search
Back to results

A Dose Finding Study With I.V. Panobinostat (LBH589), Docetaxel, and Prednisone in Patients With Hormone Refractory Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
LBH589 (i.v. panobinostat)
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Male, Prostate, Cancer, HRPC, DACi

Eligibility Criteria

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

Inclusion criteria:

  • 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

Exclusion criteria:

  • 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.

Other protocol-defined inclusion/exclusion criteria may apply

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

LBH589

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

To compare the PK profile of i.v. LBH589 with and without docetaxel
To determine safety and tolerability of i.v. LBH589 in combination with docetaxel and prednisone in patients with HRPC
To determine preliminary activity of i.v. LBH589 in combination with docetaxel and prednisone

Full Information

First Posted
April 18, 2008
Last Updated
December 16, 2020
Sponsor
Novartis Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT00663832
Brief Title
A Dose Finding Study With I.V. Panobinostat (LBH589), Docetaxel, and Prednisone in Patients With Hormone Refractory Prostate Cancer
Official Title
An Open Label, Single Arm, Phase Ib Dose Finding Study of i.v. Panobinostat (LBH589) With Docetaxel and Prednisone in Patients With Hormone Refractory Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Male, Prostate, Cancer, HRPC, DACi

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LBH589
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
LBH589 (i.v. panobinostat)
Other Intervention Name(s)
Panobinostat
Intervention Description
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
Primary Outcome Measure Information:
Title
To determine the MTD of i.v. LBH589 in combination with docetaxel and prednisone in patients with HRPC
Time Frame
determine if MTD occurs after every 3 - 6 pts
Secondary Outcome Measure Information:
Title
To compare the PK profile of i.v. LBH589 with and without docetaxel
Time Frame
PK assessment will occur during the first 2 weeks of each pt treatment. Minor safety throughout the study treatment phase
Title
To determine safety and tolerability of i.v. LBH589 in combination with docetaxel and prednisone in patients with HRPC
Time Frame
PK assessment will occur during the first 2 weeks of each pt treatment
Title
To determine preliminary activity of i.v. LBH589 in combination with docetaxel and prednisone
Time Frame
PK assessment will occur during the first 2 weeks of each pt treatment

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: 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 Exclusion criteria: 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. 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
Novartis Investigative Site
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Novartis Investigative Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Novartis Investigative Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Novartis Investigative Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89135
Country
United States
Facility Name
Novartis Investigative Site
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Novartis Investigative Site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Novartis Investigative Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Novartis Investigative Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1L8
Country
Canada
Facility Name
Novartis Investigative Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada

12. IPD Sharing Statement

Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=7783
Description
Results for CLBH589C2205 can be found on the Novartis Clinical Trial Results Website

Learn more about this trial

A Dose Finding Study With I.V. Panobinostat (LBH589), Docetaxel, and Prednisone in Patients With Hormone Refractory Prostate Cancer

We'll reach out to this number within 24 hrs