A phase Ia study of MRC202 in patients with malignant ascites caused by cancer.
- Conditions
- Malignant ascites (hydoperitoneum) associated with cancerCancer - Ovarian and primary peritoneal
- Registration Number
- ACTRN12607000078459
- Lead Sponsor
- MRC Biotech Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped early
- Sex
- All
- Target Recruitment
- 12
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Determine pharmakokinetics of MRC202 and sulfoxide metabolites[Sampling timepoints at 1, 2, 4, 6, 8, 24, 48 and 96 hours and 4 weeks after intraperitoneal administration.];Determine dose response to ensure it is within safety limits, as defined by Guidance on Good Clinical Practice (CPMP/ICH/135/95).[At 4 weeks over limited range of exposures ]
- Secondary Outcome Measures
Name Time Method Determine feasibility of : Vascular Endothelial Groth Factor (VEGF); circulating endothelial cells; and Vascular Cell Adhesion Molecule - 1 (VCAM) expression in blood and peritoneal fluid as markers of inhibition of angiogensis.[At sampling timepoints of 1, 2, 4, 6, 8, 24, 48 and 96 hours and 4 weeks after intraperitoneal administration.];Determine feasibility of intraperitoneal adminstration for MRC202.[End of Phase Ia trial]