US2012270896A1PendingUtilityA1

Antineoplastic Combinations Containing HKI-272 and Vinorelbine

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Assignee: ZACHARCHUK CHARLES MICHAELPriority: Jun 17, 2008Filed: Feb 24, 2012Published: Oct 25, 2012
Est. expiryJun 17, 2028(~1.9 yrs left)· nominal 20-yr term from priority
Inventors:Charles Michael Zacharchuk
A61P 43/00A61P 35/04A61P 35/00A61P 15/00A61N 5/10A61K 31/4745A61K 31/437A61K 31/4709A61K 31/475A61K 31/436A61K 2300/00A61K 9/20A61K 31/164
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Claims

Abstract

A combination of HKI-272 compound and a vinorelbine 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.

Claims

exact text as granted — not AI-modified
1 . A regimen for treating a neoplasm in a subject, said regimen comprising:
 administering a vinorelbine compound; and   administering a HKI-272 compound.   
     
     
         2 . The regimen according to  claim 1 , wherein the administering steps occur concurrently, sequentially, simultaneously, in a specified order, or according to a specific temporal relationship. 
     
     
         3 . The regimen according to  claim 1 , wherein said vinorelbine compound is administered in a unit dose. 
     
     
         4 . The regimen according to  claim 1 , wherein said HKI-272 compound is administered in a unit dose. 
     
     
         5 . The regimen according to  claim 1 , wherein said vinorelbine compound is vinorelbine. 
     
     
         6 . The regimen according to  claim 1 , wherein said HKI-272 compound is HKI-272. 
     
     
         7 . The regimen according to  claim 1 , wherein one or both of said vinorelbine compound and said HKI-272 compound are delivered intravenously to said subject. 
     
     
         8 . The regimen according to  claim 1 , wherein one or both of said vinorelbine compound and said HKI-272 compound are delivered orally to said subject. 
     
     
         9 . The regimen according to  claim 1 , wherein said neoplasm is associated with overexpression or amplification of HER-2. 
     
     
         10 . The regimen according to  claim 1 , wherein said neoplasm is metastatic. 
     
     
         11 . The regimen according to  claim 1 , wherein said neoplasm is selected from the group consisting of a lung cancer, breast cancer, myeloma, prostate cancer, head and neck cancer, transitional cell carcinoma, small cell neuroendocrine carcinoma of the uterine cervix, and large cell neuroendocrine carcinoma of the uterine cervix. 
     
     
         12 . The regimen according to  claim 11 , wherein said neoplasm is a breast cancer. 
     
     
         13 . The regimen according to  claim 12 , wherein said breast cancer is a metastatic, HER-2-positive breast cancer. 
     
     
         14 . The regimen according to  claim 1 , wherein said neoplasm is an advanced solid tumor. 
     
     
         15 . The regimen according to  claim 1 , wherein said vinorelbine compound is administered in an amount of at least about 20 mg/L. 
     
     
         16 . The regimen according to  claim 15 , wherein said vinorelbine compound is administered in an amount of about 20 to about 25 mg/L. 
     
     
         17 . The regimen according to  claim 16 , wherein said vinorelbine compound is administered in an amount of about 25 mg/L. 
     
     
         18 . The regimen according to  claim 1 , wherein said HKI-272 compound is administered in an amount of at least about 120 mg. 
     
     
         19 . The regimen according to  claim 18 , wherein said HKI-272 compound is administered in an amount of at least about 160 mg. 
     
     
         20 . The regimen according to  claim 19 , wherein said HKI-272 compound is administered in an amount of at least about 240 mg. 
     
     
         21 . The regimen according to  claim 4 , wherein said unit dose is a tablet. 
     
     
         22 . The regimen according to  claim 1 , wherein said HKI-272 compound is administered daily. 
     
     
         23 . The regimen according to  claim 1 , wherein said HKI-272 compound is administered at least once daily. 
     
     
         24 . The regimen according to  claim 1 , wherein said HKI-272 compound is administered on day 1 of said regimen. 
     
     
         25 . The regimen according to  claim 10 , wherein said HKI-272 compound is administered on day 2 of said regimen. 
     
     
         26 . The regimen according to  claim 1 , wherein said HKI-272 compound is administered for at least 2 continuous weeks. 
     
     
         27 . A pharmaceutical composition according to  claim 1 , further comprising at least one pharmaceutically acceptable carrier. 
     
     
         28 . The regimen according to  claim 1 , further comprising radiation.

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