drugset / Trial / NCT01103791
A Trial to Determine the Maximum Tolerated Dose and Evaluate the Safety and Pharmacokinetics of Docetaxel-PNP, Polymeric Nanoparticle Formulation of Docetaxel, in Subjects With Advanced Solid Malignancies
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is a phase I trial to determine the maximum tolerated dose and recommended phase II dose of docetaxel-PNP (polymeric nanoparticle formulation of docetaxel) and to evaluate the safety and pharmacokinetics of docetaxel-PNP in subjects with advanced solid malignancies.
Timeline
- Start
- 2010-04
- Primary completion
- 2011-09
- Completion
- 2012-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Docetaxel | Small molecule | 20 mg/m2 | — |
| Subject | Docetaxel | Small molecule | 35 mg/m2 | — |
| Subject | Docetaxel | Small molecule | 45 mg/m2 | — |
| Subject | Docetaxel | Small molecule | 60 mg/m2 | — |
| Subject | Docetaxel | Small molecule | 75 mg/m2 | — |
| Subject | Docetaxel | Small molecule | 90 mg/m2 | — |
Indications
No indication recorded.