Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00012129
Status:
COMPLETED
Last Update Posted:
2016-03-11
First Post:
2001-03-03
Brief Title:
Chemotherapy in Treating Patients With Breast Cancer
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
Phase III Clinical and Pharmacological Study of Liposomal Annamycin in Anthracycline-Resistant Breast Cancer
Status:
COMPLETED
Status Verified Date:
2016-03
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase III trial to study the effectiveness of annamycin liposomal in treating patients who have locally advanced or metastatic breast cancer that has not responded to previous chemotherapy
PURPOSE Phase III trial to study the effectiveness of annamycin liposomal in treating patients who have locally advanced or metastatic breast cancer that has not responded to previous chemotherapy
Detailed Description:
OBJECTIVES I Determine the observed anti-tumor activity of annamycin liposomal in patients with anthracycline-resistant locally advanced or metastatic breast cancer II Determine the qualitative and quantitative toxicity and reversibility of toxicity of this regimen in these patients III Determine the clinical pharmacology of this regimen in these patients IV Determine the rationale for the dose and chosen schedule of this regimen in these patients
OUTLINE Patients receive annamycin liposomal IV over 60 minutes on day 1 Treatment continues every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 14-30 patients will be accrued for this study within 7-30 months
OUTLINE Patients receive annamycin liposomal IV over 60 minutes on day 1 Treatment continues every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 14-30 patients will be accrued for this study within 7-30 months
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-G01-1914 | None | None | None |
| NYU-9851 | None | None | None |