Use of amg 900 for the treatment of cancer

Abstract

The present invention relates to methods of using AMG 900, a small molecule pan aurora kinase inhibitor, for the treatment of cancer, including solid tumors, hematologically derived tumors and the like. The invention further provides pharmaceutical compositions, dosage ranges and treatment regimens for administering AMG 900 to treat cancer.

What is claimed is: 
     
         1 . A pharmaceutical composition comprising AMG 900, or a pharmaceutically acceptable salt thereof, in a once daily dose ranging from about 1 mg to about 80 mg for use in treating cancer in a human by orally administering the composition to the human on a dosing schedule comprising 4, 5, 6 or 7 consecutive days. 
     
     
         2 . The composition of  claim 1  wherein the once daily dose of AMG 900, or a pharmaceutically acceptable salt thereof, ranges from about 5 mg to about 45 mg. 
     
     
         3 . The composition of  claim 1  wherein the once daily dose of AMG 900, or a pharmaceutically acceptable salt thereof, ranges from about 16 mg to about 35 mg. 
     
     
         4 . The composition of  claim 1  wherein the once daily dose of AMG 900, or a pharmaceutically acceptable salt thereof, ranges from about 20 mg to about 25 mg. 
     
     
         5 . The composition of  claim 1  wherein the once daily dose of AMG 900, or a pharmaceutically acceptable salt thereof, is about 24 mg. 
     
     
         6 . The composition of  claim 1  wherein the once daily dose of AMG 900, or a pharmaceutically acceptable salt thereof, ranges from about 40 mg to about 80 mg. 
     
     
         7 . The composition of  claim 1  that is orally administered for 4 consecutive days. 
     
     
         8 . The composition of  claim 1  that is orally administered for 7 consecutive days. 
     
     
         9 . The composition of  claim 1  that is orally administered to the human for 4, 5, 6 or 7 consecutive days followed immediately by non-treatment of AMG 900, or a pharmaceutically acceptable salt thereof, for a period ranging from 6 to 15 consecutive days. 
     
     
         10 . The composition of  claim 1  administered in combination with GCSF. 
     
     
         11 . The composition of  claim 1  administered in combination with GCSF in an amount ranging from about 5 mcg/kg to about 200 mcg/kg by weight of the human. 
     
     
         12 . The composition of  claim 2  administered in combination with GCSF in an amount ranging from about 5 mcg/kg to about 200 mcg/kg by weight of the human. 
     
     
         13 . The composition of  claim 2  for treating one or more of (a) a solid or hematologically derived tumor selected from (a) cancer of the bladder, breast, colon, kidney, liver, lung, small cell lung cancer, esophagus, gall-bladder, ovary, endometrium, pancreas, stomach, uterus, cervix, thyroid, brain, prostate and skin, (b) a hematopoietic tumor of lymphoid lineage selected from leukemia, acute lymphocitic leukemia, acute lymphoblastic leukemia, B-cell lymphoma, T-cell-lymphoma, Hodgkin's lymphoma, non-Hodgkin's lymphoma, hairy cell lymphoma and Burkett's lymphoma, (c) a hematopoietic tumor of myeloid lineage selected from acute and chronic myelogenous leukemias, myelodysplastic syndrome and promyelocytic leukemia (d) a tumor of mesenchymal origin selected from fibrosarcoma and rhabdomyosarcoma, (e) a tumor of the central and peripheral nervous system selected from astrocytoma, neuroblastoma, glioma and schwannoma, and (f) a melanoma, seminoma, teratocarcinoma, osteosarcoma, xenoderoma pigmentosum, keratoctanthoma, thyroid follicular cancer or Kaposi's sarcoma. 
     
     
         14 . The composition of  claim 2  for treating a solid tumor selected from cancer of the bladder, breast, colon, kidney, liver, lung, non-small cell lung, head and neck, esophageal, gastric, ovary, endometrium, pancreas, stomach, uterus, cervix, thyroid, brain and prostate or for treating a lymphoma or leukemia, or a combination thereof. 
     
     
         15 . The composition of  claim 3  for treating a solid cancer tumor of the prostate, ovary, endometrium, breast, bladder, colon, kidney, liver, lung, esophagus, pancreas, stomach, uterus, cervix, thyroid, brain or skin, or a combination thereof. 
     
     
         16 . The composition of  claim 3  for treating ovarian cancer. 
     
     
         17 . The composition of  claim 3  for treating breast cancer. 
     
     
         18 . The composition of  claim 3  for treating prostate cancer.