21 completed, 2 terminated, 1 unknown. 16 Phase 1, 8 Phase 2, 6 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 16 | Completed 15, Terminated 1 |
| Phase 2 | 8 | Completed 7, Terminated 1 |
| Phase 3 | 6 | Completed 4, Terminated 1, Unknown 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Rollover Study to Provide Continued Access to Napabucasin for Patients Enrolled in Boston Biomedical-sponsored Protocols Napabucasin, Nab-paclitaxel, Gemcitabine - Oncology | Phase 1 | Completed | Sumitomo Pharma America, Inc. | 7 | 2020-02-24 | 2023-11-08 |
| Modulation Of The Tumour Microenvironment Using Either Vascular Disrupting Agents or STAT3 Inhibition in Order to Synergise With PD1 Inhibition in Microsatellite Stable, Refractory Colorectal Cancer Nivolumab 10 MG/ML, BNC 105, BBI608 - Colorectal Cancer Metastatic | Phase 2 | Completed | Australasian Gastro-Intestinal Trials Group | 90 | 2018-09-06 | 2021-08-27 |
| A Study to Evaluate the Mass Balance of 14C-Napabucasin in Healthy Adult Male Subjects napabucasin - ADME, Healthy | Phase 1 | Completed | Sumitomo Pharma America, Inc. | 8 | 2018-05-18 | 2023-11-08 |
| A Phase III Clinical Study of Napabucasin (GB201) Plus FOLFIRI in Adult Patients With Metastatic Colorectal Cancer Napabucasin, Fluorouracil, Leucovorin - Previously Treated Metastatic Colorectal Cancer | Phase 3 | Unknown | 1Globe Health Institute LLC | 668 | 2018-04-12 | 2019-06-18 |
| A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Drug Interaction Potential of Napabucasin in Healthy Volunteers napabucasin, cytochrome P450 (CYP450) probe drugs or BCRP transporter substrate - Drug-drug Interactions | Phase 1 | Completed | Sumitomo Pharma America, Inc. | 30 | 2017-06-30 | 2023-11-14 |
| A Study of Napabucasin Plus Nab-Paclitaxel With Gemcitabine in Adult Patients With Metastatic Pancreatic Adenocarcinoma Napabucasin, Nab-paclitaxel, Gemcitabine - Carcinoma, Pancreatic Ductal | Phase 3 | Completed | Sumitomo Pharma America, Inc. | 1134 | 2016-12-01 | 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 Napabucasin, Paclitaxel - Carcinoma, Non-Small-Cell Lung | Phase 3 | Terminated | Sumitomo Pharma America, Inc. | 4 | 2016-11-01 | 2023-11-15 |
| Special Combination of BBI608 and Pembrolizumab Napabucasin, Pembrolizumab - Metastatic Colorectal Cancer | Phase 1 / Phase 2 | Terminated | Takayuki Yoshino | 55 | 2016-10-01 | 2021-09-05 |
| A Study of Napabucasin (BBI-608) in Combination With FOLFIRI in Adult Patients With Previously Treated Metastatic Colorectal Cancer Napabucasin, Fluorouracil, Leucovorin - Colorectal Cancer | Phase 3 | Completed | Sumitomo Pharma America, Inc. | 1253 | 2016-06-01 | 2023-11-15 |
| A Study of BBI608 Administrated With FOLFIRI + Bevacizumab in Adult Patients With Metastatic Colorectal Cancer BBI608, 5-FU, Irinotecan - Metastatic Colorectal Cancer | Phase 1 | Completed | Sumitomo Pharma Co., Ltd. | 4 | 2015-12-01 | 2022-04-12 |
| A Study of BBI608 Administered in Combination With Immune Checkpoint Inhibitors in Adult Patients With Advanced Cancers BBI608, Ipilimumab, Nivolumab - Cancer | Phase 1 | Completed | Sumitomo Pharma America, Inc. | 104 | 2015-08-01 | 2023-11-14 |
| A Study of BBI608 in Adult Patients With Advanced, Refractory Hematologic Malignancies BBI608, Dexamethasone, Bortezomib - Hematologic Malignancy | Phase 1 | Completed | Sumitomo Pharma America, Inc. | 15 | 2015-05-01 | 2023-11-14 |
| A Study of BBI608 and BBI503 Administered in Combination to Adult Patients With Advanced Solid Tumors BBI608, BBI503 - Cancer, Advanced Solid Tumors | Phase 1 | Completed | Sumitomo Pharma America, Inc. | 147 | 2015-04-01 | 2023-11-08 |
| A Study of BBI608 in Combination With Temozolomide in Adult Patients With Recurrent or Progressed Glioblastoma BBI608, Temozolomide - Glioblastoma | Phase 1 / Phase 2 | Completed | Sumitomo Pharma America, Inc. | 34 | 2015-03-01 | 2023-11-15 |
| A Study of BBI608 in Combination With Pemetrexed and Cisplatin in Adult Patients With Malignant Pleural Mesothelioma BBI608, Pemetrexed, Cisplatin - Malignant Pleural Mesothelioma, Non-Small Cell Lung Cancer | Phase 1 / Phase 2 | Completed | Sumitomo Pharma Co., Ltd. | 28 | 2015-02-01 | 2022-04-12 |
| A Study of BBI608 Administrated With Sorafenib in Adult Patients With Advanced Hepatocellular Carcinoma BBI608, Sorafenib - Hepatocellular Carcinoma | Phase 1 | Completed | Sumitomo Pharma Co., Ltd. | 12 | 2015-02-01 | 2022-04-12 |
| A Study of BBI608 in Combination With Sorafenib, or BBI503 in Combination With Sorafenib in Adult Patients With Hepatocellular Carcinoma BBI608, BBI503, Sorafenib - Hepatocellular Carcinoma | Phase 1 / Phase 2 | Completed | Sumitomo Pharma America, Inc. | 97 | 2014-12-01 | 2023-11-15 |
| A Study of BBI608 Plus Weekly Paclitaxel to Treat Gastric and Gastro-Esophageal Junction Cancer BBI608, Paclitaxel, Placebo - Gastric Cancer, Gastroesophageal Junction Cancer | Phase 3 | Completed | Sumitomo Pharma America, Inc. | 714 | 2014-10-01 | 2023-11-15 |
| A Study of BBI608 in Combination With Standard Chemotherapies in Adult Patients With Pancreatic Cancer BBI608, Nab-paclitaxel, Gemcitabine - Metastatic Pancreatic Adenocarcinoma | Phase 1 | Completed | Sumitomo Pharma America, Inc. | 139 | 2014-08-01 | 2023-11-18 |
| A Study of BBI608 in Combination With Standard Chemotherapies in Adult Patients With Advanced Gastrointestinal Cancer BBI608, Fluorouracil, Oxaliplatin - Advanced Gastrointestinal Cancer | Phase 1 / Phase 2 | Completed | Sumitomo Pharma America, Inc. | 495 | 2014-01-01 | 2023-11-15 |
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Neoplasms (8) · Colorectal Neoplasms (6) · Digestive System Neoplasms (4) · Neoplasms by Site (4) · Digestive System Diseases (3) · Neoplasms, Glandular and Epithelial (3) · Pancreatic Neoplasms (3) · Adenocarcinoma (2) · Carcinoma, Hepatocellular (2) · Carcinoma, Non-Small-Cell Lung (2) · Carcinoma, Pancreatic Ductal (2) · Endocrine Gland Neoplasms (2) · Neoplasms by Histologic Type (2) · Pancreatic Diseases (2) · Adenoma, Islet Cell (1)
Sumitomo Pharma America, Inc. (17) · Sumitomo Pharma Co., Ltd. (3) · 1Globe Health Institute LLC (1) · Australasian Gastro-Intestinal Trials Group (1) · NCIC Clinical Trials Group (1) · Takayuki Yoshino (1)
United States (17) · Japan (9) · Canada (8) · Australia (5) · China (4) · France (4) · Belgium (3) · Czechia (3) · Germany (3) · Italy (3) · South Korea (3) · Spain (3) · Israel (2) · Netherlands (2) · Poland (2)
Boston Biomedical (1) · Claudia Lebedinsky, MD (1) · Derek Jonker (1) · Niall Tebbutt, Prof (1) · Takayuki Yoshino, Dr (1) · William J. Edenfield, MD (1)
PMID 29397354, PMID 34107166, PMID 37188895
2014 (1), 2016 (1), 2019 (1)