Napabucasin

DRUG10 trials

Sponsors

1globe Health Institute LLC, Sumitomo Pharma America, Inc., Takayuki Yoshino, 1Globe Health Institute LLC

Conditions

ADMECarcinoma, Non-Small-Cell LungCarcinoma, Pancreatic DuctalColorectal CancerDrug-drug InteractionsHealthyHistologically confirmed adenocarcinoma of the colon or rectum that is metastatic.Histologically or cytologically confirmed advanced pancreatic adenocarcinoma that is metastatic.

Phase 1

Special Combination of BBI608 and Pembrolizumab

TerminatedNCT02851004

Takayuki YoshinoMetastatic Colorectal Cancer

Start: 2016-10-31End: 2021-08-23Updated: 2021-09-05

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Drug Interaction Potential of Napabucasin in Healthy Volunteers

CompletedNCT03411122

Sumitomo Pharma America, Inc.Drug-drug Interactions

Start: 2017-06-30End: 2018-01-23Updated: 2023-11-14

A Study to Evaluate the Mass Balance of 14C-Napabucasin in Healthy Adult Male Subjects

CompletedNCT03525405

Sumitomo Pharma America, Inc.ADME, Healthy

Start: 2018-05-18End: 2018-06-02Updated: 2023-11-08

Rollover Study to Provide Continued Access to Napabucasin for Patients Enrolled in Boston Biomedical-sponsored Protocols

CompletedNCT04299880

Sumitomo Pharma America, Inc.Oncology

Start: 2020-02-24End: 2021-05-30Updated: 2023-11-08

Phase 2

A Phase II/III Randomized, Open-Label Clinical Study of Napabucasin in Combination with Weekly Paclitaxel and Low-dose Gemcitabine in Patients with Metastatic Pancreatic Cancer Following Chemotherapy Failure

Active, not recruitingCTIS2024-518205-17-00

1globe Health Institute LLCHistologically or cytologically confirmed advanced pancreatic adenocarcinoma that is metastatic.

Start: 2022-05-27Target: 84Updated: 2025-12-10

Phase 3

A Study of Napabucasin (BBI-608) in Combination With FOLFIRI in Adult Patients With Previously Treated Metastatic Colorectal Cancer

CompletedNCT02753127

Sumitomo Pharma America, Inc.Colorectal Cancer

Start: 2016-06-30End: 2021-05-12Updated: 2023-11-15

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

TerminatedNCT02826161

Sumitomo Pharma America, Inc.Carcinoma, Non-Small-Cell Lung

Start: 2016-11-30End: 2017-04-24Updated: 2023-11-15

A Study of Napabucasin Plus Nab-Paclitaxel With Gemcitabine in Adult Patients With Metastatic Pancreatic Adenocarcinoma

CompletedNCT02993731

Sumitomo Pharma America, Inc.Carcinoma, Pancreatic Ductal

Start: 2016-12-31End: 2020-03-31Updated: 2023-11-15

A Phase III Clinical Study of Napabucasin (GB201) Plus FOLFIRI in Adult Patients With Metastatic Colorectal Cancer

1Globe Health Institute LLCPreviously Treated Metastatic Colorectal Cancer

Start: 2018-04-12End: 2021-11-30Target: 668Updated: 2019-06-18

A Phase III, Randomized, Open-Label Clinical Study of Napabucasin in Combination with FOLFIRI and Best Supportive Care (BSC) Versus Napabucasin plus BSC in Adult Patients with Previously Treated Metastatic Colorectal Cancer (CRC)

Active, not recruitingCTIS2024-518204-50-00

1globe Health Institute LLCHistologically confirmed adenocarcinoma of the colon or rectum that is metastatic.

Start: 2022-04-25Target: 123Updated: 2025-12-10

Related Papers

Napabucasin plus nab-paclitaxel with gemcitabine versus nab-paclitaxel with gemcitabine in previously untreated metastatic pancreatic adenocarcinoma: an adaptive multicentre, randomised, open-label, phase 3, superiority trial.

2023-03-1617 citations

Napabucasin Plus FOLFIRI in Patients With Previously Treated Metastatic Colorectal Cancer: Results From the Open-Label, Randomized Phase III CanStem303C Study.

2022-11-1125 citations

Napabucasin Drug‐Drug Interaction Potential, Safety, Tolerability, and Pharmacokinetics Following Oral Dosing in Healthy Adult Volunteers

Clinical Pharmacology in Drug Development2021-06-095 citations

Prognostic impact of pSTAT3 on overall survival (OS) in gastrointestinal (GI) cancers: Data from 3 phase 3, randomized controlled trials (RCTs).

Journal of Clinical Oncology2021-05-20

Scoop: Multicenter phase I/II trial of BBI608 and pembrolizumab in patients with metastatic colorectal cancer (EPOC1503).

Journal of Clinical Oncology2020-02-014 citations

Drug-drug interaction (DDI) potential of oral napabucasin in healthy adults.

Journal of Clinical Oncology2020-02-01

Canstem111P Trial: A Phase Iii Study of Napabucasin Plus Nab-Paclitaxel With Gemcitabine

Future Oncology2019-02-1542 citations

CanStem111P trial: A Phase 3 Study of napabucasin (NAPA) plus nab-paclitaxel (nPTX) with gemcitabine (Gem) in adult patients with metastatic pancreatic adenocarcinoma (mPDAC) - Trial in progress

Annals of Oncology2018-06-013 citations

CanStem303C trial: A Phase 3 Study of napabucasin (NAPA) in combination with 5-fluorouracil (5-FU), leucovorin, and irinotecan (FOLFIRI) in adult patients (pts) with previously treated metastatic colorectal cancer (mCRC) - Trial in progress

Annals of Oncology2018-06-012 citations

Phase 1b/2 trial of cancer stemness inhibitor napabucasin (NAPA) + nab-paclitaxel (nPTX) and gemcitabine (Gem) in metastatic pancreatic adenocarcinoma (mPDAC).

Journal of Clinical Oncology2018-05-2016 citations

Multicenter phase I/II trial of BBI608 and pembrolizumab combination in patients with metastatic colorectal cancer (SCOOP Study): EPOC1503.

Journal of Clinical Oncology2018-05-2010 citations

Multicenter phase I/II trial of BBI608 and pembrolizumab combination in patients with metastatic colorectal cancer (SCOOP Study): EPOC1503.

Journal of Clinical Oncology2018-02-018 citations

CanStem303C trial: A phase III study of napabucasin (BBI-608) in combination with 5-fluorouracil (5-FU), leucovorin, irinotecan (FOLFIRI) in adult patients with previously treated metastatic colorectal cancer (mCRC).

Journal of Clinical Oncology2017-05-2016 citations

CanStem111P trial: A phase III study of napabucasin (BBI-608) plus nab-paclitaxel (nab-PTX) with gemcitabine (gem) in adult patients with metastatic pancreatic adenocarcinoma (mPDAC).

Journal of Clinical Oncology2017-05-2012 citations

Multicenter phase I/II trial of BBI608 and pembrolizumab combination in patients with metastatic colorectal cancer (SCOOP Study): EPOC1503.

Journal of Clinical Oncology2017-05-203 citations

The personalized medicine for pancreatic ductal adenocarcinoma patients: The oncologist perspective

Endoscopic Ultrasound2017-01-015 citations