Claims for Patent: 8,383,607

Summary for Patent: 8,383,607

Title:	Perifosine and capecitabine as a combined treatment for cancer
Abstract:	Treatment regimens comprising co-treatment of cancer with perifosine and capecitabine are disclosed herein, as well as pharmaceutical compositions and unit dosage forms thereof formulated to be suitable for use in said treatment regimens.
Inventor(s):	Poradosu; Enrique (Brookline, MA), Sportelli; Peeter (North Andover, MA)
Assignee:	AEterna Zentaris GmbH (Frankfurt, DE)
Application Number:	13/077,766
Patent Claims:	1. A method for treating metastatic colorectal cancer which is characterized by a resistance to a chemotherapeutic agent, comprising administering to a human subject in need thereof 50 mg of perifosine per day and 2000 mg/m.sup.2 of capecitabine per day, wherein the perifosine is administered every day and the capecitabine is administered on days 1 to 14 of a 21 day cycle. 2. A method for treating metastatic colorectal cancer which is characterized by a resistance to a fluoropyrimidine, comprising administering to a human subject in need thereof 50 mg of perifosine per day and 2000 mg/m.sup.2 of capecitabine per day, wherein the perifosine is administered every day and the capecitabine is administered on days 1 to 14 of a 21 day cycle. 3. A method for treating metastatic colorectal cancer which is characterized by a resistance to 5-fluorouracil, comprising administering to a human subject in need thereof 50 mg of perifosine per day and 2000 mg/m.sup.2 of capecitabine per day, wherein the perifosine is administered every day and the capecitabine is administered on days 1 to 14 of a 21 day cycle. 4. A method for treating metastatic colorectal cancer in a human subject characterized as intolerant to a prior chemotherapeutic agent, comprising administering to the human subject 50 mg of perifosine per day and 2000 mg/m.sup.2 of capecitabine per day, wherein the perifosine is administered every day and the capecitabine is administered on days 1 to 14 of a 21 day cycle. 5. A method for treating metastatic colorectal cancer in a human subject characterized as intolerant to a 5-fluorouracil, comprising administering to the human subject 50 mg of perifosine per day and 2000 mg/m.sup.2 of capecitabine per day, wherein the perifosine is administered every day and the capecitabine is administered on days 1 to 14 of a 21 day cycle. 6. A method for treating metastatic colorectal cancer in a human subject previously treated with an anti-epidermal growth factor receptor antibody, comprising administering to the human subject 50 mg of perifosine per day and 2000 mg/m.sup.2 of capecitabine per day, wherein the perifosine is administered every day and the capecitabine is administered on days 1 to 14 of a 21 day cycle. 7. The method of claim 1, wherein the chemotherapeutic agent is paclitaxel, an anthracycline, irinotecan, oxaliplatin, bevacizumab, or an anti-epidermal growth factor receptor antibody. 8. The method of claim 7, wherein the anti-epidermal growth factor receptor antibody is cetuximab or panitumumab. 9. The method of claim 2, wherein the fluoropyrimidine is floxuridine, tegafur or capecitabine. 10. The method of claim 4, wherein the chemotherapeutic agent is paclitaxel, an anthracycline, a fluoropyrimidine, irinotecan, oxaliplatin, bevacizumab, or an anti-epidermal growth factor receptor antibody. 11. The method of claim 10, wherein the fluoropyrimidine is 5-fluorouracil, floxuridine, tegafur or capecitabine. 12. The method of claim 10, wherein the anti-epidermal growth factor receptor antibody is cetuximab or panitumumab. 13. The method of claim 10, wherein the anti-epidermal growth factor receptor antibody is cetuximab or panitumumab. 14. The method of claim 1, wherein the capecitabine is administered twice per day at a dosage of 1000 mg/m.sup.2 on days 1 to 14 of a 21 day cycle. 15. The method of claim 2, wherein the capecitabine is administered twice per day at a dosage of 1000 mg/m.sup.2 on days 1 to 14 of a 21 day cycle. 16. The method of claim 3, wherein the capecitabine is administered twice per day at a dosage of 1000 mg/m.sup.2 on days 1 to 14 of a 21 day cycle. 17. The method of claim 4, wherein the capecitabine is administered twice per day at a dosage of 1000 mg/m.sup.2 on days 1 to 14 of a 21 day cycle. 18. The method of claim 5, wherein the capecitabine is administered twice per day at a dosage of 1000 mg/m.sup.2 on days 1 to 14 of a 21 day cycle. 19. The method of claim 6, wherein the capecitabine is administered twice per day at a dosage of 1000 mg/m.sup.2 on days 1 to 14 of a 21 day cycle. 20. The method of claim 1, wherein the perifosine and capecitabine are orally administered. 21. The method of claim 2, wherein the perifosine and capecitabine are orally administered. 22. The method of claim 3, wherein the perifosine and capecitabine are orally administered. 23. The method of claim 4, wherein the perifosine and capecitabine are orally administered. 24. The method of claim 5, wherein the perifosine and capecitabine are orally administered. 25. The method of claim 6, wherein the perifosine and capecitabine are orally administered.

Details for Patent 8,383,607

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Eli Lilly And Company	ERBITUX	cetuximab	Injection	125084	02/12/2004		2030-03-31
Eli Lilly And Company	ERBITUX	cetuximab	Injection	125084	03/28/2007		2030-03-31
Genentech, Inc.	AVASTIN	bevacizumab	Injection	125085	02/26/2004		2030-03-31
Amgen, Inc.	VECTIBIX	panitumumab	Injection	125147	09/27/2006		2030-03-31