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This was a phase I study aimed at identifying safe doses of DMXAA (now known as ASA404) to be used in future combination studies with chemotherapy.
Full description
This was a multi-centre randomized, double blind study to further characterize the effect of DMXAA on QTc interval, ophthalmic safety and pharmacodynamic effects on tumour blood flow.
Patients with refractory tumors were to each undergo six doses of treatment at weekly intervals, receiving each of six doses of DMXAA (300, 600, 1200, 1800, 2400 and 3000 mg/m2)
Enrollment
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Inclusion criteria
Evidence of cancer, by histopathology or cytology, which was not amenable to any standard therapy or was refractory to conventional therapy
Age ≥ 18 years
Life expectancy of at least 12 weeks
WHO performance status of 0-2
Hematological and biochemical indices at the start of treatment:
Presence of a lesion which was amenable to dynamic MRI
Written informed consent and the ability of the patient to co-operate with treatment and follow up
Exclusion criteria
Radiotherapy (except for palliative reasons), endocrine therapy, immunotherapy or chemotherapy during the previous four weeks prior to treatment
Pregnant or lactating women were excluded
Patients who were poor medical risks because of non-malignant systemic disease, as well as those with active uncontrolled infection
Current malignancies at other sites
Significant history of recreational drug abuse
Glucocorticosteroids in doses exceeding those required for physiological replacement within the previous 2 weeks
Skin lesions that may prevent long-term ECG acquisition
Body mass index above 30 kg/m2
Patients who were taking certain medications
Patients with clinical evidence of brain metastases
Patients with certain cardiac conditions
Women with breast implants as these may have interfered with the recording of the ECG
Patients with severe electrolyte abnormalities and patients in whom transient electrolyte abnormalities may have been expected during any visit of the study
Patients in whom concomitant neurotropic drug therapy was known to change or was likely to change during the course of the study, where such therapy was likely to affect the patients ERG measurement
Ophthalmic conditions where in the opinion of the investigator they might affect the recording of the ERG
Primary purpose
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Interventional model
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Data sourced from clinicaltrials.gov
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