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Capecitabine

Generic Name
Capecitabine
Brand Names
Ecansya, Xeloda, Capecitabine Medac, Ecansya (previously Capecitabine Krka), Capecitabine Accord, Capecitabine Teva
Drug Type
Small Molecule
Chemical Formula
C15H22FN3O6
CAS Number
154361-50-9
Unique Ingredient Identifier
6804DJ8Z9U
Background

Capecitabine is an orally-administered chemotherapeutic agent used in the treatment of metastatic breast and colorectal cancers. Capecitabine is a prodrug, that is enzymatically converted to fluorouracil (antimetabolite) in the tumor, where it inhibits DNA synthesis and slows growth of tumor tissue.

Indication

Capecitabine is indicated as treatment for a variety of cancer types. For colorectal cancer, capecitabine is indicated as a single agent or a component of a combination chemotherapy regiment for the adjuvant treatment of stage III colon cancer and treatment unresectable or metastatic colorectal cancer. It can also be used as a part of a combination chemotherapy perioperative treatment of adult locally advanced rectal cancer. For breast cancer, capecitabine is indicated for advanced or metastatic breast cancer as a single agent if an anthracycline- or taxane-containing chemotherapy is not indicated or as a regimen with docetaxel after disease progression on prior anthracycline-containing chemotherapy. For gastric, esophageal, or gastroesophageal junction (GEJ) cancer, capecitabine is indicated as a component of a combination chemotherapy treatment for the treatment of adult unresectable or metastatic gastric, esophageal, or GEJ cancer or adult HER2-overexpressing metastatic gastric or GEJ adenocarcinoma who have not received prior treatment for metastatic disease. Finally, for pancreatic cancer, capecitabine is indicated as adjuvant treatment for adult pancreatic adenocarcinoma as a component of a combination chemotherapy regimen.

Associated Conditions
Advanced or Metastatic Breast Cancer, Carcinoma of Gallbladder, Cholangiocarcinoma, Hepatocellular Carcinoma, Locally Advanced Rectal Cancer (LARC), Metastatic Adenocarcinoma of the Gastroesophageal Junction, Metastatic Gastric Cancers, Metastatic Neuroendocrine Tumors, Pancreatic Adenocarcinoma, Pancreatic Cancer, Advanced or Metastatic, Platinum-resistant Epithelial Ovarian Cancer, Refractory Fallopian Tube Carcinoma, Stage III Colon Cancer, Unresectable or Metastatic Colorectal Cancer, Metastatic pancreatic endocrine carcinoma, Refractory peritoneal cancer, Refractory, metastatic Colorectal carcinoma, Unresectable, metastatic Esophageal Cancer, Unresectable, metastatic Gastric Cancer, Unresectable, metastatic Gastroesophageal Junction Cancer
Associated Therapies
Chemotherapy

Phase III Study in First-line Treatment of Patients With Metastatic Colorectal Cancer Who Are Not Candidate for Intensive Therapy.

Phase 3
Active, not recruiting
Conditions
Metastatic Colorectal Cancer
Interventions
First Posted Date
2019-03-11
Last Posted Date
2024-12-19
Lead Sponsor
Institut de Recherches Internationales Servier
Target Recruit Count
856
Registration Number
NCT03869892
Locations
🇦🇺

Lake Macquarie Private Hospital, Gateshead, Australia

🇧🇷

Hospital de Base Centro Integrado de Pesquisa, São José Do Rio Preto, Brazil

🇮🇪

The Adelaide and Meath Hospital, Dublin, Ireland

and more 186 locations

Tesetaxel Plus Reduced Dose of Capecitabine in Patients With HER2 Negative, HR Positive, LA/MBC

Phase 2
Terminated
Conditions
Breast Cancer
Interventions
First Posted Date
2019-03-01
Last Posted Date
2021-07-30
Lead Sponsor
Odonate Therapeutics, Inc.
Target Recruit Count
152
Registration Number
NCT03858972
Locations
🇺🇸

Texas Oncology - Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States

🇰🇷

Asan Medical Center, Seoul, Korea, Republic of

🇨🇦

Hopital Maisonneuve-Rosemont, Montréal, Canada

and more 22 locations

Ipatasertib in Combination With Carboplatin, Carboplatin/Paclitaxel, or Capecitabine/Atezolizumab in Treating Patients With Metastatic Triple Negative Breast Cancer

Phase 1
Completed
Conditions
Anatomic Stage IV Breast Cancer AJCC v8
Metastatic Triple-Negative Breast Carcinoma
Prognostic Stage IV Breast Cancer AJCC v8
Interventions
Drug: Carboplatin
Drug: Atezolizumab
Drug: Ipatasertib
Drug: Capecitabine
Drug: Paclitaxel
Other: Quality-of-Life Assessment
Other: Questionnaire Administration
First Posted Date
2019-02-26
Last Posted Date
2024-02-20
Lead Sponsor
City of Hope Medical Center
Target Recruit Count
28
Registration Number
NCT03853707
Locations
🇺🇸

City of Hope Medical Center, Duarte, California, United States

Immunotherapy In Locally Advanced Rectal Cancer

Phase 2
Completed
Conditions
Colon Rectal Cancer
Interventions
Drug: Avelumab
Drug: Capecitabine
Radiation: EXTERNAL---BEAM IRRADIATION 50.4 GY
First Posted Date
2019-02-26
Last Posted Date
2023-10-19
Lead Sponsor
Gruppo Oncologico del Nord-Ovest
Target Recruit Count
101
Registration Number
NCT03854799
Locations
🇮🇹

Policlinico Gemelli, Rome, Italy

A Study of AK104, a PD-1/CTLA-4 Bispecific Antibody, for Advanced Solid Tumors or With mXELOX/XELOX as First-line Therapy for Advanced Gastric or GEJ Adenocarcinoma

Phase 1
Completed
Conditions
Gastric Adenocarcinoma
Advanced Solid Tumors
Gastroesophageal Junction Adenocarcinoma
Interventions
First Posted Date
2019-02-25
Last Posted Date
2024-08-02
Lead Sponsor
Akeso
Target Recruit Count
338
Registration Number
NCT03852251
Locations
🇨🇳

Beijing Cancer Hospital, Beijing, Beijing, China

Capecitabine in the Treatment of Breast Cancer With Low-hormone Receptor Expression After Neoadjuvant Chemotherapy

Not Applicable
Conditions
Breast Cancer
Interventions
Drug: Placebos
Drug: Capecitabine
First Posted Date
2019-01-29
Last Posted Date
2019-02-01
Lead Sponsor
Zhejiang Cancer Hospital
Target Recruit Count
50
Registration Number
NCT03821454

Evaluate the Clinical Benefit of a Post-operative Treatment Associating Radiotherapy + Nivolumab + Ipilimumab Versus Radiotherapy + Capecitabine for Triple Negative Breast Cancer Patients With Residual Disease

Phase 2
Active, not recruiting
Conditions
Breast Cancer
Triple Negative Breast Neoplasms
Interventions
First Posted Date
2019-01-28
Last Posted Date
2024-02-12
Lead Sponsor
Centre Leon Berard
Target Recruit Count
95
Registration Number
NCT03818685
Locations
🇫🇷

Hopital Prive Jean Mermoz, Lyon, France

🇫🇷

Centre Antoine Lacassagne, Nice, France

🇫🇷

Clinique de la Sauvegarde, Lyon, France

and more 12 locations

Telatinib in Combination With Capecitabine/ Oxaliplatin in 1st Line Gastric or GEJ Cancer

Phase 2
Conditions
Gastric Cancer
Interventions
First Posted Date
2019-01-25
Last Posted Date
2019-05-07
Lead Sponsor
Taizhou EOC Pharma Co., Ltd.
Target Recruit Count
90
Registration Number
NCT03817411
Locations
🇨🇳

Shanghai Easter Hospital, Shanghai, China

RALOX or CAPOX + Bevacizumab in the First-line Treatment of Advanced CRC(ROCB Study)

Phase 2
Conditions
Colorectal Cancer
Interventions
First Posted Date
2019-01-23
Last Posted Date
2019-09-09
Lead Sponsor
Shenzhen People's Hospital
Target Recruit Count
100
Registration Number
NCT03813641
Locations
🇨🇳

Shenzhen People's Hospital, Shenzhen, Guangdong, China

A Study to Evaluate SHR-1210 in Combination With Capecitabine + Oxaliplatin Sequenced by SHR-1210 + Apatinib as First-line Therapy in Treatment of Advanced Gastric Cancer

Phase 3
Completed
Conditions
GastroEsophageal Cancer
Gastric Cancer
Interventions
First Posted Date
2019-01-23
Last Posted Date
2024-11-08
Lead Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Target Recruit Count
885
Registration Number
NCT03813784
Locations
🇨🇳

Beijing Cancer Hospital, Peking University, Beijing, Beijing, China

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