Health Condition 1: C509- Malignant neoplasm of breast of unspecified site Health Condition 2: C189- Malignant neoplasm of colon, unspecified
Conditions
Interventions
Intervention1: Treatment A- Test Drug
Capecitabine Extended-release Tablets, 150 mg
Capecitabine Extended-release Tablets, 1000 mg
: Dose: 2000 mg/m2 or 2500 mg/m2 dose
Route of Administration: Ora
Sponsors
Mylan Pharmaceuticals Inc.
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relative bioavailability of two extended-release formulations of Mylan’s Capecitabine Extended-release Tablets following a single, oral dose of 2500 mg/m2/day or 2000 mg/m2 dose to reference immediate-release Capecitabine Tablets following a single oral dose of 1250 mg/m2 or 1000 mg/m2 will be evaluated by comparison of various pharmacokinetic parameters derived from the plasma concentration time curves (e.g. AUCL, AUCINF, and CPEAK) of capecitabine.Timepoint: PK sampling: From pre-dose till 24 hours in each period administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety & tolerability of Capecitabine Extended-release Tablets in cancer patientsTimepoint: Safety & tolerability of Capecitabine Extended-release Tablets in cancer patients will be assessed from Screening till day 12 (End of study). | — |
Countries
India
Contacts
Public ContactDr Sandeep Singh
CBCC Global Research LLP
Outcome results
None listed