SOLID FORMS OF PRALSETINIB
The compound cis)-N—((S)-1-(6-(4-fluoro-1H-pyrazol-1-yl)pyridin-3-yl)ethyl)-1-methoxy-4-(4 methyl-6-(5-methyl-1H-pyrazol-3-ylamino)pyrimidin-2-yl)cyclohexanecarboxamide can be prepared as a free base in various crystalline solid forms, and in various salt forms each having one or more solid forms.
1 - 59 . (canceled)
60 . An amorphous form of a free base of (cis)-N—((S)-1-(6-(4-fluoro-1H-pyrazol-1-yl)pyridin-3-yl)ethyl)-1-methoxy-4-(4 methyl-6-(5-methyl-1H-pyrazol-3-ylamino)pyrimidin-2-yl)cyclohexanecarboxamide.
61 . The amorphous form of claim 60 , having an X-ray powder diffraction pattern substantially as shown in FIG. 19 A .
62 . The amorphous form of claim 60 , having a thermal gravimetric analysis plot substantially as shown in FIG. 19 B .
63 . The amorphous form of claim 60 , having a differential scanning calorimetry plot comprising melting events with onset temperatures of about 117° C. and about 161° C.
64 . The amorphous form of claim 60 , having a differential scanning calorimetry plot substantially as shown in FIG. 19 B .
65 . A pharmaceutical composition comprising the amorphous form of claim 60 and a pharmaceutically acceptable carrier, diluent or excipient.
66 . A method of treatment of a disease in a patient comprising administering to the patient a therapeutically effective amount of the amorphous form of claim 60 , wherein the disease is unresectable or metastatic non-small cell lung cancer (NSCLC) or medullary thyroid cancer (MTC).
67 . A method of treatment of a disease in a patient comprising administering to the patient a therapeutically effective amount of the amorphous form of claim 60 , wherein the disease is a RET-altered solid tumor.
68 . The method of claim 67 , wherein the disease is RET-altered non-small cell lung cancer.
69 . The method of claim 67 , wherein the disease is RET fusion-positive, metastatic non-small cell lung cancer.