Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00075192
Status:
COMPLETED
Last Update Posted:
2012-06-06
First Post:
2004-01-05
Brief Title:
CP-675206 With Neoadjuvant Hormone Therapy in Patients With High Risk Prostate Cancer
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Phase 1 Open Label Non-Randomized Dose Escalation Study to Evaluate the Safety of CP-675206 in Combination With Neoadjuvant Androgen Ablation and a Phase 2 Open Label Randomized Study to Evaluate the Efficacy of CP-675206 in Combination With Neoadjuvant Androgen Ablation and Androgen Ablation Alone in Patients With High Risk Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multi-center open label randomized study Patients will be randomized to one of the following arms with an allocation ratio of 31 respectively Arm A CP-675206 neoadjuvant hormone therapy NHT OR Arm B neoadjuvant hormone therapy After randomization patients will receive study treatment for three cycles one cycle is defined as 28 days After completion of three cycles patients will undergo a prostatectomy and pathology assessments will be completed at a central laboratory the Armed Forces Institute of Pathology AFIP in Washington DC
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None