Method for administration of pegylated liposomal doxorubicin

Details Method for administration of pegylated liposomal doxorubicin Method for administration of pegylated liposomal doxorubicin

A - Human Necessities

61

K

A61K 9/127 (2006.01) A61K 31/337 (2006.01) A61P 35/00 (2006.01)

Patent

CA 2673717

An embodiment of the present invention comprises a method of treating malignancies in a subject in need of treatment comprising administering to the subject a high loading dose of a pegylated liposomal doxorubicin (PLD) in an initial cycle, followed by a reduced dose in a second cycle, wherein the second cycle reduced dose is in the range of 20% to 50%, preferably 50%, of the initial loading dose, and thereafter one or more maintenance doses in further cycles. The interval between dose cycles is in the range of about three-to-four weeks, preferably about four weeks. The initial loading dose is in the range of between the maximum tolerated dose (MTD) and the recommended dose, preferably the MTD (for instance, in the range of about 70 mg/m2 to 50 mg/m2, preferably 60 mg/m2). The one or more maintenance doses are in the range of about 40 mg/m2 to 50 mg/m2, preferably 45 mg/m2).

Dans une exécution, l'invention porte sur une méthode de traitement de tumeurs malignes consistant à administrer à un patient le nécessitant une forte dose de charge de doxorubicine liposomale pégylée (PLD) dans un cycle initial, suivie dans un deuxième cycle d'une dose réduite de 20 % à 50 %, de préférence 50 %, de la dose de charge initiale, puis de doses d'entretien dans des cycles ultérieurs. L'intervalle entre des cycles est d'environ "trois à quatre" semaines, de préférence environ quatre semaines. La dose de charge initiale se situe entre la la dose tolérée maximale (MTD) et la dose recommandée, de préférence la MTD (par exemple, entre environ 70 mg/m2 à 50 mg/m2, de préférence 60 mg/m2). La ou les doses d'entretien sont d'environ 40 mg/m2 à 50 mg/m2, de préférence 45 mg/m2.

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