TerminatedPhase 1ACTRN12607000078459

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.

Sponsor

MRC Biotech Pty Ltd

Enrollment

12 participants

Start Date

Feb 10, 2007

Study Type

Interventional

Conditions

Malignant ascites (hydoperitoneum) associated with cancer

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

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria1

Histologically or cytologically proven advanced or metastatic cancer.Positive or suggestive peritoneal cytology.Judged likely to benefit from insertion of peritoneal port for symptom control.Must have measurable or evaluable disease.Ascites refractory to standard treatments.ECOG 0-3 performance status.At least 3 weeks since prior chemotherapy (at least 6 weeks from agents know to be toxic to stem cells)Must have recovered from reversible side effects of prior therapy.At least 2 weeks since any prior radiotherapy.

Exclusion Criteria1

Unresolved ongoing infection requiring treatment.Decompensated liver disease with non-malignant ascites or coagulopathy or encephalopathy.Severe co-morbidity at the discretion of the investigatorsUnwilling or unable to have insertion of an intraperitoneal portacath.Pregnant or breast-feeding mothers.

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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

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)

Australia

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ACTRN12607000078459