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A Phase IA/IB, Two Arm, Multi-center, Open-label, Dose Escalation Study of Oral LBH589 Alone and in Combination With IV Docetaxel and Oral Prednisone in Hormone Refractory Prostate Cancer (HRPC)


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

Thank you

Trial Information

A Phase IA/IB, Two Arm, Multi-center, Open-label, Dose Escalation Study of Oral LBH589 Alone and in Combination With IV Docetaxel and Oral Prednisone in Hormone Refractory Prostate Cancer (HRPC)


Inclusion Criteria:



- Patients with hormone refractory prostate cancer

- Patients must have metastatic disease with at least 1 measurable soft tissue lesion
that can be assessed by CT or MRI and/or detectable lesion(s) on bone scintigraphy
scan. Patients with only elevated PSA levels are not eligible for entry.

- Patients must meet laboratory inclusion criteria defined in the protocol

- Patients must be able to provide written informed consent

Exclusion Criteria:

- Patients with prior or concurrent brain metastases

- Impaired cardiac, gastrointestinal, kidney or liver function

- Use of therapeutic androgens Other protocol-defined inclusion/exclusion criteria may
apply

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the maximum tolerated dose

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CLBH589A2105

NCT ID:

NCT00419536

Start Date:

May 2006

Completion Date:

Related Keywords:

  • Hormone Refractory Prostate Cancer Disease
  • LBH
  • LBH589
  • Prostate Cancer
  • HRPC
  • Prostatic Neoplasms

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021
Washington University School of MedicineSaint Louis, Missouri  63110
Dana Farber Cancer InstituteBoston, Massachusetts  02115