Ignite Creation Date:
2024-05-05 @ 10:46 PM
Last Modification Date:
2024-10-26 @ 10:24 AM
Study NCT ID:
NCT01186731
Status:
COMPLETED
Last Update Posted:
2012-09-12
First Post:
2010-08-18
Brief Title:
Efficacy and Safety Study of LE-DT to Treat Locally Advanced or Metastatic Pancreatic Cancer
Sponsor:
INSYS Therapeutics Inc
Organization:
INSYS Therapeutics Inc
Study Overview
Official Title:
A Multicenter Open-Label Phase II Study of LE-DT for Efficacy and Safety in Patients With Locally Advanced or Metastatic Pancreatic 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:
LE-DT is a novel proprietary delivery system of docetaxel developed by NeoPharm Inc Docetaxel currently marketed as Taxotere is an anti-microtubule agent that prevents cell division By removing toxic detergent used in Taxotere the form of LE-DT shows reduced toxicity and comparable therapeutic efficacy in pre-clinical study The clinical evidence obtained from the NeoPharm Phase I study shows fewer side effects and possibly administered at higher dose to induce greater effectiveness of LE-DT In addition docetaxel has shown positive activity of protein bound taxane therapy in treating patients with pancreatic cancer The current Phase II study is designed to accomplish the following objectives
1 Assess the antitumor effect of 110 mgm2 LE-DT administered intravenous IV every three weeks in pancreatic cancer patients with locally advanced or metastatic disease
2 To evaluate the progression-free survival and overall survival
3 To correlate secreted protein acid rich in cysteine expression with tumor response
4 To evaluate the safety of LE-DT in particular peripheral neuropathy water retention as well as myelotoxicity
5 To correlate pharmacogenetic variations in patients with LE-DT pharmacodynamic endpoints including toxicities
1 Assess the antitumor effect of 110 mgm2 LE-DT administered intravenous IV every three weeks in pancreatic cancer patients with locally advanced or metastatic disease
2 To evaluate the progression-free survival and overall survival
3 To correlate secreted protein acid rich in cysteine expression with tumor response
4 To evaluate the safety of LE-DT in particular peripheral neuropathy water retention as well as myelotoxicity
5 To correlate pharmacogenetic variations in patients with LE-DT pharmacodynamic endpoints including toxicities
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