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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00663832
First received: April 18, 2008
Last updated: May 15, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
 Drug: LBH589 (i.v. panobinostat)
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 44
Study Start Date: February 2008
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LBH589 Drug: LBH589 (i.v. panobinostat)

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

Other Name: Panobinostat

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00663832

Locations
United States, Maryland
Novartis Investigative Site
Rockville, Maryland, United States, 20850
United States, Michigan
Novartis Investigative Site
Detroit, Michigan, United States, 48201
United States, Missouri
Novartis Investigative Site
St. Louis, Missouri, United States, 63110
United States, Nevada
Novartis Investigative Site
Las Vegas, Nevada, United States, 89135
United States, New York
Novartis Investigative Site
New York, New York, United States, 10021
United States, North Carolina
Novartis Investigative Site
Durham, North Carolina, United States, 27710
United States, Oregon
Novartis Investigative Site
Portland, Oregon, United States, 97239
Canada, British Columbia
Novartis Investigative Site
Vancouver, British Columbia, Canada, V5Z 1L8
Canada, Ontario
Novartis Investigative Site
Hamilton, Ontario, Canada, L8V 5C2
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00663832     History of Changes
Other Study ID Numbers: CLBH589C2205, 2007-003315-30
Study First Received: April 18, 2008
Last Updated: May 15, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Novartis:
Male
Prostate
Cancer
HRPC
DACi

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Prednisone
Docetaxel
 Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 23, 2013