Pharmaceutical compositions of 7-(6-(2-hydroxypropan-2-yl)pyridin-3-yl)-1-((trans)-4-methoxycyclohexyl)-3,4-dihydropyrazino[2,3- B]pyrazin-2(1H)-one, a solid form there of and methods of their use
First Claim
1. A method for achieving a Response Evaluation Criteria in Solid Tumors (RECIST 1.1) of at least partial response or stable disease in a patient having a solid tumor, comprising administering to the patient a pharmaceutical composition comprising an effective amount of 7-(6-(2-hydroxypropan-2-yl)pyridin-3-yl)-1-(trans-4-methoxycyclohexyl)-3,4-dihydropyrazino[2,3-b]pyrazin-2(1H)-one, or a pharmaceutically acceptable salt or isotopologue thereof, about 40-60% by weight of lactose monohydrate, about 20-40% by weight of low-moisture grade microcrystalline cellulose, about 1-5% by weight of croscarmellose sodium and about 0.5-3% by weight of magnesium stearate,wherein the patient has a neuroendocrine tumor, non-small cell lung cancer, glioblastoma multiforme, hepatocellular carcinoma, breast cancer, non-Hodgkin lymphoma, or multiple myeloma.
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Abstract
Provided herein are compositions of 7-(6-(2-hydroxypropan-2-yl)pyridin-3-yl)-1-((trans)-4-methoxycyclohexyl)-3,4-dihydropyrazino[2,3-b]pyrazin-2(1H)-one, solid forms, isotopologs and metabolites thereof, and methods of their use for the treatment of a disease, disorder, or condition.
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Citations
18 Claims
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1. A method for achieving a Response Evaluation Criteria in Solid Tumors (RECIST 1.1) of at least partial response or stable disease in a patient having a solid tumor, comprising administering to the patient a pharmaceutical composition comprising an effective amount of 7-(6-(2-hydroxypropan-2-yl)pyridin-3-yl)-1-(trans-4-methoxycyclohexyl)-3,4-dihydropyrazino[2,3-b]pyrazin-2(1H)-one, or a pharmaceutically acceptable salt or isotopologue thereof, about 40-60% by weight of lactose monohydrate, about 20-40% by weight of low-moisture grade microcrystalline cellulose, about 1-5% by weight of croscarmellose sodium and about 0.5-3% by weight of magnesium stearate,
wherein the patient has a neuroendocrine tumor, non-small cell lung cancer, glioblastoma multiforme, hepatocellular carcinoma, breast cancer, non-Hodgkin lymphoma, or multiple myeloma.
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11. A method for achieving a Response Evaluation Criteria in Solid Tumors (RECIST 1.1) of at least partial response or stable disease in a patient having a solid tumor, comprising administering to the patient a pharmaceutical composition comprising an effective amount of a crystal form of 7-(6-(2-hydroxypropan-2-yl)pyridin-3-yl)-1-(trans-4-methoxycyclohexyl)-3,4-dihydropyrazino[2,3-b]pyrazin-2(1H)-one, or a salt thereof, about 40-60% by weight of lactose monohydrate, about 20-40% by weight of low-moisture grade microcrystalline cellulose, about 1-5% by weight of croscarmellose sodium and about 0.5-3% by weight of magnesium stearate, wherein the crystal form has an X-ray powder diffraction pattern comprising peaks at approximately 7.46, 13.70 and 23.06°
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,wherein the patient has a neuroendocrine tumor, non-small cell lung cancer, glioblastoma multiforme, hepatocellular carcinoma, breast cancer, non-Hodgkin lymphoma, or multiple myeloma. - View Dependent Claims (12, 13, 14, 15, 16, 17, 18)
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Specification