Claims for Patent: 12,509,450

Summary for Patent: 12,509,450

Title:	Solid forms of a dual RAF/MEK inhibitor
Abstract:	Solid forms of a dual RAF/MEK inhibitor, pharmaceutical compositions thereof, oral dosage forms thereof, and methods of treating cancer are described herein. Also provided herein are processes for preparing solid forms of a dual RAF/MEK inhibitor and pharmaceutical compositions and oral dosage forms thereof.
Inventor(s):	Farzaneh Seyedi
Assignee:	Verastem Inc
Application Number:	US18/524,947
Patent Claims:	1. A solid oral dosage form comprising a composition comprising: (a) crystalline Form 1 of a compound of Formula II: wherein Form 1 exhibits an X-ray power diffraction pattern comprising a characteristic XRPD peak at the following diffraction angles (2θ (degrees)): 4.5±0.2, 9.0±0.2, and 18.1±0.2; (b) a filler in an amount of about 90% w/w to about 99% w/w of the composition; and (c) a lubricant in an amount of about 0.1% w/w to about 3% w/w of the composition. 2. The oral dosage form of claim 1, wherein the filler is in an amount of about 95% w/w to about 99% w/w of the composition. 3. The oral dosage form of claim 1, wherein the filler is in an amount of about 97% w/w to about 99% w/w of the composition. 4. The oral dosage form of claim 1, wherein the filler is mannitol. 5. The oral dosage form of claim 4, wherein the mannitol is a mixture of fine mannitol and granular mannitol. 6. The oral dosage form of claim 1, wherein the lubricant is in an amount of about 1% w/w to about 3% w/w of the composition. 7. The oral dosage form of claim 1, wherein the lubricant is in an amount of about 1% w/w to about 2% w/w of the composition. 8. The oral dosage form of claim 1, wherein the lubricant is magnesium stearate. 9. The oral dosage form of claim 1, wherein the crystalline Form 1 is in an amount of about 0.864% w/w of the composition. 10. The oral dosage form of claim 1, wherein the oral dosage form is a capsule. 11. The oral dosage form of claim 1, wherein Form 1 exhibits an X-ray power diffraction pattern further comprising characteristic XRPD peaks at the following diffraction angles (2θ (degrees)); 14.7±0.2 and 22.7±0.2. 12. The oral dosage form of claim 1, wherein Form 1 exhibits an X-ray power diffraction pattern further comprising at least one characteristic XRPD peak selected from the following diffraction angles (2θ (degrees)): 7.3±0.2, 14.7±0.2, 17.1±0.2, 19.4±0.2, and 22.7±0.2. 13. The oral dosage form of claim 1, wherein Form 1 exhibits an X-ray powder diffraction pattern substantially the same as depicted in FIG. 1C. 14. The oral dosage form of claim 1, wherein the composition comprises less than 3% by weight of an impurity selected from the group consisting of Compound B, Compound C, and Compound D: as determined by HPLC. 15. The oral dosage form of claim 1, wherein the composition comprises less than 2% by weight of an impurity selected from the group consisting of Compound B, Compound C, and Compound D: as determined by HPLC. 16. The oral dosage form of claim 1, wherein the composition comprises less than 5% by weight of other solid forms or patterns of the compound of Formula II. 17. The oral dosage form of claim 1, wherein the composition comprises less than 1% by weight of other solid forms or patterns of the compound of Formula II. 18. The oral dosage form of claim 1, wherein the composition comprises less than 0.5% by weight of other solid forms or patterns of the compound of Formula II. 19. The oral dosage form of claim 1, wherein the composition comprises less than 0.1% by weight of other solid forms or patterns of the compound of Formula II. 20. The oral dosage form of claim 1, wherein Form 1 is an anhydrate.