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Placebo + Capecitabine
Capecitabine is a prodrug that converts to fluorouracil in tumor tissue, inhibiting thymidylate synthase to disrupt DNA synthesis and induce cancer cell death.
Capecitabine is a prodrug that converts to fluorouracil in tumor tissue, inhibiting thymidylate synthase to disrupt DNA synthesis and induce cancer cell death. Used for Metastatic colorectal cancer, Metastatic breast cancer, Gastric cancer.
At a glance
| Generic name | Placebo + Capecitabine |
|---|---|
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University |
| 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 is metabolized preferentially in tumor tissue to its active form, 5-fluorouracil (5-FU). 5-FU inhibits thymidylate synthase, blocking dTMP synthesis and disrupting DNA replication, while also incorporating into RNA to disrupt protein synthesis. This combination of mechanisms leads to apoptosis in rapidly dividing cancer cells.
Approved indications
- Metastatic colorectal cancer
- Metastatic breast cancer
- Gastric cancer
Common side effects
- Hand-foot skin reaction
- Diarrhea
- Nausea
- Fatigue
- Vomiting
- Stomatitis
- Neutropenia
Key clinical trials
- A Study to Investigate the Efficacy and Safety of ONO-4578 in Combination With Nivolumab and Chemotherapy in Chemotherapy-naïve Participants With HER2-negative Unresectable Advanced or Recurrent Gastric Cancer (Including Esophagogastric Junction Cancer) (PHASE2)
- A Study of Zolbetuximab Together With Pembrolizumab and Chemotherapy in Adults With Gastric Cancer (PHASE3)
- Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy for HR+/HER2- Locally Recurrent Inoperable or Metastatic Breast Cancer (MK-3475-B49/KEYNOTE-B49) (PHASE3)
- Vasodilator Therapy With Isosorbide Mononitrate or Diltiazem to Reduce Vasotoxicity in Patients With Gastrointestinal Cancer Receiving Fluoropyrimidine Therapy (PHASE1, 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)
- 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)-China Extension (PHASE3)
- Rilvegostomig + Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection (ARTEMIDE-Biliary01) (PHASE3)
- Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-859/KEYNOTE-859) (PHASE3)
Primary sources
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| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |