Capecitabine 500mg tablets two treatment will be provided for 4 days to cancer patients and Plasma sample will be collected at multiple time points at different centers in India
- 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/2020/02/023140
- Lead Sponsor
- Hetero Labs Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
A patient fulfilling all the following criteria will be included in the present study:
Patients
1)a)Willing to provide written informed consent for participation in the study;
b)Having ability to comprehend the nature and purpose of the study;
c)Willing to be available for the entire study period and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures, including anticipated ability to swallow tablets, as per study protocol
2)Disease population: Patients with clinical diagnosis of
3)Metastatic colorectal cancer; OR
Locally advanced or metastatic breast cancer; OR
Stage III (Dukeâ??s stage C) colon cancer after surgery and eligible for adjuvant treatment
Treatment condition: Patients requiring twice daily dose of Capecitabine 1250 mg/m2 monotherapy as multiple of 500 mg tablets, and titration away from this dosing regimen is unlikely during the study;
4)Age of 18-65 years (both inclusive);
5)Patients with Eastern Cooperative Oncology Group (ECOG) performance status not less than 2;
6)Patients with life expectancy of at least 3 months;
Adequate bone marrow, hematological, renal and hepatic functions, defined for at least following lab parameters, but not limited to:
Hemoglobin Not more than 9.0 gm per dL;
Absolute neutrophil count (ANC) not more than 1500 cells per mm3;
Platelet count not more than 100,000 per mm3;
Total bilirubin not less than 1.5 x upper limit of normal (ULN);
SGPT / SGOT not less than 3 x ULN (not less than 5 x ULN, if liver metastases present);
Serum creatinine not less than 1.5 x ULN;
Creatinine clearance not more than 51 to 128 mL pre min (calculated by Cockcroft and Gault equation);
7)With a normal or clinically non-significant laboratory values (apart from those mentioned above) as determined by hematological, biochemestry tests and urine analysis;
8)With a normal or clinically non-significant 12-lead ECG;
9)With a normal or clinically non-significant 2D Echo (performed within 3 months of screening);
10)No persistent clinically significant toxicities from prior drugs at screening;
11)Non-smokers or ex-smoker or mild / moderate smokers and willing to abstain from chewing or smoking any tobacco containing product at least 72.00 hrs prior to first dosing of the study and throughout study;
12)Willing to abstain from alcohol or alcoholic products within 24.00 hrs prior to first dosing of the study and throughout the study;
13)Willing to abstain from, xanthine or its derivative containing food or beverages (e.g. chocolates, tea, coffee or cola drinks) within 48.00 hrs prior to first sample collection and throughout sampling points during each study period;
14)Willing to abstain from grapefruit or its juice within 72.00 hrs prior to first dosing of the study and throughout the study;
15)In case of concomitant drugs used along with Capecitabine, these drugs:
a)Must be the same for all the study period;
b)Must not require any change in their dosing regimen during the study;
c)Do not interfere with the assay for measuring Capecitabine in the plasma;
16)In case of male patients:
a)Patients either abstain from sexual intercourse or who are willing to use adequate contraception (e.g. use of condoms) during sexual intercourse w
A patient fulfilling any one of the following criteria will be excluded from the study:
1)Institutionalized patients;
2)History of known hypersensitivity or contraindication to fluoropyrimidine therapy or known sensitivity to 5-fluorouracil;
3)Known deficiency of Dihydropyrimidine Dehydrogenase (DPD);
4)Hypersensitivity to Capecitabine or related group of drugs or to any of the excipients of formulation which in the opinion of Investigator, would compromise the safety of the patient or the study;
5)Significant history or current evidence of chronic â?? infections, cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic (endocrine), hematological, gastrointestinal,
immunological or psychiatric diseases, or organ dysfunction, which in the opinion of Investigator, would compromise the safety of the patient or the study;
6)Any of the following features within 3 months of the administration of Capecitabine: myocardial infarction/ischemia, angina, coronary artery disease, coronary artery/peripheral artery bypass graft, cerebrovascular accident, transient ischemic attack, dysrhythmias, electrocardiographic changes, cardiomyopathy or uncontrolled coagulopathy;
7)Grade not more than 3 hemorrhage (as per CTCAE, Version 5.0, Nov 2017) within 4 weeks prior to first dose of IP;
8)Currently under significant bleeding disorder and/or receiving concomitant therapy of coumarin-derivative anticoagulants such as warfarin and phenprocoumon or history of usage of coumarin-derivative anticoagulants in the previous 01 month prior to study start (1st dosing);
9)Receiving Phenytoin, Leucoverin or CYP2C9 substrates at the time of screening or anticipated use of these drugs during the study period [if the patient was on any of these drugs before screening, a wash out period of at least 5 half-lives must have elapsed since the last dose of the such drug];
10)History of difficulty in swallowing which could affect drug absorption;
11)A medical or surgical condition that might interfere with the absorption, distribution, metabolism, or excretion of Capecitabine during the study;
12)History or current evidence of significant hematological or renal disorder (drug-induced or idiopathic);
13)History or current evidence of significant liver disease;
14)Concurrent use of drugs known to suppress bone marrow function;
15)A history of alcohol or drug dependence during the 6-month period immediately prior to first dosing of the study;
16)Positive alcohol breath or urine drug of abuse (except for prescribed benzodiazepines) tests at check-in procedure of the study period;
Positive test for Human Immunodeficiency Virus (HIV) type I/II antibodies or Hepatitis B surface antigen (HbsAg) or Hepatitis C virus (HCV) antibodies during screening;
17)In case of female patients:
a)Planning to become pregnant;
b)Lactating or nursing patients;
18)Participated in any clinical investigation requiring repeated blood
sampling, blood donation, or have blood loss of >200 mL or participated in any clinical study within 90 days prior to first dosing of the study;
19)Any major illness or hospitalization within 90 days prior to first dosing of the study;
20)History of difficulty in accessibility of veins in arms.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of the study is to assess whether the test product is bioequivalent to reference product after dosing subjects for 04 days on Capecitabine 500mg twice a dayTimepoint: Pre-dose, 0.25, 0.50, 0.75, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.50, 4.00, 4.50, 5.00, 6.00, 7.00, 8.00 and 10.00 hours after morning dose of each period
- Secondary Outcome Measures
Name Time Method The secondary objective is assessment of safety and tolerability profile of test and reference products.Timepoint: Pre-dose, 0.25, 0.50, 0.75, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.50, 4.00, 4.50, 5.00, 6.00, 7.00, 8.00 and 10.00 hours after morning dose of each period