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

NCT00915369 ↗

Phase 1 Unknown 24 enrolled Fresenius Kabi Oncology Ltd.
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

EvaluationDrugModalityDoseRoute
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 —

Indications