A multicentre, randomized, open label, two-period, two-treatment, two-way crossover, bioequivalence study comparing Capecitabine Tablets USP 500 mg (Manufactured by: Intas Pharmaceuticals Ltd, India) to the reference listed drug Xeloda® (Capecitabine) Tablets 500 mg (Distributed by: Roche Chemical and Pharmaceutical Products SA, Brazil) in Metastatic Breast Cancer or Colorectal Cancer patients under fed condition
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 15
- 主要终点
- To characterise the pharmacokinetic profile of the sponsor’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.
研究概览
简要总结
This is A multicentre, randomized, open label, two-period, two-treatment, two-way crossover, bioequivalence study comparing Capecitabine Tablets USP 500 mg (Manufactured by: Intas Pharmaceuticals Ltd, India) to the reference listed drug Xeloda® (Capecitabine) Tablets 500 mg (Distributed by: Roche Chemical and Pharmaceutical Products SA, Brazil) in Metastatic Breast Cancer or Colorectal Cancer patients under fed condition.
Background xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
XELODA® (Capecitabine) is a fluoropyrimidine carbamate with antineoplastic activity. It is an orally administered systemic prodrug of 5’-deoxy-5-fluorouridine (5’-DFUR) which is converted to 5-fluorouracil. The chemical name for Capecitabine is 5’-deoxy-5-fluoro-N-[(pentyloxy) carbonyl]-cytidine
Rationale For Study Design
Capecitabine is a cytotoxic drug. It would be unethical to do this study on healthy volunteers. Therefore the bioequivalence study is proposed to be carried out on patients of Metastatic Breast Cancer or Colorectal cancer, who in the opinion of their treating physicians are candidates for Capecitabine therapy. Moreover, this is also in agreement with the current draft guidance on Capecitabine by OGD, USFDA.
The recommended dose of XELODA® is 1250 mg/m2 administered orally twice daily (morning and evening; equivalent to 2500 mg/m2 total daily dose) for 2 weeks followed by a 1-week rest period given as 3 week cycles. The dose of Capecitabine can be reduced in case of toxicity as per the Prescribing information of XELODA®.
The elimination half-life of Capecitabine is about ¾ of an hour.
In current study, Test and Reference formulation of Capecitabine Tablets USP 500 mg will be administered as a single dose as multiples of 500 mg on Day 1 and Day 2 morning dose as per randomization schedule. The evening dose on day 1 and day 2 will be locally approved and marketed capecitabine Tablets 500 mg. Locally approved and marketed Capecitabine will also be provided for the remaining treatment cycle/s.
Objective
Primary Objective:
To characterise the pharmacokinetic profile of the sponsor’s test formulation [Capecitabine Tablets USP 500 mg (Manufactured by: Intas Pharmaceuticals Ltd, xml:namespace prefix = st1 ns = "urn:schemas-microsoft-com:office:smarttags" /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.
Secondary Objective:
To monitor the safety of the patients, who are exposed to the Investigational Medicinal Product.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18.00 Year(s) 至 79.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
To characterise the pharmacokinetic profile of the sponsor’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.
时间窗: NIL
次要结局
- To monitor the safety of the patients, who are exposed to the Investigational Medicinal Product.(NIL)