Therapy Detail

Therapy Name Sonidegib
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).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Sonidegib Odomzo NVP-LDE225|Erismodedgib 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 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 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 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 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 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 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 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 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
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 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
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
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
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 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 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
Clinical Trial Phase Therapies Title Recruitment Status
NCT03434262 Phase I Filgrastim + Gemcitabine + Pegfilgrastim + Ribociclib Trametinib Sonidegib Ribociclib Ribociclib + Trametinib Ribociclib + Sonidegib Molecularly-Driven Doublet Therapy for Recurrent CNS Malignant Neoplasms Recruiting
NCT02151864 Phase I Sonidegib LDE225 in Patients With Advanced or Metastatic Hepatocellular Carcinoma and Child-Pugh A Cirrhosis Active, not recruiting
NCT02182622 Phase I Docetaxel Sonidegib LDE225 + Docetaxel/Prednisone for Adv/Met Castrate Resistant Prostate Cancer w/ Disease Progression After Docetaxel Unknown status
NCT02129101 Phase I Azacitidine Sonidegib Azacitidine and Sonidegib in Treating Patients With Myeloid Malignancies Active, not recruiting
NCT02002689 Phase II Sonidegib LDE225 for Patients With PTCH1 or SMO Mutated Tumors Terminated
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
NCT02111187 Phase I Sonidegib A Pre-surgical Study of LDE225 in Men With High-risk Localized Prostate Cancer Completed
NCT01485744 Phase I FOLFIRINOX Sonidegib LDE225 With Fluorouracil, Leucovorin, Oxaliplatin, and Irinotecan for Untreated Advanced Pancreatic Cancer Active, not recruiting
NCT01757327 Phase II Sonidegib LDE225 in Treating Patients With Stage II-III Estrogen Receptor- and HER2-Negative Breast Cancer Withdrawn