This is an open-label, multi-center, multi-national, non-randomized rollover study designed to allow continued access to napabucasin for patients who have participated in a Boston Biomedical-sponsored study and are being treated with napabucasin (monotherapy or combination) and who are deriving continued clinical benefit in the parent study at the time of closure.

Start Date24 Feb 2020

Sponsor / Collaborator

Sumitomo Pharma America, Inc.

NCT03721744 / RecruitingPhase 2/3

A Phase II/III Randomized, Open-Label Clinical Study of GB201 in Combination With Weekly Paclitaxel and Low-dose Gemcitabine in Patients With Metastatic Pancreatic Cancer Following Chemotherapy Failure

This is a Phase II/III Randomized, Open-Label Clinical Study of GB201 in Combination with Weekly Paclitaxel and Low-dose Gemcitabine in Patients With Metastatic Pancreatic Cancer Following Chemotherapy Failure

Start Date25 Oct 2018

Sponsor / Collaborator

1globe Health Institute LLC

CTR20180947 / RecruitingPhase 3

评价GB201联合紫杉醇和低剂量吉西他滨在一线治疗失败的转移性胰腺癌有效性和安全性的Ⅲ期临床研究

[Translation] Phase III clinical study to evaluate the efficacy and safety of GB201 combined with paclitaxel and low-dose gemcitabine in patients with metastatic pancreatic cancer who have failed first-line treatment

在一线治疗失败的转移性胰腺癌患者中对GB201联合紫杉醇和低剂量吉西他滨与标准治疗方案的总生存期（OS）的比较

[Translation]

Comparison of overall survival (OS) of GB201 combined with paclitaxel and low-dose gemcitabine versus standard of care in patients with metastatic pancreatic cancer who have failed first-line therapy

Start Date25 Oct 2018

Sponsor / Collaborator

1globe Health Institute LLC

[+2]

100 Clinical Results associated with Napabucasin

100 Translational Medicine associated with Napabucasin

100 Patents (Medical) associated with Napabucasin

145

Literatures (Medical) associated with Napabucasin

01 Feb 2025·BIOMATERIALS

Napabucasin deactivates STAT3 and promotes mitoxantrone-mediated cGAS-STING activation for hepatocellular carcinoma chemo-immunotherapy

Article

Author: Yu, Shihan ; Li, Yutong ; Gao, Yuqiong ; Li, Zhuo ; Yang, Leilei ; Zou, Yifang ; Zhou, Xinyi ; Wang, Lingzhi ; Bi, Shengnan ; Shi, Jia ; Yu, Zhuo ; Liao, Anqi ; Zhang, Xuemei ; Guo, Jianfeng ; Liu, Xiaobo

The immune resistance of tumor microenvironment (TME) causes immune checkpoint blockade therapy inefficient to hepatocellular carcinoma (HCC). Emerging strategies of using chemotherapy regimens to reverse the immune resistance provide the promise for promoting the efficiency of immune checkpoint inhibitors. The induction of cyclic guanosine monophosphate-adenosine monophosphate synthase (cGAS)-stimulator of interferon genes (STING) in tumor cells evokes the adaptive immunity and remodels the immunosuppressive TME. In this study, we report that mitoxantrone (MIT, a chemotherapeutic drug) activates the cGAS-STING signaling pathway of HCC cells. We provide an approach to augment the efficacy of MIT using a signal transducer and activator of transcription 3 (STAT3) inhibitor called napabucasin (NAP). We prepare an aminoethyl anisamide (AEAA)-targeted polyethylene glycol (PEG)-modified poly (lactic-co-glycolic acid) (PLGA)-based nanocarrier for co-delivery of MIT and NAP. The resultant co-nanoformulation can elicit the cGAS-STING-based immune responses to reshape the immunoresistant TME in the mice orthotopically grafted with HCC. Consequently, the resultant co-nanoformulation can promote anti-PD-1 antibody for suppressing HCC development, generating long-term survival, and inhibiting tumor recurrence. This study reveals the potential of MIT to activate the cGAS-STING signaling pathway, and confirms the feasibility of nano co-delivery for MIT and NAP on achieving HCC chemo-immunotherapy.

01 Nov 2024·BIOCHIMICA ET BIOPHYSICA ACTA-REVIEWS ON CANCER

Structure, function, signaling pathways and clinical therapeutics: The translational potential of STAT3 as a target for cancer therapy

Review

Author: Tao, Jiejing ; Guo, Lanping ; Gao, Wenyuan ; Ma, Long ; Huang, Luqi ; Man, Shuli ; Zhang, Ning ; Shi, Dandan

Cancer remains one of the most difficult human diseases to overcome because of its complexity and diversity. Signal transducers and transcriptional activators 3 (STAT3) protein has been found to be overexpressed in a wide range of cancer types. Hyperactivation of STAT3 is particularly associated with low survival in cancer patients. This review summarizes the specific molecular mechanisms of STAT3 in cancer development. STAT3 is activated by extracellular signals in the cytoplasm, interacts with different enzymes in the nucleus, mitochondria or endoplasmic reticulum, and subsequently participates in cancer development. The phosphorylated STAT3 at tyrosine 705 site (YP-STAT3) enters the nucleus and regulates a number of tumor-related biological processes such as angiogenesis, migration invasion, cell proliferation and cancer cell stemness. In contrast, the phosphorylated STAT3 at serine 727 site (SP-STAT3) is found on the mitochondria, affects electron respiration transport chain activity and thereby prevents tumor cell apoptosis. SP-STAT3 also appears on the mitochondria-associated endoplasmic reticulum membrane, influences the flow of Ca²⁺, and affects tumor progression. In addition, we summarize the direct and indirect inhibitors of STAT3 which are currently undergoing clinical studies. Some of them such as TTI101 and BBI608 have been approved by the FDA for the treatment of certain cancers. All in all, STAT3 plays an important role in cancer progression and becomes a potential target for cancer treatment.

30 Oct 2024·RAPID COMMUNICATIONS IN MASS SPECTROMETRY

Identification, characterization, and in silico ADMET prediction of nirmatrelvir and its degradation products using HPLC‐PDA and LC‐QTOF‐MS/MS

Article

Author: Sundararajan, Raja ; Kumar, Matta Ashwin

Rationale:

Nirmatrelvir is a protease inhibitor that is essential for virus replication. Nirmatrelvir is indicated for the management of mild to severe cases of COVID‐19 in individuals who are 12 years of age or older. Forced degradation studies of nirmatrelvir were carried out on the drug substance in solid and solution forms, subjecting it to various stress conditions according to International Conference on Harmonisation (ICH) Q1A(R2) and Q1B guidelines. The analytical method was validated as per the ICH Q2(R1) guidelines.

Methods:

The drug substance (nirmatrelvir) was subjected to hydrolysis (acidic, alkaline, and neutral), thermal, photolytic, and oxidative stress conditions. Five degradation products (DPs) of nirmatrelvir formed under hydrolytic (acidic and alkaline) and oxidative (2,2‐azobisisobutyronitrile) stress conditions. These degradation products were identified and separated using reverse‐phase HPLC on a phenomenex kinetex C8 column (250 mm × 4.6 mm × 5 μm) with gradient elution. The mobile phase consisted of 0.1% formic acid and acetonitrile, and detection was carried out at a wavelength of 210 nm.

Results and conclusions:

Nirmatrelvir and its five DPs were efficiently separated using reverse phase–HPLC. These five DPs were identified and characterized using LC‐electrospray ionization (ESI)‐Q‐TOF‐coupled mass spectrometry analysis in the ESI‐positive ionization mode. The formation mechanisms of the DPs and the most probable mass fragmentation pathways for both nirmatrelvir and its DPs were elucidated. The developed method demonstrated selectivity, accuracy, linearity, and reproducibility, making it appropriate for quality control of nirmatrelvir and future research studies. Additionally, the physicochemical and Absorption, Distribution, Metabolism, Excretion, and Toxicity (ADMET) properties of nirmatrelvir and its DPs were predicted using ADMET predictor software. The toxicity profile revealed that DP2 and DP3 have teratogenic effects while DP1 and DP3 caused phospholipidosis.

News (Medical) associated with Napabucasin

21 Dec 2022

·www.prnewswire.com

Gastric Cancer Pipeline Space Brims With Novel Emerging Therapies with Over 200 Key Companies Working in the Domain | DelveInsight

The prevalence of gastric cancer has been rising since the past few years, which prompts the growing demand for treatment options. The increasing prevalence of cancer, the robust pipeline, and the growing research and development activities to develop novel therapies to treat Gastric Cancer drive the market. The companies developing the potential therapies in the last stage of development include Henlix Biotech, Eli Lilly and Company, Jiangsu Hengrui Medicine, and several others. LAS VEGAS, Dec. 21, 2022 /PRNewswire/ -- DelveInsight's ' Gastric Cancer Pipeline Insight – 2022 ' report provides comprehensive global coverage of available, marketed, and pipeline gastric cancer therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the gastric cancer pipeline domain. Key Takeaways from the Gastric Cancer Pipeline Report DelveInsight's gastric cancer pipeline report depicts a robust space with 200+ active players working to develop 230+ pipeline therapies for gastric cancer treatment. Key gastric cancer companies such as EMD Serono, Sumitomo Pharma, LintonPharm Co., Ltd., Rapa Therapeutics LLC, Jiangsu HengRui Medicine Co., Ltd., Janssen Pharmaceutical K.K., Genentech, Exelixis, Bristol-Myers Squibb, Pieris Pharmaceuticals, Inc., Pfizer, Leap Therapeutics, CSPC ZhongQi Pharmaceutical, Ellipses Pharma, Amgen, Hanmi Pharmaceutical, Taiho Oncology, Inc., Shanghai Henlius Biotech, LianBio LLC, Chengdu Kanghong Biotech,Eisai Inc., AB Science, Maxinovel Pharmaceuticals, Shanghai Miracogen Inc., GlaxoSmithKline, Hoffmann-La Roche, Merck Sharp & Dohme, Hutchison Medipharma Limited, Genome & Company, Minneamrita Therapeutics LLC, Suzhou Suncadia Biopharmaceuticals Co., Ltd., MacroGenics, ALX Oncology Inc., Codiak BioSciences, Turning Point Therapeutics, Inc., TCRx Therapeutics, InxMed (Shanghai) Co., Ltd., Imugene Limited, SOTIO Biotech, CARsgen Therapeutics Co., Ltd., Zymeworks Inc., NextCure, Inc., Phanes Therapeutics, Pieris Pharmaceuticals, Inc., Athenex, Inc., Curis, Inc., Qurient Co., Ltd., Acepodia Biotech, Inc., Sichuan Baili Pharmaceutical Co., Ltd., Tarus Therapeutics, Inc., Lumicell, Inc., Legend Biotech,Cue Biopharma, TORL Biotherapeutics, LLC, OBI Pharma, Inc, Astellas Pharma, HiberCell, Inc., Celon Pharma SA, Linnaeus Therapeutics, Inc., Inspirna, Inc., Klus Pharma Inc., Genzada Pharmaceuticals, Shanghai PerHum Therapeutics, VM Oncology, LLC, Immunomic Therapeutics, Peptron, and others are evaluating new gastric cancer drugs to improve the treatment landscape. Promising gastric cancer pipeline therapies in various stages of development include Avelumab, BBI608, Camrelizumab, Catumaxomab, RAPA-201, SHR-1210, Amivantamab, Atezolizumab, Bevacizumab, Cabozantinib, Cinrebafusp alfa, Crizotinib, DKN-01, DP303c, Eflornithine, EP0057, Epacadostat, FLX475, Futibatinib, GEN-001, HLX07, HLX22, Infigratinib, KH903, Lenvatinib, Masitinib, MAX-40279, MRG002, MRG003, Niraparib, Savolitinib, Minnelide, SHR-1701, Margetuximab, Bemarituzumab, Evorpacept, Lenvatinib, CDK-004, TPX-0022, TCRx_T Cells, IN10018, IMU-131, SOT102, CT041, AB011, Zanidatamab, NC410, PT 886, PRS-343, Oraxol, CA-4948, Q702, ACE1702, SI-B001, TT-4, LUM015, LB 1908, CUE-102, TORL-2-307-MAB, OBI-833/OBI-821, ASP2138, NC410, SO-C101, HC-5404-FU, CPL304110, LNS8801, RGX-202-01, A166, GZ17-6.02, HMPL-453, CCT303-406, VMD-928, ITI 4000, PAb 001, and others. In December 2022, Daiichi Sankyo and AstraZeneca's ENHERTU (trastuzumab deruxtecan) has been approved in the European Union (EU) as a monotherapy for the treatment of adult patients with advanced HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen. In December 2022, RemeGen Co., Ltd. announced on December 7, 2022, that its latest antibody-drug conjugate (ADC), RC118 for injection, has been granted two orphan drug designations (ODD) by the United States Food and Drug Administration (FDA) for gastric cancer (including gastroesophageal junction cancer) and pancreatic cancer. This marks the Company's fourth, having previously been twice granted ODD for Disitamab Vedotin (RC48) and Telitacicept (RC18) earlier this year. In December 2022, Zhejiang Doer Biologics Co., Ltd. announced that it has entered into a clinical trial collaboration agreement with MSD (Merck & Co., Inc., Rahway, NJ, USA), to investigate Doer Bio's anti-Claudin18.2 antibody DR30303, in combination with MSD's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in patients with Gastric or Gastroesophageal Junction Cancer. Under this agreement, Doer Bio will conduct a clinical study based on a mutually- agreed and finalized protocol to evaluate the safety and efficacy of DR30303 in combination with KEYTRUDA® in patients with Claudin18.2-positive, locally advanced unresectable or metastatic gastric or gastroesophageal junction (GC/GEJ) cancer. In November 2022, Triumvira Immunologics announced preclinical data for its investigational TAC-T cell therapies CLDN18.2-TAC T and GUCY2C-TAC T, and data on HER2-specific TAC-T products. Data was shared in three posters at the Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting being held virtually and in-person in Boston.Triumvira announced updated data on its novel T cell antigen coupler (TAC)-T cell candidate targeting Claudin 18.2 (CLDN18.2) for the treatment of gastric cancer. The data continue to demonstrate that CLDN18.2-TAC T effectively eliminates CLDN18.2-expressing gastric cancer cells in vitro and in vivo. The study also demonstrated that the activation of CLDN18.2-TAC T cells was specific to target cells that expressed CLDN18.2. In vitro data show strong and persistent anti-tumor activity and in vivo treatment led to complete and sustained tumor clearance with no signs of toxicity. In September 2022, Nuvectis Pharma, Inc. announced positive data for NXP800 in a preclinical xenograft model of ARID1a-mutated gastric carcinoma.Mice in each group were treated with either vehicle or NXP800, and tumor volumes were measured over 28 days. Treatment with NX800 resulted in tumor regression and substantial tumor growth inhibition versus the control. In March 2022, Imugene (ASX: IMU) announced a new clinical trial collaboration and supply agreement with MSD, a tradename of Merck & Co., Inc., Kenilworth, NJ, USA, to evaluate the safety and efficacy of Imugene's HER-Vaxx, B-cell activating immunotherapy, in combination with MSD's anti-PD-1 therapy, pembrolizumab (KEYTRUDA®), in patients with HER-2 positive gastric cancer. Request a sample and discover the recent advances in gastric cancer drug treatment @ Gastric Cancer Pipeline Report The gastric cancer pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage gastric cancer drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the gastric cancer clinical trial landscape. Gastric Cancer Overview Stomach cancer is cancer that begins within the stomach or on the stomach wall. It is also known as gastric cancer. Stomach cancer is more common in the elderly. People aged 75 and above account for approximately 50 out of every 100 cases (around 50%). It affects men more than women. The exact gastric cancer causes are not known. Stomach cancer is linked to Helicobacter pylori, a bacteria that lives in the stomach. The most common gastric cancer symptoms are difficulty swallowing (dysphagia), weight loss, persistent indigestion (dyspepsia), feeling full after eating small amounts, feeling or being sick, and fatigue due to low red blood cell count (anaemia). Several tests, such as ultrasound, imaging tests, blood tests, and others, are used for gastric cancer diagnosis. Gastric cancer patients can receive a variety of treatments. Standard gastric cancer treatment consists of seven types: surgery, endoscopic mucosal resection, chemotherapy, radiation therapy, chemoradiation, targeted therapy, and immunotherapy. Find out more about chemotherapy drugs for gastric cancer @ New Gastric Cancer Drugs A snapshot of the Gastric Cancer Pipeline Drugs mentioned in the report: Learn more about the emerging gastric cancer pipeline therapies @ Gastric Cancer Clinical Trials Gastric Cancer Therapeutics Assessment The gastric cancer pipeline report proffers an integral view of gastric cancer emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Gastric Cancer Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Oral, Parenteral, Intravenous, Subcutaneous, Topical Therapeutics Assessment By Molecule Type: Monoclonal Antibody, Peptides, Polymer, Small molecule, Gene therapy Therapeutics Assessment By Mechanism of Action: Antibody-dependent cell cytotoxicity, Programmed cell death-1 receptor antagonists, T lymphocyte stimulants, Apoptosis stimulants, Macrophage stimulants, Natural killer cell stimulants, Cyclin-dependent kinase 4 inhibitors, Cyclin-dependent kinase 6 inhibitors, Antibody-dependent cell cytotoxicity, Angiogenesis inhibitors, Epidermal growth factor receptor antagonists, EIF 2 kinase inhibitors Key Gastric Cancer Companies: EMD Serono, Sumitomo Pharma, LintonPharm Co., Ltd., Rapa Therapeutics LLC, Jiangsu HengRui Medicine Co., Ltd., Janssen Pharmaceutical K.K., Genentech, Exelixis, Bristol-Myers Squibb, Pieris Pharmaceuticals, Inc., Pfizer, Leap Therapeutics, CSPC ZhongQi Pharmaceutical, Ellipses Pharma, Amgen, Hanmi Pharmaceutical, Taiho Oncology, Inc., Shanghai Henlius Biotech, LianBio LLC, Chengdu Kanghong Biotech,Eisai Inc., AB Science, Maxinovel Pharmaceuticals, Shanghai Miracogen Inc., GlaxoSmithKline, Hoffmann-La Roche, Merck Sharp & Dohme, Hutchison Medipharma Limited, Genome & Company, Minneamrita Therapeutics LLC, Suzhou Suncadia Biopharmaceuticals Co., Ltd., MacroGenics, ALX Oncology Inc., Codiak BioSciences, Turning Point Therapeutics, Inc., TCRx Therapeutics, InxMed (Shanghai) Co., Ltd., Imugene Limited, SOTIO Biotech, CARsgen Therapeutics Co., Ltd., Zymeworks Inc., NextCure, Inc., Phanes Therapeutics, Pieris Pharmaceuticals, Inc., Athenex, Inc., Curis, Inc., Qurient Co., Ltd., Acepodia Biotech, Inc., Sichuan Baili Pharmaceutical Co., Ltd., Tarus Therapeutics, Inc., Lumicell, Inc., Legend Biotech,Cue Biopharma, TORL Biotherapeutics, LLC, OBI Pharma, Inc, Astellas Pharma, HiberCell, Inc., Celon Pharma SA, Linnaeus Therapeutics, Inc., Inspirna, Inc., Klus Pharma Inc., Genzada Pharmaceuticals, Shanghai PerHum Therapeutics, VM Oncology, LLC, Immunomic Therapeutics, Peptron, and others. Key Gastric Cancer Pipeline Therapies: Avelumab, BBI608, Camrelizumab, Catumaxomab, RAPA-201, SHR-1210, Amivantamab, Atezolizumab, Bevacizumab, Cabozantinib, Cinrebafusp alfa, Crizotinib, DKN-01, DP303c, Eflornithine, EP0057, Epacadostat, FLX475, Futibatinib, GEN-001, HLX07, HLX22, Infigratinib, KH903, Lenvatinib, Masitinib, MAX-40279, MRG002, MRG003, Niraparib, Savolitinib, Minnelide, SHR-1701, Margetuximab, Bemarituzumab, Evorpacept, Lenvatinib, CDK-004, TPX-0022, TCRx_T Cells, IN10018, IMU-131, SOT102, CT041, AB011, Zanidatamab, NC410, PT 886, PRS-343, Oraxol, CA-4948, Q702, ACE1702, SI-B001, TT-4, LUM015, LB 1908, CUE-102, TORL-2-307-MAB, OBI-833/OBI-821, ASP2138, NC410, SO-C101, HC-5404-FU, CPL304110, LNS8801, RGX-202-01, A166, GZ17-6.02, HMPL-453, CCT303-406, VMD-928, ITI 4000, PAb 001, and others. Dive deep into rich insights for new drugs for gastric cancer treatment; visit @ Gastric Cancer Medications Table of Contents For further information on the gastric cancer pipeline therapeutics, reach out @ Gastric Cancer Drug Treatment Related Reports Gastric Cancer Epidemiology Forecast Gastric Cancer Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, and the gastric cancer epidemiology trends. Gastric Cancer Market Gastric Cancer Market Insight, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key gastric cancer companies, including CSPC ZhongQi Pharmaceutical, Ellipses Pharma, Amgen, Hanmi Pharmaceutical, Taiho Oncology, Inc., Shanghai Henlius Biotech, among others. HER2+ Gastric Cancer Market HER2+ Gastric Cancer Market Insight, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key HER2+ gastric cancer companies, including Pieris Pharmaceuticals, BioInvent International, Bellicum Pharmaceuticals, Mersana Therapeutics, Acepodia Biotech, Inc., Klus Pharma Inc, among others. HER2+ Gastric Cancer Pipeline HER2+ Gastric Cancer Pipeline Insight – 2022 report provides comprehensive insights about the pipeline landscape, including clinical and non-clinical stage products, and the key HER2+ gastric cancer companies, including Pieris Pharmaceuticals, BioInvent International, Bellicum Pharmaceuticals, Mersana Therapeutics, Acepodia Biotech, Inc., Klus Pharma Inc, among others. HER2+ Gastric Cancer Epidemiology HER2+ Gastric Cancer Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, and the HER2+ gastric cancer epidemiology trends. Other Trending Oncology Reports Follicular lymphoma | Indolent lymphoma | Severe Toxicities In Lymphoma | Marginal Zone Lymphoma | Vulvar Squamous Cell Carcinoma | Cholangiocarcinoma | Metastatic Cutaneous Squamous cell Carcinoma | Nasopharyngeal Carcinoma | Ductal Carcinoma in Situ | Oncolytic Virus Cancer Therapy | Cancer Cachexia | Intratumoral Cancer Therapies | Brain Cancer Related Cases Studies Competitive Intelligence Market Assessment Product Assessment Epidemiology Assessment Related Healthcare Services Healthcare Business Consulting Healthcare Competitive Intelligence Services Healthcare Asset Prioritization Services About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. Connect with us at LinkedIn Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

ImmunotherapyOrphan DrugDrug Approval

100 Deals associated with Napabucasin

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D10717	-	-	DB12155

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Pancreatic Cancer	Phase 3	CN	1globe Health Institute LLC	25 Oct 2018
Secondary malignant neoplasm of pancreas	Phase 3	CN	1globe Health Institute LLC	25 Oct 2018
Secondary malignant neoplasm of pancreas	Phase 3	FR	1globe Health Institute LLC	25 Oct 2018
Secondary malignant neoplasm of pancreas	Phase 3	ES	1globe Health Institute LLC	25 Oct 2018
Metastatic Pancreatic Ductal Adenocarcinoma	Phase 3	AT	Sumitomo Pharma America, Inc.	01 Dec 2016
Metastatic Pancreatic Ductal Adenocarcinoma	Phase 3	CZ	Sumitomo Pharma America, Inc.	01 Dec 2016
Metastatic Pancreatic Ductal Adenocarcinoma	Phase 3	DE	Sumitomo Pharma America, Inc.	01 Dec 2016
Metastatic Pancreatic Ductal Adenocarcinoma	Phase 3	PL	Sumitomo Pharma America, Inc.	01 Dec 2016
Metastatic Pancreatic Ductal Adenocarcinoma	Phase 3	PT	Sumitomo Pharma America, Inc.	01 Dec 2016
Metastatic Pancreatic Ductal Adenocarcinoma	Phase 3	TW	Sumitomo Pharma America, Inc.	01 Dec 2016

Clinical Result

Indication

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02358395 (Pubmed)	Phase 1	Unresectable Hepatocellular Carcinoma	6	Napabucasin (480 mg/day) plus Sorafenib (800 mg/day)	uxularnkbp(hylyojodue) = stable disease okfezgxjxw (fyxdbedssy )	-	15 May 2023
NCT02641873 (Pubmed \| Int J Clin Oncol) Manual	Phase 1	Metastatic Colorectal Carcinoma	4	bevacizumab+fluorouracil+leucovorin+irinotecan+napabucasin	debblefpcu(vhkqyulmat) = All four patients experienced diarrhoea and decreased appetite (considered napabucasin-related in four and two patients, respectively), and three patients experienced neutrophil count decreased veozvjhxwf (qayjvhmlcx )	Positive	01 Nov 2021
NCT02347917 (CTgov)	Phase 1/2	Malignant Pleural Mesothelioma \| Non-Small Cell Lung Cancer	28	Pem+CDDP+BBI608 (MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part))	ojlsxaeoah(otzxewjuvp) = enfssfrdwq vwhajgvloz (haobfbiwqv, izladgicqv - quxsetkqco) View more	-	01 Oct 2021
				Pem+CDDP+BBI608 (MPM: BBI608 + Pem + CDDP (Phase 2 Part))	ipfxekrkcy(nifzdkquua) = cqmlgeqbna kzszogoctr (swotizedpd, ucmhsntexh - mdlouxrtuv) View more
NCT02753127 (CanStem303C, ESMO_GI2021)	Phase 3	Metastatic Colorectal Carcinoma pSTAT3+	1,253	FOLFIRI + napabucasin 240 mg oral, twice daily	kzwwaxmdym(rihfdusbrj) = hbphtogyez kmqmgoqqmb (qkulxkmwjx )	Negative	03 Jul 2021
				FOLFIRI	kzwwaxmdym(rihfdusbrj) = cwhbmphlyv kmqmgoqqmb (qkulxkmwjx )
NCT02178956 (BRIGHTER, CTgov)	Phase 3	Gastrooesophageal junction cancer \| Advanced Gastroesophageal Junction Adenocarcinoma	714	Paclitaxel+Napabucasin (Napabucasin + Paclitaxel)	gbaflewuij(seadpfurxl) = rlovfxrnlr asmpjivuiy (jeixuplxpy, eogdtqokxp - evvtzrkcyj) View more	-	10 May 2021
				Placebo+Paclitaxel (Placebo + Paclitaxel)	gbaflewuij(seadpfurxl) = ccslspbtnd asmpjivuiy (jeixuplxpy, lkzjmiqgdo - pimcdiplty) View more
NCT03411122 (ASCO_GI2020)	Phase 1	-	17	Napabucasin 240 mg BID	kaflbnfglj(gswuxlcnqt) = Of the 17 subjects, 12 (70.6%) reported adverse events (AEs); 58.8% reported gastrointestinal disorders. One patient had a grade 3 AE (neutrophil count low); no serious AEs were observed. yujebspmow (frarmqpcit )	-	04 Feb 2020
NCT01830621 (CTgov)	Phase 3	Advanced Colorectal Adenocarcinoma	282	best supportive care+BBI608 (BBI608)	nlhwelrgmr(pkqfhnufjw) = rlpbfpiuuh drgdxmihxi (ijuckjmqvt, rcfcqbwxkw - gcgdyjkgap) View more	-	11 Mar 2019
				Placebo (Placebo)	nlhwelrgmr(pkqfhnufjw) = gzwyzubjok drgdxmihxi (ijuckjmqvt, xtncfgvvpp - oiyjxoodga) View more
NCT02231723 (ASCO2018) Manual	Phase 1/2	Pancreatic adenocarcinoma metastatic	59	nab-paclitaxel+gemcitabine+napabucasin	bysyzebnyi(rwnvpyrruf) = grade 1 diarrhea, neuropathy, pyrexia, and grades 1/2 nausea and fatigue psnvivmhot (bblmfcxzaf ) View more	Positive	03 Jun 2018
NCT02178956 (BRIGHTER, ASCO2018) Manual	Phase 3	Gastroesophageal junction adenocarcinoma	565	Paclitaxel+napabucasin	nzausmzvej(ykhizqqbbk) = lovxkuwnqm eutcgsekdl (zuhvixijrr ) View more	Negative	01 Jun 2018
				Paclitaxel+ placebo	nzausmzvej(ykhizqqbbk) = ajgobypwpi eutcgsekdl (zuhvixijrr ) View more
NCT02315534 (BBI608-201GBM, ASCO2017)	Phase 2	Recurrent Glioblastoma	11	Napabucasin 480mg BID	vixlymctbf(kjurplxeeq) = dglntefyrv divvigkwxb (yhydztpygf ) View more	Positive	30 May 2017

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