Study of DMXAA (Now Known as ASA404) in Solid Tumors
This is a phase I study aimed at identifying safe doses of DMXAA in patients with solid tumors.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Trial of 5,6 Dimethylxanthenone - 4 - Acetic Acid (DMXAA) in Solid Tumors|
- Toxicity of DMXAA [ Designated as safety issue: Yes ]
- Maximum tolerated dose of DMXAA [ Designated as safety issue: Yes ]
- Pharmacokinetics of DMXAA [ Designated as safety issue: No ]
- Effect of DMXAA on coagulation parameters, TNF and other cytokine production, nitric oxide, and serotonin production [ Designated as safety issue: No ]
- Efficacy of DMXAA [ Designated as safety issue: No ]
- Effect of DMXAA on tumor vasculature [ Designated as safety issue: No ]
|Study Start Date:||May 1996|
|Study Completion Date:||March 2000|
|Primary Completion Date:||March 2000 (Final data collection date for primary outcome measure)|
- 5,6 Dimethylxanthenone-4-Acetic Acid
This is a dose escalation study conducted at a single center in New Zealand. Patients received dimethylxanthenone acetic acid (DMXAA) IV over 20 minutes once every three weeks, up to a maximum of 12 courses.
Cohorts of 3 patients received escalated doses of DMXAA until the maximum tolerated dose (MTD) was determined. The MTD is defined as the dose preceding that at which 2 of 3 patients experience dose limiting toxicity.
Patients had solid tumors for which there was no standard therapy or were refractory to conventional therapy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00863733
|Principal Investigator:||Dr Paul Thompson||Auckland Hospital|