BACKGROUND: We conducted a phase I study with MDL 73,147EF, a new 5 hydroxytryptamine 3 (5-HT3) receptor antagonist, in 25 patients requiring emetogenic chemotherapy. PATIENTS AND METHODS: 5 groups of 5 patients received rising unit doses of MDL 73,147EF (10 to 50 mg) intravenously before chemotherapy, with two additional doses per day if needed. Nausea was assessed by a patient-completed visual analogue scale and episodes of vomiting were recorded by an independent observer. RESULTS: 42% of the patients were complete or major responders on day one. Five patients were given other rescue antiemetic therapy. Adverse effects included headache (16%) diarrhea (8%) and other minor events. The best results were obtained with the 30, 40 and 50 mg doses. CONCLUSIONS: MDL 73,147EF is a well-tolerated and probably effective antiemetic agent which requires further evaluation in randomised controlled clinical studies.
BACKGROUND: We conducted a phase I study with MDL 73,147EF, a new 5 hydroxytryptamine 3 (5-HT3) receptor antagonist, in 25 patients requiring emetogenic chemotherapy. PATIENTS AND METHODS: 5 groups of 5 patients received rising unit doses of MDL 73,147EF (10 to 50 mg) intravenously before chemotherapy, with two additional doses per day if needed. Nausea was assessed by a patient-completed visual analogue scale and episodes of vomiting were recorded by an independent observer. RESULTS: 42% of the patients were complete or major responders on day one. Five patients were given other rescue antiemetic therapy. Adverse effects included headache (16%) diarrhea (8%) and other minor events. The best results were obtained with the 30, 40 and 50 mg doses. CONCLUSIONS: MDL 73,147EF is a well-tolerated and probably effective antiemetic agent which requires further evaluation in randomised controlled clinical studies.
Authors: B Chevallier; P Cappelaere; T Splinter; M Fabbro; J L Wendling; L Cals; G Catimel; M Giovannini; D Khayat; P Bastit; N Claverie Journal: Support Care Cancer Date: 1997-01 Impact factor: 3.603