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Annals of Oncology 5:549-551, 1994
© 1994 European Society for Medical Oncology

other

A phase I antiemetic study of MDL 73,147EF, a novel 5-hydroxytryptamine antagonist in cancer patients receiving emetogenic chemotherapy

Y. Merrouche, G. Catimel, P. Rebattu, A. Dumortier, J. P. Guastalla, P. O'Grady1 and M. Clavel

Clinical Pharmacology Unit and Medical Oncology Department, Centre Léon Bérard Lyon
1Clinical Research Department, Merrell Dow Research Institute Strasbourg, France

Correspondence to: Y. Merrouche, MD Medical Oncology Department Centre Léon Berard 28, rue Laënnec 69373 Lyon Cedex 08, France

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 independant observer.

RESULTS: 42% of the patients were complete or major re-sponders 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.

MDL 73, 147EF, 5-HT3 receptor antagonist, antiemetic, cancer chemotherapy


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