Solid Tumors Clinical Trial
Official title:
A Phase 1 Study of Liposome Encapsulated Docetaxel (LE-DT) in Patients With Advanced Solid Tumors
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.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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