drugset / Trial / NCT00666991
Pharmacokinetic, Safety and Efficacy Study of Nanoparticle Paclitaxel in Patients With Peritoneal Cancers
Phase 1
Completed
22 enrolled
CritiTech, Inc.
Beckloff Associates, Inc. · collabUniversity of Kansas Medical Center · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the safety, pharmacokinetics and preliminary efficacy of an intraperitoneally administered suspension of nanoparticulate paclitaxel in patients with refractory malignancies principally confined to the peritoneal cavity.
Timeline
- Start
- 2008-07
- Primary completion
- 2013-05
- Completion
- 2013-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nanoparticulate paclitaxel | Unknown | 50 mg/m2 | Other |
| Subject | Nanoparticulate paclitaxel | Unknown | 82.5 mg/m2 | Other |
| Subject | Nanoparticulate paclitaxel | Unknown | 125 mg/m2 | Other |
| Subject | Nanoparticulate paclitaxel | Unknown | 175 mg/m2 | Other |
| Subject | Nanoparticulate paclitaxel | Unknown | 225 mg/m2 | Other |
| Subject | Nanoparticulate paclitaxel | Unknown | 275 mg/m2 | Other |