TAS-102 is supported by numerous clinical trials evaluating its utility across solid tumors, particularly metastatic colorectal cancer, gastric adenocarcinoma, and bladder cancer. Spanning Early Phase 1 through Phase 3 along with marketing access programs, these studies encompass various recruitment statuses including recruiting, active, and completed. Sponsorship is driven by major academic institutions such as M.D. Anderson Cancer Center and the University of California, Irvine, alongside industry leaders like Taiho Oncology.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07656038 | NOT_YET_RECRUITING | Colonrectal Cancer (CRC) |
STCube, Inc. |
2026-06-30 | PHASE1 |
| NCT05854498 | RECRUITING | Metastatic Colorectal Cancer |
University of Wisconsin, Madison |
2023-10-13 | PHASE2 |
| NCT07649655 | NOT_YET_RECRUITING | Unresectable/Metastatic Colorectal Cancer |
Shanghai EpimAb Biotherapeutics Co., Ltd. |
2026-07 | PHASE1 |
| NCT06699836 | ACTIVE_NOT_RECRUITING | Metastatic Colorectal Cancer (mCRC) |
CytoDyn, Inc. |
2025-06-16 | PHASE2 |
| NCT06992258 | RECRUITING | Colorectal Cancer |
Criterium, Inc. |
2025-10-27 | PHASE2 |
| NCT07371871 | NOT_YET_RECRUITING | Advanced Gastric Cancer |
Anhui Provincial Cancer Hospital |
2026-01-08 | |
| NCT07212933 | RECRUITING | Gastric (Stomach) Cancer; Biological Therapy; Immunotherapy |
Chinese PLA General Hospital |
2025-07-01 | PHASE2 |
| NCT07090031 | ACTIVE_NOT_RECRUITING | EFS; pCR Rate |
Qingdao Central Hospital |
2025-07-01 | PHASE2 |
| NCT07730489 | NOT_YET_RECRUITING | Colorectal Cancer |
Sichuan Baili Pharmaceutical Co., Ltd. |
2026-08 | PHASE3 |
| NCT07384377 | NOT_YET_RECRUITING | HER2-positive Colorectal Cancer |
Shanghai JMT-Bio Inc. |
2026-02-06 | PHASE3 |
| NCT07318389 | NOT_YET_RECRUITING | Dynamic Tumor Resistance; Metastatic Colorectal Cancer |
M.D. Anderson Cancer Center |
2026-06-10 | EARLY_PHASE1 |
| NCT07196345 | NOT_YET_RECRUITING | ESCC; TAS 102; Radiotherapy |
Qianfoshan Hospital |
2025-09-25 | PHASE1; PHASE2 |
| NCT07116577 | NOT_YET_RECRUITING | mCRC |
Jinan Central Hospital |
2025-08-31 | PHASE2 |
| NCT07085169 | RECRUITING | Colo-rectal Cancer; Third-line and Beyond Therapy; TAS 102; Bevacizumab |
Ruijin Hospital |
2025-08-01 | PHASE2 |
| NCT07483684 | NOT_YET_RECRUITING | HER2 IHC3+ Advanced Colorectal Cancer |
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. |
2026-03 | PHASE3 |
| NCT07138885 | ACTIVE_NOT_RECRUITING | Hepatocellular Carcinoma (HCC); Second Line Treatment |
Sun Yat-sen University |
2025-08-01 | PHASE2 |
| NCT06850090 | RECRUITING | Rectal Cancer; Rectal Cancer Patients |
Shandong Cancer Hospital and Institute |
2025-07-30 | PHASE3 |
| NCT04999761 | RECRUITING | Advanced or Metastatic Solid Tumor; Pancreatic Ductal Adenocarcinoma; Colorectal Cancer; Non-small Cell Lung Cancer; Gastric Cancer; Alveolar Soft Part Sarcoma; Esophageal Cancer; Head and Neck Cancer; Biliary Tract Cancer |
Taiho Pharmaceutical Co., Ltd. |
2021-06-01 | PHASE1 |
| NCT05343013 | RECRUITING | Colorectal Cancer |
M.D. Anderson Cancer Center |
2022-06-06 | PHASE2 |
| NCT06882915 | NOT_YET_RECRUITING | Colorectal Cancer (CRC) |
Second Affiliated Hospital, Zhejiang University, School of Medicine |
2026-06-06 | PHASE1 |
| NCT04701476 | RECRUITING | Colorectal Cancer; Lung Cancer |
Teclison Ltd. |
2021-05-20 | PHASE2 |
| NCT04920032 | RECRUITING | Colon Adenocarcinoma; Colorectal Cancer |
University of California, Irvine |
2021-08-26 | PHASE1 |
| NCT06711471 | RECRUITING | Gastric Cancer Adenocarcinoma Metastatic |
LIN YANG |
2024-11-14 | PHASE2 |
| NCT05991102 | RECRUITING | Refractory Metastatic Colorectal Cancer |
Charite University, Berlin, Germany |
2023-12-15 | |
| NCT06936488 | ENROLLING_BY_INVITATION | MSS/pMMR Type Metastatic Colorectal Adenocarcinoma Patients |
Huai'an First People's Hospital |
2025-03-01 | |
| NCT07044908 | RECRUITING | RAS/BRAF Wild Type Colorectal Cancer |
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. |
2025-07-30 | PHASE1; PHASE2 |
| NCT06856187 | RECRUITING | Metastatic Colorectal Cancer (CRC) |
Fudan University |
2025-02-28 | PHASE2 |
| NCT07491159 | ACTIVE_NOT_RECRUITING | Colorectal Cancer |
Tianjin Medical University Cancer Institute and Hospital |
2023-07-01 | PHASE1; PHASE2 |
| NCT06346392 | ACTIVE_NOT_RECRUITING | Gastric Cancer; Gastroesophageal Junction Cancer |
AstraZeneca |
2024-03-04 | PHASE3 |
| NCT05806931 | RECRUITING | Colon Cancer; Rectal Cancer |
Rutgers, The State University of New Jersey |
2023-05-17 | PHASE2 |
| NCT06872606 | NOT_YET_RECRUITING | Rectal Adenocarcinoma |
Sir Run Run Shaw Hospital |
2025-04-01 | PHASE2 |
| NCT06199973 | ACTIVE_NOT_RECRUITING | Advanced Colorectal Cancer |
Suzhou Suncadia Biopharmaceuticals Co., Ltd. |
2024-03-01 | PHASE3 |
| NCT06092242 | NOT_YET_RECRUITING | Colorectal Cancer |
The Second Affiliated Hospital of Shandong First Medical University |
2023-10-15 | PHASE2 |
| NCT06293014 | RECRUITING | Colorectal Cancer |
Henan Cancer Hospital |
2024-02-23 | PHASE2 |
| NCT06202001 | RECRUITING | Metastatic Colorectal Cancer |
Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
2022-10-01 | PHASE1; PHASE2 |
| NCT04042714 | TERMINATED | High-grade Extra Pulmonary Neuroendocrine Cancer |
Baylor Research Institute |
2019-08-15 | PHASE2 |
| NCT05328908 | TERMINATED | Colorectal Neoplasms |
Bristol-Myers Squibb |
2022-04-28 | PHASE3 |
| NCT03368963 | ACTIVE_NOT_RECRUITING | Colorectal Adenocarcinoma; Gastric Adenocarcinoma; Metastatic Pancreatic Adenocarcinoma; Non-Resectable Cholangiocarcinoma; Stage IV Colorectal Cancer; Stage IV Gastric Cancer; Stage IV Pancreatic Cancer; Stage IVA Colorectal Cancer; Stage IVB Colorectal Cancer; Stage III Colorectal Cancer; Stage III Gastric Cancer; Stage III Pancreatic Cancer; Unresectable Digestive System Adenocarcinoma; Unresectable Pancreatic Carcinoma |
Emory University |
2018-01-30 | PHASE1; PHASE2 |
| NCT05364489 | NOT_YET_RECRUITING | Advanced Colorectal Cancer |
The First Affiliated Hospital of Zhengzhou University |
2022-06-15 | PHASE2 |
| NCT05481463 | COMPLETED | Pancreatic Neoplasms |
Sun Yat-sen University |
2023-01-30 | PHASE2 |
| NCT03223779 | COMPLETED | Colorectal Cancer |
Massachusetts General Hospital |
2017-10-13 | PHASE1; PHASE2 |
| NCT06039202 | UNKNOWN | Metastatic Colorectal Cancer |
Holy Stone Healthcare Co., Ltd |
2024-01 | PHASE2 |
| NCT05029102 | UNKNOWN | Gastric Cancer |
Zhejiang University |
2021-09-01 | PHASE2 |
| NCT04627961 | UNKNOWN | Metastatic Nasopharyngeal Carcinoma; Recurrent Nasopharyngeal Carcinoma |
National University Hospital, Singapore |
2020-08-26 | PHASE2 |
| NCT04776148 | COMPLETED | Colorectal Neoplasms |
Merck Sharp & Dohme LLC |
2021-03-29 | PHASE3 |
| NCT04104139 | COMPLETED | Rectal Adenocarcinoma; Stage IIA Rectal Cancer AJCC v8; Stage IIB Rectal Cancer AJCC v8; Stage III Rectal Cancer AJCC v8; Stage IIIA Rectal Cancer AJCC v8; Stage IIIB Rectal Cancer AJCC v8; Stage IIIC Rectal Cancer AJCC v8 |
OHSU Knight Cancer Institute |
2019-12-11 | PHASE1 |
| NCT05356897 | WITHDRAWN | Metastatic Colon Adenocarcinoma; Metastatic Colorectal Adenocarcinoma; Metastatic Rectal Adenocarcinoma; Stage IV Colon Cancer AJCC V8; Stage IV Colorectal Cancer AJCC V8; Stage IV Rectal Cancer AJCC V8 |
Academic and Community Cancer Research United |
2023-10-31 | PHASE2 |
| NCT04109924 | COMPLETED | Advanced Colorectal Carcinoma; Metastatic Colon Adenocarcinoma; Metastatic Rectal Adenocarcinoma; Recurrent Colon Adenocarcinoma; Recurrent Colorectal Adenocarcinoma; Recurrent Rectal Adenocarcinoma; Stage III Colon Cancer AJCC v8; Stage III Colorectal Cancer AJCC v8; Stage III Rectal Cancer AJCC v8; Stage IIIA Colon Cancer AJCC v8; Stage IIIA Colorectal Cancer AJCC v8; Stage IIIB Colorectal Cancer AJCC v8; Stage IIIB Rectal Cancer AJCC v8; Stage IIIC Colon Cancer AJCC v8; Stage IIIC Colorectal Cancer AJCC v8; Stage IV Colon Cancer AJCC v8; Stage IVA Colorectal Cancer AJCC v8; Stage IVA Rectal Cancer AJCC v8; Stage IVB Colon Cancer AJCC v8; Stage IVB Colorectal Cancer AJCC v8; Stage IVB Rectal Cancer AJCC v8; Stage IVC Colon Cancer AJCC v8; Stage IVC Colorectal Cancer AJCC v8; Stage IVC Rectal Cancer AJCC v8; Unresectable Colon Adenocarcinoma; Unresectable Colorectal Carcinoma; Unresectable Rectal Adenocarcinoma |
Roswell Park Cancer Institute |
2019-12-27 | PHASE2 |
| NCT05600309 | COMPLETED | Colorectal Cancer |
Merck Sharp & Dohme LLC |
2022-06-14 | PHASE3 |
| NCT05064059 | COMPLETED | Colorectal Cancer |
Merck Sharp & Dohme LLC |
2021-11-10 | PHASE3 |
| NCT06403709 | UNKNOWN | Metastatic Colorectal Cancer |
Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
2022-08-01 | PHASE2 |
| NCT04660760 | RECRUITING | Clinical Stage III Gastric Cancer AJCC v8; Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8; Clinical Stage IV Gastric Cancer AJCC v8; Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8; Clinical Stage IVA Gastric Cancer AJCC v8; Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8; Clinical Stage IVB Gastric Cancer AJCC v8; Clinical Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8; Locally Advanced Unresectable Gastric Adenocarcinoma; Locally Advanced Unresectable Gastroesophageal Junction Adenocarcinoma; Metastatic Gastric Adenocarcinoma; Metastatic Gastroesophageal Junction Adenocarcinoma; Pathologic Stage III Gastric Cancer AJCC v8; Pathologic Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8; Pathologic Stage IIIA Gastric Cancer AJCC v8; Pathologic Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8; Pathologic Stage IIIB Gastric Cancer AJCC v8; Pathologic Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8; Pathologic Stage IIIC Gastric Cancer AJCC v8; Pathologic Stage IV Gastric Cancer AJCC v8; Pathologic Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8; Pathologic Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8; Pathologic Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8; Postneoadjuvant Therapy Stage III Gastric Cancer AJCC v8; Postneoadjuvant Therapy Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8; Postneoadjuvant Therapy Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8; Postneoadjuvant Therapy Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8; Postneoadjuvant Therapy Stage IV Gastric Cancer AJCC v8; Postneoadjuvant Therapy Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8; Postneoadjuvant Therapy Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8; Postneoadjuvant Therapy Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8 |
Academic and Community Cancer Research United |
2021-06-16 | PHASE2 |
| NCT03520946 | COMPLETED | Colorectal Cancer |
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest |
2019-01-24 | PHASE3 |
| NCT04294264 | ACTIVE_NOT_RECRUITING | Metastatic Colorectal Carcinoma; Recurrent Colon Carcinoma; Refractory Colorectal Carcinoma; Stage IV Colon Cancer AJCC v7; Stage IVA Colon Cancer AJCC v7; Stage IVB Colon Cancer AJCC v7 |
Rutgers, The State University of New Jersey |
2019-02-12 | PHASE2 |
| NCT04923529 | COMPLETED | Pancreas Cancer |
The University of Hong Kong |
2021-03-01 | PHASE2 |
| NCT04683965 | UNKNOWN | Colorectal Neoplasms |
The First Affiliated Hospital with Nanjing Medical University |
2021-01-01 | PHASE2 |
| NCT06039202 | Not yet recruiting | Metastatic Colorectal Cancer |
Holy Stone Healthcare Co. Ltd |
2024-01 | Phase 2 |
| NCT04417699 | COMPLETED | Rectal Cancer |
Providence Health & Services |
2022-07-05 | PHASE2 |
| NCT03717038 | WITHDRAWN | Metastatic Colorectal Cancer; Colorectal Cancer Metastatic; Carcinoma |
Symphogen A/S |
2019-02 | PHASE3 |
| NCT05004831 | UNKNOWN | Metastatic Colorectal Cancer |
Sun Yat-sen University |
2022-03-11 | PHASE2 |
| NCT04868773 | COMPLETED | Colorectal Cancer; Colorectal Carcinoma; Metastatic Cancer; CRC |
University of California, Irvine |
2021-07-16 | PHASE1 |
| NCT03317119 | COMPLETED | Metastatic Colon Carcinoma; Metastatic Colorectal Carcinoma; Metastatic Rectal Carcinoma; RAS Family Gene Mutation; Stage III Colon Cancer AJCC v7; Stage III Colorectal Cancer AJCC v7; Stage III Rectal Cancer AJCC v7; Stage IIIA Colon Cancer AJCC v7; Stage IIIA Colorectal Cancer AJCC v7; Stage IIIA Rectal Cancer AJCC v7; Stage IIIB Colon Cancer AJCC v7; Stage IIIB Colorectal Cancer AJCC v7; Stage IIIB Rectal Cancer AJCC v7; Stage IIIC Colon Cancer AJCC v7; Stage IIIC Colorectal Cancer AJCC v7; Stage IIIC Rectal Cancer AJCC v7; Stage IV Colon Cancer AJCC v7; Stage IV Colorectal Cancer AJCC v7; Stage IV Rectal Cancer AJCC v7; Stage IVA Colon Cancer AJCC v7; Stage IVA Colorectal Cancer AJCC v7; Stage IVA Rectal Cancer AJCC v7; Stage IVB Colon Cancer AJCC v7; Stage IVB Colorectal Cancer AJCC v7; Stage IVB Rectal Cancer AJCC v7 |
City of Hope Medical Center |
2018-04-11 | PHASE1 |
| NCT04808791 | COMPLETED | Gastroesophageal Junction Adenocarcinoma; Advanced Gastric Carcinoma |
AHS Cancer Control Alberta |
2021-10-27 | PHASE2 |
| NCT03762161 | UNKNOWN | Bladder Cancer |
Rahul Parikh |
2019-01-03 | PHASE2 |
| NCT05130060 | COMPLETED | Metastatic Colon Adenocarcinoma; Metastatic Colorectal Adenocarcinoma; Metastatic Colorectal Carcinoma; Metastatic Microsatellite Stable Colon Carcinoma; Metastatic Microsatellite Stable Colorectal Carcinoma; Metastatic Rectal Adenocarcinoma; Microsatellite Stable Rectal Carcinoma; Stage IV Colorectal Cancer AJCC v8; Stage IVA Colorectal Cancer AJCC v8; Stage IVB Colorectal Cancer AJCC v8; Stage IVC Colorectal Cancer AJCC v8 |
Mayo Clinic |
2022-01-10 | PHASE1 |
| NCT05314101 | UNKNOWN | Immunotherapy; Colorectal Cancer |
Fujian Cancer Hospital |
2022-04-01 | PHASE2 |
| NCT05266820 | UNKNOWN | Metastatic Colorectal Cancer |
Fujian Cancer Hospital |
2021-10-01 | PHASE2 |
| NCT04097028 | COMPLETED | Clinical Stage IIA Esophageal Adenocarcinoma AJCC v8; Clinical Stage IIA Gastroesophageal Junction Adenocarcinoma AJCC v8; Clinical Stage III Esophageal Adenocarcinoma AJCC v8; Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8; Clinical Stage IVA Esophageal Adenocarcinoma AJCC v8; Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8; Pathologic Stage IIB Esophageal Adenocarcinoma AJCC v8; Pathologic Stage IIB Gastroesophageal Junction Adenocarcinoma AJCC v8; Pathologic Stage III Esophageal Adenocarcinoma AJCC v8; Pathologic Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8; Pathologic Stage IIIA Esophageal Adenocarcinoma AJCC v8; Pathologic Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8; Pathologic Stage IIIB Esophageal Adenocarcinoma AJCC v8; Pathologic Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8; Pathologic Stage IVA Esophageal Adenocarcinoma AJCC v8; Pathologic Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8 |
Roswell Park Cancer Institute |
2019-12-20 | PHASE2 |
| NCT05343013 | Recruiting | Colorectal Cancer |
M.D. Anderson Cancer Center|Taiho |
2022-06-06 | Phase 2 |
| NCT03810742 | COMPLETED | Refractory Solid Tumors |
PharmaEngine |
2019-03-05 | PHASE1 |
| NCT03686488 | COMPLETED | Gastric Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma; Gastric Cancer |
H. Lee Moffitt Cancer Center and Research Institute |
2018-12-20 | PHASE2 |
| NCT04517747 | COMPLETED | Gastric Adenocarcinoma; Metastatic Adenocarcinoma of the Gastroesophageal Junction |
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest |
2020-10-15 | |
| NCT04074343 | COMPLETED | Gastric Adenocarcinoma; GastroEsophageal Cancer |
University of California, Irvine |
2019-08-26 | PHASE1 |
| NCT03909724 | UNKNOWN | Colorectal Cancer; Metastasis |
Amsterdam UMC, location VUmc |
2019-10-01 | PHASE2; PHASE3 |
| NCT04868773 | Active not recruiting | Colorectal Cancer|Colorectal Carcinoma|Metastatic Cancer|CRC |
University of California Irvine |
2021-07-16 | Phase 1 |
| NCT02602327 | COMPLETED | Colon Cancer; Rectal Cancer; Liver Metastases |
University of California, San Francisco |
2017-01-09 | PHASE1 |
| NCT03306394 | COMPLETED | Metastatic Colorectal Cancer |
Institut de Recherches Internationales Servier |
2016-10-18 | PHASE3 |
| NCT02943733 | TERMINATED | Neuroendocrine Tumors; Neoplasms; Cancer; Tumors |
University of Wisconsin, Madison |
2017-08-22 | PHASE1 |
| NCT02921737 | TERMINATED | Pancreatic Cancer |
University of Florida |
2017-11-09 | PHASE2 |
| NCT02848079 | COMPLETED | Colorectal Neoplasms |
Yale University |
2016-10-31 | PHASE1; PHASE2 |
| NCT03297710 | COMPLETED | Rectal Adenocarcinoma; Recurrent Rectal Carcinoma; Stage IV Rectal Cancer AJCC v7; Stage IVA Rectal Cancer AJCC v7; Stage IVB Rectal Cancer AJCC v7 |
Mayo Clinic |
2017-12-11 | PHASE1 |
| NCT01896856 | COMPLETED | Previously Treated Metastatic Colorectal Cancer |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
2013-10-23 | PHASE1; PHASE2 |
| NCT02848443 | COMPLETED | Metastatic Colorectal Cancer |
Institut de Recherches Internationales Servier |
2016-05 | PHASE1 |
| NCT04074343 | Completed | Gastric Adenocarcinoma|GastroEsophageal Cancer |
University of California Irvine|Taiho Pharmaceutical Co. Ltd. |
2019-08-26 | Phase 1 |
| NCT03974594 | COMPLETED | Colorectal Cancer |
Chia Tai Tianqing Pharmaceutical Group Co., Ltd. |
2019-05-21 | PHASE1 |
| NCT02301117 | COMPLETED | Advanced Solid Tumors |
Taiho Oncology, Inc. |
2015-01 | PHASE1 |
| NCT02920476 | COMPLETED | Squamous Cell Lung Carcinoma |
University of Florida |
2017-07-19 | PHASE2 |
| NCT03278106 | COMPLETED | Cholangiocarcinoma; Stage III Gallbladder Cancer AJCC v7; Stage IIIA Gallbladder Cancer AJCC v7; Stage IIIB Gallbladder Cancer AJCC v7; Stage IV Gallbladder Cancer AJCC v7; Stage IVA Gallbladder Cancer AJCC v7; Stage IVB Gallbladder Cancer AJCC v7 |
Mayo Clinic |
2017-10-20 | PHASE2 |
| NCT03305913 | COMPLETED | Pretreated Metastatic Colorectal Cancer |
AIO-Studien-gGmbH |
2017-07-31 | PHASE1 |
| NCT02500043 | COMPLETED | Refractory Metastatic Gastric Cancer |
Taiho Oncology, Inc. |
2016-02-24 | PHASE3 |
| NCT02743221 | COMPLETED | Metastatic Colorectal Cancer |
Institut de Recherches Internationales Servier |
2016-04-29 | PHASE2 |
| NCT03274882 | COMPLETED | Metastatic Colorectal Cancer |
Institut de Recherches Internationales Servier |
2017-03-03 | PHASE2 |
| NCT02654639 | TERMINATED | Metastatic Colorectal Cancer |
Georgetown University |
2016-02 | PHASE2 |
| NCT02613221 | COMPLETED | Colorectal Cancer |
Takeda |
2015-12-07 | PHASE1; PHASE2 |
| NCT01916447 | COMPLETED | Advanced Gastrointestinal Tumors |
Taiho Oncology, Inc. |
2013-09 | PHASE1 |
| NCT02860546 | COMPLETED | Refractory Metastatic Colorectal Cancer |
Taiho Oncology, Inc. |
2016-08-29 | PHASE2 |
| NCT02301104 | COMPLETED | Advanced Solid Tumors |
Taiho Oncology, Inc. |
2015-01 | PHASE1 |
| NCT01955837 | COMPLETED | Colorectal Cancer |
Taiho Pharmaceutical Co., Ltd. |
2013-09 | PHASE3 |
| NCT02261532 | COMPLETED | Advanced or Metastatic Solid Tumors |
Taiho Pharmaceutical Co., Ltd. |
2014-09 | PHASE1 |
| NCT01874522 | COMPLETED | Advanced Solid Tumors (Excluding Breast Cancer) |
Taiho Oncology, Inc. |
2013-07 | PHASE1 |
| NCT02031055 | COMPLETED | Advanced Solid Tumors |
Taiho Oncology, Inc. |
2014-02 | PHASE1 |
| NCT01867879 | COMPLETED | Advanced Solid Tumors (Excluding Breast Cancer) |
Taiho Oncology, Inc. |
2013-06 | PHASE1 |
| NCT01904253 | TERMINATED | Small Cell Lung Cancer (SCLC) |
Taiho Oncology, Inc. |
2013-07 | PHASE2 |
| NCT01607957 | COMPLETED | Colorectal Cancer |
Taiho Oncology, Inc. |
2012-06-17 | PHASE3 |
| NCT01867866 | COMPLETED | Advanced Solid Tumors |
Taiho Oncology, Inc. |
2013-05 | PHASE1 |
(data from https://clinicaltrials.gov, updated on 2026-06-18)
Check the
TAS-102 (Trifluridine/Tipiracil Hydrochloride Mixture)
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
- TAS-102 (Trifluridine/Tipiracil Hydrochloride Mixture) Solubility in DMSO
- TAS-102 (Trifluridine/Tipiracil Hydrochloride Mixture) Stock Solution
- TAS-102 (Trifluridine/Tipiracil Hydrochloride Mixture) Storage
- TAS-102 (Trifluridine/Tipiracil Hydrochloride Mixture) Stability
- TAS-102 (Trifluridine/Tipiracil Hydrochloride Mixture) Molecular Weight
- TAS-102 (Trifluridine/Tipiracil Hydrochloride Mixture) SMILES
- TAS-102 (Trifluridine/Tipiracil Hydrochloride Mixture) CAS Number
- TAS-102 (Trifluridine/Tipiracil Hydrochloride Mixture) Chemical Structure (2D and 3D)
- TAS-102 (Trifluridine/Tipiracil Hydrochloride Mixture) SDS｜MSDS
Note: Technical data last updated: Sep 1, 2026.