To compare bioavailibilityof Capecitabine 500 mg tablets(manufactured by Reliance Life Sciences Pvt.Ltd., India) with Xeloda® (Capecitabine 500 mgtablets distributed by Genentech USA, Inc.) inadult cancer patients under fed condition.
- Conditions
- Health Condition 1: C189- Malignant neoplasm of colon, unspecifiedHealth Condition 2: C508- Malignant neoplasm of overlappingsites of breast
- Registration Number
- CTRI/2017/09/009930
- Lead Sponsor
- Reliance Life sciences Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 84
1. Males or non-pregnant or non-lactating females of age between 18 to 65 years (both inclusive).
a) Females of childbearing potential must have a negative serum pregnancy test at screening
and negative urine pregnancy test at period I hospitalization. Females of childbearing
potential include females who have entered puberty and all women who have a uterus and
ovaries and have not completed menopause. Females who have 12 consecutive months of
spontaneous amenorrhea (not amenorrhea induced by a medical condition or medical
therapy) or have bilateral absence of the ovaries (surgical or congenital) have completed
menopause.
b) Females of reproductive potential must be willing to use adequate contraception (as
defined below) at least four weeks before the first dose of the study drug except as noted
and continuing at least six months after the last dose of the study drug. For this study,
acceptable and effective methods of contraception for females includei.
Intrauterine device placed at least 3 months prior to the start of the study and
remaining in place during the study period,
ii. Two barrier methods used together (cervical cap, diaphragm, contraceptive sponge,
or vaginal spermicide plus a male or female condom) or
iii. Absolute sexual abstinence (no sexual intercourse or genital contact with a male
partner).
c) Females will not be considered of childbearing potential if one of the following is reported
and documented on the medical history:
i. Postmenopausal with spontaneous amenorrhea for at least one year; or
ii. Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding
for at least 6 months; or
iii. Total hysterectomy and an absence of bleeding for at least 3 months
d) Males with female partners of reproductive potential must be willing to use a male condom
throughout the entire study and continuing for three months after the last dose of study
medication.
2. Patients in whom capecitabine therapy is indicated
i. Dukesâ?? C colon cancer: Adjuvant therapy; or
ii. Metastatic colorectal cancer: First-line as monotherapy when treatment with
fluoropyrimidine therapy alone is preferred; or
iii. Metastatic Breast Cancer: As monotherapy in patients resistant to both paclitaxel and
an anthracycline containing regimen
3. Patients already receiving a stable twice-daily dosing regimen of capecitabine (i.e. 1250
mg/m2, twice daily, equivalent to 2500 mg/m2 total daily dose, for two-weeks followed by a
one-week rest period given as three-week cycles).
4. Patients with Body Mass Index (BMI) between 17 kg/m2 and 30 kg/m2.
5. Patients with Eastern Cooperative Oncology Group (ECOG) performance status <= 2.
6. Patients with life expectancy of at least 3 months.
7. Patients should be non-smokers.
8. Patients should be able to comply with protocol requirements and assessments.
9. Patients willing to provide written informed consent for participation in the study.
1. Patients with known hypersensitivity to capecitabine or to any of its components of
formulation or 5-fluorouracil
2. Use of oral-coumarin derivative anticoagulants such as warfarin or phenprocoumon within 3
months prior to randomization or patients who may require these drugs within 1 month after
completion of the study.
3. Patients receiving concomitant therapy of Phenytoin, Leucovorin, and CYP2C9 substrates or
need to receive these medications within one month after last dose of receiving the study drug.
4. Known history of dihydropyrimidine dehydrogenase (DPD) deficiency
5. Patients with the following abnormal laboratory parameters:
6. Hemoglobin 9.0 g/dL.
7. Absolute Neutrophil Count (ANC) 1.5 x 109 /L.
8. Platelet count 100,000/μL.
9. Serum bilirubin 2 times the upper limit of normal
10. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) 2.5 times of upper
normal limit
11. Creatinine clearance according to Cockcroft-Gault Equation <= 50 mL/min
12. 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.
13. Consumption of grapefruit, grapefruit-like or grapefruit containing products within 7 days prior
to study drug administration.
14. Ingestion of any alcoholic, caffeine or xanthine containing food or beverage within the 48
hours prior to study drug administration.
15. Use of enzyme modifying drugs within 30 days prior to study drug administration. They can be
allowed depending on Principal Investigatorâ??s discretion in consultation with medical monitor,
if they are kept constant in the last 30 days and are expected to remain constant during the
study period.
16. Major surgery to the gastrointestinal tract, liver or kidney within 3 months prior to study entry
which may affect the pharmacokinetics of capecitabine.
17. History of difficulty in swallowing, or any gastrointestinal disease e.g. ulcerative colitis,
ulcerative stomatitis, malabsorption syndrome and/or lack of physical integrity of the upper
intestinal tract which could affect drug absorption.
18. History or presence of cardiac disease including myocardial infarction, unstable angina,
coronary artery disease, heart failure, dysrhythmias, cardiomyopathy, significant pericardial
disease or any other cardiac illness that could affect patient safety.
19. Electrocardiographic evidence of acute ischemic or active conduction system abnormalities
20. History or evidence of uncontrolled coagulopathy
21. Patients with severe hepatic or renal impairment
22. History of difficulty with donating blood or difficulty in accessibility of veins or intolerance to
venepuncture or patients who have bled more than 300 mL in the past 3 months
23. Participation in any clinical trial of investigational drugs or devices in the past 3 months
24. Any significant disease or condition of haemopoeitic, gastrointestinal, renal, hepatic,
cardiovascular, respiratory, central nervous system, diabetes, psychosis or any other body
system which might compromise patient safety or affect study results.
25. Patients with history of alcoholism, or
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method