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Capecitabine monotherapy
Capecitabine is a prodrug that is converted to fluorouracil in tumor tissue, where it inhibits thymidylate synthase and gets incorporated into DNA and RNA to disrupt cancer cell growth.
Capecitabine is a prodrug that is converted to fluorouracil in tumor tissue, where it inhibits thymidylate synthase and gets incorporated into DNA and RNA to disrupt cancer cell growth. Used for Metastatic colorectal cancer, Metastatic breast cancer, Gastric cancer.
At a glance
| Generic name | Capecitabine monotherapy |
|---|---|
| Also known as | Capecitabine |
| Sponsor | Zhen-Hai Lu |
| Drug class | Fluoropyrimidine antimetabolite |
| Target | Thymidylate synthase |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Capecitabine is an oral fluoropyrimidine carbamate that undergoes hepatic and tumor-selective conversion to 5-fluorouracil (5-FU). Once activated, 5-FU inhibits thymidylate synthase, blocking dTMP synthesis and DNA replication, while also being incorporated into RNA to disrupt protein synthesis. This dual mechanism leads to cancer cell death, particularly in rapidly dividing cells.
Approved indications
- Metastatic colorectal cancer
- Metastatic breast cancer
- Gastric cancer
- Pancreatic cancer
Common side effects
- Hand-foot skin reaction (palmar-plantar erythrodysesthesia)
- Diarrhea
- Nausea
- Vomiting
- Stomatitis
- Fatigue
- Neutropenia
- Thrombocytopenia
Key clinical trials
- A Clinical Study of Patritumab Deruxtecan to Treat Breast Cancer (MK-1022-016) (PHASE3)
- Pan Tumor Rollover Study (PHASE2)
- Perioperative Systemic Therapy for Isolated Resectable Colorectal Peritoneal Metastases (PHASE2, PHASE3)
- Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03) (PHASE2)
- A Study of ASP2138 Given Before Surgery, Then Chemotherapy After Surgery, in People With Pancreatic Ductal Cancer (PHASE1)
- A Study of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenocarcinoma (PHASE2)
- Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants With Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-585/KEYNOTE-585) (PHASE3)
- Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer (DESTINY-Gastric03) (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Capecitabine monotherapy CI brief — competitive landscape report
- Capecitabine monotherapy updates RSS · CI watch RSS
- Zhen-Hai Lu portfolio CI