Safety of LBH589 Alone and in Combination With Intravenous Docetaxel and Prednisone
Phase 1
Terminated
- Conditions
- Hormone Refractory Prostate Cancer Disease
- Registration Number
- NCT00419536
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This 2-arm study is designed to determine the maximum tolerated dose of LBH589 as a single agent and in combination with docetaxel and prednisone 5 mg twice daily (second arm) and to characterize the safety, tolerability, biologic activity and pharmacokinetic profile.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Male
- Target Recruitment
- 108
Inclusion Criteria
- Patients with hormone refractory prostate cancer
- Patients must have metastatic disease with at least 1 measurable soft tissue lesion that can be assessed by CT or MRI and/or detectable lesion(s) on bone scintigraphy scan. Patients with only elevated PSA levels are not eligible for entry.
- Patients must meet laboratory inclusion criteria defined in the protocol
- Patients must be able to provide written informed consent
Exclusion Criteria
- Patients with prior or concurrent brain metastases
- Impaired cardiac, gastrointestinal, kidney or liver function
- Use of therapeutic androgens Other protocol-defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method To determine the maximum tolerated dose
- Secondary Outcome Measures
Name Time Method Safety Tolerability Biologic activity Pharmacokinetic profile
Trial Locations
- Locations (3)
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Washington University School of Medicine
🇺🇸St. Louis, Missouri, United States