Health Condition 1: C189- Malignant neoplasm of colon, unspecified Health Condition 2: C508- Malignant neoplasm of overlappingsites of breast
Conditions
Interventions
Intervention1: Capecitabine: Administered as per the body surface area Orally, twice daily under fed condition from Day 1 to Day 3.
Control Intervention1: Xeloda®: Administered as per the body surfac
Sponsors
Reliance Life sciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Males or non-pregnant or non-lactating females of age between 18 to 65 years (both inclusive). a) Females of childbearing potential must have a negative serum pregnancy test at screening and negative urine pregnancy test at period I hospitalization. Females of childbearing potential include females who have entered puberty and all women who have a uterus and ovaries and have not completed menopause. Females who have 12 consecutive months of spontaneous amenorrhea (not amenorrhea induced by a medical condition or medical therapy) or have bilateral absence of the ovaries (surgical or congenital) have completed menopause. b) Females of reproductive potential must be willing to use adequate contraception (as defined below) at least four weeks before the first dose of the study drug except as noted and continuing at least six months after the last dose of the study drug. For this study, acceptable and effective methods of contraception for females includei. Intrauterine device placed at least 3 months prior to the start of the study and remaining in place during the study period, ii. Two barrier methods used together (cervical cap, diaphragm, contraceptive sponge, or vaginal spermicide plus a male or female condom) or iii. Absolute sexual abstinence (no sexual intercourse or genital contact with a male partner). c) Females will not be considered of childbearing potential if one of the following is reported and documented on the medical history: i. Postmenopausal with spontaneous amenorrhea for at least one year; or ii. Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months; or iii. Total hysterectomy and an absence of bleeding for at least 3 months d) Males with female partners of reproductive potential must be willing to use a male condom throughout the entire study and continuing for three months after the last dose of study medication. 2. Patients in whom capecitabine therapy is indicated i. Dukesâ?? C colon cancer: Adjuvant therapy; or ii. Metastatic colorectal cancer: First-line as monotherapy when treatment with fluoropyrimidine therapy alone is preferred; or iii. Metastatic Breast Cancer: As monotherapy in patients resistant to both paclitaxel and an anthracycline containing regimen 3. Patients already receiving a stable twice-daily dosing regimen of capecitabine (i.e. 1250 mg/m2, twice daily, equivalent to 2500 mg/m2 total daily dose, for two-weeks followed by a one-week rest period given as three-week cycles). 4. Patients with Body Mass Index (BMI) between 17 kg/m2 and 30 kg/m2. 5. Patients with Eastern Cooperative Oncology Group (ECOG) performance status 6. Patients with life expectancy of at least 3 months. 7. Patients should be non-smokers. 8. Patients should be able to comply with protocol requirements and assessments. 9. Patients willing to provide written informed consent for participation in the study.
Exclusion criteria
Exclusion criteria: 1. Patients with known hypersensitivity to capecitabine or to any of its components of formulation or 5-fluorouracil 2. Use of oral-coumarin derivative anticoagulants such as warfarin or phenprocoumon within 3 months prior to randomization or patients who may require these drugs within 1 month after completion of the study. 3. Patients receiving concomitant therapy of Phenytoin, Leucovorin, and CYP2C9 substrates or need to receive these medications within one month after last dose of receiving the study drug. 4. Known history of dihydropyrimidine dehydrogenase (DPD) deficiency 5. Patients with the following abnormal laboratory parameters: 6. Hemoglobin 9.0 g/dL. 7. Absolute Neutrophil Count (ANC) 1.5 x 109 /L. 8. Platelet count 100,000/μL. 9. Serum bilirubin 2 times the upper limit of normal 10. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) 2.5 times of upper normal limit 11. Creatinine clearance according to Cockcroft-Gault Equation 12. Patients with known brain metastasis and/or pre-existing motor or sensory neurotoxicity of severity >=2 by National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) criteria. 13. Consumption of grapefruit, grapefruit-like or grapefruit containing products within 7 days prior to study drug administration. 14. Ingestion of any alcoholic, caffeine or xanthine containing food or beverage within the 48 hours prior to study drug administration. 15. Use of enzyme modifying drugs within 30 days prior to study drug administration. They can be allowed depending on Principal Investigatorâ??s discretion in consultation with medical monitor, if they are kept constant in the last 30 days and are expected to remain constant during the study period. 16. Major surgery to the gastrointestinal tract, liver or kidney within 3 months prior to study entry which may affect the pharmacokinetics of capecitabine. 17. History of difficulty in swallowing, or any gastrointestinal disease e.g. ulcerative colitis, ulcerative stomatitis, malabsorption syndrome and/or lack of physical integrity of the upper intestinal tract which could affect drug absorption. 18. History or presence of cardiac disease including myocardial infarction, unstable angina, coronary artery disease, heart failure, dysrhythmias, cardiomyopathy, significant pericardial disease or any other cardiac illness that could affect patient safety. 19. Electrocardiographic evidence of acute ischemic or active conduction system abnormalities 20. History or evidence of uncontrolled coagulopathy 21. Patients with severe hepatic or renal impairment 22. History of difficulty with donating blood or difficulty in accessibility of veins or intolerance to venepuncture or patients who have bled more than 300 mL in the past 3 months 23. Participation in any clinical trial of investigational drugs or devices in the past 3 months 24. Any significant disease or condition of haemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system, diabetes, psychosis or any other body system which might compromise patient safety or affect study results. 25. Patients with history of alcoholism, or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate the bioequivalence between Test product capecitabine 500 mg tablets and Reference product Xeloda® (capecitabine 500 mg tablets)Timepoint: Day 1, 2 & 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To monitor the safety of patients. 2. To collect other pharmacokinetic data.Timepoint: Day 1, 2 & 3. | — |
Countries
India
Contacts
Public ContactShraddha Ekhatpurkar
Reliance Life Sciences Pvt. Ltd
Outcome results
None listed