{"id":"abiraterone-acetate-escalated-dose","safety":{"commonSideEffects":[{"rate":"10-20","effect":"Hypokalemia"},{"rate":"20-30","effect":"Hypertension"},{"rate":"10-15","effect":"Fluid retention/edema"},{"rate":"15-25","effect":"Fatigue"},{"rate":"10-15","effect":"Diarrhea"},{"rate":"10-15","effect":"Nausea"},{"rate":"5-10","effect":"Elevated liver enzymes"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"anthropic-haiku","explanation":"Abiraterone acetate inhibits the enzyme 17α-hydroxylase/17,20-lyase (CYP17A1), which is critical for androgen biosynthesis in the adrenal glands and tumor cells. By blocking this enzyme, it reduces circulating and intratumoral testosterone levels, thereby suppressing androgen receptor signaling in hormone-sensitive cancers. The escalated dose regimen aims to achieve higher drug exposure for potentially improved efficacy in advanced disease.","oneSentence":"Abiraterone acetate is a CYP17A1 inhibitor that blocks androgen synthesis, reducing testosterone production to treat androgen-dependent cancers.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T02:28:23.893Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Metastatic castration-resistant prostate cancer"},{"name":"Castration-sensitive prostate cancer (in combination with androgen deprivation therapy)"}]},"trialDetails":[{"nctId":"NCT05818683","phase":"PHASE1","title":"A Study of JNJ-78278343 in Combination With Either JNJ-63723283 (Cetrelimab), Taxane Chemotherapy, or Androgen Receptor Pathway Inhibitors for Metastatic Prostate Cancer","status":"RECRUITING","sponsor":"Janssen Research & Development, LLC","startDate":"2023-04-26","conditions":"Metastatic Castration-resistant Prostate Neoplasms, Metastatic Hormone-sensitive Prostate Cancer","enrollment":277},{"nctId":"NCT03458247","phase":"PHASE2","title":"Study of Dose Escalation of Abiraterone Actetate in Prostate Cancer","status":"COMPLETED","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2018-06-22","conditions":"Prostate Cancer","enrollment":94},{"nctId":"NCT02106507","phase":"PHASE1","title":"ARN 509 Plus Everolimus in Men With Progressive Metastatic Castration-Resistant Prostate Cancer After Treatment With Abiraterone Acetate","status":"COMPLETED","sponsor":"Memorial Sloan Kettering Cancer Center","startDate":"2014-04","conditions":"Prostate Cancer","enrollment":9},{"nctId":"NCT01637402","phase":"PHASE2","title":"A Phase II Study of Increased-Dose Abiraterone Acetate in Patients With Castration Resistant Prostate Cancer","status":"COMPLETED","sponsor":"Terence Friedlander, MD","startDate":"2013-03-13","conditions":"Castration Resistant Prostate Cancer","enrollment":41},{"nctId":"NCT00473746","phase":"PHASE1, PHASE2","title":"Abiraterone Acetate Dose-Escalation Study in Hormone Refractory Prostate Cancer","status":"COMPLETED","sponsor":"Janssen Research & Development, LLC","startDate":"2006-06","conditions":"Prostate Neoplasms","enrollment":66}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_2","status":"active","brandName":"Abiraterone acetate escalated dose","genericName":"Abiraterone acetate escalated dose","companyName":"Assistance Publique - Hôpitaux de Paris","companyId":"assistance-publique-h-pitaux-de-paris","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Abiraterone acetate is a CYP17A1 inhibitor that blocks androgen synthesis, reducing testosterone production to treat androgen-dependent cancers. Used for Metastatic castration-resistant prostate cancer, Castration-sensitive prostate cancer (in combination with androgen deprivation therapy).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}