A Bioequivalence study of two formulations of Capecitabine tablets in breast cancer and colorectal cancer patients.
- Conditions
- Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
- Registration Number
- CTRI/2012/01/002386
- Lead Sponsor
- Intas Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 104
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 <= 2.
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
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
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method