`Docket 578133000901
`
`Claims
`
`1.
`
`A method of extending relapse free survival in a cancer patient whois
`
`undergoing treatment with a chemotherapeutic, the method comprising administering a
`
`therapeutically effective amount of a hedgehog inhibitorto the patient.
`
`2.
`
`The methodof claim 1, wherein the hedgehog inhibitor is administered
`
`concurrently with the chemotherapeutic.
`
`3.
`
`The method of claim 2, wherein administration of the hedgehog inhibitor
`
`continues after treatment with the chemotherapeutic has ceased.
`
`4,
`
`The method of claim 1, wherein the hedgehog inhibitor is administered after
`
`10
`
`treatment with the chemotherapeutic has ceased.
`
`5.
`
`The methodof any one of claims 1-4, wherein the cancer is selected from
`
`lung cancer, bladder cancer, ovarian cancer, colon cancer, breast cancer, prostate cancer, and
`
`multiple myeloma.
`
`6.
`
`The method of claim 5, wherein the lung canceris selected from small cell
`
`15
`
`lung cancer and non-small cell lung cancer.
`
`7,
`
`The method of any one of claims 1-4, wherein the cancer is small cell lung
`
`cancer and the chemotherapeutic is selected from etoposide, carboplatin, cisplatin,
`
`irinotecan, topotecan, gemcitabine, radiation therapy, and combinationsthereof.
`
`8.
`
`The methodof any one of claims 1-4, wherein the cancer is non-small cell
`
`20
`
`lung cancer and the chemotherapeutic is selected from vinorelbine, cisplatin, docetaxel,
`
`pemetrexed, etoposide, gemcitabine, carboplatin, bevacizumab, gefitinib, erlotinib,
`
`cetuximab, radiation therapy, and combinations thereof.
`
`9.
`
`The method of any one of claims 1-4, wherein the canceris bladder cancer
`
`and the chemotherapeutic is selected from gemcitabine, cisplatin, methotrexate, vinblastin,
`
`sd-452317
`
`22
`
`
`
`P A T EN T
`Docket 578133000901
`
`doxorubicin, paclitaxel, docetaxel, pemetrexed, mitomycin C, 5-fluorouracil, radiation
`
`therapy, and combinations thereof.
`
`10.
`
`The method of any one of claims 1-4, wherein the cancer is ovarian cancer
`
`and the chemotherapeutic is selected from paclitaxel, docetaxel, carboplatin, gemcitabine,
`
`doxorubicin, topotecan, cisplatin, irinotecan, bevacizumab, radiation therapy, and
`
`combinations thereof.
`
`11.
`
`The method of any one of claims 1-4, wherein the cancer is colon cancer and
`
`the chemotherapeutic is selected from paclitaxel, 5-fluorouracil, leucovorin, irinotecan,
`
`oxaliplatin, capecitabine, bevacizumab, cetuximab, panitumumab, radiation therapy, and
`
`10
`
`combinations thereof.
`
`12.
`
`The method of any one of claims 1-11, wherein the hedgehog inhibitoris:
`
`
`
`or a pharmaceutically acceptable salt thereof.
`
`13.
`
`The method of claim 12, wherein the pharmaceutically acceptable salt is the
`
`15
`
`hydrochloride salt.
`
`14.
`
`The methodof any one of claims 1-13, wherein the hedgehoginhibitoris
`
`administered as a pharmaceutical composition comprising the hedgehog inhibitor and a
`
`pharmaceutically acceptable excipient.
`
`15.
`
`A method of extending relapse free survival in a cancer patient who had
`
`20
`
`previously been treated with a chemotherapeutic, the method comprising administering a
`
`therapeutically effective amountof a hedgehog inhibitor to the patient after treatment with
`
`the chemotherapeutic has ceased.
`
`sd-452317
`
`23
`
`
`
`P A T EN T
`Docket 578133000901
`
`16.
`
`The method of claim 15, wherein the canceris selected from lung cancer,
`
`bladder cancer, ovarian cancer, and colon cancer.
`
`17.
`
`The method of claim 17, wherein the lung cancer is selected from small cell
`
`lung cancer and non-small cell lung cancer.
`
`18.
`
`The method of claim 15, wherein the cancer is small cell lung cancer and the
`
`chemotherapeutic is selected from etoposide, carboplatin, cisplatin, irinotecan, topotecan,
`
`gemcitabine, radiation therapy, and combinations thereof.
`
`19.
`
`The method of claim 15, wherein the cancer is non-small cell lung cancer and
`
`the chemotherapeutic is selected from vinorelbine, cisplatin, docetaxel, pemetrexed,
`
`10
`
`etoposide, gemcitabine, carboplatin, bevacizumab, gefitinib, erlotinib, cetuximab, radiation
`
`therapy, and combinations thereof.
`
`20.
`
`The method of claim 15, wherein the canceris bladder cancerand the
`
`chemotherapeutic is selected from gemcitabine, cisplatin, methotrexate, vinblastin,
`
`doxorubicin, paclitaxel, docetaxel, pemetrexed, mitomycin C, 5-fluorouracil, radiation
`
`15
`
`therapy, and combinationsthereof.
`
`21.
`
`The method of claim 15, wherein the cancer is ovarian cancer and the
`
`chemotherapeutic is selected from paclitaxel, docetaxel, carboplatin, gemcitabine,
`
`doxorubicin, topotecan, cisplatin, irinotecan, bevacizumab, radiation therapy, and
`
`combinations thereof.
`
`20
`
`22.
`
`The method of claim 15, wherein the cancer is colon cancer and the
`
`chemotherapeutic is selected from paclitaxel, 5-fluorouracil, leucovorin, irinotecan,
`
`oxaliplatin, capecitabine, bevacizumab, cetuximab, panitumumab, radiation therapy, and
`
`combinations thereof.
`
`sd-452317
`
`24
`
`
`
`23.
`
`The method of any one of claims 15-22, wherein the hedgehog inhibitor
`
`comprises a compoundof formulaI:
`
`P A T EN T
`Docket 578133000901
`
` P
`
`~g_
`aN
`
`I
`
`5
`
`or a pharmaceutically acceptable salt thereof.
`
`24.
`
`The method of claim 23, wherein the pharmaceutically acceptable salt is a
`
`hydrochloridesalt.
`
`25,
`
`The method of any one of claims 15-24, wherein the hedgehog inhibitoris
`
`administered as a pharmaceutical composition comprising the hedgehog inhibitor, or a
`
`10~~pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable excipient.
`
`26,
`
`A method of treating pancreatic cancer, the method comprising administering
`
`to a patient in need thereof a therapeutically effective amount of a compound of formulaI:
`
`
`
`15
`
`or a pharmaceutically acceptable salt thereof.
`
`27,
`
`The method of claim 26, wherein the pharmaceutically acceptable salt is a
`
`hydrochloride salt.
`
`28.
`
`The methodof claim 26, wherein the compound of formula I is administered
`
`in combination with a chemotherapeutic.
`
`sd-452317
`
`25
`
`
`
`P A T EN T
`Docket 578133000901
`
`29.
`
`The method of claim 28, wherein the chemotherapeutic is selected from
`
`gemcitabine, cisplatin, epirubicin, 5-fluorouracil, and combinations thereof.
`
`30.
`
`The method of claim 28, wherein administration of the compound of
`
`formula I continues after treatment with the chemotherapeutic has ceased.
`
`31.
`
`The method of any one of claims 26-30, wherein the compound of formula I
`
`is administered as a pharmaceutical composition comprising the compound of formula I, or a
`
`pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable excipient.
`
`sd-452317
`
`26
`
`
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