Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00100139
Status:
COMPLETED
Last Update Posted:
2011-07-04
First Post:
2004-12-23
Brief Title:
Comparison of Liposome Entrapped Paclitaxel Easy to Use LEP-ETU and Taxol Pharmacokinetics in Patients With Advanced Cancer
Sponsor:
INSYS Therapeutics Inc
Organization:
INSYS Therapeutics Inc
Study Overview
Official Title:
A Randomized Two-Period Crossover Clinical Bioequivalence Study Comparing the Pharmacokinetics of Liposome Entrapped Paclitaxel Easy to Use LEP-ETU Formulation Versus Taxol in Patients With Advanced Cancer
Status:
COMPLETED
Status Verified Date:
2011-06
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:
In this study Liposome Entrapped Paclitaxel Easy to Use LEP-ETU is being compared to Taxol to examine whether the paclitaxel in these 2 formulations undergoes similar processing by the body Safety and tolerability of LEP-ETU and Taxol will also be assessed In this study each patient will receive one intravenous infusion of LEP-ETU or Taxol followed 3 weeks later by an infusion of the other drug at the same dose and infusion duration Multiple blood samples will be taken for analysis before during and after both drug infusions Upon completing these 2 Cycles of treatment eligible patients may enroll in an extension study LEP-ETU-102B to continue treatment with LEP-ETU
LEP-ETU is a liposomal formulation of paclitaxel a widely used anti-cancer drug This LEP-ETU formulation of paclitaxel is being developed to potentially reduce toxicities associated with Taxol by eliminating the drug formulation component polyoxyethylated castor oil Cremophor EL In LEP-ETU paclitaxel is associated with liposomes which are microscopic membrane-like structures created from lipids fats Thus the LEP-ETU formulation could potentially have reduced toxicity while maintaining or enhancing efficacy
LEP-ETU is a liposomal formulation of paclitaxel a widely used anti-cancer drug This LEP-ETU formulation of paclitaxel is being developed to potentially reduce toxicities associated with Taxol by eliminating the drug formulation component polyoxyethylated castor oil Cremophor EL In LEP-ETU paclitaxel is associated with liposomes which are microscopic membrane-like structures created from lipids fats Thus the LEP-ETU formulation could potentially have reduced toxicity while maintaining or enhancing efficacy
Detailed Description:
This Phase 1B open-label two-period crossover bioequivalence study is designed to compare the pharmacokinetics PK of LEP-ETU and Taxol in patients with advanced cancer Patients are randomized to determine which drug is administered first A single dose of LEP-ETU or Taxol Cycle A will be administered followed 3 weeks later by a single dose of the other drug Cycle B Blood samples for PK analysis will be taken before during and after the infusion of each drug Following successful completion of both Cycles in this study patients may be eligible for additional cycles of treatment with LEP-ETU in the LEP-ETU-102B extension study
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