Product Description
Capecitabine is used to help treat patients with Dukes' C colon cancer (colon cancer that has spread to lymph nodes in the area close to the colon), after having surgery. This medicine is also used to treat metastatic colorectal cancer (cancer of the colon or rectum that has spread to other parts of the body). (Sourced from: https://www.mayoclinic.org/drugs-supplements/capecitabine-oral-route/side-effects/drg-20062501?p=1)
Mechanisms of Action: TS Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: *
Approval Status: Approved
Approved Countries: Algeria | Argentina | Australia | Austria | Bangladesh | Belgium | Bosnia | Brazil | Bulgaria | Canada | Chile | China | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Malta | Mexico | Morocco | Netherlands | New Zealand | Norway | Pakistan | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Thailand | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: None
Known Adverse Events: None
Company: Hoffmann-La Roche
Company Location: BASEL SWITZERLAND V8
Company CEO: Severin Schwan
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Australia, Austria, Belgium, Bosnia, Brazil, Canada, Chile, China, Colombia, Cuba, Denmark, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Kazakhstan, Korea, Malaysia, Mexico, Montenegro, Morocco, Netherlands, Norway, Panama, Peru, Poland, Portugal, Puerto Rico, Russia, Serbia, Singapore, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey, United Kingdom, United States, Unknown Location, Vietnam
Active Clinical Trial Count: 8
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Adenocarcinoma|Biliary Tract Cancer|Breast Cancer|Colorectal Cancer|Esophageal Cancer|Gastrointestinal Cancer|Nasopharyngeal Cancer|Squamous Cell Carcinoma
Phase 2: Bladder Cancer|Brain Cancer|Digestive System Cancer|Esophageal Diseases|Intestinal Diseases|Liver Cancer|Lung Cancer|Meningeal Cancer|Meningeal Carcinomatosis|Oncology Solid Tumor Unspecified|Pancreatic Cancer|Pseudomyxoma Peritonei|Spinal Cord Cancer|Stomach Diseases|Triple Negative Breast Cancer
Phase 1: Adrenocortical Carcinoma|Glioma|Healthy Volunteers|Multiple Sclerosis
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
ACTRN12617001268336 |
SYS-CAPLIOX | P2 |
Recruiting |
Liver Cancer|Colorectal Cancer |
2023-05-01 |
2025-12-04 |
Treatments |
|
NCT06239727 |
2023-FXY-204-FLK | P3 |
Recruiting |
Nasopharyngeal Cancer |
2027-02-20 |
2024-04-27 |
Primary Endpoints|Start Date |
|
NCT06764940 |
BG01-2402 | P2 |
Recruiting |
Breast Cancer|Brain Cancer |
2027-01-15 |
2% |
2025-09-11 |
Primary Endpoints|Start Date|Treatments |
NCT05800275 |
ETIC-LM | P2 |
Recruiting |
Breast Cancer|Meningeal Carcinomatosis|Spinal Cord Cancer|Meningeal Cancer |
2026-12-01 |
37% |
2024-09-20 |
Primary Endpoints|Treatments |
NCT06568692 |
PCS6422-BC-01 | P2 |
Recruiting |
Triple Negative Breast Cancer |
2026-09-01 |
12% |
2024-08-24 |
Primary Endpoints|Treatments |
NCT05065957 |
Inno-Go-05 | P3 |
Recruiting |
Biliary Tract Cancer |
2026-07-01 |
44% |
2022-12-28 |
Primary Endpoints|Start Date|Treatments|Trial Status |
NCT05249101 |
CG-745-2-08 | P2 |
Recruiting |
Pancreatic Cancer|Adenocarcinoma |
2026-02-01 |
12% |
2025-01-18 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT06247956 |
SHR-8068-201-GC | P2 |
Active, not recruiting |
Gastrointestinal Cancer|Squamous Cell Carcinoma|Esophageal Cancer|Adenocarcinoma |
2025-12-30 |
2% |
2025-09-04 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Treatments|Trial Status |
NCT06065371 |
HFH-23-03 | P1 |
Recruiting |
Gastrointestinal Cancer |
2025-12-01 |
12% |
2024-12-10 |
Primary Endpoints|Start Date|Treatments|Trial Status |
NCT05576480 |
SPARC | P2 |
Recruiting |
Colorectal Cancer |
2025-10-01 |
12% |
2025-08-29 |
Primary Endpoints |
NCT05494060 |
EXPLORING | P2 |
Recruiting |
Esophageal Cancer|Digestive System Cancer|Adenocarcinoma|Intestinal Diseases|Esophageal Diseases|Stomach Diseases|Gastrointestinal Cancer |
2024-12-01 |
41% |
2023-11-08 |
Primary Endpoints|Start Date|Treatments|Trial Status |
2018-000655-40 |
ACAPP | P2 |
Completed |
Pseudomyxoma Peritonei |
2024-10-25 |
2025-05-06 |
||
NCT03844256 |
CRIMI | P2 |
Recruiting |
Bladder Cancer |
2024-07-01 |
66% |
2022-08-13 |
Primary Endpoints |
CTR20200664 |
CTR20200664 | P1 |
Completed |
Oncology Solid Tumor Unspecified |
2023-06-08 |
2025-04-29 |
Patient Enrollment|Primary Completion Date|Study Completion Date|Treatments|Trial Status |
|
NCT06764875 |
ARTEMIDE-Gastric01 | P3 |
Recruiting |
Gastrointestinal Cancer|Esophageal Cancer|Adenocarcinoma |
2029-04-27 |
66% |
2025-07-11 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
jRCT2031250297 |
jRCT2031250297 | P3 |
Not yet recruiting |
Breast Cancer |
2033-07-14 |
|||
NCT06374459 |
BC200714 | P2 |
Recruiting |
Breast Cancer |
2032-05-31 |
2% |
2025-02-07 |
Primary Endpoints|Treatments |
NCT06247995 |
CAAA603D12101 | P2 |
Recruiting |
Breast Cancer |
2031-09-09 |
12% |
2024-07-03 |
|
2023-506717-21-00 |
CAAA603D12101 | P2 |
Recruiting |
Breast Cancer |
2031-06-30 |
2025-05-02 |
Treatments |
|
2023-509814-12-00 |
2023-509814-12-00 | P2 |
Recruiting |
Colorectal Cancer |
2031-03-31 |
2025-05-02 |
||
NCT07118527 |
SHR-A1811-316 | P3 |
Recruiting |
Gastrointestinal Cancer|Esophageal Cancer|Adenocarcinoma |
2030-10-01 |
61% |
2025-09-05 |
Primary Endpoints|Start Date|Treatments|Trial Status |
NCT03424005 |
Morpheus-panBC | P2 |
Recruiting |
Breast Cancer |
2030-09-30 |
12% |
2025-11-29 |
|
NCT04495088 |
ACO/ARO/AIO-18.2 | P3 |
Recruiting |
Colorectal Cancer |
2030-08-01 |
2020-11-13 |
Primary Endpoints|Start Date |
|
NCT06205485 |
NEO-RT | P3 |
Recruiting |
Colorectal Cancer |
2030-01-30 |
2024-08-14 |
Primary Endpoints|Start Date |
|
jRCT2051200152 |
jRCT2051200152 | P2 |
Active, not recruiting |
Breast Cancer |
2028-12-06 |
12% |