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

Sponsor:	Novartis Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00663832

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 I

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized 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:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Prednisone Docetaxel LBH589

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 ]

Estimated Enrollment:	46
Study Start Date:	February 2008
Estimated Primary Completion Date:	July 2009 (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

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, Michigan
Wayne State University/Karmanos Cancer Center
Detroit, Michigan, United States, 48201
United States, Missouri
Washington University School of Medicine in St. Louis
St. Louis, Missouri, United States, 63110
United States, Nevada
Nevada Cancer Institute
Las Vegas, Nevada, United States, 89135
United States, New York
Memorial Sloane Kettering Cancer Center
New York, New York, United States, 10017
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Canada, British Columbia
Novartis Investigative Site
Vancouver, British Columbia, Canada
Canada
Novartis Investigative Site
Ontario, Canada

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00663832 History of Changes
Other Study ID Numbers:	CLBH589C2205, EUDRACT # = 2007-003315-30
Study First Received:	April 18, 2008
Last Updated:	October 7, 2010
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 February 09, 2012