NCT00863733

Study of DMXAA (Now Known as ASA404) in Solid Tumors

Phase I Trial of 5,6 Dimethylxanthenone - 4 - Acetic Acid (DMXAA) in Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Cancer Research UK · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase I study aimed at identifying safe doses of DMXAA in patients with solid tumors.

Detailed description

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.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	DMXAA	Administered as a 20 minute IV infusion, once every three weeks at doses ranging from 6 mg/m2 to 4900 mg/m2

Timeline

• Start date: 1996-05-01
• Primary completion: 2000-03-01
• Completion: 2000-03-01
• First posted: 2009-03-18
• Last updated: 2009-03-18