Safety of LBH589 Alone and in Combination With IV Docetaxel and Prednisone
- Registration Number
- NCT00493766
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This is a parallel, two-arm, open-label, multicenter phase IA/IB study of LBH589 (oral formulation) alone and in combination with docetaxel in patients with progressing hormone refractory prostate cancer. This study is designed to determine the maximum tolerated dose of LBH589 as a single agent and in combination with docetaxel and prednisone 5 mg two times a day , and to characterize the safety, tolerability, biologic activity and pharmacokinetic profile
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 16
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description oral LBH589 + IV docetaxel + oral prednisone LBH589 - oral LBH589 alone LBH589 -
- Primary Outcome Measures
Name Time Method • To determine the maximum-tolerated dose (MTD) and dose-limiting toxicity (DLT) of esca-lating doses of LBH589 in adult men with HRPC. at study start and at study end • To determine the MTD and DLT of escalating doses of LBH589 in combination with a stan-dard dose of docetaxel q3wks and daily Prednisone® in adult men with HRPC. at study start and at study end
- Secondary Outcome Measures
Name Time Method • To characterize the safety and tolerability of LBH589 alone and in combination with do-cetaxel and Prednisone® including acute and chronic toxicities at study start and at study end • To characterize the single-dose and multidose pharmacokinetic (PK) profiles of LBH589 alone and in combination with docetaxel and Prednisone®. To characterize the PK profiles of docetaxel alone and in combination with LBH589. at study start and at study end
Trial Locations
- Locations (5)
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Nevada Cancer Institute
🇺🇸Las Vegas, Nevada, United States
Washing University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States