Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2025-12-26 @ 2:36 AM
Study NCT ID:
NCT00442260
Status:
COMPLETED
Last Update Posted:
2021-01-22
First Post:
2007-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Doxorubicin HCL Liposome Injection (DOXIL) in Combination With Abraxane in Patients With Metastatic Breast Cancer
Sponsor:
West Virginia University
Organization:
Study Overview
Official Title:
Dose Finding and Efficacy Evaluation of DOXIL (Doxorubicin HCL Liposome Injection) in Combination With Abraxane (Abraxane) in Patients With Metastatic Breast Cancer (MBC) [Phase I and II]
Status:
COMPLETED
Status Verified Date:
2020-12
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:
Dose Finding and Efficacy Evaluation of DOXIL (Doxorubicin HCL Liposome Injection) in Combination with Abraxane (Abraxane) in Patients with Metastatic Breast Cancer (MBC) \[Phase I and II\]
Detailed Description:
Phase I Objectives
* To determine the Maximum Tolerated Dose (MTD) of the combination of (DOXIL) and Abraxane in patients with Metastatic Breast Cancer (MBC).
* Determine the dose-limiting toxicity (DLT) of DOXIL and Abraxane.
Phase II Objectives
Primary Objective
* To determine the response rate of DOXIL and Abraxane in patients with MBC.
Secondary Objectives
* To determine the time to disease progression in patients with MBC receiving DOXIL and Abraxane.
* To assess the tolerability of this regimen in women with MBC and assess toxicity profile
* To determine the Maximum Tolerated Dose (MTD) of the combination of (DOXIL) and Abraxane in patients with Metastatic Breast Cancer (MBC).
* Determine the dose-limiting toxicity (DLT) of DOXIL and Abraxane.
Phase II Objectives
Primary Objective
* To determine the response rate of DOXIL and Abraxane in patients with MBC.
Secondary Objectives
* To determine the time to disease progression in patients with MBC receiving DOXIL and Abraxane.
* To assess the tolerability of this regimen in women with MBC and assess toxicity profile
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?: