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Therapy Name | Sonidegib |
Synonyms | |
Therapy Description |
Odomzo (sonidegib) is a small molecule inhibitor of SMO, which inhibits proliferation (PMID: 23935925). Odomzo (sonidegib) is FDA approved for use in patients with locally advanced basal cell carcinoma (FDA.gov). |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
---|---|---|---|---|
Sonidegib | Odomzo | NVP-LDE225|Erismodedgib|LDE-225 | SMO Inhibitor 16 | Odomzo (sonidegib) is a small molecule inhibitor of SMO, which inhibits proliferation (PMID: 23935925). Odomzo (sonidegib) is FDA approved for use in patients with locally advanced basal cell carcinoma (FDA.gov). |
Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
---|---|---|---|---|---|---|---|
SMO D473H | basal cell carcinoma | resistant | Sonidegib | Phase I | Actionable | In an open-label clinical trial, treatment with Sonidegib (LDE225) resulted in progressive disease in a basal cell carcinoma patient harboring SMO D473H with resistance to Erivedge (vismodegib) (PMID: 26546616). | 26546616 |
SMO D473G | basal cell carcinoma | resistant | Sonidegib | Phase I | Actionable | In an open-label clinical trial, treatment with Sonidegib (LDE225) resulted in progressive disease in a basal cell carcinoma patient harboring SMO D473G with resistance to Erivedge (vismodegib) (PMID: 26546616). | 26546616 |
SMO S533N | basal cell carcinoma | resistant | Sonidegib | Phase I | Actionable | In an open-label clinical trial, treatment with Sonidegib (LDE225) resulted in progressive disease in a basal cell carcinoma patient with resistance to Erivedge (vismodegib) harboring SMO D533N (PMID: 26546616). | 26546616 |
SMO E518K | Advanced Solid Tumor | decreased response | Sonidegib | Preclinical | Actionable | In a preclinical study, transformed mouse fibroblast cells over expressing murine SMO E522K (corresponding to human SMO E518K) demonstrated decreased response to Odomzo (sonidegib) induced Hedgehog pathway inhibition in cell culture (PMID: 26823493). | 26823493 |
SMO S387N | Advanced Solid Tumor | resistant | Sonidegib | Preclinical | Actionable | In a preclinical study, transformed mouse fibroblast cells over expressing murine SMO S391N (corresponding to human SMO S387N) were resistant to Odomzo (sonidegib) induced Hedgehog pathway inhibition in cell culture (PMID: 26823493). | 26823493 |
SMO W535L | basal cell carcinoma | predicted - sensitive | Sonidegib | Phase I | Actionable | In an open-label clinical trial, treatment with Sonidegib (LDE225) resulted in stable disease in a basal cell carcinoma patient harboring SMO W535L with resistance to Erivedge (vismodegib) (PMID: 26546616). | 26546616 |
SMO Q477E | basal cell carcinoma | no benefit | Sonidegib | Phase I | Actionable | In an open-label clinical trial, treatment with Sonidegib (LDE225) resulted in progressive disease in a basal cell carcinoma patient harboring SMO Q477E with resistance to Erivedge (vismodegib) (PMID: 26546616). | 26546616 |
SMO A459V | Advanced Solid Tumor | decreased response | Sonidegib | Preclinical | Actionable | In a preclinical study, primary cerebellar granule neuron precursor cells over expressing SMO A459V on the background of PTCH1 and TP53 deletion demonstrated reduced response to Odomzo (sonidegib) induced growth inhibition in cell culture (PMID: 25759019). | 25759019 |
SMO D384N | Advanced Solid Tumor | resistant | Sonidegib | Preclinical | Actionable | In a preclinical study, transformed mouse fibroblast cells over expressing murine SMO D388N (corresponding to human SMO D384N) were resistant to Odomzo (sonidegib) induced Hedgehog pathway inhibition in cell culture (PMID: 26823493). | 26823493 |
SMO W281C | Advanced Solid Tumor | decreased response | Sonidegib | Preclinical | Actionable | In a preclinical study, primary cerebellar granule neuron precursor cells over expressing SMO W281C on the background of PTCH1 and TP53 deletion demonstrated reduced response to Odomzo (sonidegib) induced growth inhibition in cell culture (PMID: 25759019). | 25759019 |
SMO C469Y | Advanced Solid Tumor | decreased response | Sonidegib | Preclinical | Actionable | In a preclinical study, primary cerebellar granule neuron precursor cells over expressing SMO C469Y on the background of PTCH1 and TP53 deletion demonstrated reduced response to Odomzo (sonidegib) induced growth inhibition in cell culture (PMID: 25759019). | 25759019 |
SMO T241M | Advanced Solid Tumor | decreased response | Sonidegib | Preclinical | Actionable | In a preclinical study, primary cerebellar granule neuron precursor cells over expressing SMO T241M on the background of PTCH1 and TP53 deletion demonstrated reduced response to Odomzo (sonidegib) induced growth inhibition in cell culture (PMID: 25759019). | 25759019 |
SMO I408V | Advanced Solid Tumor | decreased response | Sonidegib | Preclinical | Actionable | In a preclinical study, primary cerebellar granule neuron precursor cells over expressing SMO I408V on the background of PTCH1 and TP53 deletion demonstrated reduced response to Odomzo (sonidegib) induced growth inhibition in cell culture (PMID: 25759019). | 25759019 |
Unknown unknown | basal cell carcinoma | not applicable | Sonidegib | FDA approved | Actionable | In a Phase II trial that supported FDA approval, treatment with Odomzo (sonidegib) resulted in an objective response in 36% (20/55) of patients with locally advanced basal cell carcinoma (PMID: 25981810). | 25981810 detail... |
SMO N219D | Advanced Solid Tumor | resistant | Sonidegib | Preclinical | Actionable | In a preclinical study, transformed mouse fibroblast cells over expressing murine SMO N223D (corresponding to human SMO N219D) were resistant to Odomzo (sonidegib) induced Hedgehog pathway inhibition in cell culture (PMID: 26823493). | 26823493 |
SMO V321M | Advanced Solid Tumor | decreased response | Sonidegib | Preclinical | Actionable | In a preclinical study, primary cerebellar granule neuron precursor cells over expressing SMO C469Y on the background of PTCH1 and TP53 deletion demonstrated reduced response to Odomzo (sonidegib) induced growth inhibition in cell culture (PMID: 25759019). | 25759019 |
Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
---|---|---|---|---|---|---|
NCT02111187 | Phase I | Sonidegib | A Pre-surgical Study of LDE225 in Men With High-risk Localized Prostate Cancer | Completed | USA | 0 |
NCT01485744 | Phase I | Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin Sonidegib | LDE225 With Fluorouracil, Leucovorin, Oxaliplatin, and Irinotecan for Untreated Advanced Pancreatic Cancer | Completed | USA | 0 |
NCT02129101 | Phase I | Azacitidine Sonidegib | Azacitidine and Sonidegib in Treating Patients With Myeloid Malignancies | Completed | USA | 0 |
NCT02151864 | Phase I | Sonidegib | LDE225 in Patients With Advanced or Metastatic Hepatocellular Carcinoma and Child-Pugh A Cirrhosis | Completed | USA | 0 |
NCT01757327 | Phase II | Sonidegib | LDE225 in Treating Patients With Stage II-III Estrogen Receptor- and HER2-Negative Breast Cancer | Withdrawn | 0 | |
NCT02182622 | Phase I | Docetaxel Sonidegib | LDE225 + Docetaxel/Prednisone for Adv/Met Castrate Resistant Prostate Cancer w/ Disease Progression After Docetaxel | Withdrawn | USA | 0 |
NCT02002689 | Phase II | Sonidegib | LDE225 for Patients With PTCH1 or SMO Mutated Tumors | Terminated | USA | 0 |
NCT01769768 | Phase I | Sonidegib Warfarin Bupropion | Phase I Study to Evaluate the Effect of LDE225 on the Pharmacokinetics of Bupropion and Warfarin in Patients | Completed | USA | 0 |