Therapy Detail

Therapy Name Vismodegib
Synonym
Therapy Description

Erivedge (vismodegib) binds to and inhibits Smoothened (SMO), resulting in inhibition of downstream signaling and decreased tumor growth (PMID: 24259609, PMID: 19716296). Erivedge (vismodegib) is FDA approved for use in patients with basal cell carcinoma (FDA.gov).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Vismodegib Erivedge GDC-0449 SMO Inhibitor 16 Erivedge (vismodegib) binds to and inhibits Smoothened (SMO), resulting in inhibition of downstream signaling and decreased tumor growth (PMID: 24259609, PMID: 19716296). Erivedge (vismodegib) is FDA approved for use in patients with basal cell carcinoma (FDA.gov).
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
SMO N476K Advanced Solid Tumor no benefit Vismodegib Preclinical - Cell culture Actionable In a preclinical study, Erivedge (vismodegib) treatment of cells expressing SMO N476K resulted in Hedgehog pathway activity similar to that of wild-type Smo in culture (PMID: 25801792). 25801792
SMO Q477E basal cell carcinoma resistant Vismodegib Preclinical Actionable In a preclinical study, a transformed cell line expressing SMO Q477E was resistant to Erivedge (vismodegib) as demonstrated by elevated gene expression levels of GLI1 resulting in increased signaling of the hedgehog pathway (PMID: 25759020). 25759020
SMO C390R Advanced Solid Tumor no benefit Vismodegib Preclinical - Cell culture Actionable In a preclinical study, Erivedge (vismodegib) treatment of cells expressing SMO C390R resulted in Hedgehog pathway activity similar to that of wild-type Smo in culture (PMID: 25801792). 25801792
SMO P739L Advanced Solid Tumor no benefit Vismodegib Preclinical - Cell culture Actionable In a preclinical study, Erivedge (vismodegib) treatment of cells expressing SMO P739L resulted in Hedgehog pathway activity similar to that of wild-type Smo in culture (PMID: 25801792). 25801792
SMO T349P Advanced Solid Tumor no benefit Vismodegib Preclinical - Cell culture Actionable In a preclinical study, Erivedge (vismodegib) treatment of cells expressing SMO T349P resulted in Hedgehog pathway activity similar to that of wild-type Smo in culture (PMID: 25801792). 25801792
SMO D473G Advanced Solid Tumor resistant Vismodegib Preclinical Actionable In a preclinical study, transformed mouse fibroblast cells over expressing murine SMO D477G (corresponding to human SMO D473G) were resistant to Erivedge (vismodegib) induced Hedgehog pathway inhibition in cell culture (PMID: 26823493). 26823493
SMO D473G Advanced Solid Tumor resistant Vismodegib Preclinical - Cell culture Actionable In a preclinical study, mouse fibroblast cells expressing human SMO D473G were resistant to Hedgehog pathway inhibition by Erivedge (vismodegib) in culture (PMID: 25801792). 25801792
SMO S387N Advanced Solid Tumor resistant Vismodegib Preclinical Actionable In a preclinical study, transformed mouse fibroblast cells over expressing murine SMO S391N (corresponding to human SMO S387N) were resistant to Erivedge (vismodegib) induced Hedgehog pathway inhibition in cell culture (PMID: 26823493). 26823493
SMO N219D sarcoma decreased response Vismodegib Preclinical Actionable In a preclinical study, mouse sarcoma cell lines over expressing SMO N219D demonstrated reduced response to Erivedge (vismodegib) induced Hedgehog pathway inhibition in cell culture (PMID: 25759019). 25759019
SMO V414A Advanced Solid Tumor no benefit Vismodegib Preclinical - Cell culture Actionable In a preclinical study, Erivedge (vismodegib) treatment of cells expressing SMO V414A resulted in Hedgehog pathway activity similar to that of wild-type Smo in culture (PMID: 25801792). 25801792
SMO D473Y basal cell carcinoma predicted - resistant Vismodegib Case Reports/Case Series Actionable In a clinical case study, a de novo SMO D473Y mutation was identified in a recurrent lesion from a basal cell carcinoma patient following an initial 11-month complete clinical response to Erivedge (vismodegib) during a Phase II trial (PMID: 25306392; NCT01367665). 25306392
Unknown unknown basal cell carcinoma not applicable Vismodegib FDA approved Actionable In a Phase II trial that supported FDA approval, treatment with Erivedge (vismodegib) resulted in an objective response rate of 30% (10/33) in patients with metastatic basal cell carcinoma and 43% (27/63) in patients with locally advanced basal cell carcinoma, with 21% (13/63) patients with locally advanced basal cell carcinoma demonstrating complete response (PMID: 22679179, PMID: 22670903). detail... 22679179 22670903
SMO L221P Advanced Solid Tumor no benefit Vismodegib Preclinical - Cell culture Actionable In a preclinical study, Erivedge (vismodegib) treatment of cells expressing SMO L221P resulted in Hedgehog pathway activity similar to that of wild-type Smo in culture (PMID: 25801792). 25801792
SMO P513L Advanced Solid Tumor no benefit Vismodegib Preclinical - Cell culture Actionable In a preclinical study, Erivedge (vismodegib) treatment of cells expressing SMO P513L resulted in Hedgehog pathway activity similar to that of wild-type Smo in culture (PMID: 25801792). 25801792
SMO G453D Advanced Solid Tumor no benefit Vismodegib Preclinical - Cell culture Actionable In a preclinical study, Erivedge (vismodegib) treatment of cells expressing SMO G453D resulted in Hedgehog pathway activity similar to that of wild-type Smo in culture (PMID: 25801792). 25801792
SMO I408V Advanced Solid Tumor decreased response Vismodegib 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 Erivedge (vismodegib) induced growth inhibition in cell culture (PMID: 25759019). 25759019
SMO R199Q Advanced Solid Tumor no benefit Vismodegib Preclinical - Cell culture Actionable In a preclinical study, Erivedge (vismodegib) treatment of cells expressing SMO R199Q resulted in Hedgehog pathway activity similar to that of wild-type Smo in culture (PMID: 25801792). 25801792
SMO K519R Advanced Solid Tumor no benefit Vismodegib Preclinical - Cell culture Actionable In a preclinical study, Erivedge (vismodegib) treatment of cells expressing SMO K519R resulted in Hedgehog pathway activity similar to that of wild-type Smo in culture (PMID: 25801792). 25801792
SMO G497W basal cell carcinoma predicted - resistant Vismodegib Case Reports/Case Series Actionable In a clinical case study, a basal cell carcinoma patient who did not respond to Erivedge (vismodegib) during a Phase II trial was found to harbor a SMO G497W mutation in the initial and progressing lesions (PMID: 25306392; NCT01367665). 25306392
SMO D384N Advanced Solid Tumor resistant Vismodegib Preclinical Actionable In a preclinical study, transformed mouse fibroblast cells over expressing murine SMO D388N (corresponding to human SMO D384N) were resistant to Erivedge (vismodegib) induced Hedgehog pathway inhibition in cell culture (PMID: 26823493). 26823493
SMO E481G Advanced Solid Tumor no benefit Vismodegib Preclinical - Cell culture Actionable In a preclinical study, Erivedge (vismodegib) treatment of cells expressing SMO E481G resulted in Hedgehog pathway activity similar to that of wild-type Smo in culture (PMID: 25801792). 25801792
SMO P739S Advanced Solid Tumor no benefit Vismodegib Preclinical - Cell culture Actionable In a preclinical study, Erivedge (vismodegib) treatment of cells expressing SMO P739S resulted in Hedgehog pathway activity similar to that of wild-type Smo in culture (PMID: 25801792). 25801792
SMO D506N Advanced Solid Tumor no benefit Vismodegib Preclinical - Cell culture Actionable In a preclinical study, Erivedge (vismodegib) treatment of cells expressing SMO D506N resulted in Hedgehog pathway activity similar to that of wild-type Smo in culture (PMID: 25801792). 25801792
SMO F605L Advanced Solid Tumor no benefit Vismodegib Preclinical - Cell culture Actionable In a preclinical study, Erivedge (vismodegib) treatment of cells expressing SMO F605L resulted in Hedgehog pathway activity similar to that of wild-type Smo in culture (PMID: 25801792). 25801792
SMO L412F Advanced Solid Tumor resistant Vismodegib Preclinical Actionable In a preclinical study, a transformed cell line expressing SMO L412F demonstrated resistance to Erivedge (vismodegib) (PMID: 25759020). 25759020
SMO T640A Advanced Solid Tumor no benefit Vismodegib Preclinical - Cell culture Actionable In a preclinical study, Erivedge (vismodegib) treatment of cells expressing SMO T640A resulted in Hedgehog pathway activity similar to that of wild-type Smo in culture (PMID: 25801792). 25801792
SMO P698T Advanced Solid Tumor no benefit Vismodegib Preclinical - Cell culture Actionable In a preclinical study, Erivedge (vismodegib) treatment of cells expressing SMO P698T resulted in Hedgehog pathway activity similar to that of wild-type Smo in culture (PMID: 25801792). 25801792
SMO V321M basal cell carcinoma predicted - resistant Vismodegib Case Reports/Case Series Actionable In a clinical case study, a de novo SMO V321M mutation was identified in a recurrent lesion from a basal cell carcinoma patient following an initial twenty week response to Erivedge (vismodegib) (PMID: 25199678). 25199678
SMO F460L Advanced Solid Tumor resistant Vismodegib Preclinical Actionable In a preclinical study, a transformed cell line expressing SMO F460L demonstrated resistance to Erivedge (vismodegib) as compared to wild-type (PMID: 25759020). 25759020
SMO A459V Advanced Solid Tumor decreased response Vismodegib 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 Erivedge (vismodegib) induced growth inhibition in cell culture (PMID: 25759019). 25759019
SMO D384N sarcoma decreased response Vismodegib Preclinical Actionable In a preclinical study, mouse sarcoma cell lines over expressing SMO D384N demonstrated reduced response to Erivedge (vismodegib) induced Hedgehog pathway inhibition in cell culture (PMID: 25759019). 25759019
SMO S387N sarcoma decreased response Vismodegib Preclinical Actionable In a preclinical study, mouse sarcoma cell lines over expressing SMO S387N demonstrated reduced response to Erivedge (vismodegib) induced Hedgehog pathway inhibition in cell culture (PMID: 25759019). 25759019
SMO T349I Advanced Solid Tumor no benefit Vismodegib Preclinical - Cell culture Actionable In a preclinical study, Erivedge (vismodegib) treatment of cells expressing SMO T349I resulted in Hedgehog pathway activity similar to that of wild-type Smo in culture (PMID: 25801792). 25801792
SMO R168H Advanced Solid Tumor no benefit Vismodegib Preclinical - Cell culture Actionable In a preclinical study, Erivedge (vismodegib) treatment of cells expressing SMO R168H resulted in Hedgehog pathway activity similar to that of wild-type Smo in culture (PMID: 25801792). 25801792
SMO H231R basal cell carcinoma resistant Vismodegib Preclinical Actionable In a preclinical study, a transformed cell line expressing SMO H231R was resistant to Erivedge (vismodegib) as demonstrated by elevated gene expression levels of GLI1 resulting in increased signaling of the hedgehog pathway (PMID: 25759020). 25759020
SMO L353F Advanced Solid Tumor no benefit Vismodegib Preclinical - Cell culture Actionable In a preclinical study, Erivedge (vismodegib) treatment of cells expressing SMO L353F resulted in Hedgehog pathway activity similar to that of wild-type Smo in culture (PMID: 25801792). 25801792
SMO V404M Advanced Solid Tumor no benefit Vismodegib Preclinical - Cell culture Actionable In a preclinical study, Erivedge (vismodegib) treatment of cells expressing SMO V404M resulted in Hedgehog pathway activity similar to that of wild-type Smo in culture (PMID: 25801792). 25801792
SMO W281C basal cell carcinoma resistant Vismodegib Preclinical Actionable In a preclinical study, a transformed cell line expressing SMO W281C was resistant to Erivedge (vismodegib) as demonstrated by elevated gene expression levels of GLI1 resulting in increased signaling of the hedgehog pathway (PMID: 25759020). 25759020
SMO W535L Advanced Solid Tumor resistant Vismodegib Preclinical Actionable In a preclinical study, a transformed cell line expressing SMO W535L demonstrated resistance to Erivedge (vismodegib) (PMID: 25759020). 25759020
SMO W535L Advanced Solid Tumor resistant Vismodegib Preclinical - Cell culture Actionable In a preclinical study, mouse fibroblast cells expressing human SMO W535L were resistant to Hedgehog pathway inhibition by Erivedge (vismodegib) in culture (PMID: 25801792). 25801792
SMO D473G basal cell carcinoma resistant Vismodegib Preclinical Actionable In a preclinical study, a transformed cell line expressing SMO D473G was resistant to Erivedge (vismodegib) as demonstrated by elevated gene expression levels of GLI1 resulting in increased signaling of the hedgehog pathway (PMID: 25759020). 25759020
SMO T548I Advanced Solid Tumor no benefit Vismodegib Preclinical - Cell culture Actionable In a preclinical study, Erivedge (vismodegib) treatment of cells expressing SMO T548I resulted in Hedgehog pathway activity similar to that of wild-type Smo in culture (PMID: 25801792). 25801792
SMO V321M Advanced Solid Tumor resistant Vismodegib Preclinical Actionable In a preclinical study, a transformed cell line expressing SMO V321M demonstrated resistance to Erivedge (vismodegib) (PMID: 25759020). 25759020
SMO wild-type stomach cancer predicted - sensitive Vismodegib Preclinical Actionable In a preclinical study, Vismodegib (GDC-0449) inhibited Hedgehog pathway signaling, increased apoptosis, and decreased proliferation of a gastric cancer cell line in culture (PMID: 26676867). 26676867
SMO K564E Advanced Solid Tumor no benefit Vismodegib Preclinical - Cell culture Actionable In a preclinical study, Erivedge (vismodegib) treatment of cells expressing SMO K564E resulted in Hedgehog pathway activity similar to that of wild-type Smo in culture (PMID: 25801792). 25801792
SMO T336I Advanced Solid Tumor no benefit Vismodegib Preclinical - Cell culture Actionable In a preclinical study, Erivedge (vismodegib) treatment of cells expressing SMO T336I resulted in Hedgehog pathway activity similar to that of wild-type Smo in culture (PMID: 25801792). 25801792
SMO E518K Advanced Solid Tumor resistant Vismodegib Preclinical Actionable In a preclinical study, transformed mouse fibroblast cells over expressing murine SMO E522K (corresponding to human SMO E518K) were resistant to Erivedge (vismodegib) induced Hedgehog pathway inhibition in cell culture (PMID: 26823493). 26823493
SMO C469Y Advanced Solid Tumor decreased response Vismodegib 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 Erivedge (vismodegib) induced growth inhibition in cell culture (PMID: 25759019). 25759019
SMO V386A Advanced Solid Tumor no benefit Vismodegib Preclinical - Cell culture Actionable In a preclinical study, Erivedge (vismodegib) treatment of cells expressing SMO V386A resulted in Hedgehog pathway activity similar to that of wild-type Smo in culture (PMID: 25801792). 25801792
SMO T534I Advanced Solid Tumor no benefit Vismodegib Preclinical - Cell culture Actionable In a preclinical study, Erivedge (vismodegib) treatment of cells expressing SMO T534I resulted in Hedgehog pathway activity similar to that of wild-type Smo in culture (PMID: 25801792). 25801792
SMO E181K Advanced Solid Tumor no benefit Vismodegib Preclinical - Cell culture Actionable In a preclinical study, Erivedge (vismodegib) treatment of cells expressing SMO E181K resulted in Hedgehog pathway activity similar to that of wild-type Smo in culture (PMID: 25801792). 25801792
SMO W281L basal cell carcinoma predicted - resistant Vismodegib Case Reports/Case Series Actionable In a clinical case study, a de novo SMO W281L mutation was identified in a recurrent lesion from a basal cell carcinoma patient following an initial twenty week response to Erivedge (vismodegib) (PMID: 25199678). 25199678
SMO T241M Advanced Solid Tumor decreased response Vismodegib 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 Erivedge (vismodegib) induced growth inhibition in cell culture (PMID: 25759019). 25759019
SMO A327P Advanced Solid Tumor no benefit Vismodegib Preclinical - Cell culture Actionable In a preclinical study, Erivedge (vismodegib) treatment of cells expressing SMO A327P resulted in Hedgehog pathway activity similar to that of wild-type Smo in culture (PMID: 25801792). 25801792
Clinical Trial Phase Therapies Title Recruitment Status
NCT02067104 Phase II Vismodegib Vismodegib in Basal Cell Carcinomas (BCC) Chemoprevention Active, not recruiting
NCT02523014 Phase II GSK2256098 Vismodegib A Study Looking at Targeted Therapy According to Tumor Markers for People With Meningiomas Suspended
NCT02091141 Phase II Erlotinib Alectinib Cobimetinib + Vemurafenib Pertuzumab + Trastuzumab Vismodegib Atezolizumab My Pathway: A Study Evaluating Herceptin/Perjeta, Tarceva, Zelboraf/Cotellic, Erivedge, Alecensa, and Tecentriq Treatment Targeted Against Certain Molecular Alterations in Participants With Advanced Solid Tumors Recruiting
NCT02788201 Phase II Erlotinib Thiotepa Imatinib Dacarbazine Arsenic trioxide Idarubicin Mitomycin C Thioguanine Mercaptopurine Methotrexate Cladribine Epirubicin Gemcitabine Doxorubicin Bleomycin Etoposide Gefitinib Daunorubicin Lomustine Sorafenib Sunitinib Ifosfamide Asparaginase Ixabepilone Abiraterone Azacitidine Ruxolitinib Decitabine Axitinib Estramustine Floxuridine Lapatinib Carmustine Fludarabine Nilotinib Cisplatin Vismodegib Vandetanib Melphalan Busulfan Carboplatin Toremifene Crizotinib Dactinomycin Temsirolimus Vorinostat Romidepsin Fluorouracil Irinotecan Bortezomib Tamoxifen Topotecan Chlorambucil Pentostatin Eribulin Carfilzomib Vemurafenib Hydroxyurea Exemestane Vincristine Dasatinib Mitoxantrone Vinblastine Cytarabine Tretinoin Clofarabine Teniposide Docetaxel Pazopanib Oxaliplatin Streptozocin Paclitaxel Bendamustine Mechlorethamine Mitotane Genomic Based Assignment of Therapy in Advanced Urothelial Carcinoma Recruiting
NCT02366312 Phase II Vismodegib A Phase 2, Single-center, Single-arm, Open Label Trial of Vismodegib in Patients With Keratocystic Odontogenic Tumors Active, not recruiting
NCT03297606 Phase II Bosutinib Palbociclib Vismodegib Ipilimumab + Nivolumab Cobimetinib + Vemurafenib Temsirolimus Olaparib Erlotinib Crizotinib Sunitinib Afatinib Dasatinib Pertuzumab + Trastuzumab Axitinib Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR) (CAPTUR) Recruiting
NCT01835626 Phase II Vismodegib Phase II Study of Radiation Therapy and Vismodegib for Advanced Head/Neck Basal Cell Carcinoma Recruiting
NCT01154452 Phase Ib/II Vismodegib RO4929097 + Vismodegib RO4929097 Vismodegib and Gamma-Secretase/Notch Signalling Pathway Inhibitor RO4929097 in Treating Patients With Advanced or Metastatic Sarcoma Completed
NCT01543581 Vismodegib Vismodegib for Treatment of Basal Cell Carcinoma Completed
NCT02639117 Phase I Vismodegib Photodynamic Therapy and Vismodegib for Multiple Basal Cell Carcinomas Completed
NCT02115828 Phase I Vismodegib A Study of Vismodegib in Men With Metastatic CRPC With Accessible Metastatic Lesions for Tumor Biopsy Completed
NCT01878617 Phase II Vismodegib Cisplatin + Cyclophosphamide + Vincristine Gemcitabine + Pemetrexed A Clinical and Molecular Risk-Directed Therapy for Newly Diagnosed Medulloblastoma Recruiting
NCT01815840 Phase II Vismodegib A Study of Two Vismodegib Regimens in Patients With Multiple Basal Cell Carcinomas Completed
NCT02436408 FDA approved Vismodegib VISmodegib for ORbital and Periocular Basal Cell Carcinoma Recruiting
NCT01774253 Phase II Vismodegib Erivedge (Vismodegib) in the Treatment of Pediatric Patients With Refractory Pontine Glioma Terminated
NCT02465060 Phase II Erdafitinib Copanlisib Trametinib Crizotinib Sunitinib Sapanisertib Nivolumab AZD4547 Dasatinib Pertuzumab + Trastuzumab Dabrafenib + Trametinib Binimetinib Adavosertib Osimertinib Palbociclib Afatinib Capivasertib Defactinib GSK2636771 Vismodegib Ado-trastuzumab emtansine Larotrectinib Taselisib Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) Recruiting
NCT01700049 Phase II Vismodegib Study Evaluating the Efficacy of Oral Vismodegib in Various Histologic Subtypes Active, not recruiting
NCT01367665 Phase II Vismodegib STEVIE: A Study of Vismodegib in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma Completed
NCT01898598 Phase II Vismodegib A Study of Vismodegib With Surgery in Patients With Previously Untreated Basal Cell Carcinoma Terminated