drugset / Trial / NCT01611961
Docetaxel Lipid Microsphere (DT-LM) for Injection in Chemotherapy Patients
Non-randomizedParallel-groupOpen-labelTreatment
Summary
Docetaxel Lipid Microsphere (DT-LM) is a novel proprietary delivery system of docetaxel developed by Shenyang Pharmaceutical University. In this Phase I study, the DT-LM was evaluated for the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) in patients with advance solid tumors. It was also evaluated for pharmacokinetic and anti-tumor effects of DT-LM compared to commerical docetaxel.
Timeline
- Start
- 2012-08
- Primary completion
- 2014-09
- Completion
- 2014-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | DT-LM | Unknown | 45 mg/m2 | Intravenous |
| Subject | DT-LM | Unknown | 60 mg/m2 | Intravenous |
| Subject | DT-LM | Unknown | 75 mg/m2 | Intravenous |
| Subject | DT-LM | Unknown | 90 mg/m2 | Intravenous |
| Subject | DT-LM | Unknown | 105 mg/m2 | Intravenous |
| Subject | DT-LM | Unknown | 120 mg/m2 | Intravenous |
| Comparator | Docetaxel | Small molecule | 60 mg/m2 | Intravenous |
| Comparator | Docetaxel | Small molecule | 75 mg/m2 | Intravenous |
| Comparator | Docetaxel | Small molecule | 90 mg/m2 | Intravenous |
Indications
No indication recorded.