A multicentre, randomized, open label, two-period, two-treatment, two-way crossover, bioequivalence study comparing Capecitabine Tablets USP 500 mg (Manufactured by: Dr. Reddyâ??s Laboratories., India) to the reference listed drug XelodaÂ® (Capecitabine) Tablets 500 mg (Distributed by: Roche Laboratories Inc., New Jersey 07110) in Metastatic Breast Cancer or Colorectal Cancer patients under fed condition - NI

Dr Reddys Laboratories0 个研究点目标入组 110 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Male or Female18 to 79 years of age (both inclusive) 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 Dukesâ?? C colon cancer who have undergone complete resection of the primary tumor when treatment with fluoropyrimidine therapy alone is preferred.
•Patients with metastatic colorectal carcinoma when treatment with fluoropyrimidine therapy alone is preferred
•Patients with metastatic breast cancer resistant to both Paclitaxel and an anthracycline containing chemotherapy regimen or resistant to Paclitaxel and 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.
•7.Patient with adequate bone marrow, renal and hepatic function

•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.Any of the following cardiac conditions:
•a.Unstable angina
•b.Myocardial infarction within the past 6 months
•c.NYHA (New York State Heart Association) class II-IV heart failure
•d.Severe uncontrolled ventricular arrhythmias
•e.Clinically significant pericardial disease
•f.Electrocardiographic evidence of acute ischemic or active conduction system abnormalities
•g.Any other cardiac illness that could lead to a safety risk to the patient in case of enrolment in the study
•4.History of drug/alcohol addiction
•5.Known brain metastasis
•6.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.
•7.Pre-existing motor or sensory neurotoxicity of a severity >= grade 2 by NCI CTCAE criteria.
•8.A positive hepatitis screen including hepatitis B surface antigen, HCV or HAV (IgM) antibodies

发起方

Dr Reddys Laboratories