( M)) versus irinotecan as treatment for...)Alchemia Reports Preliminary Positive Efficacy Data From HyCAMP,Phase II Trial,Health

M)) versus irinotecan as treatment for patients with metastatic colorectal cancer who have failed 5-FU based chemotherapy Blinding Status Open label, randomised Treatment Method HyCAMP(TM) arm: Irinotecan: 350mg/mm2 day 1 every 3 weeks or 300 mg/mm2 day 1 every 3 weeks for age 70-75 HA: 1000 mg/mm2 day 1 every 3 weeks Irinotecan arm: Irinotecan: 350mg/mm2 day 1 every 3 weeks or 300 mg/mm2 day 1 every 3 weeks for age 70-75 Duration of treatment: maximum of 8 cycles Route of administration: intravenous No of subjects 80 Key Subject Selection Criteria Metastatic colorectal cancer Failure of previous fluorouracil chemotherapy, Adequate major organ function ECOG PS (performance score) 0-1. Age 18-75 years Trial Location 10 sites in Australia Primary endpoint Comparison of the incidence of late grade 3 or 4 diarrhoea in patients receiving HyCAMP(TM) versus irinotecan alone Main Secondary safety end points 1. Incidence of grade 3 or 4 diarrhoea in cycle 1 or cycle 2 2. Requirement for dose reduction for any cause after 2 cycles of therapy 3. Requirement for dose reduction for any reason 4. Overall incidence of grade 3 or 4 neutropenia 5. Overall adverse events Main Secondary efficacy end points 1. Number of patients completing 2 cycles of therapy 2. Number of patients completing 8 cycles of therapy 3. Median number of cycles delivered 4. Disease Control Rate 5. Median
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