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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 CenterNew York, New York  10021
University of MarylandBaltimore, Maryland  21201
Washington UniversitySt. Louis, Missouri  63110
University of WisconsinMadison,, Wisconsin  53792-5666
Johns Hopkins HospitalBaltimore, Maryland  21287