To evaluate the bioequivalence of two formulation of capecitabine Tablets 500 mg tablets in patients of Breast Cancer or Colorectal Cancer under fed condition

Completed

• Conditions: Malignant neoplasm of colon, unspecified,

• Registration Number: CTRI/2010/091/000136
• Lead Sponsor: Intas Pharmaceuticals Ltd India

Brief Summary

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 Laboratories Inc., New Jersey 07110) in patients of Breast Cancer or Colorectal Cancer under fed condition. XELODA® (Capecitabine) is a fluoropyrimidine carbamate with antineoplastic activity In the present study, the relative bioavailability of test formulation [Capecitabine Tablets USP 500 mg (Manufactured by: Intas Pharmaceuticals Ltd., India)] in comparison to the reference formulation [Xeloda® (capecitabine) Tablets 500 mg (Distributed by: Roche Laboratories Inc.,New Jersey 07110)] will be assessed after single oral dose (3 x 500 mg tablets) in adult patients with Breast Cancer or Colorectal Cancer. 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 Breast Cancer or Colorectal cancer, who in the opinion of their treating physicians are candidate for Capecitabine therapy. Moreover, this is also in agreement with the current draft guidance on Capecitabine by OGD, USFDA Totally 110 patient will be enrolled.However, it may be possible that the actual intra-patient variability for the current formulation may differ. The intra-patient variability for the current formulation will be estimated using the data of first 30 patients (completing both the periods) by the biostatistician not involved in the actual statistical analysis of the study using SAS program (Version 9.1.3 or higher). The proboble date of enrollment of the first patient will be 15 May 2010

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-05
• Last Update Posted: 2018-11-22

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 118

Inclusion Criteria

• 1.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 BSA between 1.26-1.91 (Both inclusive) should be included.
• 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.Patients with life expectancy of at least 3 months.
• 9.Able to comply with study requirement in opinion of Principal Investigator.
• 11.In case of female patient the serum pregnancy test at screening visit and urine pregnancy test at day 0 must be negative.

Exclusion Criteria

• Prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to5-fluorouracil, or known DPD (Dihydropyrimidine Dehydrogenase) deficiency.2. Pregnant or breast-feeding female3.
• Any of the following cardiac conditions:a.
• Unstable anginab.
• Myocardial infarction within the past 6 monthsc.
• NYHA (New York State Heart Association) class II-IV heart failured.
• Severe uncontrolled ventricular arrhythmiase.
• Clinically significant pericardial diseasef.
• Electrocardiographic evidence of acute ischemic or active conduction systemabnormalitiesg.
• Any other cardiac illness that could lead to a safety risk to the patient in case ofenrolment in the study4.
• History of drug/alcohol addiction5.
• Known brain metastasis.

Study & Design

• Study Type: BA/BE
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To characterise the pharmacokinetic profile of the sponsors 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., New Jersey 07110)] in patients of Breast Cancer or Colorectal Cancer under fed condition and to assess the bioequivalence	NIL

Secondary Outcome Measures

Name	Time	Method
To monitor the safety of the patients	NIL

Trial Locations

Locations (10)

Cancer hospital & research institute; 🇮🇳 Gwalior, MADHYA PRADESH, India

Central India Cancer Research Centre; 🇮🇳 Nagpur, MAHARASHTRA, India

Dept. of Medical Oncology, M S Patel Cancer Centre, Shree Krishna Hospital; 🇮🇳 Anand, GUJARAT, India

Dr.Rai Memorial Medical Centre; 🇮🇳 Chennai, TAMIL NADU, India

Jeevandeep Hospital; 🇮🇳 Surat, GUJARAT, India

Mahavir Cancer Sansthan; 🇮🇳 Patna, BIHAR, India

Manvata Curie Cancer centre; 🇮🇳 Nashik, MAHARASHTRA, India

Meeneakshi Mission Hospital; 🇮🇳 Madurai, TAMIL NADU, India

Noble Hospital (Oncology Department); 🇮🇳 Pune, MAHARASHTRA, India

Shatabdi Hospital; 🇮🇳 Nashik, MAHARASHTRA, India

Cancer hospital & research institute

🇮🇳Gwalior, MADHYA PRADESH, India

Dr B R Shrivastav

Principal investigator

br_shrivastav08@yahoo.com