A study of Capecitabine 200 mg/ ml with Xeloda 500 mg (Capecitabine) at a dose of 2000 mg in adult human cancer patients under fed conditions.
- Conditions
- Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
- Registration Number
- CTRI/2020/10/028417
- Lead Sponsor
- Shilpa Medicare Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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 per height in m2.
3. Patients having Body Surface Area between 1.27 to 1.92 m2 both inclusive measured as per the Dubois formula.
4. Patients with histopathologically or cytologically confirmed colon or colorectal or breast cancer.
5. Patients with Dukesâ?? 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 per m2 for 2 weeks followed by a one week rest period.
7. Cardiac ejection fraction greater or equal to 50 Percent by echocardiogram ECHO at screening.
8. Eastern Cooperative Oncology Group ECOG performance status less than or equal to 2.
9. Acceptable hematology status
a. Hemoglobin greater or equal to 9 g per dL
b. Absolute neutrophil count ANC greater or equal to 1500 cells per mm3
c. Platelet count greater or equal to 100,000 cells per mm3
10. Acceptable liver function:
a. Alanine aminotransferase ALT less than or equal to 2.5 X ULN
b. Aspartate aminotransferase AST less than or equal to 2.5 X ULN
c. Bilirubin less than or equal to 1.5 X ULN
d. Alkaline phosphatase less than or equal to 2.5 X ULN
11. Patients with creatinine clearance greater than 60 mL per minute.
12. Patients with life expectancy of at least 3 months at the time of enrolment.
13. Non-smokers and non-alcoholics
14. Male patients must agree to use an effective method of contraception from screening, during study and for at least 03 months after treatment discontinuation.
15. Female patients with negative serum pregnancy test at screening and negative urine pregnancy test on Day 0.
16. Women of child bearing potential, defined as women physiologically capable of becoming pregnant, unless they are using effective method of contraception during dosing of the investigational product practicing two acceptable methods of contraception.
Acceptable methods of contraception are:
a. Oral or parenteral injection, patch or implant) hormonal contraception which has been used continuously for at least one month prior to the first dose of study medication
b. Intrauterine device IUD or intrauterine system IUD or IUS
c. Double barrier method of contraception Condom and occlusive cap or condom and spermicidal agent)
d. Male sterilization at least 6 months prior to the screening, should be the sole male partner for that patient
e. Female sterilization surgical bilateral oophorectomy or tubal ligation within at least 6 weeks prior to study participation
f. Total abstinence,
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 investigational product.
2. Known hypersensitivity or contraindication to Ondansetron.
3. Known CNS metastasis.
4. Known deficiency of dihydropyrimidine dehydrogenase (DPD)
5. Patient with history of cardiac disease
6. Major surgical procedure (including periodontal) within 28 days of first dose of Investigational Product.
7. Surgical or other non-healing wounds.
8. Patients with positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV).
9. Patients with positive urine screen for drugs of abuse.
10. History of other malignancies in the last 5 years (except in situ cancer or basal or squamous cell skin cancer).
11. Has not recovered to Grade 0 or 1 toxicity from previous anticancer treatments or previous investigational agents. Exceptions are alopecia (any grade is acceptable), haemoglobin greater or equal to 9.0 g/dL, fatigue (Grade 2 is acceptable), and peripheral neuropathy (stable Grade 2 is acceptable) (As per National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], V5.0)
12. Participation in any clinical study within 90 days prior to receiving the first dose of Investigational Product.
13. Loss of blood greater or equal to 350 mL within 90 days prior to receiving the first dose of investigational product for the current study.
14. Patients taking or scheduled to receive any of the Cytochrome P450 2C9 substrates (As per appendix B)
15. Any other medical condition or uncontrolled systemic disease (e.g. cardiovascular disease, hypertension, diabetes mellitus etc.) that, in the opinion of the Investigator, may make it undesirable for the patient to participate in the study including but not limited to cirrhosis or psychiatric illness/social situations that would limit adherence to study requirements.
16. Lactating women.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare and evaluate bioavailability of Capecitabine 200 mg/ ml oral suspension of Shilpa Medicare Limited, India and Xeloda 500 mg Film-Coated Tablets (Capecitabine) marketed by Roche Registration Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom at a dose of 2000 mg in adult human cancer patients under fed conditions.Timepoint: A total of eighteen (18) blood samples of 3.0 mL each will be collected for PK analysis in each period of the study. A total of 72 blood samples will be collected during the study. Sample 1:Pre-dose blood sample (00.00)-within 1.00 hour prior to dosing,2- 0.17Hrs ,3- 00.33 Hrs,4-00.50Hrs ,5-00.67Hrs, 6-01.00Hrs,7-01.25Hrs ,8-01.50Hrs ,9-01.75Hrs,10-02.00Hrs,11-02.33Hrs,12-02.67Hrs,13-03.00Hrs,14-03.50Hrs,15-04.00Hrs,16-05.00Hrs,17-06.00Hrs ,18-08.00Hrs(± 02 minutes)
- Secondary Outcome Measures
Name Time Method To monitor the adverse events and to ensure the safety of patients.Timepoint: A total of eighteen (18) blood samples of 3.0 mL each will be collected for PK analysis in each period of the study. A total of 72 blood samples will be collected during the study. Sample 1:Pre-dose blood sample (00.00)-within 1.00 hour prior to dosing,2- 0.17Hrs ,3- 00.33 Hrs,4-00.50Hrs ,5-00.67Hrs, 6-01.00Hrs,7-01.25Hrs ,8-01.50Hrs ,9-01.75Hrs,10-02.00Hrs,11-02.33Hrs,12-02.67Hrs,13-03.00Hrs,14-03.50Hrs,15-04.00Hrs,16-05.00Hrs,17-06.00Hrs ,18-08.00Hrs(± 02 minutes)