DOSING REGIMENS FOR THE TREATMENT OF CANCER

• US 20110034498A1
• Filed: 03/24/2006
• Published: 02/10/2011
• Est. Priority Date: 03/24/2006
• Status: Abandoned Application

• Current Assignee: Infinity Pharmaceuticals, Inc.
• Original Assignee: Infinity Pharmaceuticals, Inc.
• Inventors: Wright, James L., Mcgovern, Karen J., Pien, Christine S.
• Application Number:
  US12/293,524
• Publication Number:
  US 20110034498A1
• Time in Patent Office: Days
• US Class Current: 514/278
• CPC Class Codes: A61K 31/58 containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin digitoxin A61K31/7048
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
• CPC Class Codes: A61K 9/0019 Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner non-active ingredients are additionally classified in A61K47/00
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61P 35/00 Antineoplastic agents

Abstract

The invention relates to a method of treating cancer. The method includes administering systemically a therapeutically effective amount of a small molecule hedgehog pathway inhibitor, such that the concentration of the inhibitor in the blood does not vary by more than about ±30% from the average concentration, and such that the concentration remains at or below the maximum tolerated dose of the inhibitor for a time period of at least about one day.

Claims

1. A method of treating cancer in a human in need of such treatment, comprising administering systemically to said human a therapeutically effective amount of a small molecule hedgehog pathway inhibitor, wherein the concentration of said inhibitor in the blood of said human does not vary by more than about ±

30% from the average concentration of said inhibitor in the blood of said human, and said concentration remains at or below the maximum tolerated dose of said inhibitor for a time period of at least about one day.

2. The method of claim 1, wherein said inhibitor is a steroidal alkaloid.

3. The method of claim 1, wherein said inhibitor is administered intramuscularly, intravenously, or subcutaneously.

4. The method of claim 1, wherein said inhibitor is administered orally.

5. The method of claim 1, wherein said inhibitor is formulated in a sustained release pill.

6. The method of claim 1, wherein said inhibitor is administered using continuous infusion or a sustained release device.

7. The method of claim 6, wherein said sustained release device is a pump or a biodegradable polymer.

8. The method of claim 1, wherein said time period is at least about three days.

9. The method of claim 1, wherein said time period is at least about one week.

10. The method of claim 1, wherein said time period is at least about two weeks.

11. The method of claim 1, wherein said time period is at least about one month.

12. The method of claim 1, wherein the concentration of said inhibitor in the blood of said human does not vary by more than about ±

20% from the average concentration of said inhibitor in the blood of said human.

13. The method of claim 1, wherein the concentration of said inhibitor in the blood of said human does not vary by more than about ±

15% from the average concentration of said inhibitor in the blood of said human.

29. The method of claim 1 or 14, wherein the small molecule hedgehog pathway inhibitor is selected from the group consisting of:

14. A method of treating cancer in a human in need of such treatment, comprising administering systemically to said human a therapeutically effective amount of a small molecule hedgehog pathway inhibitor, wherein said inhibitor is present in the blood of said human at a concentration that is maintained above a threshold concentration, and remains at or below the maximum tolerated dose of said inhibitor in a human for a time period of at least about one day.

15. The method of claim 14, wherein said inhibitor is a steroidal alkaloid.

16. The method of claim 14, wherein said inhibitor is administered intramuscularly, intravenously, or subcutaneously.

17. The method of claim 14, wherein said inhibitor is administered orally.

18. The method of claim 14, wherein said inhibitor is formulated in a sustained release pill.

19. The method of claim 14, wherein said inhibitor is administered using continuous infusion or a sustained release device.

20. The method of claim 19, wherein said sustained release device is a pump or a biodegradable polymer.

21. The method of claim 14, wherein said inhibitor is present in the blood at a concentration of about two times said threshold concentration.

22. The method of claim 14, wherein said inhibitor is present in the blood at a concentration of about five times said threshold concentration.

23. The method of claim 14, wherein said inhibitor is present in the blood at a concentration of about ten times said threshold concentration.

24. The method of claim 14, wherein said inhibitor is present in the blood at a concentration of about twenty times said threshold concentration.

25. The method of claim 14, wherein said time period is at least about three days.

26. The method of claim 14, wherein said time period is at least about one week.

27. The method of claim 14, wherein said time period is at least about two weeks.

28. The method of claim 14, wherein said time period is at least about one month.