NCT00419536

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P75+ for phase_1

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 8, 2007

Completed
Last Updated

April 8, 2010

Status Verified

April 1, 2010

First QC Date

January 5, 2007

Last Update Submit

April 7, 2010

Conditions

Hormone Refractory Prostate Cancer Disease

Keywords

LBHLBH589Prostate CancerHRPC

Outcome Measures

Primary Outcomes (1)

  • To determine the maximum tolerated dose

Secondary Outcomes (4)

  • Safety

  • Tolerability

  • Biologic activity

  • Pharmacokinetic profile

Interventions

LBH589DRUG

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 be able to provide written informed consent

You may not qualify if:

  • Patients with prior or concurrent brain metastases
  • Impaired cardiac, gastrointestinal, kidney or liver function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Dana Farber Cancer Institute

Boston, Massachusetts, 02115-6084, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63119, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Panobinostat

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Hydroxamic AcidsHydroxylaminesAminesOrganic ChemicalsHydroxy AcidsCarboxylic AcidsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 5, 2007

First Posted

January 8, 2007

Study Start

May 1, 2006

Last Updated

April 8, 2010

Record last verified: 2010-04

Locations

US(3)