Cocrystals, pharmaceutical compositions thereof, and methods of treatment involving same
Provided are solid forms of a compound useful for treating cancer, pharmaceutical compositions thereof, and methods of treating cancer comprising administering the solid forms described herein to a patient in need thereof.
1 . A crystalline form of a compound of formula (I)
wherein the crystalline form comprises at least one peak position, in degrees 2-theta (±0.2 degrees 2-theta), selected from the group consisting of 11.7, 12.8, 14.2, 17.8, 19.8, 20.7, 21.8, 22.2, and 25.0.
2 . The crystalline form of claim 1 , wherein the crystalline form is characterized by an X-ray powder diffraction pattern, acquired in reflection mode, comprising at least two peak positions, in degrees 2-theta (±0.2 degrees 2-theta), selected from the group consisting of 11.7, 12.8, 14.2, 17.8, 19.8, 20.7, 21.8, 22.2, and 25.0.
3 . The crystalline form of claim 1 , wherein the X-ray powder diffraction pattern comprises at least three peak positions, in degrees 2-theta (±0.2 degrees 2-theta), selected from the group consisting of 11.7, 12.8, 14.2, 17.8, 19.8, 20.7, 21.8, 22.2, and 25.0.
4 . The crystalline form of claim 1 , wherein the X-ray powder diffraction pattern comprises at least four peak positions, in degrees 2-theta (±0.2 degrees 2-theta), selected from the group consisting of 11.7, 12.8, 14.2, 17.8, 19.8, 20.7, 21.8, 22.2, and 25.0.
5 . The crystalline form of claim 1 , wherein the X-ray powder diffraction pattern comprises peak positions, in degrees 2-theta (±0.2 degrees 2-theta), of 11.7, 17.8, and 21.8, and at least three peak positions selected from the group consisting of 12.8, 14.2, 19.8, 20.7, 22.2, and 25.0.
6 . The crystalline form of claim 1 , wherein the X-ray powder diffraction pattern comprises peak positions, in degrees 2-theta (±0.2 degrees 2-theta), of 11.7, 12.8, 14.2, 17.8, 19.8, 20.7, 21.8, 22.2, and 25.0.
7 . The crystalline form of claim 1 , wherein the crystalline form is characterized by a differential scanning calorimetry thermogram comprising endothermic peaks having an onset temperature of 221.9° C. (±5.0° C.).
8 . A pharmaceutical composition comprising a therapeutically effective amount of the crystalline form of claim 1 , and one or more pharmaceutical excipients.
9 . A method for treating a cancer characterized by the presence of an IDH1 or IDH2 mutation in a patient in need thereof, comprising administering to the patient a therapeutically effective amount of the crystalline form of claim 1 .
10 . The method of claim 9 , wherein the cancer is characterized by the presence of an IDH1 mutation.
11 . The method of claim 10 , wherein the IDH1 mutation is an R132X mutation.
12 . The method of claim 11 , wherein the IDH1 mutation is an R132H or R132C mutation.
13 . The method of claim 9 , wherein the cancer is characterized by the presence of an IDH2 mutation.
14 . The method of claim 13 , wherein the IDH2 mutation is an R140X mutation.
15 . The method of claim 14 , wherein the IDH2 mutation is an R140Q, R140W, or R140L mutation.
16 . The method of claim 13 , wherein the IDH2 mutation is an R172X mutation.
17 . The method of claim 16 , wherein the IDH2 mutation is an R172K or R172G mutation.
18 . The method of claim 9 , wherein the cancer is selected from glioma, acute myelogenous leukemia, sarcoma, melanoma, non-small cell lung cancer (NSCLC), cholangiocarcinomas, chondrosarcoma, myelodysplastic syndromes (MDS), myeloproliferative neoplasm (MPN), colon cancer, and angio-immunoblastic non-Hodgkin's lymphoma (NHL).
19 . The method of claim 18 , wherein the cancer is glioma.
20 . The method of claim 19 , wherein the glioma is a low grade glioma or a secondary high grade glioma.
21 . The method of claim 19 , wherein the glioma is a low grade glioma.
22 . The method of claim 19 , wherein the glioma is a secondary high grade glioma, and the secondary high grade glioma is glioblastoma.
23 . The method of claim 9 , wherein the cancer is refractory or relapsed.
24 . The method of claim 9 , wherein the cancer is newly diagnosed or previously untreated.
25 . The method of claim 9 , wherein the crystalline form is administered to the patient in combination with an additional therapy.
26 . The method of claim 9 , wherein the patient was previously administered a cancer therapy for the cancer.
27 . The method of claim 9 , wherein the crystalline form is administered to the patient at a daily dose of about 10 mg, about 25 mg, about 50 mg, about 100 mg, about 200 mg, or about 300 mg of the compound of formula (I).
28 . The method of claim 9 , wherein the crystalline form is administered to the patient at a dose of about 10 mg or about 50 mg of the compound of formula (I) twice per day.