{"id":"bbi608","safety":{"commonSideEffects":[{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Vomiting"},{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Abdominal pain"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"BBI608 inhibits the Wnt signaling pathway, which is critical for cancer stem cell maintenance and tumor growth. By disrupting β-catenin-mediated transcription, the drug aims to eliminate the population of cancer stem cells responsible for tumor initiation, progression, and chemotherapy resistance. This mechanism is intended to work synergistically with conventional chemotherapy agents.","oneSentence":"BBI608 is a Wnt/β-catenin pathway inhibitor that targets cancer stem cells by blocking their self-renewal capacity.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:03:40.069Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Colorectal cancer (in combination with chemotherapy)"},{"name":"Pancreatic cancer (in combination with chemotherapy)"},{"name":"Gastric cancer (in combination with chemotherapy)"}]},"trialDetails":[{"nctId":"NCT02231723","phase":"PHASE1","title":"A Study of BBI608 in Combination With Standard Chemotherapies in Adult Patients With Pancreatic Cancer","status":"COMPLETED","sponsor":"Sumitomo Pharma America, Inc.","startDate":"2014-08","conditions":"Metastatic Pancreatic Adenocarcinoma","enrollment":139},{"nctId":"NCT01325441","phase":"PHASE1, PHASE2","title":"A Study of BBI608 Administered With Paclitaxel in Adult Patients With Advanced Malignancies","status":"COMPLETED","sponsor":"Sumitomo Pharma America, Inc.","startDate":"2011-04","conditions":"Cancer","enrollment":565},{"nctId":"NCT02315534","phase":"PHASE1, PHASE2","title":"A Study of BBI608 in Combination With Temozolomide in Adult Patients With Recurrent or Progressed Glioblastoma","status":"COMPLETED","sponsor":"Sumitomo Pharma America, Inc.","startDate":"2015-03","conditions":"Glioblastoma","enrollment":34},{"nctId":"NCT01776307","phase":"PHASE2","title":"A Study of BBI608 in Adult Patients With Advanced Colorectal Cancer","status":"COMPLETED","sponsor":"Sumitomo Pharma America, Inc.","startDate":"2012-03","conditions":"Colorectal Cancer","enrollment":200},{"nctId":"NCT02826161","phase":"PHASE3","title":"A Study of Napabucasin (BBI-608) Plus Weekly Paclitaxel Versus Weekly Paclitaxel Alone in Patients With Advanced, Previously Treated, Non-Squamous Non-Small Cell Lung Cancer","status":"TERMINATED","sponsor":"Sumitomo Pharma America, 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Inc.","startDate":"2014-01","conditions":"Advanced Gastrointestinal Cancer","enrollment":495},{"nctId":"NCT02279719","phase":"PHASE1, PHASE2","title":"A Study of BBI608 in Combination With Sorafenib, or BBI503 in Combination With Sorafenib in Adult Patients With Hepatocellular Carcinoma","status":"COMPLETED","sponsor":"Sumitomo Pharma America, Inc.","startDate":"2014-12","conditions":"Hepatocellular Carcinoma","enrollment":97},{"nctId":"NCT02753127","phase":"PHASE3","title":"A Study of Napabucasin (BBI-608) in Combination With FOLFIRI in Adult Patients With Previously Treated Metastatic Colorectal Cancer","status":"COMPLETED","sponsor":"Sumitomo Pharma America, Inc.","startDate":"2016-06","conditions":"Colorectal Cancer","enrollment":1253},{"nctId":"NCT03411122","phase":"PHASE1","title":"A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Drug Interaction Potential of Napabucasin in Healthy Volunteers","status":"COMPLETED","sponsor":"Sumitomo Pharma America, 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Balance of 14C-Napabucasin in Healthy Adult Male Subjects","status":"COMPLETED","sponsor":"Sumitomo Pharma America, Inc.","startDate":"2018-05-18","conditions":"ADME, Healthy","enrollment":8},{"nctId":"NCT02432326","phase":"PHASE1","title":"A Study of BBI608 and BBI503 Administered in Combination to Adult Patients With Advanced Solid Tumors","status":"COMPLETED","sponsor":"Sumitomo Pharma America, Inc.","startDate":"2015-04","conditions":"Cancer, Advanced Solid Tumors","enrollment":147},{"nctId":"NCT04299880","phase":"PHASE1","title":"Rollover Study to Provide Continued Access to Napabucasin for Patients Enrolled in Boston Biomedical-sponsored Protocols","status":"COMPLETED","sponsor":"Sumitomo Pharma America, Inc.","startDate":"2020-02-24","conditions":"Oncology","enrollment":7},{"nctId":"NCT01830621","phase":"PHASE3","title":"BBI608 and Best Supportive Care vs Placebo and Best Supportive Care in Pretreated Advanced Colorectal Carcinoma","status":"COMPLETED","sponsor":"NCIC Clinical Trials Group","startDate":"2013-05-10","conditions":"Colorectal Carcinoma","enrollment":282},{"nctId":"NCT02358395","phase":"PHASE1","title":"A Study of BBI608 Administrated With Sorafenib in Adult Patients With Advanced Hepatocellular Carcinoma","status":"COMPLETED","sponsor":"Sumitomo Pharma Co., Ltd.","startDate":"2015-02","conditions":"Hepatocellular Carcinoma","enrollment":12},{"nctId":"NCT02347917","phase":"PHASE1, PHASE2","title":"A Study of BBI608 in Combination With Pemetrexed and Cisplatin in Adult Patients With Malignant Pleural Mesothelioma","status":"COMPLETED","sponsor":"Sumitomo Pharma Co., Ltd.","startDate":"2015-02","conditions":"Malignant Pleural Mesothelioma, Non-Small Cell Lung Cancer","enrollment":28},{"nctId":"NCT02641873","phase":"PHASE1","title":"A Study of BBI608 Administrated With FOLFIRI + Bevacizumab in Adult Patients With Metastatic Colorectal Cancer","status":"COMPLETED","sponsor":"Sumitomo Pharma Co., Ltd.","startDate":"2015-12","conditions":"Metastatic Colorectal Cancer","enrollment":4},{"nctId":"NCT02851004","phase":"PHASE1, PHASE2","title":"Special Combination of BBI608 and Pembrolizumab","status":"TERMINATED","sponsor":"Takayuki Yoshino","startDate":"2016-10","conditions":"Metastatic Colorectal Cancer","enrollment":55},{"nctId":"NCT03647839","phase":"PHASE2","title":"Modulation Of The Tumour Microenvironment Using Either Vascular Disrupting Agents or STAT3 Inhibition in Order to Synergise With PD1 Inhibition in Microsatellite Stable, Refractory Colorectal Cancer","status":"COMPLETED","sponsor":"Australasian Gastro-Intestinal Trials Group","startDate":"2018-09-06","conditions":"Colorectal Cancer Metastatic","enrollment":90},{"nctId":"NCT03522649","phase":"PHASE3","title":"A Phase III Clinical Study of Napabucasin (GB201) Plus FOLFIRI in Adult Patients With Metastatic Colorectal Cancer","status":"UNKNOWN","sponsor":"1Globe Health Institute LLC","startDate":"2018-04-12","conditions":"Previously Treated Metastatic Colorectal Cancer","enrollment":668}],"_emaApprovals":[],"_faersSignals":[{"count":7,"reaction":"ANAEMIA"},{"count":4,"reaction":"ABDOMINAL PAIN"},{"count":4,"reaction":"DIARRHOEA"},{"count":3,"reaction":"PNEUMONIA"},{"count":3,"reaction":"THROMBOCYTOPENIA"},{"count":2,"reaction":"ACUTE KIDNEY INJURY"},{"count":2,"reaction":"CHOLESTASIS"},{"count":2,"reaction":"CHRONIC OBSTRUCTIVE PULMONARY DISEASE"},{"count":2,"reaction":"CLOSTRIDIUM DIFFICILE INFECTION"},{"count":2,"reaction":"DYSPNOEA"}],"_approvalHistory":[],"publicationCount":47,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Napabucasin","BB608","BBI-608"],"phase":"phase_3","status":"active","brandName":"BBI608","genericName":"BBI608","companyName":"NCIC Clinical Trials Group","companyId":"ncic-clinical-trials-group","modality":"Small molecule","firstApprovalDate":"","aiSummary":"BBI608 is a Wnt/β-catenin pathway inhibitor that targets cancer stem cells by blocking their self-renewal capacity. Used for Colorectal cancer (in combination with chemotherapy), Pancreatic cancer (in combination with chemotherapy), Gastric cancer (in combination with chemotherapy).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":2,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}