TREATMENT OF CANCERS WITH ACQUIRED RESISTANCE TO KIT INHIBITORS

1 - 29 . (canceled)

30 . A method to determine the ability of DAST to treat a hyper-proliferative disease, such as cancer, with acquired resistance to a KIT inhibitor, comprising culturing cancer cells in the presence of DAST, wherein DAST is 4{4-[3-(4-chloro-3-trifluoromethylphenyl)-ureido]-3-fluorophenoxy}-pyridine-2-carboxylic acid methylamide or a polymorph, hydrate, pharmaceutically acceptable salt, metabolite, prodrug or solvate thereof, or a combination thereof.

31 . A method according to claim 30 , wherein the cells express a double-mutation.

32 . A method according to claim 30 , wherein the cells express the constitutively active KIT polypeptide.

33 . A method to suggest cancer treatment for a patient, comprising taking a cancer cell sample from said patient, test the cells in the method according to claim 30 , and if cells die as a result of the test, determine that the cells are sensitive to DAST and thus useful in treating the patient who has acquired resistance to the KIT inhibitor.

34 . A method of determining whether to treat a subject having cancer with DAST, comprising determining the presence of a mutation in a KIT gene, wherein said mutation is an activating and/or KIT-inhibitor resistance mutation, wherein DAST is 4{4-[3-(4-chloro-3-trifluoromethylphenyl)-ureido]-3-fluorophenoxy}-pyridine-2-carboxylic acid methylamide or a polymorph, hydrate, pharmaceutically acceptable salt, metabolite, prodrug or solvate thereof, or a combination thereof.

35 . A method according to claim 34 , further comprising suggesting the administration of DAST to the subject.

36 . A method according to claim 34 , further comprising the administration of DAST to the subject.

37 . A method for enhancing a patient's quality of life who has cancer, which patient has a secondary mutation that is one or more of

i) deletion of amino acid residues 557-558;

ii) deletion of amino acid residues 551-555;

iii) deletion of amino acid residues 550-558;

iv) deletion of amino acid residues 559-560;

v) deletion of amino acid residues 557-561;

vi) deletion of amino acid residues 554-558;

vii) deletion of amino acid residues 552-557;

viii) mutations at residue 559, including V559D, V559A, or V559G;

ix) mutations at residue 560, including V560D, V560E, or V560G;

x) W557S, alone, or in combination with a deletion of amino acids 552-556;

xi) mutations at amino acid residue 557, including W557R; and

xii) mutations at amino acid residue 576, including L576P,

comprising administering to said patient an effective amount of DAST, wherein DAST is 4{4-[3-(4-chloro-3-trifluoromethylphenyl)-ureido]-3-fluorophenoxy}-pyridine-2-carboxylic acid methylamide or a polymorph, hydrate, pharmaceutically acceptable salt, metabolite, prodrug or solvate thereof, or a combination thereof.

38 . A method according to claim 37 , wherein the DAST is in the form of a solid dispersion.

39 . A method according to claim 37 , wherein the DAST is administered with sugar.

40 . A method according to claim 37 , wherein the DAST is in a preparation that is colored to provide a palatable preparation.

41 . A method according to claim 37 , wherein the cancer is in the form of an unspecified adult solid tumor.

42 . A method according to claim 37 , wherein the DAST is in a preparation that has been formulated with ethanol and is given orally.

43 . A method according to claim 37 , wherein to reduce undesirable side effects, the DAST has been modified with one or more labile functional groups.

44 . A method according to claim 37 , wherein the DAST has been formulated for controlled release, where release of the active ingredient is regulated or modulated to achieve a desired rate of delivery into the systemic circulation, preferably rapid or fast release.

45 . Use of DAST according to claim 37 , wherein the cancer was initially sensitive to a derivative of imatinib mesylate and acquired resistance to a derivative of imatinib mesylate, other than a salt of imatinib mesylate, and wherein an effective amount of DAST is administered to the patient.

46 . Use according to claim 45 , further comprising additionally administering imatinib mesylate, a derivative of imatinib mesylate, or a salt of imatinib mesylate.

47 . DAST, which is used according to claim 37 .

48 . DAST, which is used together with imatinib mesylate, a derivative of imatinib mesylate, or a salt of imatinib mesylate as recited in claim 45 .