To evaluate bioavailability of oral Capecitabine in adult human cancer patients under fed conditions
- Conditions
- Health Condition 1: C509- Malignant neoplasm of breast of unspecified siteHealth Condition 2: C189- Malignant neoplasm of colon, unspecifiedHealth Condition 3: C20- Malignant neoplasm of rectum
- Registration Number
- CTRI/2021/06/034321
- Lead Sponsor
- ShilpaMedicareLimited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 35
The patients will be considered eligible for the study based on the following criteria:
1. Willing and able to provide voluntary informed consent and able to comply with protocol requirements
2. Male or Female aged 18 to 65 years (both inclusive) having body mass index (BMI) at least 17.00 calculated as weight in kg/height in m2.
3. Patients having Body Surface Area between 1.27-1.92m2 (both inclusive) measured as per the Dubois formula.
4. Patients with histopathologically/cytologically confirmed colon or colorectal or breast cancer.
5. Patients with Dukesââ?¬• C colon cancer who have undergone complete resection of the primary tumor and when treatment with fluoropyrimidine therapy alone is preferred.
Or
Patients with metastatic colorectal carcinoma in whom treatment with fluoropyrimidine therapy alone is preferred.
Or
Patients with locally advanced or metastatic breast cancer, after failure of taxanes and an anthracycline-containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.
6. Patients requiring a daily dose of Capecitabine monotherapy and stabilized at least one cycle of Capecitabine chemotherapy (i.e. twice daily at a dose of 1250 mg/m2 for 2 weeks followed by a one- week rest period).
7. Cardiac ejection fraction � 50% by echocardiogram (ECHO) within 14 days prior to first dose of Investigational Product.
8. Eastern Cooperative Oncology Group (ECOG) performance status � 2.
9. Acceptable hematology status:
a. Hemoglobin � 9 g/dL
b. Absolute neutrophil count (ANC) � 1500 cells/mm3
c. Platelet count � 100,000 cells/mm3
10. Acceptable liver function:
d. Alanine aminotransferase (ALT) � 2.5 X ULN (�5 x ULN if liver metastases present)
e. Aspartate aminotransferase (AST) � 2.5 X ULN (�5 x ULN if liver metastases present)
f. Bilirubin � 1.5 X ULN
g. Alkaline phosphatase � 2.5 X ULN (�5 x ULN if liver metastases present)
11. Patients with Creatinine clearance � 60 mL/minute.
12. Patients with life expectancy of at least 3 months at the time of enrolment.
13. Non-smokers and non-alcoholics
14. Female patients with negative serum pregnancy test at screening and negative urine pregnancy test on Day 0.
15. Patients who agree to use adequate contraception (e.g., hormonal, chemical, double-barrier methods such as condom or diaphragm with intra-vaginally applied spermicide, or abstinence) while in the study
16. No history of addiction to any recreational drug or drug dependence.
17. In case of male patients: Either partner or patient must use an effective method of avoiding pregnancy for at least 4 weeks prior to study drug administration, during study and up to 30 days after the last dose of study drug or till next chemotherapy cycle.
The patients will be excluded from the study based on the following criteria:
1.Known hypersensitivity or contraindication to fluoropyrimidine therapy or to any of the components of
Capecitabine.
2.Known hypersensitivity or contraindication to Ondansetron.
3.History or presence of any uncontrolled debilitating systemic disease (e.g. cardiovascular disease, hypertension, diabetes mellitus etc.)
4.Known CNS metastasis.
5.Major surgical procedure (including periodontal) within 28 days of first dose of Investigational Product.
6.Surgical or other non-healing wounds.
7.Patients with positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV).
8.Patients with positive urine screen for Drugs of Abuse.
9.History of other malignancies in the last 5 years (except in situ cancer or basal or squamous cell skin cancer).
10.Has not recovered to Grade 0 or 1 toxicity from previous anticancer treatments or previous investigational agents. Exceptions are alopecia (any grade is acceptable), fatigue (Grade 2 is acceptable), and peripheral neuropathy (stable Grade 2 is acceptable) (Per National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], V5.0)
11.Participation in any clinical study within 90 days prior to receiving the first dose of Investigational Product.
12.In patients with severe leukopenia, neutropenia, or thrombocytopenia
13.In patients with severe hepatic impairment
14.In patients with severe renal impairment (Creatinine clearance below 30 ml/min)
15.Severe liver and kidney diseases
16.Donation of blood � 350 mL within 90 days prior to receiving the first dose of investigational product for the current study.
17.Patients taking or scheduled to receive any of the Cytochrome P450 2C9 substrates (As per appendix B)
18.Any other medical condition or serious inter current illness that, in the opinion of the Investigator, may make it undesirable for the subject to participate in the study including but not limited to cirrhosis or psychiatric illness/social situations that would limit adherence to study requirements.
19.Lactating women.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To establish bioequivalence between Capecitabine Dispersible Tablets 1000 mg of Shilpa Medicare Limited, India with Xeloda�® 500 mg Film-Coated Tablets (Capecitabine) of Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany.Timepoint: Pre-dose samples will be collected at 00.00hrs post dose samples will be collected on 0.17hrs, 0.33hrs,0.50hrs,0.67hrs,1.00hrs,1.25hrs,1.50hrs,1.75,2.00hrs,2.33hrs,2.67hrs,3.00hrs,3.50hrs,4.00hrs,5.00hrs,6.00hrs,8.00hrs as we are comparing test and reference up to four days total blood samples will be collected up to four days. Samples analyses will be evaluated after 2 weeks of the study completion
- Secondary Outcome Measures
Name Time Method To monitor the adverse events and to ensure the safety of patients.Timepoint: Till end of six weeks