drugset / Trial / NCT00856336
Phase I Safety Study of DMXAA in Refractory Tumors
RandomizedCrossoverDouble-blindTreatment
Summary
This was a phase I study aimed at identifying safe doses of DMXAA (now known as ASA404) to be used in future combination studies with chemotherapy.
Timeline
- Start
- 2003-05
- Primary completion
- 2004-01
- Completion
- 2004-01
Publications
- Results McKeage MJ, Fong P, Jeffery M, Baguley BC, Kestell P, Ravic M, Jameson MB. 5,6-Dimethylxanthenone-4-acetic acid in the treatment of refractory tumors: a phase I safety study of a vascular disrupting agent. Clin Cancer Res. 2006 Mar 15;12(6):1776-84. doi: 10.1158/1078-0432.CCR-05-1939.
- Jameson MB, Sharp DM, Sissingh JI, Hogg CR, Thompson PI, McKeage MJ, Jeffery M, Waller S, Acton G, Green C, Baguley BC. Transient retinal effects of 5,6-dimethylxanthenone-4-acetic acid (DMXAA, ASA404), an antitumor vascular-disrupting agent in phase I clinical trials. Invest Ophthalmol Vis Sci. 2009 Jun;50(6):2553-9. doi: 10.1167/iovs.08-2068. Epub 2009 Apr 22.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 5,6-Dimethylxanthenone-4-acetic acid | Unknown | 300 mg/m2 | Intravenous |
| Subject | 5,6-Dimethylxanthenone-4-acetic acid | Unknown | 600 mg/m2 | Intravenous |
| Subject | 5,6-Dimethylxanthenone-4-acetic acid | Unknown | 1200 mg/m2 | Intravenous |
| Subject | 5,6-Dimethylxanthenone-4-acetic acid | Unknown | 1800 mg/m2 | Intravenous |
| Subject | 5,6-Dimethylxanthenone-4-acetic acid | Unknown | 2400 mg/m2 | Intravenous |
| Subject | 5,6-Dimethylxanthenone-4-acetic acid | Unknown | 3000 mg/m2 | Intravenous |