drugset / Trial / NCT01151384

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

NCT01151384 ↗

Phase 1 Completed 30 enrolled INSYS Therapeutics Inc
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2008-02
Primary completion
2010-05
Completion
2010-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Docetaxel Small molecule 50 mg/m2 Intravenous
Subject Docetaxel Small molecule 65 mg/m2 Intravenous
Subject Docetaxel Small molecule 85 mg/m2 Intravenous
Subject Docetaxel Small molecule 110 mg/m2 Intravenous
Subject Docetaxel Small molecule 132 mg/m2 Intravenous

Indications