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

Phase 1

Completed

• Conditions: Solid Tumors

• Registration Number: NCT00863733
• Lead Sponsor: Cancer Research UK

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.

Study Timeline

• Study Start: 1996-05
• Primary Completion: 2000-03
• Study Completion: 2000-03
• Status Verified: 2009-03
• Study First Submitted: 2009-03-17
• Study First Submitted QC: 2009-03-17
• Last Update Submitted: 2009-03-17
• Study First Posted: 2009-03-18
• Last Update Posted: 2009-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics of DMXAA
Effect of DMXAA on coagulation parameters, TNF and other cytokine production, nitric oxide, and serotonin production
Toxicity of DMXAA
Maximum tolerated dose of DMXAA

Secondary Outcome Measures

Name	Time	Method
Efficacy of DMXAA
Effect of DMXAA on tumor vasculature