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Efficacy and Safety Study of Panobinostat in Patients With Metastatic Hormone Refractory Prostate Cancer
This study is currently recruiting participants.
Verified by Novartis, September 2008
First Received: April 18, 2008   Last Updated: September 10, 2008   History of Changes
Sponsored by: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00667862
  Purpose

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 II

MedlinePlus related topics: Cancer Prostate Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase II, Open Label, Single Arm Study of i.v. Panobinostat (LBH589) in Patients With Metastatic Hormone Refractory Prostate Cancer

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Determine progression-free survival at 24 weeks

Secondary Outcome Measures:
  • Assess the safety and tolerability of LBH589

Estimated Enrollment: 35
Study Start Date: April 2008
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00667862

Contacts
Contact: Novartis U.S. 862-778-2705
Contact: Novartis Basel 41-61-324-1111

Locations
United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States
Contact: Regina huminski     410-955-4142     prietreg@jhmi.edu    
Principal Investigator: Roberto Pili, M.D.            
University of Maryland Recruiting
Baltimore, Maryland, United States
Contact: Michelle Besche     410-328-8610     mbesche@umm.edu    
Principal Investigator: Arif Hussein, M.D.            
United States, Missouri
Washington University Recruiting
St. Louis, Missouri, United States
Contact: Rebecca Patton         rpatton@im.wustl.edu    
Principal Investigator: Joel Picus, M.D.            
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States
Contact: Erika Tanaka     212-557-0787     tanakae@mskcc.org    
Principal Investigator: Dana Rathkopf, M.D.            
United States, Wisconsin
University of Wisconsin Recruiting
Madison, Wisconsin, United States
Contact: Mary-Jane Staab     608-263-7107     mjs@medicine.wisc.edu    
Principal Investigator: George Wilding, M.D.            
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Novartis
  More Information

Additional Information:
No publications provided

Study ID Numbers: CLBH589C2208
Study First Received: April 18, 2008
Last Updated: September 10, 2008
ClinicalTrials.gov Identifier: NCT00667862     History of Changes
Health Authority: United States: Food and Drug Administration;   Canada: Health Canada

Keywords provided by Novartis:
Prostate
Cancer
Adenocarcinoma
Prostate-Specific Antigen
metastatic
male
HRPC
DACi

Study placed in the following topic categories:
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Adenocarcinoma
Hormones
Prostatic Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009