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ARTICLE | Clinical News

Trabedersen: Additional Phase I/II data

June 11, 2012 7:00 AM UTC

Additional data from the open-label, dose-escalation Phase I/II P001 trial in 61 previously treated patients showed that IV trabedersen for 4 or 7 consecutive days of a 2-week cycle for up to 10 cycles was well tolerated with DLTs of maculopapular rash, thrombocytopenia and gastrointestinal hemorrhage reported. There were 2 serious adverse events possibly related to trabedersen - gastrointestinal hemorrhage and pyrexia. The MTD was not reached for the 4-day on-treatment regimen and was once-daily 160 mg/m 2 trabedersen for the 7-day on-treatment regimen. Median overall survival (OS) in pancreatic cancer patients (n=37) was 4.9 months for all doses of trabedersen and 13.4 months for the recommended Phase II dose of once-daily 140 mg/m 2 trabedersen for 4 days on and 10 days off (n=9). Median OS in pretreated malignant melanoma patients (n=19) was 11.4 months. There was 1 complete response in a pancreatic cancer patient who had liver metastasis. The trial enrolled patients with pancreatic adenocarcinoma, malignant melanoma or colorectal cancer. Data were presented at the American Society of Clinical Oncology meeting in Chicago. ...