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).

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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).

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  • Separate multiple filter terms with a spaces, order doesn't matter (a b c and c b a are equivalent )
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  • Use quotes to match a longer phrase which contains spaces "mtor c1483f"

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
Unknown unknown Advanced Solid Tumor not applicable Napabucasin Phase I Actionable In a Phase I trial, BBI608 treatment demonstrated safety and preliminary efficacy in patients with advanced solid tumors (J Clin Oncol 32:5s, 2014 (suppl; abstr 2546)). detail...
Unknown unknown pancreatic cancer not applicable Napabucasin Preclinical Actionable In a preclinical study, BBI608 inhibited tumor growth and metastasis in xenograft models of pancreatic cancer (PMID: 25605917). 25605917
Unknown unknown colorectal cancer not applicable Napabucasin Phase I Actionable In a Phase I trial, colorectal cancer patients treated with BBI608 demonstrated a median PFS of 14 weeks and OS of 47 months while 67% (8/12) experienced stable disease (J Clin Oncol May 2013 vol. 31 no. 15_suppl 2542). detail...
Unknown unknown ovarian cancer not applicable Napabucasin Phase Ib/II Actionable In a Phase Ib/II clinical trial, treatment with BBI608 demonstrated safety in patients with platinum-resistant ovarian cancer (including patients with epithelial ovarian, fallopian, or peritoneal cancer), and resulted in a disease control rate of 68% (27/40) and an objective response rate of 25% (10/40) in evaluable patients (J Clin Oncol, May 2016 vol. 34 no. 15_suppl 5578). detail...

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Clinical Trial Phase Therapies Title Recruitment Status
NCT02352558 Phase I Imatinib Napabucasin Bortezomib Ibrutinib Dexamethasone A Study of BBI608 in Adult Patients With Advanced, Refractory Hematologic Malignancies Completed
NCT01775423 Phase Ib/II Napabucasin A Study of BBI608 in Adult Patients With Advanced Malignancies Completed
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
NCT02432326 Phase I BBI503 Napabucasin A Study of BBI608 and BBI503 Administered in Combination to Adult Patients With Advanced Solid Tumors Completed
NCT02315534 Phase Ib/II Napabucasin Temozolomide A Study of BBI608 in Combination With Temozolomide in Adult Patients With Recurrent or Progressed Glioblastoma Completed
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
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
NCT02178956 Phase III Napabucasin Paclitaxel A Study of BBI608 Plus Weekly Paclitaxel to Treat Gastric and Gastro-Esophageal Junction Cancer Completed
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) Active, not recruiting


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