A Study Comparing Capecitabine Capsule 500 mg (IntasPharmaceuticals Ltd., India) To The Reference Listed Drug Xeloda®(Capecitabine 500 mg; Roche Pharmaceuticals) In Patients Of BreastCancer Or Colorectal Cancer Under Fed Conditio
- Conditions
- Health Condition 1: C189- Malignant neoplasm of colon, unspecified
- Registration Number
- CTRI/2016/03/006741
- Lead Sponsor
- Intas Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 24
1. Male or Female >=18 to <= 65 years of age and having a Body Mass Index (BMI) at least 17 calculated as weight in kg / height in m2
2. Patients must have/have had histopathologically /cytologically confirmed breast cancer or colorectal cancer.
3.Patients with
a. Metastatic colorectal carcinoma when treatment with fluoro pyrimidine therapy alone is preferred.
b. Metastatic breast cancer resistant to both paclitaxel and an anthracycline-containing chemotherapy regimen
4. Eastern Cooperative Oncology Group (ECOG) performance status <= 2.
5. Patient with adequate bone marrow, renal and hepatic function.
6. Adequate Cardiac function (left ventricular ejection fraction[LVEF] >=50%)
7. Patient should have recovered from any toxic effects of previous chemotherapy as judged by the Investigator
8. Able to comply with study requirement in opinion of Principal Investigator.
9. Able to give written informed consent for participation in the trial.
1.Prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil, or known DPD (Dihydropyrimidine Dehydrogenase) deficiency.
2. Pregnant or breast-feeding female
3. History of drug/alcohol addiction
4. Known brain metastasis
5. Pre-existing motor or sensory neurotoxicity of a severity >= grade 2 by NCI CTCAE criteria.
6. A positive hepatitis screen including hepatitis B surface antigen and HCV antibodies
7. Known case of HIV infection.
8. 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 of the study.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AUCTimepoint: Day 07 and Day 14
- Secondary Outcome Measures
Name Time Method To monitor the safety of the patients who are exposed to the investigational medicinal product.Timepoint: Day 1 to Day 14