Safety Study of OXi4503 (a Vascular Disrupting Agent) Given by 3 x Weekly Intravenous Infusions to Patients With Advanced Solid Tumors
NCT ID: NCT00977210
Last Updated: 2011-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
40 participants
INTERVENTIONAL
2005-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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OXi4503
OXi4503
OXi4503 will be administered weekly for 3 weeks followed by a week with no treatment. The starting dose will be 0.06 mg/m2 given as an intravenous infusion over 10 minutes.
Interventions
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OXi4503
OXi4503 will be administered weekly for 3 weeks followed by a week with no treatment. The starting dose will be 0.06 mg/m2 given as an intravenous infusion over 10 minutes.
Eligibility Criteria
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Inclusion Criteria
* Written informed consent.
* Age \>/= 18 years.
* Life expectancy of at least 12 weeks.
* World Health Organization (WHO) performance status of 0 or 1.
* Adequate Hematological and biochemical indices to support investigational therapy.
* All women of childbearing potential (WOCBP) must have a negative serum pregnancy test.
* WOCBP and fertile men and their partners must agree to use an effective form of contraception during the study and for 90 days after the last dose of study medication.
* Measurable and evaluable disease.
* All toxic manifestations of previous treatment must have resolved.
* Able to undergo MRI scanning.
Exclusion Criteria
* Pregnant and lactating women.
* Major thoracic and/or abdominal surgery in the preceding four weeks from which the patient has not yet recovered.
* Patients which have active uncontrolled infections.
* Patients with any other condition that in the Investigator's opinion would not make the patient a good candidate for the clinical trial.
* Patients known to be serologically positive for Hepatitis B, Hepatitis C or Human Immunodeficiency Virus (HIV).
* Previous or ongoing cardiac conditions.
* Uncontrolled hypertension.
* Patients taking any drug known to prolong the QTc interval.
* Patients who have had any ischaemic or vascular damage from previous radiotherapy.
* Patients taking warfarin or heparin.
* Patients taking naproxen.
* Patients taking supplements or multivitamins containing vitamin C.
* Patients should not be taking any other investigational drug for the duration of the study.
* Patients with brain metastases or neurological tissue involvement of the spinal column.
18 Years
ALL
No
Sponsors
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Cancer Research UK
OTHER
Mateon Therapeutics
INDUSTRY
Responsible Party
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Locations
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CRUK Investigational Site
Manchester, , United Kingdom
CRUK Investigational Site
Middlesex, , United Kingdom
Countries
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References
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Patterson DM, Zweifel M, Middleton MR, Price PM, Folkes LK, Stratford MR, Ross P, Halford S, Peters J, Balkissoon J, Chaplin DJ, Padhani AR, Rustin GJ. Phase I clinical and pharmacokinetic evaluation of the vascular-disrupting agent OXi4503 in patients with advanced solid tumors. Clin Cancer Res. 2012 Mar 1;18(5):1415-25. doi: 10.1158/1078-0432.CCR-11-2414. Epub 2012 Jan 10.
Other Identifiers
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PH1/098
Identifier Type: -
Identifier Source: org_study_id