Drugs / Napabucasin
Napabucasin
also known as
BBI608 · 2-acetylfuranonaphthoquinone · 2-acetylfuro-1,4-naphthoquinone · Napabucasina · Napabucasine
Trials 23
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 110 trials | ||||||
| Phase 1 | NCT04299880 | Feb 2020 → May 2021 | — | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03525405 | May → Jun 2018 | — | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03411122 | Jun 2017 → Jan 2018 | — | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02641873 | Dec 2015 → Dec 2016 | colorectal cancer | Sumitomo Pharma Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT02467361 | Aug 2015 → Jan 2021 | cancer | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02352558 | May 2015 → Dec 2018 | hematopoietic and lymphoid system neoplasm | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02432326 | Apr 2015 → Dec 2019 | cancer | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02358395 | Feb 2015 → Nov 2017 | hepatocellular carcinoma | Sumitomo Pharma Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT02231723 | Aug 2014 → Jun 2020 | pancreatic adenocarcinoma | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01775423 | Mar 2009 → Aug 2015 | cancer of unknown primary site | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 1/26 trials | ||||||
| Phase 1/2 | NCT02851004 | Oct 2016 → Feb 2020 | colorectal cancer | Takayuki Yoshino | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT02315534 | Mar 2015 → Oct 2018 | glioblastoma | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT02347917 | Feb 2015 → May 2018 | malignant pleural mesothelioma, non-small cell lung carcinoma | Sumitomo Pharma Co., Ltd. | Completed | No outcome recorded |
| Phase 1/2 | NCT02279719 | Dec 2014 → Jul 2019 | hepatocellular carcinoma | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT02024607 | Jan 2014 → Mar 2019 | digestive system cancer | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT01325441 | Apr 2011 → Jun 2021 | cancer | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT03647839 | Sep 2018 → Jan 2021 | colorectal cancer | Australasian Gastro-Intestinal Trials Group | Completed | No outcome recorded |
| Phase 2 | NCT01776307 | Mar 2012 → Jun 2018 | colorectal cancer | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 35 trials · 2 missed | ||||||
| Phase 3 | NCT03522649 | Apr 2018 → Nov 2021 | — | 1Globe Health Institute LLC | Unknown | No outcome recorded |
| Phase 3 | NCT02993731 | Dec 2016 → Mar 2020 | pancreatic ductal adenocarcinoma | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02826161 | Nov 2016 → Apr 2017 | non-small cell lung carcinoma | Sumitomo Pharma America, Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT02753127 | Jun 2016 → Apr 2020 | colorectal cancer | Sumitomo Pharma America, Inc. | Completed | Missed primary |
| Phase 3 | NCT02178956 | Oct 2014 → Sep 2017 | gastric cancer, gastroesophageal junction adenocarcinoma | Sumitomo Pharma America, Inc. | Completed | Missed primary |
| Comparator or background therapy1 trial | ||||||
| Phase 3 | NCT01830621 Comparator | May 2013 → May 2016 | colorectal carcinoma | NCIC Clinical Trials Group | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2021-02-09 | Sumitomo Pharma America, Inc. | Results Sumitomo Dainippon Pharma Announces Topline Results of Phase 3 Study on Investigational Anti-Cancer Agent Napabucasin Fails to Reach Primary Endpoints in Patients with Colorectal Cancer sumitomo-pharma.com ↗ |
| 2019-07-02 | Sumitomo Pharma America, Inc. | Results Sumitomo Dainippon Pharma Announces Discontinuation of Phase 3 CanStem111P Study of Investigational Anti-Cancer Agent Napabucasin in Patients with Pancreatic Cancer Following Interim Analysis sumitomo-pharma.com ↗
Sumitomo Dainippon Pharma has accepted the recommendation and decided to discontinue the study for patients with pancreatic cancer. |
| 2017-06-26 | Sumitomo Pharma America, Inc. | Results Sumitomo Dainippon Pharma Announces Unblinding of Phase 3 Study of Napabucasin, a cancer stemness inhibitor, in Patients with Gastric/GEJ Cancer sumitomo-pharma.com ↗
The DSMB determined that the study was unlikely to reach its primary endpoint of superior overall survival for the napabucasin arm versus the control arm at the conclusion of the study. |
| 2017-01-23 | Sumitomo Pharma America, Inc. | Results Sumitomo Dainippon Pharma Announces Clinical Data of Investigational Cancer Stemness Inhibitor Napabucasin were presented at 2017 ASCO GI Symposium sumitomo-pharma.com ↗
Among 56 pts enrolled who received RECIST evaluation, disease control rate(DCR: CR+PR+SD) was observed in 88%(49 pts) with an overall response rate(ORR: CR+PR) of 29%(16 pts) with 1 pt achieving CR. |
| 2016-10-06 | Sumitomo Pharma America, Inc. | Results Sumitomo Dainippon Pharma announces the final data analysis of a global phase 3 study of an investigational anti-cancer drug Napabucasin (CO.23 study) will be presented at the ESMO 2016 Congress sumitomo-pharma.com ↗
No significant difference was observed in OS, progression free survival (PFS) or DCR between NAPA and PBO in the ITT analysis. |
| 2014-06-06 | Sumitomo Pharma America, Inc. | Results Dainippon Sumitomo Pharma announces clinical data of anti-cancer drugs BBI608 and BBI503 were presented at the 2014 ASCO Annual Meeting sumitomo-pharma.com ↗
Dainippon Sumitomo Pharma Co., Ltd. (Head office: Osaka, Japan; President: Masayo Tada) ("DSP") announced that clinical study data of BBI608 and BBI503 were presented in poster sessions at the 2014 American Society of Clinical Oncology (ASCO) Annual Meeting which began in Chicago on May 30, 2014. |
| 2014-05-23 | Sumitomo Pharma America, Inc. | Results Dainippon Sumitomo Pharma announces closure to furtherpatient accrual on its CO.23 study: a phase III global colorectal carcinoma monotherapy trial sumitomo-pharma.com ↗
DSMC recommended that further enrollment of new patients be stopped and all study drug be discontinued because while there is no safety concern, the futility analysis, based on disease control rate, met protocol defined criteria for stopping. |
| 2014-05-15 | Sumitomo Pharma America, Inc. | Results Dainippon Sumitomo Pharma announces clinical data of anti-cancer drugs BBI608 and BBI503 will be presented at the 2014 ASCO Annual Meeting sumitomo-pharma.com ↗
Neither significant difference in plasma exposure between the original formulation (DP1) and DP2A nor significant food effect wa |
| 2013-06-04 | Sumitomo Pharma America, Inc. | Results Dainippon Sumitomo Pharma announces BBI608 Phase 1/2 Clinical Study Data (Dose-Escalation Study) was presented at the 2013 ASCO Annual Meeting sumitomo-pharma.com ↗
Osaka, Japan, June 4, 2013 - Dainippon Sumitomo Pharma Co., Ltd. (DSP) (Headquarters: Osaka, Japan; President: Masayo Tada) announces that the dose-escalation study results from the Phase 1/2 clinical study on BBI608, an anti-cancer treatment under development, was presented on June 3, 2013 (U.S. time) at the 2013 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. |
| 2013-05-16 | Sumitomo Pharma America, Inc. | Results Dainippon Sumitomo Pharma announces BBI608 Clinical Study Data to be presented at the 2013 ASCO Annual Meeting sumitomo-pharma.com ↗
17/26 patients evaluable for tumor response, achieved stable disease (SD), for a disease control rate (DCR) of 65%. |
All press releases naming this drug 13 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 25 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Napabucasin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03522649 ↗ |
| Known as | 2-acetylfuranonaphthoquinone | ChEMBL registry synonym — accepted as the source's own label CHEMBL64130 ↗ |
| Known as | 2-acetylfuro-1,4-naphthoquinone | ChEMBL registry synonym — accepted as the source's own label CHEMBL64130 ↗ |
| Known as | BBI608 | “BBI-608 will be supplied free of charge by Boston Biomedical as capsules.” NCT03647839 ↗ |
| Known as | Napabucasina | ChEMBL registry synonym — accepted as the source's own label CHEMBL64130 ↗ |
| Known as | Napabucasine | ChEMBL registry synonym — accepted as the source's own label CHEMBL64130 ↗ |
| Action | Inhibit | “cancer stem cell pathway inhibitor napabucasin” NCT02753127 ↗ |
| Modality | Small molecule | — CHEMBL64130 ↗ |
| Route | Oral | “Patients will receive BBI608 orally continuously at 200mg BID.” NCT01325441 ↗ |