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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
Both
Hormone Refractory Prostate Cancer

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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


Inclusion criteria:

- Histologically documented adenocarcinoma of the prostate.

- Patients must have metastatic disease with at least one measurable soft tissue lesion
that can be assessed by computerized tomography (CT), or magnetic resonance imaging
(MRI) and/or detectable lesion(s) on bone scintigraphy scan. Patients with only
elevated prostate specific antegen (PSA) levels are not eligible for entry.

- Patients who have undergone medical castration must continue Luteinizing
hormone-releasing hormone (LHRH) agonist or antagonist therapy during study treatment

- 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: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

• To determine the maximum-tolerated dose (MTD) and dose-limiting toxicity (DLT) of esca-lating doses of LBH589 in adult men with HRPC.

Outcome Time Frame:

at study start and at study end

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CLBH589B2105

NCT ID:

NCT00493766

Start Date:

May 2006

Completion Date:

Related Keywords:

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

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Duke University Medical CenterDurham, North Carolina  27710
Dana Farber Cancer InstituteBoston, Massachusetts  02115
Nevada Cancer InstituteLas Vegas, Nevada  89135
Washing University School of MedicineSt. Louis, Missouri  63110