A Dose Finding Study With I.V. Panobinostat (LBH589), Docetaxel, and Prednisone in Patients With Hormone Refractory Prostate Cancer
Phase 1
Completed
- Conditions
- Prostate Cancer
- Interventions
- Drug: LBH589 (i.v. panobinostat)
- Registration Number
- NCT00663832
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 44
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description LBH589 LBH589 (i.v. panobinostat) -
- Primary Outcome Measures
Name Time Method To determine the MTD of i.v. LBH589 in combination with docetaxel and prednisone in patients with HRPC determine if MTD occurs after every 3 - 6 pts
- Secondary Outcome Measures
Name Time Method To compare the PK profile of i.v. LBH589 with and without docetaxel 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 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 PK assessment will occur during the first 2 weeks of each pt treatment
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie panobinostat's synergy with docetaxel in hormone refractory prostate cancer?
How does the LBH589-docetaxel-prednisone combination compare to abiraterone/enzalutamide in first-line HRPC treatment?
Which biomarkers (e.g., AR-V7, PSA dynamics) predict response to panobinostat in NCT00663832 HRPC patients?
What are the most common adverse events and management strategies for panobinostat/docetaxel/prednisone in Phase 1 HRPC trials?
Are there alternative HDAC inhibitor combinations with docetaxel for castration-resistant prostate cancer under Novartis investigation?
Trial Locations
- Locations (1)
Novartis Investigative Site
🇨🇦Hamilton, Ontario, Canada