Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00397878
Status:
TERMINATED
Last Update Posted:
2019-08-20
First Post:
2006-11-09
Brief Title:
AZD0530 NSC 735464 in Treating Patients With Previously Treated Metastatic Colon Cancer or Rectal Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study of AZD0530 NSC 735464 in Patients With Previously Treated Metastatic Colorectal Cancer
Status:
TERMINATED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was terminated after all enrolled participants progressed
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 previously treated metastatic colon cancer or rectal cancer AZD0530 may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth
Detailed Description:
PRIMARY OBJECTIVES
I Determine the progression-free survival PFS at 4 months in metastatic colorectal carcinoma patients receiving daily doses of AZD0530
SECONDARY OBJECTIVES
I Evaluate the objective response rate RR and overall survival OS of patients with metastatic colorectal cancer who are treated with AZD0530
II In patients who consent both blood and tissue samples will be collected for laboratory correlates Assess in a preliminary manner the association between correlative markers and the potential downstream effects of AZD0530 on IL-8 VEGF specific Src-regulated markers in focal adhesions adherens junctions and angiogenesis on clinical outcome in pre- and post-treatment tumor samples
OUTLINE
Patients receive oral AZD0530 once daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed at 4 weeks and then every 3 months thereafter
PROJECTED ACCRUAL A total of 35 patients will be accrued for this study
I Determine the progression-free survival PFS at 4 months in metastatic colorectal carcinoma patients receiving daily doses of AZD0530
SECONDARY OBJECTIVES
I Evaluate the objective response rate RR and overall survival OS of patients with metastatic colorectal cancer who are treated with AZD0530
II In patients who consent both blood and tissue samples will be collected for laboratory correlates Assess in a preliminary manner the association between correlative markers and the potential downstream effects of AZD0530 on IL-8 VEGF specific Src-regulated markers in focal adhesions adherens junctions and angiogenesis on clinical outcome in pre- and post-treatment tumor samples
OUTLINE
Patients receive oral AZD0530 once daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed at 4 weeks and then every 3 months thereafter
PROJECTED ACCRUAL A total of 35 patients will be accrued for this study
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 |
|---|---|---|---|
| P30CA016672 | NIH | CTEP | httpsreporternihgovquickSearchP30CA016672 |
| NCI-2013-00067 | REGISTRY | None | None |
| CDR0000512970 | None | None | None |
| MDA-2005-0977 | None | None | None |
| NCI-7569 | None | None | None |
| 2005-0977 | OTHER | None | None |
| 7565 | OTHER | None | None |
| N01CM62202 | NIH | None | None |