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

Study Overview
=================
Brief Summary
-----------------
This is a parallel, two-arm, open-label, multicenter phase IA/IB study of LBH589 (oral formulation) alone and in combination with docetaxel in patients with progressing hormone refractory prostate cancer. This study is designed to determine the maximum tolerated dose of LBH589 as a single agent and in combination with docetaxel and prednisone 5 mg two times a day , and to characterize the safety, tolerability, biologic activity and pharmacokinetic profile

Official Title
-----------------
A Phase IA/IB, Two Arm, Multi-center, Open-label, Dose Escalation Study of Oral LBH589 Alone and in Combination With IV Docetaxel and Oral Prednisone in Hormone Refractory Prostate Cancer (HRPC)

Conditions
-----------------
Hormone Refractory Prostate Cancer

Intervention / Treatment
-----------------
* Drug: LBH589


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Histologically documented adenocarcinoma of the prostate. Patients must have metastatic disease with at least one measurable soft tissue lesion that can be assessed by computerized tomography (CT), or magnetic resonance imaging (MRI) and/or detectable lesion(s) on bone scintigraphy scan. Patients with only elevated prostate specific antegen (PSA) levels are not eligible for entry. Patients who have undergone medical castration must continue Luteinizing hormone-releasing hormone (LHRH) agonist or antagonist therapy during study treatment 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 Use of therapeutic androgens Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: oral LBH589 alone<br> | Drug: LBH589<br> <br> |
| Experimental: oral LBH589 + IV docetaxel + oral prednisone<br> | Drug: LBH589<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • To determine the maximum-tolerated dose (MTD) and dose-limiting toxicity (DLT) of esca-lating doses of LBH589 in adult men with HRPC. |  | at study start and at study end | 
| • To determine the MTD and DLT of escalating doses of LBH589 in combination with a stan-dard dose of docetaxel q3wks and daily Prednisone® in adult men with HRPC. |  | at study start and at study end | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • To characterize the safety and tolerability of LBH589 alone and in combination with do-cetaxel and Prednisone® including acute and chronic toxicities |  | at study start and at study end | 
| • To characterize the single-dose and multidose pharmacokinetic (PK) profiles of LBH589 alone and in combination with docetaxel and Prednisone®. To characterize the PK profiles of docetaxel alone and in combination with LBH589. |  | at study start and at study end | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
LBH589, Prostate Cancer, HRPC, Hormone Refractory Prostate Cancer