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Safety of LBH589 Alone and in Combination With Intravenous Docetaxel and Prednisone

Primary Purpose

Hormone Refractory Prostate Cancer Disease

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

LBH589

About this trial

This is an interventional treatment trial for Hormone Refractory Prostate Cancer Disease focused on measuring LBH, LBH589, Prostate Cancer, HRPC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Dana Farber Cancer Institute
Washington University School of Medicine
Memorial Sloan Kettering Cancer Center

Outcomes

Primary Outcome Measures

To determine the maximum tolerated dose

Secondary Outcome Measures

Safety

Tolerability

Biologic activity

Pharmacokinetic profile

Full Information

NCT ID

NCT00419536

First Posted

January 5, 2007

Last Updated

April 7, 2010

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00419536

Brief Title

Safety of LBH589 Alone and in Combination With Intravenous Docetaxel and Prednisone

Official Title

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)

Study Type

Interventional

2. Study Status

Record Verification Date

April 2010

Overall Recruitment Status

Terminated

Study Start Date

May 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary

This 2-arm study is designed to determine the maximum tolerated dose of LBH589 as a single agent and in combination with docetaxel and prednisone 5 mg twice daily (second arm) and to characterize the safety, tolerability, biologic activity and pharmacokinetic profile.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hormone Refractory Prostate Cancer Disease

Keywords

LBH, LBH589, Prostate Cancer, HRPC

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

108 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

LBH589

Primary Outcome Measure Information:

Title

To determine the maximum tolerated dose

Secondary Outcome Measure Information:

Title

Safety

Title

Tolerability

Title

Biologic activity

Title

Pharmacokinetic profile

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Dana Farber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115-6084

Country

United States

Facility Name

Washington University School of Medicine

City

St. Louis

State/Province

Missouri

ZIP/Postal Code

63119

Country

United States

Facility Name

Memorial Sloan Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Safety of LBH589 Alone and in Combination With Intravenous Docetaxel and Prednisone

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