A clinical study to demonstrate bioequivalence between two drugs Xeloda (Reference) and Capecitabine 500 mg Tablets (Test) in cancer patients

Not yet recruiting

• Conditions: Locally advanced or metastatic breast cancer or metastatic colorectal cancer

• Registration Number: CTRI/2011/12/002266
• Lead Sponsor: Reliance Life Sciences Pvt Ltd

Brief Summary

**This study is a randomized, open-label, single-dose, two-treatment, three-sequence, three-period, partial replicate, crossover, comparative bioequivalence study. Trial comparing bioequivalence of Xeloda 500 mg and Capacitabine 500 mg in 66 patients of locally advanced or metastatic breast cancer or metastatic colorectal cancer.**

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-02
• Last Update Posted: 2012-10-25

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• Males or females 18 to 70 years of age.
• Patients with Body Mass Index (BMI) between 17 kg/m2 and 30 kg/m2.
• Patients with histopathologically/ cytologically confirmed breast cancer or colorectal cancer.
• Cancer patients who are already receiving stable twice daily dosing regimen of capecitabine as prescribed by treating physician.
• Patients with Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
• Patients with life expectancy of at least 3 months.
• Patients should be non-smokers.
• Patients willing to voluntarily provide written informed consent or consent from a Legally Acceptable Representative (LAR), if the patient is not in a condition to give consent.

Exclusion Criteria

• Patients with inadequate venous access to allow the collection of all samples via venous cannula in the study.
• Pregnant (female patients with a positive urine pregnancy test at screening and positive serum pregnancy test before period I of hospitalization) or lactating females.
• Patients with the following abnormal laboratory parameters: a.Serum creatinine more than 2.0 times of upper normal limit b.Aspartate amino transferase (AST) or alanine amino transferase (ALT) more than 2.5 times of upper normal limit c.Alkaline phosphatase ≥ 1.5 times of upper normal limit d.Platelet count les than 100,000/μL.
• e.Hemoglobin less than 8.0 g/dL.
• f.Absolute Neutrophil Count (ANC) less than 1.5 x 10 to power 9 /L.
• Patients with a known hypersensitivity to fluoropyrimidine therapy or known sensitivity to 5- fluorouracil or known Dihydropyrimidine dehydrogenase (DPD) deficiency.
• Patients with known brain metastasis and/or pre-existing motor or sensory neurotoxicity of severity ≥2 by National; Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) criteria.
• History or evidence of uncontrolled coagulopathy.
• History of hereditary galactose/ glucose/ lactase disorders.
• History or evidence of cardiac disease (Myocardial Infarction in last 6 months, unstable angina, heart failure, uncontrolled ventricular arrhythmia, significant pericardial disease).
• Patients with a history of alcoholism, found with current alcohol abuse based on Alcohol breath test and/ or drug abuse or who test positive in the urinary screening for drugs of abuse (Amphetamines, Morphine, Benzodiazepines, Marijuana, Cocaine and Barbiturates) except as required as medication for the current medical condition.
• Patients diagnosed to be HIV 1 and 2 or Hepatitis B (HBsAg) or Hepatitis C (HCV) virus positive.
• Patients having an abnormal serum calcium level at screening visit which as judged by the investigator could lead to safety risk to the patient upon participation in the trial or could interfere with the conduct of the trial.
• Patients who have participated in any other clinical investigation using experimental drugs or have bled more than 300 mL in the past 3 months.
• Any other condition which the investigator feels would pose a significant hazard to the patient if IP is administered.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
•AUC0—t	•D1, D3, D5 | •D1, D3, D5
Establish the bioequivalence of Test vs Reference in relation to the rate and extent of absorption on the basis of the following pharmacokinetic parameters:	•D1, D3, D5 | •D1, D3, D5
•Cmax	•D1, D3, D5 | •D1, D3, D5

Secondary Outcome Measures

Name	Time	Method
To monitor adverse events, including laboratory parameters	D1, D3, D5, D6
To determine other pharmacokinetic parameters of Test and Reference products.	•Tmax

Trial Locations

Locations (12)

Cancer Clinic; 🇮🇳 Nagpur, MAHARASHTRA, India

Columbia Hospital and Research Centre; 🇮🇳 Nagpur, MAHARASHTRA, India

Curie Manavata Cancer Centre; 🇮🇳 Nashik, MAHARASHTRA, India

Dr. Baraskar Hospital and Cancer Care Center; 🇮🇳 Nagpur, MAHARASHTRA, India

Kodlikeri Memorial Hospital; 🇮🇳 Aurangabad, MAHARASHTRA, India

Medipoint Hospitals Pvt. Ltd; 🇮🇳 Pune, MAHARASHTRA, India

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

Narayana Hrudayalaya Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Ruby Hall Clinic; 🇮🇳 Pune, MAHARASHTRA, India

Shatabdi Super Specialty Hospital; 🇮🇳 Nashik, MAHARASHTRA, India

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Cancer Clinic

🇮🇳Nagpur, MAHARASHTRA, India

Dr Smita Gupte

Principal investigator

09373107176

smita_gupte@rediffmail.com