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:
Company Founding Year: 1896
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: 1
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Adenocarcinoma|Biliary Tract Cancer|Breast Cancer|Colic|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|Oncology Solid Tumor Unspecified|Pancreatic Cancer|Pseudomyxoma Peritonei|Small Cell Carcinoma|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 |
|---|---|---|---|---|---|---|---|---|
NCT06568692 |
PCS6422-BC-01 | P2 |
Recruiting |
Triple Negative Breast Cancer |
2026-09-01 |
12% |
2024-08-24 |
Primary Endpoints|Treatments |
NCT05249101 |
CG-745-2-08 | P2 |
Active, not recruiting |
Adenocarcinoma|Pancreatic Cancer |
2026-06-01 |
12% |
2025-12-20 |
Primary Completion Date|Primary Endpoints|Study Completion Date |
NCT06247956 |
SHR-8068-201-GC | P2 |
Active, not recruiting |
Gastrointestinal Cancer|Adenocarcinoma|Esophageal Cancer|Squamous Cell Carcinoma |
2025-12-30 |
2% |
2025-09-04 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Treatments|Trial Status |
2025-520471-29-00 |
FCO-FOX-2024-01 | P3 |
Not yet recruiting |
Colorectal Cancer|Adenocarcinoma|Colic |
2030-12-31 |
|||
NCT06239727 |
2023-FXY-204-FLK | P3 |
Recruiting |
Nasopharyngeal Cancer |
2027-02-20 |
12% |
2026-03-07 |
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 |
NCT05144854 |
ONO-4538-113 | P3 |
Active, not recruiting |
Gastrointestinal Cancer |
2026-05-01 |
86% |
2024-09-06 |
Primary Completion Date|Primary Endpoints|Treatments |
NCT05576480 |
SPARC | P2 |
Recruiting |
Colorectal Cancer |
2025-10-01 |
12% |
2025-08-29 |
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 |
|
NCT05494060 |
EXPLORING | P2 |
Recruiting |
Adenocarcinoma|Digestive System Cancer|Esophageal Cancer|Stomach Diseases|Intestinal Diseases|Gastrointestinal Cancer|Esophageal Diseases |
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 |
2025-521966-91-00 |
PHP-MBC-202 | P2 |
Not yet recruiting |
Liver Cancer|Breast Cancer |
2028-12-26 |
|||
NCT07331155 |
Substudy 03(ESCC) | P2 |
Recruiting |
Esophageal Cancer|Squamous Cell Carcinoma|Small Cell Carcinoma |
2028-12-26 |
12% |
2026-03-10 |
Primary Endpoints|Start Date|Treatments|Trial Status |
NCT06764940 |
BG01-2402 | P2 |
Recruiting |
Brain Cancer|Breast Cancer |
2027-01-15 |
2% |
2025-09-11 |
Primary Endpoints|Start Date|Treatments |
NCT03377387 |
NCT03377387 | P2 |
Active, not recruiting |
Breast Cancer |
2026-12-01 |
12% |
2025-03-18 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT07118527 |
SHR-A1811-316 | P3 |
Recruiting |
Adenocarcinoma|Esophageal Cancer|Gastrointestinal Cancer |
2030-10-01 |
26% |
2025-09-05 |
Primary Endpoints|Start Date|Treatments|Trial Status |
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 |
|
NCT06134375 |
STUDY02001837 | P2 |
Recruiting |
Triple Negative Breast Cancer |
2031-06-26 |
2026-01-13 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
|
2023-509814-12-00 |
2023-509814-12-00 | P2 |
Recruiting |
Colorectal Cancer |
2031-03-31 |
2025-05-02 |
||
NCT03424005 |
Morpheus-panBC | P2 |
Recruiting |
Breast Cancer |
2030-09-30 |
12% |
2025-11-29 |
|
NCT07281768 |
J25118 | P2 |
Not yet recruiting |
Colorectal Cancer|Adenocarcinoma |
2030-03-01 |
12% |
2025-12-16 |
Primary Endpoints|Treatments |
jRCT2031250297 |
jRCT2031250297 | P3 |
Not yet recruiting |
Breast Cancer |
2033-07-14 |
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