Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003796
Status:
COMPLETED
Last Update Posted:
2013-02-11
First Post:
1999-11-01
Brief Title:
Irofulven in Treating Patients With Metastatic Breast Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study of MGI-114 in Patients With Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2003-03
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:
Phase II trial to study the effectiveness of irofulven in treating patients who have metastatic breast cancer Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
Detailed Description:
OBJECTIVES
I Evaluate the response rate and time to treatment failure in patients with refractory metastatic adenocarcinoma of the breast treated with irofulven
II Assess the qualitative and quantitative toxic effects of this drug in these patients
III Determine the population pharmacokinetics and the pharmacokinetics-pharmacodynamic relationships of this drug in these patients
OUTLINE This is a multicenter study
Patients receive irofulven IV over 30 minutes on days 1 and 15 Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity
I Evaluate the response rate and time to treatment failure in patients with refractory metastatic adenocarcinoma of the breast treated with irofulven
II Assess the qualitative and quantitative toxic effects of this drug in these patients
III Determine the population pharmacokinetics and the pharmacokinetics-pharmacodynamic relationships of this drug in these patients
OUTLINE This is a multicenter study
Patients receive irofulven IV over 30 minutes on days 1 and 15 Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity
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 |
|---|---|---|---|
| NCI-T98-0060 | None | None | None |
| UTHSC-IDD-98-23 | None | None | None |
| SACI-IDD-98-23 | None | None | None |