer therapy, death, or withdrawal of consent.

Group Type EXPERIMENTAL

Panobinostat

Intervention Type DRUG

Interventions

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Panobinostat

Intervention Type DRUG

Other Intervention Names

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LBH589

Eligibility Criteria

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Inclusion Criteria

* Confirmed diagnosis of adenocarcinoma of the prostate
* Participants with metastatic hormone refractory prostate cancer
* Participants that have had at least one, but not more than two prior cytotoxic treatments for prostate cancer
* Evidence of disease progression by at least one of the following:

1. two or more lesions on bone scan
2. progressive measurable disease
3. two documented increases in prostate-specific antigen (PSA)
* Willing to use contraception throughout the study and for 12 weeks after study completion

Exclusion Criteria

* History or clinical signs of central nervous system (CNS) disease
* History of other cancers not curatively treated with no evidence of disease for more than 5 years
* Prior radiotherapy within 3 weeks of starting study treatment
* Prior radiopharmaceuticals (strontium, samarium)
* Impaired cardiac function
* Heart disease
* Liver or renal disease with impaired function

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No