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

This study has been terminated.
Information provided by:
Novartis Identifier:
First received: January 5, 2007
Last updated: April 7, 2010
Last verified: April 2010
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 Intervention Phase
Hormone Refractory Prostate Cancer Disease
Drug: LBH589
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • To determine the maximum tolerated dose

Secondary Outcome Measures:
  • Safety
  • Tolerability
  • Biologic activity
  • Pharmacokinetic profile

Estimated Enrollment: 108
Study Start Date: May 2006

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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Please refer to this study by its identifier: 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
  More Information

Responsible Party: External Affairs, Novartis Pharmaceuticals Identifier: NCT00419536     History of Changes
Other Study ID Numbers: CLBH589A2105
Study First Received: January 5, 2007
Last Updated: April 7, 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 processed this record on April 28, 2017