Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2026-03-01 @ 11:27 AM
Study NCT ID:
NCT00863733
Status:
COMPLETED
Last Update Posted:
2009-03-18
First Post:
2009-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of DMXAA (Now Known as ASA404) in Solid Tumors
Sponsor:
Cancer Research UK
Organization:
Study Overview
Official Title:
Phase I Trial of 5,6 Dimethylxanthenone - 4 - Acetic Acid (DMXAA) in Solid Tumors
Status:
COMPLETED
Status Verified Date:
2009-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DMXAA
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: