Ignite Creation Date:
2024-05-05 @ 10:49 PM
Last Modification Date:
2024-10-26 @ 10:24 AM
Study NCT ID:
NCT01190982
Status:
COMPLETED
Last Update Posted:
2012-08-24
First Post:
2010-08-26
Brief Title:
Efficacy and Safety Study of LEP-ETU to Treat Metastatic Breast Cancer
Sponsor:
INSYS Therapeutics Inc
Organization:
INSYS Therapeutics Inc
Study Overview
Official Title:
A Multicenter Open-Label Phase II Study of LEP-ETU for Efficacy and Safety in Patients With Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2012-08
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:
LEP-ETU is a novel proprietary delivery system of paclitaxel developed by NeoPharm Inc Paclitaxel currently marketed as Taxol is an anti-microtubular network agent and is active in a broad spectrum of malignancies Paclitaxel has poor solubility In order to enhance the solubility this drug is formulated with polyoxyethylated castor oil which leading to infusion-related hypersensitivity reactions The NeoPharm LEP-ETU is formulated with a mixture of well characterized synthetic phospholipids and cholesterol This design eliminates the need for the oil The LEP-ETU formulation has improved safety profile that is necessary for administering higher doses than would commonly be used with Taxol The clinical evidence obtained from the NeoPharm Phase I study shows LEP-ETU is better tolerated than Taxol as indicated by a higher maximum-tolerated dose MTD The current Phase II study is designed to accomplish the following objectives
1 Assess the Overall Response Rate ORR of patients with metastatic breast cancer after administered over 90 minutes at the dose of 275 mgm2 LEP-ETU
2 To evaluate the Progression-Free Survival PFS
3 To evaluate the safety of LEP-ETU at 275 mgm2 level in particular peripheral neuropathy
4 To evaluate the Overall Survival OS
1 Assess the Overall Response Rate ORR of patients with metastatic breast cancer after administered over 90 minutes at the dose of 275 mgm2 LEP-ETU
2 To evaluate the Progression-Free Survival PFS
3 To evaluate the safety of LEP-ETU at 275 mgm2 level in particular peripheral neuropathy
4 To evaluate the Overall Survival OS
Detailed Description:
None
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