A clinical study, to Investigate the Safety and bioequivalence study of Capecitabine 500 mg Film Coated Tablets.
- Registration Number
- CTRI/2018/08/015269
- Lead Sponsor
- Onko Ila San ve Tic AS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Willing and able to provide voluntary informed consent and to follow the 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 1.27-1.92 m2 (Both inclusive) measured as per the Dubois formula.
4.Patients with histopathologically/cytologically confirmed colon, colorectal or breast cancer.
5.Patients with Dukesâ?? C colon cancer who have undergone complete resection of the primary tumor when treatment with fluoropyrimidine therapy alone is preferred.
Or
Patients with metastatic colorectal carcinoma when 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 on one cycle of Capecitabine chemotherapy on twice daily dosing at a dose of 1250 mg/m2 for 14 days.
7.Eastern Cooperative Oncology Group (ECOG) performance status <= 2.
8.Acceptable hematology status:
a.Hemoglobin >= 9 g/dL
b.Absolute neutrophil count (ANC) >= 1500 cells/mm3
c.Platelet count >= 100,000 cells/mm3
9.Acceptable liver function:
a.Alanine aminotransferase (ALT) <= 2.5 X ULN (<=5 x ULN if liver metastases present)
b.Aspartate aminotransferase (AST) <= 2.5 X ULN (<=5 x ULN if liver metastases present)
c.Bilirubin <= 1.5 X ULN
d.Alkaline phosphatase <= 2.5 X ULN (<=5 x ULN if liver metastases present)
10.Patients with Creatinine clearance >= 60 mL/minute
11.Patients with life expectancy of at least 6 months at the time of enrolment.
12.Female patients with negative serum pregnancy test at screening and negative urine pregnancy test at Day 0.
13.Patients who agree to use adequate contraception (eg, hormonal, chemical, double-barrier, or abstinence) while in the study.
14.No history of addiction to any recreational drug or drug dependence or alcohol addiction.
1.Known hypersensitivity or contraindication to fluoropyrimidine therapy.
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 before the first dose of Investigational Product.
12.Donation of blood (1 unit or 350 ml) within 90 days prior to receiving the first dose of investigational product for the current study.
13.Patients with difficulties in swallowing and retaining oral medications.
14.Patients taking any of the Cytochrome P450 2C9 substrates.
15.Any other medical condition or serious intercurrent 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.
16.Any other condition(s) which could significantly interfere with Protocol compliance including, but not limited to, dementia, psychosis, cognitive impairment, altered mental status, or other major psychiatric disorder.
17.Pregnant or breastfeeding.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To establish bioequivalence between Capecitabine 500 mg Film-Coated <br/ ><br>Tablets of Onko Ä°laç San. ve Tic. A.Å?. with Xeloda 500mg Film-Coated <br/ ><br>Tablets (Capecitabine) marketed by Roche Registration Limited, 6 Falcon <br/ ><br>Way, Shire Park, Welwyn Garden City, AL7 1TW, United KingdomTimepoint: Day 1, 2, 3 and 4
- Secondary Outcome Measures
Name Time Method To monitor the adverse events and to ensure safety of patients.Timepoint: Day 1 2 3 4