Clinical trial · Interventional
Study of DMXAA (Now Known as ASA404) in Solid Tumors
Phase I Trial of 5,6 Dimethylxanthenone - 4 - Acetic Acid (DMXAA) in Solid Tumors
NCT00863733CI-TRIAL-00002138DMXAAcompletedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a phase I study aimed at identifying safe doses of DMXAA in patients with solid tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DMXAA | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Toxicity of DMXAA
- measure
- Maximum tolerated dose of DMXAA
- measure
- Pharmacokinetics of DMXAA
- measure
- Effect of DMXAA on coagulation parameters, TNF and other cytokine production, nitric oxide, and serotonin production
Secondary outcomes (2)
- measure
- Efficacy of DMXAA
- measure
- Effect of DMXAA on tumor vasculature
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically confirmed solid tumor that is not amenable to any standard therapy or is refractory to conventional therapy 2. Performance status WHO 0-2 3. Life expectancy greater than 3 months 4. Hemoglobin at least 90 g/L; WBC at least 3,000/mm3; Platelet count at least 100,000/mm3 5. Bilirubin within normal limits; ALT less than 2 times upper limit of normal (ULN); Alkaline phosphatase less than 2 times ULN 6. Creatinine less than 130 umol/L 7. INR and APTT within normal limits 8. Fertile patients must use effective contraception 9. At least 4 weeks since prior anticancer therapy and recovered from toxic effects Exclusion Criteria: 1. Concurrent malignancy except cone biopsied carcinoma in situ of the cervix and adequately treated basal or squamous cell carcinoma of the skin 2. Other serious medical condition 3. Uncontrolled infection or serious infection within the past 28 days 4. Pregnant or lactating 5. Treatment with glucocorticosteroids within previous two weeks
References
Publications (2)
- RESULTJameson MB, Thompson PI, Baguley BC, Evans BD, Harvey VJ, Porter DJ, McCrystal MR, Small M, Bellenger K, Gumbrell L, Halbert GW, Kestell P; Phase I/II Trials Committee of Cancer Research UK. Clinical aspects of a phase I trial of 5,6-dimethylxanthenone-4-acetic acid (DMXAA), a novel antivascular agent. Br J Cancer. 2003 Jun 16;88(12):1844-50. doi: 10.1038/sj.bjc.6600992. PMID 12799625
- DERIVEDJameson 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. PMID 19387077