Health Condition 1: C189- Malignant neoplasm of colon, unspecified
Conditions
Interventions
Intervention1: Capecitabine Tablets USP 500 mg: Patients will be on an overnight fast for at least 10 hours prior to serving of a high-fat, high-calorie breakfast (approximately 800 to 1000 kilocalori
Sponsors
Intas Pharmaceuticals limited
Lambda Therapeutic Research Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or Female18 to 79 years of age (both inclusive) of Indian nationality and having a Body Mass Index (BMI) at least 17 calculated as weight in kg / height in m2. 2. Patients must have histopathologically /cytologically confirmed breast cancer or colorectal cancer. 3. Patients with Dukes C colon cancer who have undergone complete resection of the primary tumour, where treatment with Fluoropyrimidine therapy alone is indicated as adjuvant treatment. Or Firstline treatment of patients with metastatic colorectal cancer. Or Patient with advanced or metastatic breast cancer after failure of standard therapy including a Taxane, unless therapy with a Taxane is clinically contraindicated. 4. Patients who require a daily dose of Capecitabine monotherapy, who are stabilized on twice daily dosing for at least one cycle of chemotherapy before randomization and who are eligible to receive a dose of 2500 mg/m2/day. 5. Eastern Cooperative Oncology Group (ECOG) performance status. 6. Patient with adequate bone marrow, renal and hepatic function.
Exclusion criteria
Exclusion criteria: 1. Prior unanticipated severe reaction to Fluoropyrimidine therapy or known sensitivity to 5-fluorouracil or known DPD (Dihydropyrimidine Dehydrogenase) deficiency. 2. Pregnant or breast-feeding female 3. Any of the following cardiac conditions: a. Unstable angina b. Myocardial infarction within the past 6 months c. NYHA (New York State Heart Association) class II-IV heart failure d. Severe uncontrolled ventricular arrhythmias e. Clinically significant pericardial disease f. Electrocardiographic evidence of acute ischemic or active conduction system abnormalities g. Any other cardiac illness that could lead to a safety risk to the patient in case of enrolment in the study 4. History of drug/alcohol addiction. 5. Known brain metastasis. 6. Patient having abnormal serum calcium level at screening visit, which as judged by Investigator could lead to safety risk to the patient upon participation in the trial or could interfere with the conduct of the trial. 7. Pre-existing motor or sensory neurotoxicity of a severity grade 2 by NCI CTCAE criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To characterize the pharmacokinetic profile of the sponsors test formulation [Capecitabine Tablets USP 500 mg (Manufactured by: Intas Pharmaceuticals limited, India)] relative to that of reference formulation [Xeloda (capecitabine) Tablets 500 mg (Distributed by: Hoffmann-La Roche Limited., Mississauga ON L5N 6L7, Canada)] in patients of Metastatic Breast Cancer or Colorectal Cancer under fed condition and to assess the bioequivalenceTimepoint: NIL | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety of the patients, who are exposed to the Investigational Medicinal ProductTimepoint: NIL | — |
Countries
India
Contacts
Public ContactDr Praveen Shetty
Outcome results
None listed