{"entity":{"id":"bolt","kind":"trial","name":"BOLT","aka":[],"tldr":"BOLT showed that sonidegib, a second hedgehog pathway pill, shrinks about four in ten locally advanced basal cell carcinomas at its lower dose, and that the higher dose adds side effects rather than responses.","summary":"BOLT randomised 230 patients with locally advanced or metastatic basal cell carcinoma to sonidegib 200 mg or 800 mg daily in a double-blind design with no placebo arm, the question being dose rather than efficacy against a comparator.\n\nAt the 200 mg dose the objective response rate by central review was 43 percent in locally advanced and 15 percent in metastatic disease (Lancet Oncology 2015), with more toxicity and no more responses at 800 mg. Long-term follow-up to 42 months showed durable responses and the same muscle spasm, hair loss and taste disturbance seen with vismodegib.\n\nSonidegib 200 mg was approved for locally advanced basal cell carcinoma in July 2015 and is used interchangeably with vismodegib; neither has been compared with the other head to head.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT01327053","url":"https://clinicaltrials.gov/study/NCT01327053"},{"label":"Lancet Oncology 2015","url":"https://doi.org/10.1016/S1470-2045(15)70100-2"}],"tags":[],"related":[],"cancers":["locally-advanced-bcc","basal-cell-carcinoma"],"sections":[],"technologies":["hedgehog-inhibitors"],"targets":["smoothened"],"drugs":["sonidegib"],"companies":["novartis","sun-pharma"],"institutions":[],"pathways":["hedgehog","basal-cell-carcinoma-signalling"],"terms":[],"trials":[],"people":["reinhard-dummer"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01327053","phase":"2","setting":"Locally advanced or metastatic basal cell carcinoma: sonidegib 200 mg versus 800 mg daily","sponsor":"Novartis (now Sun Pharma)","result":"Objective response at 200 mg: 43% in locally advanced and 15% in metastatic basal cell carcinoma (central review).","yearReported":2015,"enrolled":230,"outcomes":[{"endpoint":"Objective response rate, 200 mg (locally advanced)","primary":true,"unit":"%","arms":[{"name":"Sonidegib 200 mg","value":43}],"source":"https://doi.org/10.1016/S1470-2045(15)70100-2"}],"replication":"ERIVANCE (vismodegib) found the same response rate for hedgehog inhibition in locally advanced basal cell carcinoma."},"route":"/trials/bolt/","neighbours":{"cancer":[{"id":"basal-cell-carcinoma","kind":"cancer","name":"Basal cell carcinoma","route":"/cancers/basal-cell-carcinoma/"},{"id":"locally-advanced-bcc","kind":"cancer","name":"Locally advanced and metastatic basal cell carcinoma","route":"/cancers/locally-advanced-bcc/"}],"technology":[{"id":"hedgehog-inhibitors","kind":"technology","name":"Hedgehog pathway inhibitors","route":"/technologies/hedgehog-inhibitors/"}],"target":[{"id":"smoothened","kind":"target","name":"Smoothened (hedgehog pathway)","route":"/targets/smoothened/"}],"drug":[{"id":"sonidegib","kind":"drug","name":"Sonidegib","route":"/drugs/sonidegib/"}],"company":[{"id":"novartis","kind":"company","name":"Novartis","route":"/companies/novartis/"},{"id":"sun-pharma","kind":"company","name":"Sun Pharmaceutical Industries","route":"/companies/sun-pharma/"}],"pathway":[{"id":"basal-cell-carcinoma-signalling","kind":"pathway","name":"Basal cell carcinoma (KEGG map)","route":"/pathways/basal-cell-carcinoma-signalling/"},{"id":"hedgehog","kind":"pathway","name":"Hedgehog signalling","route":"/pathways/hedgehog/"}],"person":[{"id":"reinhard-dummer","kind":"person","name":"Reinhard Dummer","route":"/people/reinhard-dummer/"}]}}