A clinical trial to study the bioequivlence study of Capeciatabine in Locally Advanced Breast Cancer or Metastatic Breast Cancer or Colorectal Cancer patients under fed conditio
- Conditions
- Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
- Registration Number
- CTRI/2011/091/000032
- Lead Sponsor
- Dr Reddys Laboratories Hyderabad India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 88
1.Male or Female 18-79 years of age (both inclusive) and having a Body Mass Index (BMI) in between 18.5 and 30 calculated as weight in kg / height in m2
2.Patients must have/have had histopathologically /cytologically confirmed breast cancer or
colorectal cancer.
3. Adjuvant treatment for Patients following surgery of stage III (Dukesâ?? stage C) colon cancer.
Or
Patients with metastatic colorectal cancer
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.
4.Patients who require a daily dose of Capecitabine monotherapy, who are stabilized on twice daily dosing at a dose of 1250 mg/m2 and who have completed at least one cycle of chemotherapy
5.Patients should have their BSA (as per the DuBois formula) between 1.26-1.91 m2 (Both inclusive).
Note : Dosage and administration of Capecitabine will be as per instructions given in section 1.7 Dosage and administration.
6.Eastern Cooperative Oncology Group (ECOG) performance status <= 2
Prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil, or known DPD (Dihydropyrimidine Dehydrogenase) deficiency.
Pregnant or breast-feeding female
Any other condition that, in the investigator?s judgment, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.
Abnormal baseline findings considered by the investigator to indicate conditions that might affect study endpoints
Donation of blood (1 unit or 350 ml) within 90 days prior to receiving the first dose of investigational medicinal product for the current study.
Known, existing uncontrolled coagulopathy.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To characterise the pharmacokinetic profile of the sponsorâ??s test formulation (Capecitabine Tablets 500 mg, Manufactured by Dr. Reddyâ??s Laboratories, India) relative to that ofreference formulation (XELODA® 500 mg tablets, Manufacturedby Roche Registration Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom) in patients of Locally Advanced or Metastatic Breast Cancer or <br/ ><br>Colorectal Cancer under fed condition and to assess the bioequivalenceTimepoint: NI
- Secondary Outcome Measures
Name Time Method To monitor the safety of the patients, who are exposed to the Investigational Medicinal ProductTimepoint: NI