drugset / Trial / NCT00915369
A Clinical Trial to Study the Effects of Nanoparticle Based Paclitaxel Drug, Which Does Not Contain the Solvent Cremophor, in Advanced Breast Cancer
NaSingle-groupOpen-labelTreatment
Summary
This study is a multicentre, open label, non-randomized phase I study. The main objectives of the study are to determine the pharmacokinetic profile of the drug at different dose levels in the patients with Advanced Breast Cancer. Maximum Tolerated Dose (MTD) and safety of Paclitaxel Nanoparticle will also be simultaneously assessed.
Timeline
- Start
- 2009-03
- Primary completion
- 2010-04
- Completion
- 2010-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Paclitaxel | Small molecule | 220 mg/m2 | — |
| Subject | Paclitaxel | Small molecule | 260 mg/m2 | — |
| Subject | Paclitaxel | Small molecule | 310 mg/m2 | — |
| Subject | Paclitaxel | Small molecule | 375 mg/m2 | — |