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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00493766
Recruitment Status : Terminated (Because of a strategic decision by Novartis)
First Posted : June 28, 2007
Last Update Posted : November 27, 2012
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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

Condition or disease Intervention/treatment Phase
Hormone Refractory Prostate Cancer Drug: LBH589 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Study Start Date : May 2006
Actual Primary Completion Date : July 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: oral LBH589 alone Drug: LBH589
Experimental: oral LBH589 + IV docetaxel + oral prednisone Drug: LBH589

Primary Outcome Measures :
  1. • 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 ]
  2. • 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 Outcome Measures :
  1. • 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 ]
  2. • 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00493766

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United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115-6-84
United States, Missouri
Washing University School of Medicine
St. Louis, Missouri, United States, 63110
United States, Nevada
Nevada Cancer Institute
Las Vegas, Nevada, United States, 89135
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Novartis Pharmaceuticals
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals Identifier: NCT00493766     History of Changes
Other Study ID Numbers: CLBH589B2105
First Posted: June 28, 2007    Key Record Dates
Last Update Posted: November 27, 2012
Last Verified: November 2012
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Prostate Cancer
Hormone Refractory Prostate Cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antineoplastic Agents, Hormonal
Histone Deacetylase Inhibitors
Enzyme Inhibitors