Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00046514
Status:
COMPLETED
Last Update Posted:
2016-12-15
First Post:
2002-09-30
Brief Title:
ABI-007 in Taxol Resistant Patients With Metastatic Breast Cancer
Sponsor:
Celgene Corporation
Organization:
Celgene Corporation
Study Overview
Official Title:
A Phase II Clinical Trial of ABI-007 A Cremophor-Free Protein Stabilized Nanoparticle PaclitaxelAdministered Weekly in Taxol Resistant Patients With Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2016-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The anticancer agent paclitaxel marketed as Taxol has shown remarkable activity against metastatic breast cancer However the Taxol formulation requires prolonged administration times and there are safety problems that have been attributed to the solvent rather than the active ingredient paclitaxel This is a new formulation of paclitaxel that has been found to have fewer safety problems than Taxol and may be administered safely at higher doses This study will investigate the safety and efficacy of this new formulation of paclitaxel given intravenously once a week for three weeks followed by a rest week This cycle will be repeated until safety problems or treatment failure require that the patient stop therapy
Detailed Description:
The anticancer agent paclitaxel Taxol for Injection Concentrate Bristol-Meyers Squibb has a broad spectrum of activity against several human cancers including carcinomas of ovary breast lung esophagus and head and neck cancer Taxol has shown remarkable activity against metastatic breast cancer yielding response rates in the range of 40 to 60 in chemotherapy-naive patients and 25-30 in patients refractory to anthracycline-containing regimens Taxol package insert The major limitation of Taxol is its poor water soluability requiring Cremophor containing castor oil and ethanol as a solvent Taxol in this vehicle must be administered over 3-24 hours and hypersensitivity reactions to Cremophor require a premedication routine of a corticosteroid an antihistamine and an H2 antagonist
In this study the test medication ABI-007 is a nanoparticle colloidal composition of protein-stabilized paclitaxel that is reconstituted in saline The infusion time for ABI-007 is minimal compared to Taxol under an hour and there is no premedication required The maximally tolerated dose of this formulation of paclitaxel is 300 mgm2 as compared to 175 mgm2 for Taxol As tumor response has been shown to be dose-dependent for paclitaxel a higher dose allows for a potentially better response
This open-label Phase II study will determine the safety tolerability and anti-tumor effect of ABI-007 monotherapy administered weekly in patients with metastatic breast cancer that have been previously treated with Taxol
In this study the test medication ABI-007 is a nanoparticle colloidal composition of protein-stabilized paclitaxel that is reconstituted in saline The infusion time for ABI-007 is minimal compared to Taxol under an hour and there is no premedication required The maximally tolerated dose of this formulation of paclitaxel is 300 mgm2 as compared to 175 mgm2 for Taxol As tumor response has been shown to be dose-dependent for paclitaxel a higher dose allows for a potentially better response
This open-label Phase II study will determine the safety tolerability and anti-tumor effect of ABI-007 monotherapy administered weekly in patients with metastatic breast cancer that have been previously treated with Taxol
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