A phase Ia study of MRC202 in patients with malignant ascites caused by cancer.
A phase Ia (pharmacokinetic) study of intraperitoneal MRC202 in patients with peritoneal cancer refractory to standard treatments.
MRC Biotech Pty Ltd
12 participants
Feb 10, 2007
Interventional
Conditions
Summary
The study is aimed at evaluating the suitablility of MRC202 as a therapy for malignant ascites associated with cancer. based on extensive animal studies MRC202 has been shown as potential an effective agent to slow or treat malignant ascites. This initial study is aimed as determining an appropriate dose concentration. Data from the study will be used to design a more comprehensive study assessing the efficacy of the drug.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
This is an open label study of patients with malignant ascites. The patients will initially have ascites drained. A 1L dose (varying concetrations of either 800mg/L, 1600mg/L or 2000mg/L) of MRC202 will be administered, immediately following drainage, via an intraperitoneal catheter. Patients will remain under observation for 4 weeks, after which a wash-out product will be administered. Blood and peritoneal fluid will be sampled regularly (1, 2, 4, 6, 8, 24, 48, 96 hours and at the 4 week timepoint).
Locations(1)
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ACTRN12607000078459