Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Intervention1: Capecitabine Tablets USP 500 mg
Each film -coated tablet contains: Capecitabine USP 500 mg Manufactured by: Intas Pharmaceuticals Ltd, India.
: The recommended dose of XELODA® is
equivalent to 2500 mg/m2 total daily dose) for 2 weeks followed by a 1-week rest period given as 3 week cycles. In current study, Test and Reference formulation of Capecitabine Tablets USP 500 mg will
Sponsors
Intas Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Patients should have their BSA (as per the DuBois formula) between 1.26-1.91 m2 (Both inclusive Pateints with metastatic breast cancer, colorectal cancer Eastern Cooperative Oncology Group (ECOG) performance status Patient with adequate bone marrow, renal and hepatic function. Adequate Cardiac function (left ventricular ejection fraction [LVEF] >=50%) Patient should have recovered from any toxic effects of previous chemotherapy as judged by the Investigator
Exclusion criteria
Exclusion criteria: 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 of the following cardiac conditions: Unstable angina Myocardial infarction within the past 6 months NYHA (New York State Heart Association) class II-IV heart failure Severe uncontrolled ventricular arrhythmias Clinically significant pericardial disease Electrocardiographic evidence of acute ischemic or active conduction system abnormalities Any other cardiac illness that could lead to a safety risk to the patient in case of enrolment in the study History of drug/alcohol addiction Known brain metastasis 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. Pre-existing motor or sensory neurotoxicity of a severity >= grade 2 by NCI CTCAE criteria. A positive hepatitis screen including hepatitis B surface antigen, HCV or HAV (IgM) antibodies Patients with HIV infection. Positive for Drug of abuse test
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To characterise the pharmacokinetic profile of the sponsorâ??s test formulation [Capecitabine Tablets USP 500 mg (Manufactured by: Intas Pharmaceuticals Ltd, India)] relative to that of reference formulation [Xeloda®(capecitabine) Tablets 500 mg (Distributed by: Roche Laboratories Inc., Brazil)] in patients of Metastatic Breast Cancer or Colorectal Cancer under fed condition and to assess the bioequivalence.Timepoint: NIL | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety of the patients, who are exposed to the Investigational Medicinal Product.Timepoint: NIL | — |
Countries
India
Contacts
Public ContactDr Praveen Shetty
Lambda Therapeutic Research Pvt Ltd
Outcome results
None listed