A Phase I Study to Assess the Safety, Tolerability and Pharmacokinetics of Docetaxel Lipid Microsphere for Injection in Cancer Patients Receiving Chemotherapy
Docetaxel (currently marketed as Taxotere®), given by intravenous or intraperitoneal
injection, has contributed significantly to the treatment of a variety of malignancies, such
as ovarian, breast, gastric, and non-small-cell lung cancer (NSCLC), as well as head and
neck cancer and some other cancers. In the preclinical, DT-LM showed reduced toxicity
(especially myelosuppression）and comparable therapeutic efficacy. In clinic, it is believed
that DT-LM will offer fewer side effects to the patient at similar doses, and possibly
greater effectiveness when used at higher doses. DT-LM could not only avoid the serious
hypersensitivity reactions caused by Tween 80, but also be stable, safe and convenient for
This study is designed to determine the following:
- The maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of DT-LM.
- The pharmacokinetics of docetaxel following intravenous administration of DT-LM.
- Any anti-tumor effects of DT-LM.
Controlled trial is also carrying out to reveal the differences in safety, pharmacokinetics
and pharmacodynamics between DT-LM and Taxotere.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The safety and tolerability
This Phase I, open-label, control,dose-escalation study was designed to determine the maximum tolerated dose (MTD) of DT-LM in patients with advanced cancer. DT-LM was administered by intravenous infusion, over 1 hour, once every 21 days until occurrence of disease progression or toxicity requiring early treatment discontinuation. Dose escalation was not done until the safety and tolerability at a given dose level has been confirmed.
Xing Tang, Ph.D
Shenyang Pharmaceutical University
China: Food and Drug Administration