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
- Conditions
- Health Condition 1: C509- Malignant neoplasm of breast of unspecified siteHealth Condition 2: C189- Malignant neoplasm of colon, unspecified
- Registration Number
- CTRI/2023/12/060557
- Lead Sponsor
- Mylan Pharmaceuticals Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. <br/ ><br>
- Secondary Outcome Measures
Name Time Method 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).