Claims for Patent: 11,873,296

Summary for Patent: 11,873,296

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:	US18/147,921
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 (XRPD) pattern comprising characteristic XRPD peaks at the following diffraction angles (2θ (degrees)): 4.5±0.2, 9.0±0.2, and 18.1±0.2; and (b) a pharmaceutically acceptable carrier. 2. 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))=14.7±0.2 and 22.7±0.2. 3. 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. 4. The oral dosage form of claim 1, wherein Form 1 exhibits an endotherm starting from about 255° C. based on differential scanning calorimetry. 5. The oral dosage form of claim 1, wherein Form 1 exhibits a differential scanning calorimetry curve substantially the same as shown in FIG. 2 . 6. The oral dosage form of claim 1, wherein Form 1 exhibits a dynamic vapor sorption plot substantially the same as shown in FIG. 3 . 7. The oral dosage form of claim 1, wherein Form 1 is an anhydrate. 8. The oral dosage form of claim 1, wherein the oral dosage form is substantially free of other solid forms or patterns of the compound of Formula II. 9. The oral dosage form of claim 1, wherein the oral dosage form is substantially free of an impurity selected from the group consisting of Compound B, Compound C, and Compound D: as determined by HPLC. 10. A method of treating cancer in a subject in need thereof, comprising administering to the subject an effective amount of the oral dosage form of claim 1. 11. The method of claim 10, wherein the cancer is selected from the group consisting of melanoma, lung cancer, ovarian cancer, pancreatic cancer, and colorectal cancer. 12. The method of claim 11, wherein the ovarian cancer is low grade serous ovarian cancer. 13. The method of claim 11, wherein the lung cancer is non-small cell lung cancer. 14. The oral dosage form of claim 1, wherein Form 1 exhibits an X-ray powder diffraction pattern further comprising characteristic XRPD peaks at the following diffraction angles (2θ (degrees))=14.7±0.2 and 22.7±0.2. 15. 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. 16. 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)): 7.3±0.2, 14.7±0.2, 17.1±0.2, 19.4±0.2, and 22.7±0.2. 17. 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)): 7.3±0.2, 10.7±0.2, 13.5±0.2, 14.7±0.2, 16.6±0.2, 17.1±0.2, 17.7±0.2, 19.4±0.2, 21.9±0.2, and 22.7±0.2. 18. 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. 19. 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. 20. 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. 21. 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. 22. 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. 23. 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. 24. The oral dosage form of claim 1, wherein the pharmaceutically acceptable carrier is mannitol. 25. The oral dosage form of claim 24, wherein mannitol is a mixture of fine mannitol and granular mannitol. 26. The oral dosage form of claim 1, wherein the composition further comprises a lubricant. 27. The oral dosage form of claim 26, wherein the lubricant is magnesium stearate.