www.fdanews.com/articles/72128-pro-pharmaceuticals-doses-cancer-patient-with-davanat-5-fu
Pro-Pharmaceuticals Doses Cancer Patient With Davanat/5-FU
May 10, 2005
Pro-Pharmaceuticals has announced the dosing of a colorectal cancer patient in a Phase II trial of its Davanat/5-FU product candidate.
The Phase II clinical trial is in metastatic colorectal cancer patients who have disease progression after receiving standard chemotherapeutic regimens. The company initiated a Phase II, multicenter, open-label trial to evaluate the efficacy and safety of intravenous Davanat in combination with 5-Fluorouracil (5-FU) when administered in monthly cycles as third- or fourth-line therapy for metastatic colorectal cancer.
Seven medical centers will take part in this trial, which expects to enroll up to 38 patients and uses Simon's two-stage design.