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An Open Label, Single Arm, Phase Ib Dose Finding Study of i.v. Panobinostat (LBH589) With Docetaxel and Prednisone in Patients With Hormone Refractory Prostate Cancer


Phase 1
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

An Open Label, Single Arm, Phase Ib Dose Finding Study of i.v. Panobinostat (LBH589) With Docetaxel and Prednisone in Patients With Hormone Refractory Prostate Cancer

Inclusion Criteria


Inclusion criteria:

- HRPC patients

- Evidence of disease progression

- Self care, able to perform light work activities

- Willing to use contraception throughout the study and for 12 weeks after study
completion

Exclusion criteria:

- 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 functions.

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: Treatment

Outcome Measure:

To determine the MTD of i.v. LBH589 in combination with docetaxel and prednisone in patients with HRPC

Outcome Time Frame:

determine if MTD occurs after every 3 - 6 pts

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CLBH589C2205

NCT ID:

NCT00663832

Start Date:

February 2008

Completion Date:

Related Keywords:

  • Prostate Cancer
  • Male
  • Prostate
  • Cancer
  • HRPC
  • DACi
  • Prostatic Neoplasms

Name

Location
Novartis Investigative Site Southfield, Michigan  48075
Novartis Investigative Site Portland, Oregon  97239
Novartis Investigative Site St. Louis, Missouri  63110
Novartis Investigative Site Buffalo, New York  14263
Novartis Investigative Site Durham, North Carolina  27710
Novartis Investigative Site Baltimore, Maryland  21201
Novartis Investigative Site Las Vegas, Nevada  89135