Solid forms of (S)-3-(1-(9H-purin-6-ylamino)ethyl)-8-chloro-2-phenylisoquinolin-1 (2H)-one and methods of use thereof

• US 9,840,505 B2
• Filed: 02/04/2016
• Issued: 12/12/2017
• Est. Priority Date: 01/10/2011
• Status: Active Grant

• Current Assignee: Infinity Pharmaceuticals, Inc.
• Original Assignee: Infinity Pharmaceuticals, Inc.
• Inventors: Ren, Pingda, Martin, Michael, Isbester, Paul, Lane, Benjamin S., Kropp, Jason
• Primary Examiner(s): Neagu, Irina
• Application Number:
  US15/016,117
• Publication Number:
  US 20160152619A1
• Time in Patent Office: 677 Days
• Field of Search: 51426322, 5142632, 5142634, 514309, 544277
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: C07D 473/34 attached in position 6, e.g. adenine

Abstract

Polymorphs of chemical compounds that modulate kinase activity, including PI3 kinase activity, and compounds, pharmaceutical compositions, and methods of treatment of diseases and conditions associated with kinase activity, including PI3 kinase activity, are described herein. Also provided herein are processes for preparing compounds, polymorphs thereof, and pharmaceutical compositions thereof.

Claims

1. A method of treating a PI3K mediated disorder in a subject having the disorder, comprising administering to the subject a therapeutically effective amount of a solid form comprising a hydrate of a compound of Formula (I):

2. The method of claim 1, wherein the disorder is asthma, rheumatoid arthritis, or lupus.

3. The method of claim 1, wherein the disorder is a hematological cancer.

4. The method of claim 3, wherein the cancer is leukemia or lymphoma.

5. The method of claim 3, wherein the cancer is acute myelogenous leukemia (AML), acute lymphocytic leukemia, hairy cell leukemia, chronic myelogenous leukemia (CML), multiple myeloma (MM), myelodysplastic syndrome (MDS), or human lymphotrophic virus-type 1 (HTLV-1) leukemia.

6. The method of claim 3, wherein the cancer is B-cell immunoblastic lymphoma, small non-cleaved cell lymphoma, adult T-cell lymphoma, mantle cell lymphoma (MCL), Hodgkin disease, AIDS-related lymphoma, peripheral T-cell lymphoma, cutaneous T-cell lymphoma, multiple myeloma, follicular lymphoma, or Waldenstrom Macroglobulinemia.

7. The method of claim 3, wherein the cancer is chronic lymphocytic leukemia (CLL).

8. The method of claim 3, wherein the cancer is non-Hodgkin lymphoma.

9. The method of claim 8, wherein the non-Hodgkin lymphoma is indolent non-Hodgkin lymphoma (iNHL).

10. The method of claim 3, wherein the cancer is peripheral T-cell lymphoma.

11. The method of claim 3, wherein the cancer is cutaneous T-cell lymphoma.

12. The method of claim 3, wherein the cancer is mantle cell lymphoma (MCL).

13. The method of claim 3, wherein the cancer is diffuse large B-cell lymphoma.

14. The method of claim 3, wherein the cancer is follicular lymphoma.

15. The method of claim 3, wherein the cancer is Waldenströ

m Macroglobulinemia.

16. The method of claim 3, wherein the cancer is posttransplantational lymphoproliferative disorder (PLD).

17. The method of claim 1, further comprising administering one or more second therapeutic agents to the subject.

18. The method of claim 17, wherein the second therapeutic agent is a therapeutic antibody.

19. The method of claim 18, wherein the therapeutic antibody is an anti-CD20 antibody.

20. The method of claim 18, wherein the therapeutic antibody is selected from cetuximab, panitumumab, trastuzumab, rituximab, tositumomab, alemtuzumab, bevacizumab, and gemtuzumab.

21. The method of claim 18, wherein the therapeutic antibody is rituximab.

22. The method of claim 17, wherein the second therapeutic agent is everolimus.

23. The method of claim 17, wherein the second therapeutic agent is a nitrogen mustard.

24. The method of claim 23, wherein the nitrogen mustard is bendamustine.

25. The method of claim 17, wherein the second therapeutic agents are rituximab and bendamustine.

26. The method of claim 17, wherein the second therapeutic agent is chlorambucil, chlornaphazine, estramustine, ifosfamide, mechlorethamine, mechlorethamine oxide hydrochloride, melphalan, novembichin, phenesterine, prednimustine, trofosfamide, uracil mustard, fludarabine, or cyclophosphamide.

27. The method of claim 17, wherein the second therapeutic agent is fludarabine, cyclophosphamide, or rituximab, or a combination thereof.

28. The method of claim 17, wherein the second therapeutic agent is bortezomib.

29. The method of claim 17, wherein the second therapeutic agent is gemcitabine.

30. The method of claim 17, wherein the second therapeutic agent is a corticosteroid.

31. The method of claim 17, wherein the second therapeutic agent is dexamethasone.