Health Condition 1: null- Adult human cancer patients
Conditions
Interventions
Intervention1: Capecitabine Tablets 500 mgof Shilpa Medicare Limited, India: Dose: 2500 MG/m2/Day for 14 days Duration : 1 cycle Frequency : 14 days with 7 days rest period. Mode of Admin: oral
Contro
Sponsors
Shilpa Medicare Limited
Veeda Clinical Research Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: •Male or Female 18 to 60 years of age (both inclusive) and having a Body Mass Index (BMI) at least 17 calculated as weight in kg / (height in m)2 •Patients must have histopathologically /cytologically confirmed breast cancer or colorectal cancer. •Patients with Dukesâ?? C colon cancer who have undergone complete resection of the primary tumor when treatment with fluoropyrimidine therapy alone is preferred. Or Patients with metastatic colorectal carcinoma when treatment with fluoropyrimidine therapy alone is preferred Or Patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline-containing chemotherapy regimen or for whom further anthracycline therapy is not indicated. •Patients who require a daily dose of Capecitabinemonotherapy, who are stabilized on twice daily dosing at a dose of 1250 mg/m2 and who have completed at least one cycle of chemotherapy •Patients should have their BSA (as per the DuBois formula) between 1.26-1.91 m2 (Both inclusive). •Eastern Cooperative Oncology Group (ECOG) performance status •Adequate cardiac function [left ventricular ejection fraction (LVEF) > 50 %] •Patient with adequate bone marrow, renal and hepatic function
Exclusion criteria
Exclusion criteria: •History of allergy or hypersensitivity to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil, or known DPD (Dihydropyrimidine Dehydrogenase) deficiency. •Prior unanticipated severe reaction to Capecitabine or metabolites and to fluoropyrimidine therapy •Known hypersensitivity to Ondansetron. •Pregnant or breastfeeding female •Geriatric cancer patients (80 years) •History of drug/alcohol addiction •Known brain metastasis •Presence of active infections •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 •Patients receiving concomitant therapy of warfarin, and dihydropyrimidine dehydrogenase deficiency
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢To compare and evaluate the single-dose oral bioavailability of Capecitabine Tablets 500 mg of Shilpa Medicare Limited, India with XELODA® (Capecitabine) Tablets500mg marketed by Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City,AL7 1TW,United Kingdom, following a single oral 2000mg (4X500mg) dose administration in adult human cancer patients under fed conditionTimepoint: Pre dose and 0.17, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 5, 6, 7, and 8 hrs following drug administration in each period. | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢To monitor the adverse events and to ensure the safety of PatientTimepoint: NA | — |
Countries
India
Contacts
Public ContactDr Ashoka Kumar Singh
Veeda Clinical Research Pvt. Ltd.
Outcome results
None listed