Therapy Detail

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Therapy Name Napabucasin
Synonyms
Therapy Description

Napabucasin (BBI608) is a small molecule inhibitor of cancer stemness that reduces activated Stat3 signaling, which is often activated by FGFRs, thereby decreasing proliferation of cancer stem cells, and possibly resulting in decreased cancer metastasis (PMID: 25605917, PMID: 23935373, PMID: 32694160).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Napabucasin BB608|BBI608|BBI-608 STAT3 Inhibitor 26 Napabucasin (BBI608) is a small molecule inhibitor of cancer stemness that reduces activated Stat3 signaling, which is often activated by FGFRs, thereby decreasing proliferation of cancer stem cells, and possibly resulting in decreased cancer metastasis (PMID: 25605917, PMID: 23935373, PMID: 32694160).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
TP53 R248Q colorectal cancer predicted - sensitive Napabucasin Preclinical - Cell culture Actionable In a preclinical study, Napabucasin (BBI608) treatment reduced Stat3 phosphorylation and impaired wound healing in colorectal cancer cell lines expressing TP53 R248Q in culture (PMID: 30107178). 30107178

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  • Filtering will only apply to rows that are already loaded on the page. Filtering has no impact on query parameters.
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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT01775423 Phase Ib/II Napabucasin A Study of BBI608 in Adult Patients With Advanced Malignancies Completed USA | CAN 0
NCT02315534 Phase Ib/II Napabucasin Temozolomide A Study of BBI608 in Combination With Temozolomide in Adult Patients With Recurrent or Progressed Glioblastoma Completed USA | CAN 0
NCT02024607 Phase Ib/II Capecitabine + Oxaliplatin Bevacizumab + Napabucasin Napabucasin + Regorafenib Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Napabucasin Fluorouracil + Irinotecan + Leucovorin A Study of BBI608 in Combination With Standard Chemotherapies in Adult Patients With Advanced Gastrointestinal Cancer Completed USA | CAN 0
NCT02178956 Phase III Napabucasin Paclitaxel A Study of BBI608 Plus Weekly Paclitaxel to Treat Gastric and Gastro-Esophageal Junction Cancer Completed USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS 13
NCT02352558 Phase I Imatinib Napabucasin Bortezomib Ibrutinib Dexamethasone A Study of BBI608 in Adult Patients With Advanced, Refractory Hematologic Malignancies Completed USA 0
NCT02467361 Phase Ib/II Nivolumab Pembrolizumab Ipilimumab Napabucasin A Study of BBI608 Administered in Combination With Immune Checkpoint Inhibitors in Adult Patients With Advanced Cancers Completed USA 0
NCT04299880 Phase I Gemcitabine + Nab-paclitaxel + Napabucasin Napabucasin Bevacizumab Napabucasin + Paclitaxel Napabucasin + Nivolumab Fluorouracil + Irinotecan + Leucovorin + Napabucasin Rollover Study to Provide Continued Access to Napabucasin for Patients Enrolled in Boston Biomedical-sponsored Protocols Completed USA | FRA 2
NCT02432326 Phase I Amcasertib Napabucasin A Study of BBI608 and BBI503 Administered in Combination to Adult Patients With Advanced Solid Tumors Completed USA 0
NCT02753127 Phase III Fluorouracil + Irinotecan + Leucovorin Napabucasin A Study of Napabucasin (BBI-608) in Combination With FOLFIRI in Adult Patients With Previously Treated Metastatic Colorectal Cancer (CanStem303C) Completed USA | ITA | FRA | ESP | DEU | CAN | BEL | AUS 8


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