Health Condition 1: C189- Malignant neoplasm of colon, unspecified
Conditions
Interventions
Intervention1: Capecitabine: 1250 mg/m2 oral twice a day for one day
Control Intervention1: Xeloda: 1250 mg/m2 oral twice a day for two days
Sponsors
Przedsibiorstwo Farmaceutyczne LEKAM Sp z oo
Lambda Therapeutic Research Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male or Female patients 18-79 years of age (both inclusive) and having a Body Mass Index (BMI) between 18.50 and 30.00 calculated as weight in kg/height in m2. 2.Patients must have/have had histopathologically/cytologically confirmed colorectal or breast cancer or colon cancer. 3.Eastern Cooperative Oncology Group (ECOG) performance status 4.Patients with life expectancy of at least 3 months. 5.Ability to comply with the study requirement in the opinion of the Principal Investigator. 6.Ability to give a written informed consent for participation in the trial. 7.Adequate cardiac function (left ventricular ejection fraction [LVEF] >=50%) 8.In case of female patient the serum pregnancy test at screening visit and urine pregnancy test at the time of check in must be negative
Exclusion criteria
Exclusion criteria: 1.Pregnant or breast-feeding female. 2.Patients with history of arrhythmias, myocardial infarction or any heart failure (NYHA class III-IV) within the last 6 months. 3.Patient with Known brain metastasis. 4.Pre-existing motor or sensory neurotoxicity of a severity >= grade 2 by National Cancer Institute (NCI) criteria. 5.Positive results of HBsAg and/or anti-HCV and/or HAV antibodies and/or anti-HIV tests during screening procedures. 6.Participation in another clinical research study within a period of 60 days prior to randomisation. 7.Any other condition that, in the Investigatorâ??s judgment, might increase patientâ??s risk or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study. 8.Abnormal baseline findings considered by the Investigator to indicate conditions that might affect study endpoints. 9.Blood loss/blood donation exceeding 1 unit of 350 mL within 30 days prior to randomisation. 10.Heavy smokers, who smoke or use of any tobacco products more than 10 units a day.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters: Cmax and AUC0-t of capecitabine in plasma.Timepoint: 0.250, 0.500, 1.000, 1.500 | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety of the Investigational Medicinal Products (IMPs): physical examination, clinical laboratory tests, vital signs, 12â??lead ECG, ECHO and adverse events monitoringTimepoint: On day 3 | — |
Countries
India
Contacts
Public ContactDr Praveen Shetty
Lambda Therapeutic Research Ltd.
Outcome results
None listed