Claims for Patent: 8,669,273

Summary for Patent: 8,669,273

Title:	Antineoplastic combinations of 4-anilino-3-cyanoquinolines and capecitabine
Abstract:	A combination of a 4-anilino-3-cyanoquinoline compound (e.g. HKI-272, SKI-606, EKB-569) and a capecitabine compound in the treatment of a neoplasm is provided. Regimens, kits, and methods for treatment of neoplasm, including breast cancer including metastatic breast cancer, and lung cancer, using this combination, optionally in combination with other anti-neoplastic agents, or immune modulators are also described.
Inventor(s):	Zacharchuk; Charles Michael (Westford, MA), Quinn; Susan Elizabeth (Norwood, MA), Wang; Kenneth Kuan-Yuen (Waltham, MA), Binlich; Florence Marie Helene (Ville d'Avray, FR)
Assignee:	Wyeth LLC (Madison, NJ)
Application Number:	12/534,895
Patent Claims:	1. A method for treating an ErbB-2 positive metastatic breast cancer in a subject; comprising administering to the subject neratinib and capecitabine; wherein neratinib and capecitabine act synergistically. 2. The method of claim 1, wherein the breast cancer is a locally advanced breast cancer. 3. The method according to claim 1, wherein one or both of capecitabine and neratinib is administered in a subtherapeutically effective amount. 4. The method according to claim 1, wherein neratinib and capecitabine are administered orally. 5. The method according to claim 1, wherein neratinib and capecitabine are administered concurrently, sequentially, simultaneously, in a specified order, or according to a specific temporal relationship. 6. The method according to claim 1, wherein neratinib is administered in a unit dose. 7. The method according to claim 6, wherein capecitabine is administered in a unit dose. 8. The method according to claim 1, wherein capecitabine is administered in an amount of about 1250 mg to about 3000 mg daily. 9. The method according to claim 1, wherein capecitabine is administered at least once over a period of 21 days. 10. The method according to claim 1, wherein the administration of capecitabine is continued for 3 to 6 cycles. 11. The method according to claim 1, wherein neratinib is administered in an amount of at least 40 mg per day. 12. The method according to claim 11, wherein neratinib is administered in an amount of at least 120 mg per day. 13. The method according to claim 12, wherein neratinib is administered in an amount of at least 240 mg per day. 14. The method according to claim 1, wherein neratinib is administered daily. 15. The method according to claim 1, wherein neratinib is administered at least once daily. 16. The method according to claim 1, wherein neratinib is administered for at least 2 continuous weeks. 17. The method according to claim 1, wherein neratinib is administered before capecitabine. 18. The method according to claim 1, wherein neratinib is administered after capecitabine. 19. The method according to claim 1, wherein neratinib and capecitabine are administered simultaneously. 20. The method according to claim 1, wherein administration of capecitabine is discontinued after about 24 weeks. 21. The method of claim 1, wherein neratinib is administered in a dose range of about 20 to about 240 mg per day. 22. The method of claim 1, wherein the subject is a human. 23. A method for treating an ErbB-2 positive metastatic breast cancer in a subject, wherein one treatment cycle comprises 21 days, comprising: (a) orally administering to the subject at least one unit dose of neratinib daily starting on day 1 of said cycle; and (b) orally administering to the subject at least one a unit dose of capecitabine on days 1 to 14 of said cycle; wherein neratinib and capecitabine act synergistically.