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Efficacy and Safety Study of Panobinostat in Patients With Metastatic Hormone Refractory Prostate Cancer

This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: April 18, 2008
Last updated: November 15, 2016
Last verified: November 2016
This Phase II single dose study is designed to characterize the safety, tolerability and efficacy of i.v. panobinostat as a single-agent treatment in patients with hormone refractory prostate cancer.

Condition Intervention Phase
Prostate Cancer Drug: Panobinostat Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase II, Open Label, Single Arm Study of i.v. Panobinostat (LBH589) in Patients With Metastatic Hormone Refractory Prostate Cancer

Resource links provided by NLM:

Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Determine progression-free survival at 24 weeks [ Time Frame: 24 weeks ]

Secondary Outcome Measures:
  • Assess the safety and tolerability of LBH589 [ Time Frame: at LPLV for each patient ]

Enrollment: 35
Study Start Date: April 2008
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Panobinostat Drug: Panobinostat


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

Inclusion criteria:

  • Confirmed diagnosis of adenocarcinoma of the prostate
  • Patients with metastatic hormone refractory prostate cancer
  • Patients that have had at least one, but not more than two prior cytotoxic treatments for prostate cancer
  • Evidence of disease progression by at least one of the following

    1. two or more lesions on bone scan
    2. progressive measurable disease
    3. two documented increases in PSA
  • Willing to use contraception throughout the study and for 12 weeks after study completion

Exclusion criteria:

  • History or clinical signs of CNS disease
  • History of other cancers not curatively treated with no evidence of disease for more than 5 years
  • Prior radiotherapy within 3 weeks of starting study treatment
  • Prior radiopharmaceuticals (strontium, samarium)
  • Impaired cardiac function
  • Heart disease
  • Liver or renal disease with impaired function

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00667862

United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63130
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53706-1481
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmeceuticals
  More Information

Additional Information:
Responsible Party: Novartis Pharmaceuticals Identifier: NCT00667862     History of Changes
Other Study ID Numbers: CLBH589C2208
Study First Received: April 18, 2008
Last Updated: November 15, 2016

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Prostate-Specific Antigen

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on September 21, 2017