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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00667862
First received: April 18, 2008
Last updated: May 10, 2013
Last verified: May 2013
  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 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

Primary Outcome Measures:
  • Determine progression-free survival at 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

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

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

  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
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 ClinicalTrials.gov identifier: NCT00667862

Locations
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
University of Maryland
Baltimore, Maryland, United States, 21201
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
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmeceuticals
  More Information

Additional Information:
No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00667862     History of Changes
Other Study ID Numbers: CLBH589C2208
Study First Received: April 18, 2008
Last Updated: May 10, 2013
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

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Panobinostat
Antineoplastic Agents
Enzyme Inhibitors
Histone Deacetylase Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014