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

Phase 1TerminatedNCT00493766

Novartis Pharmaceuticals16 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hormone Refractory Prostate Cancer

Interventions

LBH589DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Washing University School of Medicine

St Louis, Missouri, United States

Nevada Cancer Institute

Las Vegas, Nevada, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Outcomes

Primary Outcomes

• To determine the maximum-tolerated dose (MTD) and dose-limiting toxicity (DLT) of esca-lating doses of LBH589 in adult men with HRPC.

Time frame: 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.

Time frame: at study start and at study end

Secondary Outcomes

• To characterize the safety and tolerability of LBH589 alone and in combination with do-cetaxel and Prednisone® including acute and chronic toxicities

Time frame: 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.

Time frame: at study start and at study end

Data from ClinicalTrials.gov

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