Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-02-25 @ 5:53 PM
Study NCT ID:
NCT00659360
Status:
COMPLETED
Last Update Posted:
2018-06-29
First Post:
2008-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
AZD0530 in Treating Patients With Recurrent Locally Advanced or Metastatic Soft Tissue Sarcoma
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
A Phase 2 Study of AZD0530 in Recurrent or Metastatic Soft Tissue Sarcoma
Status:
COMPLETED
Status Verified Date:
2018-05
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 recurrent locally advanced, or metastatic soft tissue sarcoma. AZD0530 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Detailed Description:
OBJECTIVES:
I. To assess the efficacy of AZD0530, in terms of disease control rate (i.e., response rate and stable disease rate), in patients with recurrent locally advanced or metastatic soft tissue sarcoma.
II. To assess the toxicity, time to progression, and response duration of AZD0530 in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral AZD0530 once daily in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed every 8 weeks.
I. To assess the efficacy of AZD0530, in terms of disease control rate (i.e., response rate and stable disease rate), in patients with recurrent locally advanced or metastatic soft tissue sarcoma.
II. To assess the toxicity, time to progression, and response duration of AZD0530 in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral AZD0530 once daily in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed every 8 weeks.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| PHL-054 | OTHER_GRANT | N01CM62203 | View | |
| CDR0000588034 | OTHER_GRANT | N01CM62203 | View | |
| PMH-PHL-054 | OTHER_GRANT | N01CM62203 | View | |
| N01CM62203 | NIH | None | https://reporter.nih.gov/quic… | View |