Therapy Detail

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Therapy Name Napabucasin + Paclitaxel
Synonyms
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Napabucasin BB608|BBI608|BBI-608 STAT3 Inhibitor 19 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).
Paclitaxel Taxol 7-Epipaclitaxel Antimicrotubule Agent 12 BCL2 Family Inhibitor 6 Taxol (paclitaxel) binds to tubulin to inhibit microtubule disassembly, which results in decreased cell division, and also binds to the anti-apoptotic factor Bcl-2, promoting apoptosis (NCI Drug Dictionary).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
Unknown unknown gastroesophageal junction adenocarcinoma not applicable Napabucasin + Paclitaxel Phase Ib/II Actionable In a Phase I/II tiral, combination of BBI608 (Napabucasin) and Taxol (paclitaxel) demonstrated safety and clinical efficacy in patients with advanced gastric and gastroesophageal junction adenocarcinoma (J Clin Oncol 33, 2015 (suppl; abstr 4069)). detail...
Unknown unknown gastroesophageal junction adenocarcinoma not applicable Napabucasin + Paclitaxel Phase III Actionable In a Phase III (BRIGHTER) trial, combination of Napabucasin (BBI608) and Taxol (paclitaxel) did not significantly improve overall survival (6.93 vs 7.36 months, HR=1.01, p=0.8596) or progression-free survival (3.55 vs 3.65 months, HR=1.00, p=0.9679) compared to placebo in patients with pretreated, advanced gastric and gastroesophageal junction adenocarcinoma (Journal of Clinical Oncology 36, no. 15_suppl (May 20 2018) 4010-4010; NCT02178956). detail...
Unknown unknown gastric adenocarcinoma not applicable Napabucasin + Paclitaxel Phase Ib/II Actionable In a Phase I/II tiral, combination of BBI608 (Napabucasin) and Taxol (paclitaxel) demonstrated safety and clinical efficacy in patients with advanced gastric and gastroesophageal junction adenocarcinoma (J Clin Oncol 33, 2015 (suppl; abstr 4069)). detail...
Unknown unknown gastric adenocarcinoma not applicable Napabucasin + Paclitaxel Phase III Actionable In a Phase III (BRIGHTER) trial, combination of Napabucasin (BBI608) and Taxol (paclitaxel) did not significantly improve overall survival (6.93 vs 7.36 months, HR=1.01, p=0.8596) or progression-free survival (3.55 vs 3.65 months, HR=1.00, p=0.9679) compared to placebo in patients with pretreated, advanced gastric and gastroesophageal junction adenocarcinoma (Journal of Clinical Oncology 36, no. 15_suppl (May 20 2018) 4010-4010; NCT02178956). detail...

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Clinical Trial Phase Therapies Title Recruitment Status
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 Enrolling by invitation
NCT02826161 Phase III Napabucasin + Paclitaxel Paclitaxel 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 (CanStem43L) Terminated
NCT01325441 Phase Ib/II Napabucasin + Paclitaxel A Study of BBI608 Administered With Paclitaxel in Adult Patients With Advanced Malignancies Recruiting


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