Capecitabine

Generic Name: Capecitabine

Brand Names: Ecansya, Xeloda, Capecitabine Medac, Ecansya (previously Capecitabine Krka), Capecitabine Accord, Capecitabine Teva

Drug Type: Small Molecule

Chemical Formula: C_₁₅H_₂₂FN_₃O_₆

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

Clinical Trials

A Study of CS1001 in Subjects With Gastric Adenocarcinoma or Gastro-Esophageal Junction Adenocarcinoma

Phase 3

Completed

Conditions: Gastric Adenocarcinoma
Gastroesophageal Junction Adenocarcinoma

Interventions: Drug: CS1001 monoclonal antibody
Drug: CS1001 placebo
Drug: Oxaliplatin
Drug: Capecitabine

First Posted Date: 2019-01-14

Last Posted Date: 2023-11-29

Lead Sponsor: CStone Pharmaceuticals

Target Recruit Count: 479

Registration Number: NCT03802591

Locations: 🇨🇳
Beijing Cancer Hospital, Beijing, China

Intraperitoneal and System Chemotherapy Versus XELOX as First-line Chemotherapy for mCRC

Phase 2

Conditions: Chemotherapy Effect
Colorectal Cancer Metastatic
Chemotherapeutic Toxicity

Interventions: Drug: Irinotecan
Drug: Oxaliplatin
Drug: Capecitabine

First Posted Date: 2019-01-03

Last Posted Date: 2019-01-03

Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Target Recruit Count: 100

Registration Number: NCT03792269

Locations: 🇨🇳
The Comprehensive Cancer Center of Nanjing Drum Tower Hospital, Nanjing, Jiangsu, China

A Study of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma

Phase 3

Completed

Conditions: Esophageal Squamous Cell Carcinoma (ESCC)

Interventions: Drug: Cisplatin
Drug: Oxaliplatin
Drug: Fluorouracil (5-FU)
Drug: Capecitabine
Drug: Paclitaxel
Drug: Placebo
Drug: Tislelizumab

First Posted Date: 2018-12-21

Last Posted Date: 2024-10-26

Lead Sponsor: BeiGene

Target Recruit Count: 649

Registration Number: NCT03783442

Locations: 🇨🇳
Anhui Provincial Cancer Hospital, Hefei, Anhui, China
🇨🇳
Anhui Medical University - The Second Hospital, Hefei, Anhui, China
🇨🇳
Xiangyang Central Hospital, Xiangyang, Hubei, China

and more 173 locations

Adjuvant Chemotherapy for Biliary Tract Cancer After Curative Resection

Phase 3

Conditions: Cholangiocarcinoma
Gall Bladder Carcinoma

Interventions: Drug: Gemcitabine
Drug: Capecitabine

First Posted Date: 2018-12-19

Last Posted Date: 2018-12-19

Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

Target Recruit Count: 460

Registration Number: NCT03779035

Locations: 🇨🇳
Tianjin Medical University Cancer Insititute and Hospital, Tianjin, Tianjin, China

Study of CPI-100 in Patients With Advanced Tumors

Phase 1

Completed

Conditions: Advanced Tumors

Interventions: Drug: CPI-100
Drug: Capecitabine

First Posted Date: 2018-12-19

Last Posted Date: 2022-07-20

Lead Sponsor: Coordination Pharmaceuticals, Inc.

Target Recruit Count: 36

Registration Number: NCT03781362

Locations: 🇺🇸
University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States
🇺🇸
South Texas Accelerated Research Therapeutics, San Antonio, Texas, United States

Tislelizumab in Combination With Chemotherapy as First-Line Treatment in Adults With Inoperable, Locally Advanced or Metastatic Gastric, or Gastroesophageal Junction Carcinoma

Phase 3

Completed

Conditions: Gastric, or Gastroesophageal Junction Adenocarcinoma

Interventions: Drug: Tislelizumab
Drug: Placebo
Drug: Cisplatin
Drug: Oxaliplatin
Drug: Capecitabine
Drug: 5-FU

First Posted Date: 2018-12-17

Last Posted Date: 2024-12-27

Lead Sponsor: BeiGene

Target Recruit Count: 997

Registration Number: NCT03777657

Locations: 🇨🇳
Beijing Chao Yang Hospital, Beijing, Beijing, China
🇫🇷
CHU Besançon - Hôpital Jean Minjoz, Besançon, France
🇫🇷
Hôpital de la Timone, Marseille, France

and more 152 locations

Compare Apatinib Plus Capecitabine Versus Capecitabine in Maintenance Therapy for Patients With Advanced Triple-negative Breast Cancer

Phase 2

Conditions: Triple-negative Breast Cancer

Interventions: Drug: Apatinib
Drug: capecitabine

First Posted Date: 2018-12-14

Last Posted Date: 2018-12-14

Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Target Recruit Count: 80

Registration Number: NCT03775928

Locations: 🇨🇳
Cancer hospital, ChineseAMS, Beijing, Beijing, China

Study Evaluating GZ17-6.02 in Patients With Advanced Solid Tumors or in Combination With Capecitabine in Metastatic Hormone Receptor Positive Breast Cancer

Phase 1

Active, not recruiting

Conditions: Advanced Cancer
Pancreatic Cancer
Prostate Cancer Metastatic
Colo-rectal Cancer
Solid Tumor
Solid Carcinoma
Solid Carcinoma of Stomach
Head and Neck Squamous Cell Carcinoma
Basal Cell Carcinoma
Cutaneous T-cell Lymphoma

Interventions: Drug: GZ17-6.02
Drug: Capecitabine

First Posted Date: 2018-12-14

Last Posted Date: 2022-12-23

Lead Sponsor: Genzada Pharmaceuticals USA, Inc.

Target Recruit Count: 127

Registration Number: NCT03775525

Locations: 🇺🇸
Ochsner Clinic Foundation, New Orleans, Louisiana, United States
🇺🇸
HonorHealth Research Institute, Scottsdale, Arizona, United States
🇺🇸
Cedars-Sinai Medical Center, Los Angeles, California, United States

and more 1 locations

Study of Peposertib in Combination With Capecitabine and RT in Rectal Cancer

Phase 1

Completed

Conditions: Locally Advanced Rectal Cancer

Interventions: Drug: Peposertib 100 mg
Drug: Peposertib 250 mg
Drug: Peposertib 150 mg
Drug: Peposertib 50 mg
Drug: Capecitabine
Radiation: Radiotherapy (RT)

First Posted Date: 2018-12-10

Last Posted Date: 2023-03-21

Lead Sponsor: EMD Serono Research & Development Institute, Inc.

Target Recruit Count: 19

Registration Number: NCT03770689

Locations: 🇺🇸
Ohio State University Clinical Trials Management Office - Ohio State CTMO Parent, Columbus, Ohio, United States
🇺🇸
University of Colorado Cancer Center, Aurora, Colorado, United States
🇺🇸
Northwell Health, Inc, Great Neck, New York, United States

and more 11 locations

Liposomal iRInotecan, Carboplatin or oXaliplatin for Esophagogastric Cancer

Phase 2

Recruiting

Conditions: Esophageal Cancer

Interventions: Drug: Liposomal Irinotecan
Drug: Carboplatin
Drug: 5-fluorouracil
Drug: Capecitabine
Drug: Oxaliplatin
Drug: Leucovorin

First Posted Date: 2018-12-05

Last Posted Date: 2024-07-31

Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Target Recruit Count: 320

Registration Number: NCT03764553

Locations: 🇳🇱
Jeroen Bosch Ziekenhuis, 's-Hertogenbosch, Netherlands
🇳🇱
Zuyderland Medisch Centrum, Geleen, Netherlands
🇳🇱
Tergooi ziekenhuizen, Hilversum, Netherlands

and more 32 locations

Drug Development Updates

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