Safety of LBH589 Alone and in Combination With Intravenous 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: NCT00419536
Recruitment Status : Terminated
First Posted : January 8, 2007
Last Update Posted : April 8, 2010
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Brief Summary:
This 2-arm study is designed to determine the maximum tolerated dose of LBH589 as a single agent and in combination with docetaxel and prednisone 5 mg twice daily (second arm) and to characterize the safety, tolerability, biologic activity and pharmacokinetic profile.

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

Study Type : Interventional  (Clinical Trial)
Enrollment : 108 participants
Allocation: Non-Randomized
Intervention Model: Single Group 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

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. To determine the maximum tolerated dose

Secondary Outcome Measures :
  1. Safety
  2. Tolerability
  3. Biologic activity
  4. Pharmacokinetic profile

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:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with hormone refractory prostate cancer
  • Patients must have metastatic disease with at least 1 measurable soft tissue lesion that can be assessed by CT or MRI and/or detectable lesion(s) on bone scintigraphy scan. Patients with only elevated PSA levels are not eligible for entry.
  • Patients must meet laboratory inclusion criteria defined in the protocol
  • 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): NCT00419536

United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115-6084
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63119
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: External Affairs, Novartis Pharmaceuticals Identifier: NCT00419536     History of Changes
Other Study ID Numbers: CLBH589A2105
First Posted: January 8, 2007    Key Record Dates
Last Update Posted: April 8, 2010
Last Verified: April 2010

Keywords provided by Novartis:
Prostate Cancer

Additional relevant MeSH terms:
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
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Histone Deacetylase Inhibitors
Enzyme Inhibitors