Single-Dose Fed Relative Bioavailability Study of Two Formulations of Mylan’s Capecitabine Extended-release Tablets to Immediate-release Capecitabine Tablets in Adult Cancer Patients with Advanced or Metastatic Breast Cancer, Stage III Colon Cancer, or Unresectable or Metastatic Colorectal Cancer Receiving a Capecitabine Dose of 2000 mg/m2/day or 2500 mg/m2/day - NA

Mylan Pharmaceuticals Inc.0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年3月4日

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•1.Subjects who are receiving stable doses of capecitabine as a single agent for advanced or metastatic breast cancer, adjuvant treatment of colon cancer, or for unresectable or metastatic colorectal cancer.
•2.Patients must have completed at least one 21-day cycle of capecitabine.
•3.Eastern Cooperative Oncology Group (ECOG) performance status of = 2
•4.Age between 18 and 65 years
•5.Sex: Females of non-childbearing potential and Males

•1.Individuals with dihydropyrimidine dehydrogenase (DPD) deficiency
•2.Individuals with rapidly progressing disease, especially with visceral organ involvement.
•3.Individuals requiring a change in dose or regimen of either capecitabine.
•4. History of unstable or clinically significant gastrointestinal disease, including a history of chronic diarrhea, inflammatory bowel disease, unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting).
•5. History of unstable or clinically significant cardiovascular disease, hepatic, pulmonary, hematologic, endocrine, immunologic, dermatologic, neurologic (including any history of seizure disorder), psychological, musculoskeletal disease or other malignancies.
•6. Subjects receiving capecitabine for the treatment of gastric, esophageal or gastroesophageal junction cancer or pancreatic cancer.
•7.ECOG performance status = 3
•8.Pre-existing motor or sensory neurotoxicity of a severity = grade 2
•9.Donation or loss of blood or plasma

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