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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
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
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
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
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
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
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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