Vismodegib

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Information
Drug Name
Vismodegib
Description
Entry(CIViC)
9
CIViC
Disease Mutation EL ET ED CS VO TR Pubmed Links
basal cell carcinoma SMO MUTATION SMO MUTATION B Predictive Supports Resistance Somatic 2 26546616 Detail
basal cell carcinoma SMO p.Leu412Phe (p.L412F)
( ENST00000249373.8 ) SMO p.Leu412Phe (p.L412F)
( ENST00000249373.8 ) 		D Predictive Supports Resistance Somatic 25759020 Detail
basal cell carcinoma SMO p.Leu412Phe (p.L412F)
( ENST00000249373.8 ) SMO p.Leu412Phe (p.L412F)
( ENST00000249373.8 ) 		C Predictive Supports Resistance Somatic 26822128 Detail
cancer PTCH1 MUTATION PTCH1 MUTATION B Predictive Supports Sensitivity/Response Somatic 1 29320312 Detail
cancer SMO MUTATION SMO MUTATION B Predictive Does Not Support Sensitivity/Response Somatic 2 29320312 Detail
Brain Medulloblastoma SMO p.Asp473His (p.D473H)
( ENST00000249373.8 ) SMO p.Asp473His (p.D473H)
( ENST00000249373.8 ) 		C Predictive Supports Resistance Somatic 3 19726788 Detail
basal cell carcinoma SMO MUTATION SMO MUTATION B Predictive Supports Resistance Somatic 4 25759020 Detail
Brain Medulloblastoma PTCH1 LOH
( ENST00000331920.11 ) PTCH1 LOH
( ENST00000331920.11 ) 		B Predictive Supports Sensitivity/Response Somatic 2 26169613 Detail
basal cell carcinoma SMO p.Asp473His (p.D473H)
( ENST00000249373.8 ) SMO p.Asp473His (p.D473H)
( ENST00000249373.8 ) 		D Predictive Supports Resistance Somatic 3 25759020 Detail
Annotation
Description Associated Genes Associated Variants Sensitivity Supported Source Links
Study explored the response to the SMO inhibitor s... SMO SMO MUTATION SMO MUTATION Resitance or Non-Reponse true CIViC Evidence detail
In an in vitro study, mouse embryonic fibroblasts ... SMO SMO p.Leu412Phe (p.L412F)
( ENST00000249373.8 ) SMO p.Leu412Phe (p.L412F)
( ENST00000249373.8 ) 		Resitance or Non-Reponse true CIViC Evidence detail
An Arab basal cell carcinoma patient harboring SMO... SMO SMO p.Leu412Phe (p.L412F)
( ENST00000249373.8 ) SMO p.Leu412Phe (p.L412F)
( ENST00000249373.8 ) 		Resitance or Non-Reponse true CIViC Evidence detail
The phase 2a MyPathway study assigned patients wit... PTCH1 PTCH1 MUTATION PTCH1 MUTATION Sensitivity true CIViC Evidence detail
The phase 2a MyPathway study assigned patients wit... SMO SMO MUTATION SMO MUTATION Sensitivity false CIViC Evidence detail
In this case report, the D473H mutation was report... SMO SMO p.Asp473His (p.D473H)
( ENST00000249373.8 ) SMO p.Asp473His (p.D473H)
( ENST00000249373.8 ) 		Resitance or Non-Reponse true CIViC Evidence detail
In basal cell carcinoma, H231R, D473G, W281C and Q... SMO SMO MUTATION SMO MUTATION Resitance or Non-Reponse true CIViC Evidence detail
Loss-of-heterozygosity in SHH-driven medulloblasto... PTCH1 PTCH1 LOH
( ENST00000331920.11 ) PTCH1 LOH
( ENST00000331920.11 ) 		Sensitivity true CIViC Evidence detail
D473 mutations were identified in 5/30 resistant b... SMO SMO p.Asp473His (p.D473H)
( ENST00000249373.8 ) SMO p.Asp473His (p.D473H)
( ENST00000249373.8 ) 		Resitance or Non-Reponse true CIViC Evidence detail
NCT ID Status Phase Summary Start date Completion date
NCT01878617 Active, not recruiting Phase 2 A Clinical and Molecular Risk-Directed Therapy for Newly Diagnosed Medulloblastoma June 23, 2013 January 2028
NCT01267955 Active, not recruiting Phase 2 Vismodegib in Treating Patients With Advanced Chondrosarcomas December 21, 2010 July 25, 2024
NCT03498521 Active, not recruiting Phase 2 A Phase II Randomized Study Comparing the Efficacy and Safety of Targeted Therapy or Cancer Immunotherapy Versus Platinum-Based Chemotherapy in Patients With Cancer of Unknown Primary Site July 10, 2018 June 9, 2024
NCT02465060 Active, not recruiting Phase 2 Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) August 17, 2015 December 31, 2025
NCT00878163 Active, not recruiting Phase 1 GDC-0449 and Erlotinib Hydrochloride With or Without Gemcitabine Hydrochloride in Treating Patients With Metastatic Pancreatic Cancer or Solid Tumors That Cannot Be Removed by Surgery March 31, 2009 March 7, 2025
NCT06357988 Active, not recruiting Phase 2 Testing GDC-0449 (Vismodegib) as Potentially Targeted Treatment in Cancers With Smoothened or Patched 1 Mutant Tumors (MATCH - Subprotocol T) February 24, 2016 November 4, 2024
NCT02690948 Completed Phase 1/Phase 2 Pembrolizumab With or Without Vismodegib in Treating Metastatic or Unresectable Basal Cell Skin Cancer February 1, 2016 August 29, 2018
NCT03158389 Completed Phase 1/Phase 2 NCT Neuro Master Match - N²M² (NOA-20) May 7, 2018 February 22, 2023
NCT00887159 Completed Phase 2 A Randomized Phase II Study of Cisplatin and Etoposide in Combination With Either Hedgehog Inhibitor GDC-0449 or IGF-1R MOAB IMC-A12 for Patients With Extensive Stage July 16, 2009 November 15, 2016
NCT01174264 Completed Phase 1/Phase 2 Evaluation of Food Effect on Pharmacokinetics of Vismodegib October 2009 December 2014
NCT01195415 Completed Phase 2 Vismodegib and Gemcitabine Hydrochloride in Treating Patients With Advanced Pancreatic Cancer June 2010 October 10, 2014
NCT01201915 Completed Phase 2 A Study Evaluating the Efficacy and Safety of Vismodegib (GDC-0449) in Operable Basal Cell Carcinoma October 2010 May 2013
NCT01209143 Completed Phase 1 A Study of Pharmacokinetic Drug Interaction Study of the Hedgehog Pathway Inhibitor GDC-0449 in Combination With Rosiglitazone or Combined Oral Contraceptive in Patients With Locally Advanced or Metastatic Solid Tumors That Are Refractory to Standard Therapy or for Whom No Standard Therapy Exists November 2010 March 2012
NCT01239316 Completed Phase 2 Vismodegib in Treating Younger Patients With Recurrent or Refractory Medulloblastoma November 2010 August 2015
NCT01330173 Completed Phase 1 Vismodegib After Stem Cell Transplant in Treating Patients With High-Risk First Remission or Relapsed Multiple Myeloma December 2010 November 2014
NCT01367665 Completed Phase 2 STEVIE: A Study of Vismodegib in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma July 1, 2011 June 14, 2017
NCT01537107 Completed Phase 1 Sirolimus and Vismodegib in Treating Patients With Solid Tumors or Pancreatic Cancer That is Metastatic or Cannot Be Removed By Surgery March 5, 2012 June 27, 2018
NCT01543581 Completed Phase 2 Vismodegib for Treatment of Basal Cell Carcinoma May 2012 July 2013
NCT01546519 Completed Phase 1 A Study of Vismodegib in Patients With Advanced Solid Malignancies Including Hepatocellular Carcinoma With Varying Degrees of Renal or Hepatic Function March 2012 April 2014
NCT01556009 Completed Phase 2 Trial Comparing the Effects of Intermittent Vismodegib vs. PDT in Patients With Multiple Basal Cell Carcinomas April 2012 December 2015
NCT00939484 Completed Phase 2 Vismodegib in Treating Patients With Recurrent or Refractory Medulloblastoma June 2009 August 2015
NCT01631331 Completed Early Phase 1 Vismodegib in Treating Patients With Basal Cell Carcinoma (BCC) June 2012 May 31, 2016
NCT01772290 Completed Phase 1 A Drug-Drug Interaction Study of the Effect of Rabeprazole, Itraconazole or Fluconazole on the Pharmacokinetics of Vismodegib February 2013 May 2013
NCT00959647 Completed Phase 2 A Study of Vismodegib (GDC-0449) in Patients Treated With Vismodegib in a Previous Genentech-sponsored Phase I or II Cancer Study September 2009 January 2014
NCT01815840 Completed Phase 2 A Study of Two Vismodegib Regimens in Participants With Multiple Basal Cell Carcinomas April 30, 2013 August 31, 2016
NCT01835626 Completed Phase 2 Phase II Study of Radiation Therapy and Vismodegib for Advanced Head/Neck Basal Cell Carcinoma May 2013 September 10, 2019
NCT00980343 Completed Phase 2 GDC-0449 in Treating Patients With Recurrent Glioblastoma Multiforme That Can Be Removed by Surgery February 2010 June 2012
NCT00982592 Completed Phase 2 Combination Chemotherapy With or Without Vismodegib in Treating Patients With Advanced Stomach Cancer or Gastroesophageal Junction Cancer September 2009 October 2014
NCT01064622 Completed Phase 1/Phase 2 Gemcitabine Hydrochloride With or Without Vismodegib in Treating Patients With Recurrent or Metastatic Pancreatic Cancer September 2009 January 2013
NCT02073838 Completed Phase 2 Ribavirin and Hedgehog Inhibitor With or Without Decitabine in AML May 2015 November 2022
NCT02091141 Completed Phase 2 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 April 14, 2014 May 24, 2023
NCT02115828 Completed Early Phase 1 A Study of Vismodegib in Men With Metastatic CRPC With Accessible Metastatic Lesions for Tumor Biopsy April 2014 April 2016
NCT03035188 Completed Phase 2 Neoadjuvant Vismodegib in Patients With Large and/or Recurrent Resectable Basal Cell Carcinoma January 2017 January 2021
NCT01154452 Completed Phase 1/Phase 2 Vismodegib and Gamma-Secretase/Notch Signalling Pathway Inhibitor RO4929097 in Treating Patients With Advanced or Metastatic Sarcoma June 2010 February 2015
NCT02366312 Completed Phase 2 A Phase 2, Single-center, Single-arm, Open Label Trial of Vismodegib in Patients With Keratocystic Odontogenic Tumors October 27, 2015 August 2019
NCT02371967 Completed A Study to Assess the Effectiveness and Safety of Vismodegib (Erivedge®) in Participants With Advanced Basal Cell Carcinoma (BCC) April 8, 2015 August 19, 2020
NCT02436408 Completed Phase 4 VISmodegib for ORbital and Periocular Basal Cell Carcinoma July 15, 2015 September 2020
NCT00822458 Completed Phase 1 GDC-0449 in Treating Young Patients With Medulloblastoma That is Recurrent or Did Not Respond to Previous Treatment January 2009
NCT02593760 Completed Phase 1 A Study to Evaluate the Efficacy and Safety of Vismodegib in Combination With Ruxolitinib for the Treatment of Intermediate- or High-Risk Myelofibrosis (MF) January 25, 2016 July 12, 2017
NCT02639117 Completed Phase 1 Photodynamic Therapy and Vismodegib for Multiple Basal Cell Carcinomas November 30, 2015 November 18, 2017
NCT02648048 Completed Phase 1 A Study of Oral Vismodegib in Combination With Pirfenidone in Participants With Idiopathic Pulmonary Fibrosis January 15, 2016 November 30, 2016
NCT02674009 Completed Observational Study to Determine the Effectiveness and Safety of Vismodegib (Erivedge®) in Participants With Locally Advanced Basal Cell Carcinoma (laBCC) September 17, 2015 March 31, 2019
NCT05561634 Not yet recruiting Phase 2 Radiotherapy by Sonic Hedgehog Pathway Inhibitors in Basal Cell Carcinoma July 2023 July 2028
NCT02523014 Recruiting Phase 2 Vismodegib, FAK Inhibitor GSK2256098, Capivasertib, and Abemaciclib in Treating Patients With Progressive Meningiomas August 2015 October 2024
NCT03297606 Recruiting Phase 2 Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR) March 23, 2018 January 31, 2027
NCT05538091 Recruiting Phase 2 Vismodegib Combined With Atezolizumab in Platinum Resistant Ovarian, Fallopian Tube, and Primary Peritoneal Cancer May 15, 2023 April 1, 2028
NCT04341181 Recruiting Phase 2 ProTarget - A Danish Nationwide Clinical Trial on Targeted Cancer Treatment Based on Genomic Profiling August 24, 2020 April 30, 2025
NCT05159245 Recruiting Phase 2 The Finnish National Study to Facilitate Patient Access to Targeted Anti-cancer Drugs December 10, 2021 November 25, 2026
NCT05463757 Recruiting Oral Hedgehog Inhibitors in the Treatment of Basal Cell Carcinoma in the Netherlands: a Prospective Registration Study November 1, 2021 December 2024
NCT06344052 Recruiting Phase 2 To Assess the Safety and Efficacy of SP-002 With Vismodegib for the Treatment of Locally Advanced Basal Cell Carcinoma April 9, 2024 March 30, 2029
NCT02925234 Recruiting Phase 2 The Drug Rediscovery Protocol (DRUP Trial) August 2016 December 2027
NCT03878524 Terminated Phase 1 Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial April 1, 2020 December 10, 2020
NCT01071564 Terminated Phase 1 RO4929097 and Vismodegib in Treating Patients With Breast Cancer That is Metastatic or Cannot Be Removed By Surgery November 2009 June 2014
NCT01163084 Terminated Phase 1/Phase 2 Leuprolide Acetate or Goserelin Acetate With or Without Vismodegib Followed by Surgery in Treating Patients With Locally Advanced Prostate Cancer July 9, 2010 June 1, 2012
NCT01601184 Terminated Phase 1/Phase 2 Study of Vismodegib in Combination With Temozolomide Versus Temozolomide Alone in Patients With Medulloblastomas With an Activation of the Sonic Hedgehog Pathway June 2012 October 2017
NCT01774253 Terminated Phase 2 Erivedge (Vismodegib) in the Treatment of Pediatric Patients With Refractory Pontine Glioma May 2013 October 2015
NCT01880437 Terminated Phase 2 A Study of Vismodegib in Patients With Relapsed/Refractory Acute Myelogenous Leukemia and Relapsed Refractory High-Risk Myelodysplastic Syndrome September 2013 November 2014
NCT01898598 Terminated Phase 2 A Study of Vismodegib With Surgery in Participants With Previously Untreated Basal Cell Carcinoma January 23, 2014 January 26, 2016
NCT01944943 Terminated Phase 2 Phase II Study of Vismodegib in Patients With Refractory or Relapsed B-cell Lymphoma or Chronic Lymphocytic Leukemia February 2013 October 2014
NCT02067104 Terminated Phase 2 Vismodegib in Basal Cell Carcinomas (BCC) Chemoprevention February 17, 2014 December 31, 2016
NCT02337517 Terminated Phase 2 Vismodegib in Treating Patients With Steroid-Refractory Chronic Graft-Versus-Host Disease September 8, 2015 June 28, 2018
NCT02956889 Terminated Phase 2 To Assess The Efficacy And Safety Of Vismodegib And Radiotherapy In Advanced Basal Cell Carcinoma October 2016 January 2020
NCT02694224 Unknown status Phase 2 Addition of Vismodegib to Neoadjuvant Chemotherapy in Triple Negative Breast Cancer Patients April 2016 December 2018
NCT01713218 Unknown status Early Phase 1 Effect on Tumor Perfusion of a Chemotherapy Combining Gemcitabine and Vismodegib Before Surgery in Pancreatic Cancer December 2012 December 2016
NCT05238831 Withdrawn Early Phase 1 SMMART Adaptive Clinical Treatment (ACT) Trial January 30, 2023 May 31, 2026
NCT03767439 Withdrawn Phase 2 Nivolumab With Vismodegib in Patients With Basal Cell Nevus Syndrome July 2019 February 2020
NCT02168530 Withdrawn Phase 2 A Study of Oral Vismodegib for the Treatment of Idiopathic Pulmonary Fibrosis (IPF) October 2014 January 2017