NCT00663832

Brief Summary

This Phase Ib dose escalation study is designed to characterize the safety, tolerability and preliminary efficacy of i.v. panobinostat (LBH589) in combination with docetaxel and prednisone in the 1st line treatment of patients with hormone refractory prostate cancer.

Trial Health

85
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P50-P75 for phase_1 prostate-cancer

Geographic Reach
2 countries

9 active sites

Status
completed

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

February 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 22, 2008

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Last Updated

December 19, 2020

Status Verified

May 1, 2012

Enrollment Period

3.8 years

First QC Date

April 18, 2008

Last Update Submit

December 16, 2020

Conditions

Prostate Cancer

Keywords

MaleProstateCancerHRPCDACi

Outcome Measures

Primary Outcomes (1)

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

    determine if MTD occurs after every 3 - 6 pts

Secondary Outcomes (3)

  • To compare the PK profile of i.v. LBH589 with and without docetaxel

    PK assessment will occur during the first 2 weeks of each pt treatment. Minor safety throughout the study treatment phase

  • To determine safety and tolerability of i.v. LBH589 in combination with docetaxel and prednisone in patients with HRPC

    PK assessment will occur during the first 2 weeks of each pt treatment

  • To determine preliminary activity of i.v. LBH589 in combination with docetaxel and prednisone

    PK assessment will occur during the first 2 weeks of each pt treatment

Study Arms (1)

LBH589

EXPERIMENTAL
Drug: LBH589 (i.v. panobinostat)

Interventions

LBH589 (i.v. panobinostat)DRUG

i.v. LBH589 dose levels: 10, 15, or 20 mg/m2 i.v. docetaxel 75 or 60 mg/m2 oral prednisone 5mg bid. LBH589 i.v. administered on days 1 and 8 in combination with docetaxel i.v. on day 1 and prednisone p.o 5mg bid every day of a 21-day cycle

Also known as: Panobinostat
LBH589

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Novartis Investigative Site

Rockville, Maryland, 20850, United States

Location

Novartis Investigative Site

Detroit, Michigan, 48201, United States

Location

Novartis Investigative Site

St Louis, Missouri, 63110, United States

Location

Novartis Investigative Site

Las Vegas, Nevada, 89135, United States

Location

Novartis Investigative Site

New York, New York, 10021, United States

Location

Novartis Investigative Site

Durham, North Carolina, 27710, United States

Location

Novartis Investigative Site

Portland, Oregon, 97239, United States

Location

Novartis Investigative Site

Vancouver, British Columbia, V5Z 1L8, Canada

Location

Novartis Investigative Site

Hamilton, Ontario, L8V 5C2, Canada

Location

Related Links

MeSH Terms

Conditions

Prostatic NeoplasmsNeoplasms

Interventions

Panobinostat

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteGenital 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
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2008

First Posted

April 22, 2008

Study Start

February 1, 2008

Primary Completion

December 1, 2011

Last Updated

December 19, 2020

Record last verified: 2012-05

Locations

US(7)CA(2)