Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00134355
Status:
COMPLETED
Last Update Posted:
2015-01-19
First Post:
2005-08-23
Brief Title:
Study of PTK787 in the Treatment of Patients With Non-Metastatic Androgen Independent Prostate Cancer
Sponsor:
University of Michigan Rogel Cancer Center
Organization:
University of Michigan Rogel Cancer Center
Study Overview
Official Title:
Phase II Evaluation of PTK787 an Oral Vascular Endothelial Growth Factor Inhibitor in Patients With Non-Metastatic Androgen Independent Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2015-01
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:
The purpose of this study is to evaluate PTK787ZK 222584 a drug that blocks new blood vessel growth in the treatment of patients with non-metastatic androgen independent prostate cancer This study will assess the safety and tolerability of PTK787ZK 222584 and evaluate serum vascular endothelial growth factor VEGF levels
Detailed Description:
This is an open-label phase II trial of PTK787ZK 222584 Patients will receive 750 mg daily for one week 1000 mg daily for the second week and then 1250 mg per day thereafter
Response Assessment In the absence of toxicity or clinical progression patients will remain in the study until their PSA Prostate-specific Antigen has doubled from pretreatment baseline
Response Assessment In the absence of toxicity or clinical progression patients will remain in the study until their PSA Prostate-specific Antigen has doubled from pretreatment baseline
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