Phase I/II Study of ASP9521 in Castrate-Resistant Prostate Cancer (CRPC) Patients
The study has three parts. Part 1 is a dose escalation to investigate the safety and tolerability of ASP9521. Part 2 will evaluate the safety and tolerability and initial anti-tumor activity of ASP9521. Part 3 of the study will be a Food Effect study.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I/II, Multi-center, Open Label, Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Anti Tumor Activity of ASP9521 in Patients With Metastatic Castrate-resistant Prostate Cancer|
- To evaluate the safety and tolerability, based on the frequency and severity of Adverse Events (AEs), laboratory assessments, vital signs, electrocardiograms (ECGs) and clinical observations [ Time Frame: Up to day 28 and further ] [ Designated as safety issue: Yes ]
- Decline in Prostate-specific antigen (PSA) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
|Study Start Date:||March 2011|
|Study Completion Date:||September 2012|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
The purpose of the first study part is to investigate the safety and tolerability of ASP9521 in patients with Castrate Resistant Prostate Cancer. This will be done at different doses, starting at the lowest dose up to higher doses to find the maximum dose that is tolerated.
The second part will investigate the safety and tolerability and evaluate initial anti-tumor activity of ASP9521. This will be done at multiple doses which are identified in part 1 to potentially be effective. The number of patients in part 2 will be higher number compared to part I.
The third part of the study will investigate the effect of food on the drug in patients; this will be a crossover design fed to fasted and vice versa.
|Antwerp, Belgium, 2650|
|Glasgow, United Kingdom|
|Surrey, United Kingdom|
|Study Director:||Use Central Contact||Astellas Pharma Europe BV|