Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00513071
Status:
COMPLETED
Last Update Posted:
2018-04-19
First Post:
2007-08-06
Brief Title:
AZD0530 in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of AZD0530 in Hormone Refractory Prostate Cancer HRPC
Status:
COMPLETED
Status Verified Date:
2018-03
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 phase II trial is studying how well AZD0530 works in treating patients with prostate cancer that did not respond to hormone therapy AZD0530 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
Detailed Description:
PRIMARY OBJECTIVES
I To test the hypothesis that AZD0530 will improve the prostate-specific antigen PSA response rate and progression-free survival PFS in comparison with historical controls for patients with hormone-refractory prostate cancer HRPC
II Evaluate the time to treatment failure and overall survival of patients with HRPC treated with AZD0530
III Evaluate the toxicities and tolerance of AZD0530 therapy in the HRPC population
OUTLINE This is a multicenter study
Patients receive oral AZD0530 once daily Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 6 months for the first 2 years and then yearly thereafter
I To test the hypothesis that AZD0530 will improve the prostate-specific antigen PSA response rate and progression-free survival PFS in comparison with historical controls for patients with hormone-refractory prostate cancer HRPC
II Evaluate the time to treatment failure and overall survival of patients with HRPC treated with AZD0530
III Evaluate the toxicities and tolerance of AZD0530 therapy in the HRPC population
OUTLINE This is a multicenter study
Patients receive oral AZD0530 once daily Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 6 months for the first 2 years and then yearly thereafter
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000559142 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchN01CM62201 |
| PHII-79 | None | None | None |
| N01CM62209 | NIH | None | None |
| N01CM62201 | NIH | None | None |