NCT01151384

Liposome Encapsulated Docetaxel (LE-DT) in Patients With Solid Tumors

A Phase 1 Study of Liposome Encapsulated Docetaxel (LE-DT) in Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: INSYS Therapeutics Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Liposome Encapsulated Docetaxel (LE-DT) is a novel proprietary delivery system of docetaxel developed by NeoPharm, Inc. In this Phase I study, the LE-DT was evaluated for the maximum tolerated dose and dose limiting toxicity (DLT) in patients with advance solid tumors. It was also evaluated for pharmacokinetic and anti-tumor effects.

Detailed description

Liposome Entrapped Doxetaxel (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 promoting the assembly and stabilization of microtubules and is used for the treatment of malignancies from breast, prostate, lung, gastric, head and neck. By removing toxic detergent used in Taxotere®, LE-DT showed reduced toxicity and comparable therapeutic efficacy in preclinical studies. In clinic, it is believed that LE-DT will offer advantages to the patient of fewer side effects at similar doses, and possibly greater effectiveness when used at higher doses. In addition, routine premedication to prevent hypersensitivity may not be required. This study is designed to determine the following: * The maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of LE-DT. * The pharmacokinetics of docetaxel following intravenous administration of LE-DT. * Any anti-tumor effects of LE-DT. Up to 5 dose levels have been studied.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	LE-DT	Intravenous infusion, Upto 5 dose levels have been studied i.e. 50, 65, 85, 110 and 132 mg/m2, Every 3 weeks

Timeline

• Start date: 2008-02-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2010-06-28
• Last updated: 2011-07-04

Locations

2 sites across 1 country: United States