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A Phase II, Open Label, Single Arm Study of i.v. Panobinostat (LBH589) in Patients With Metastatic Hormone Refractory Prostate Cancer


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

A Phase II, Open Label, Single Arm Study of i.v. Panobinostat (LBH589) in Patients With Metastatic Hormone Refractory Prostate Cancer

Inclusion 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Determine progression-free survival at 24 weeks

Outcome Time Frame:

24 weeks

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmeceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CLBH589C2208

NCT ID:

NCT00667862

Start Date:

April 2008

Completion Date:

November 2010

Related Keywords:

  • Prostate Cancer
  • Prostate
  • Cancer
  • Adenocarcinoma
  • Prostate-Specific Antigen
  • metastatic
  • male
  • HRPC
  • DACi
  • Prostatic Neoplasms

Name

Location

Memorial Sloan Kettering Cancer Center New York, New York  10021
University of Maryland Baltimore, Maryland  21201
Washington University St. Louis, Missouri  63110
University of Wisconsin Madison,, Wisconsin  53792-5666
Johns Hopkins Hospital Baltimore, Maryland  21287