Health Condition 1: null- Patients with Metastatic Breast Cancer, Dukeâ??s C Colon Cancer or Metastatic Colorectal Cancer
Conditions
Interventions
Intervention1: XELODA® -Capecitabine 500 mg tablets: Capecitabine 1250 mg/m2 administered twice daily orally :BD (morning and evening
equivalent to 2500 mg/m2 total daily dose) for 14 days including of three study periods.
Control Intervention1: Capecitabine 500 mg tablets: Capecitabine 1250 mg/m2 administered twice daily orally
BD morning and evening
equivalent to 2500 mg/m2 total daily dose for 14 days including of three study periods.
Sponsors
Cadila Healthcare Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1) Patients must be receiving stable doses of Capecitabine (e.g.: 2500 mg/m2/day in two divided doses of 1250 mg/m2 , for 2 weeks followed by a 1 week rest period given as 3 week cycles) for the treatment of metastatic breast cancer, Dukeâ??s C colon cancer following complete resection, and metastatic colorectal carcinoma. Patients must have completed at least one cycle. 2) Males or non pregnant or non lactating females of age >= 18 years and a) Females of childbearing potential must have a negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test performed within 28 days prior to initiation of the study & at the time of check-in of each period. b) Acceptable forms of contraception include the following: i. Intrauterine device in place for at least 3 months prior to the start of the study and remaining in place during the study period, or ii. Barrier methods containing or used in conjunction with a spermicidal agent, or iii. Surgical sterilization, or iv. Practicing sexual abstinence throughout the course of the study 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 3) Life expectancy of at least 3 months. 4) Patients willing to not change their concurrent medications during the study. 5) All patients should have a Body Mass Index (BMI) less than or equal to 35 but greater than or equal to 18. BMI values should be rounded to the nearest integer. (e.g. 35.4 rounds down to 35, while 17.5 rounds up to 18) 6) Able to comply with Protocol requirements and assessments 7) Able to give written informed consent to participate in the study 8) All patients should be judged eligible by the principal investigator or co-investigator or physician during a pre-study safety assessment performed within 28 days of the first dose of study medication which will include a) A complete medical history b) A normal or clinically non-significant physical examination. c) Within normal limits or clinically non-significant laboratory evaluation results (unless otherwise noted in the exclusion criteria) for the following tests
Exclusion criteria
Exclusion criteria: Subject candidates must not be enrolled in the study if they meet any of the following criteria: 1. History of allergic responses to Capecitabine, or other related drugs and any of its formulation ingredients or 5-fluorouracil. 2. Patients receiving concomitant therapy of warfarin (coumarin anticoagulants) or history of usage of coumarin anticoagulants in the previous three months prior to study start (dosing). 3. Known history of dihydropyrimidine dehydrogenase deficiency 4. Consumption of grapefruit, grapefruit-like or grapefruit containing products within 7 days of drug administration. 5. Ingestion of any alcoholic, caffeine or xanthine containing food or beverage within the 48 hours prior to the initial dose of study medication. 6. Use of enzyme-modifying drugs within 30 days prior to receiving the first dose of study medication (listed in Appendix-II). 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. 7. History of moderate (30-50 ml/min creatinine clearance) or severe ( 8. Impaired hepatic function (bilirubin >=2.5 times the upper limit of normal, transaminases or alkaline phosphatase >= 2.5 times the upper limit of normal). 9. Major surgery to the gastrointestinal tract, the liver or kidney within 4 weeks of study entry which may impact on the pharmacokinetics of Capecitabine. 10. Participation in any investigational drug study within 30 days prior to period 1 dosing. 11. History of difficulty in swallowing, or any gastrointestinal disease which could affect drug absorption. 12. History of peptic ulcer, ulcerative colitis, ulcerative stomatitis and/or lack of physical integrity of the upper intestinal tract. 13. Patients with History of coronary artery disease. 14. Patients with prolonged QT or clinically significant ECG changes 15. Known, existing uncontrolled coagulopathy. 16. Donation or loss of blood or plasma of one unit (about 450 mL whole blood or 220 mL plasma) in the previous 60 days. 17. Any significant disease or condition which might compromise the haemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system, diabetes, psychosis or any other body system. 18. History of drug dependence, history of alcoholism in the past 2 years prior to screening. 19. Smokers, who smoke more than or equal to 10 cigarettes per day or more than or equal to 20 biddies per day or those who cannot refrain from smoking during study period. 20. History of difficulty with donating blood or difficulty in accessibility of veins or intolerance to venipuncture. 21. History of allergic response to heparin. 22. A positive hepatitis screen (includes subtypes B & C) 23. A positive test result for HIV antibody and / or syphilis (RPR/VDRL) 24. Any food allergy, intolerance, restriction or special diet that, in the opinion of the Principal Investigator or Sub-Investigator, could contraindicate the patientâ??s participation in this study 25. Any other condition that, in the investigatorâ??s judgment, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objectives
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To characterize the pharmacokinetic profile of the sponsorâ??s test formulation (Capecitabine Tablets 500 mg, Manufactured by Cadila Heathcare Limited, India) relative to that of reference formulation (XELODA® 500 mg tablets, Manufactured by Genentech USA Inc. USA) in patients of Metastatic Breast Cancer, Dukeâ??s C Colon Cancer or Metastatic Colorectal Cancer under fed condition and to assess the bioequivalence.Timepoint: Time points are 30 minutes prior to drug dosing and at 0.25hr, 0.50hr, 1hr, 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 5hr, 6hr, 8hr and 10 hours post-dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety of the patientsTimepoint: 30 minutes prior to drug dosing and 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 and 10 hours post-dose. | — |
Countries
India
Contacts
Public ContactMr Chirag Shah
Clinatha Research Ltd.
Outcome results
None listed