A Dose Finding Study With I.V. Panobinostat (LBH589), Docetaxel, and Prednisone in Patients With Hormone Refractory Prostate Cancer

Study Overview
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Brief Summary
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This Phase Ib dose escalation study is designed to characterize the safety, tolerability and preliminary efficacy of i.v. panobinostat (LBH589) in combination with docetaxel and prednisone in the 1st line treatment of patients with hormone refractory prostate cancer.

Official Title
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An Open Label, Single Arm, Phase Ib Dose Finding Study of i.v. Panobinostat (LBH589) With Docetaxel and Prednisone in Patients With Hormone Refractory Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: LBH589 (i.v. panobinostat)


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: HRPC patients Evidence of disease progression Self care, able to perform light work activities Willing to use contraception throughout the study and for 12 weeks after study completion Exclusion criteria: 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 functions. Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LBH589<br> | Drug: LBH589 (i.v. panobinostat)<br>* i.v. LBH589 dose levels: 10, 15, or 20 mg/m2 i.v. docetaxel 75 or 60 mg/m2 oral prednisone 5mg bid. LBH589 i.v. administered on days 1 and 8 in combination with docetaxel i.v. on day 1 and prednisone p.o 5mg bid every day of a 21-day cycle<br>* Other names: Panobinostat;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the MTD of i.v. LBH589 in combination with docetaxel and prednisone in patients with HRPC |  | determine if MTD occurs after every 3 - 6 pts | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the PK profile of i.v. LBH589 with and without docetaxel |  | PK assessment will occur during the first 2 weeks of each pt treatment. Minor safety throughout the study treatment phase | 
| To determine safety and tolerability of i.v. LBH589 in combination with docetaxel and prednisone in patients with HRPC |  | PK assessment will occur during the first 2 weeks of each pt treatment | 
| To determine preliminary activity of i.v. LBH589 in combination with docetaxel and prednisone |  | PK assessment will occur during the first 2 weeks of each pt treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Male, Prostate, Cancer, HRPC, DACi