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

Completed · Phase 1

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT00663832

Run by

Novartis Pharmaceuticals

People needed

44

Starts

2008-02-01

Last updated by the study team

2020-12-19

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

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.
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• Novartis Investigative Site — Rockville, Maryland, United States
• Novartis Investigative Site — Detroit, Michigan, United States
• Novartis Investigative Site — St Louis, Missouri, United States
• Novartis Investigative Site — Las Vegas, Nevada, United States
• Novartis Investigative Site — New York, New York, United States
• Novartis Investigative Site — Durham, North Carolina, United States
• Novartis Investigative Site — Portland, Oregon, United States
• Novartis Investigative Site — Vancouver, British Columbia, Canada
• Novartis Investigative Site — Hamilton, Ontario, Canada

Full record on ClinicalTrials.gov

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