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Capecitabine Oral Product
Capecitabine is a prodrug that is converted to fluorouracil in the body, which inhibits thymidylate synthase and disrupts DNA synthesis to kill rapidly dividing cancer cells.
Capecitabine is a prodrug that is converted to fluorouracil in the body, which inhibits thymidylate synthase and disrupts DNA synthesis to kill rapidly dividing cancer cells. Used for Metastatic colorectal cancer, Metastatic breast cancer, Gastric cancer.
At a glance
| Generic name | Capecitabine Oral Product |
|---|---|
| Also known as | Xeloda, Active Comparator control group |
| Sponsor | Abramson Cancer Center at Penn Medicine |
| Drug class | Antimetabolite; Fluoropyrimidine |
| 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 cellular enzymatic conversion to its active form, fluorouracil (5-FU). Once activated, 5-FU inhibits thymidylate synthase, blocking the synthesis of thymidylate and disrupting DNA replication in cancer cells. It also incorporates into RNA, further disrupting cellular function. The preferential activation in tumor tissue provides some selectivity for cancer cells over normal 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 Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032) (PHASE3)
- A Study of Sacituzumab Tirumotecan (MK-2870) as a Single Agent and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer (MK-2870-010) (PHASE3)
- Sacituzumab Tirumotecan (MK-2870) Plus Pembrolizumab Versus TPC in TNBC Who Did Not Achieve pCR (MK-2870-012) (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 Dato-DXd With or Without Durvalumab Versus Investigator's Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Without Pathological Complete Response Following Neoadjuvant Therapy (TROPION-Breast03) (PHASE3)
- Novel Combinations in Participants With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (PHASE2)
- Anti-CEACAM5 ADC M9140 in Advanced Solid Tumors (PROCEADE-CRC-01) (PHASE1)
- Neoadjuvant FOLFOXIRI and Chemoradiotherapy Versus Neoadjuvant CAPOX/FOLFOX and Chemoradiotherapy Followed by Surgery or a Watch-and-Wait Approach in High Risk Locally Advanced Rectal Cancer (PHASE3)
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 Oral Product CI brief — competitive landscape report
- Capecitabine Oral Product updates RSS · CI watch RSS
- Abramson Cancer Center at Penn Medicine portfolio CI