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.