Phase I/II Study of ASP9521 in Castrate-Resistant Prostate Cancer (CRPC) Patients
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|ClinicalTrials.gov Identifier: NCT01352208|
Recruitment Status : Terminated (It was decided to discontinue the development in consideration of the results of a P1 study)
First Posted : May 11, 2011
Last Update Posted : March 24, 2014
|Condition or disease||Intervention/treatment||Phase|
|Castrate Resistant Prostate Cancer||Drug: ASP9521||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||September 2012|
- 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 ]
- Decline in Prostate-specific antigen (PSA) [ Time Frame: Week 12 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01352208
|Antwerp, Belgium, 2650|
|Glasgow, United Kingdom|
|Surrey, United Kingdom|
|Study Director:||Use Central Contact||Astellas Pharma Europe B.V.|