CTRI/2011/10/002090 [Registered on: 25/10/2011] Trial Registered Prospectively
Last Modified On:
08/06/2012
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
Study Design
Randomized, Crossover Trial
Public Title of Study
The study will be conducted to monitor safety and compare the bioavailability of Capecitabine 500 mg tablets of Sun Pharmaceutical Industries Limited, India, and Xeloda (Capecitabine) 500 mg of Roche Registration Ltd. after administration of single dose, in Cancer patients under fed conditions.
Scientific Title of Study
A RANDOMIZED, OPEN LABEL, TWO TREATMENT, FOUR PERIOD, TWO SEQUENCE, SINGLE DOSE, REPLICATED CROSSOVER, BIOEQUIVALENCE STUDY OF CAPECITABINE 500MG TABLETS OF SUN PHARMACEUTICAL INDUSTRIES LIMITED, INDIA AND XELODA (CAPECITABINE) 500MG TABLETS OF ROCHE REGISTRATION LTD., IN CANCER PATIENTS UNDER FED CONDITIONS.
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
CPB_500T_IR_3265_11 (a); Version 00 dated 31/08/11
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Asirvatham Speciality hospital,Oncology Department, Medical Oncology Division,
22,Rajaji street,Gandhiji road,
Madurai-625020,Tamil Nadu,India. Madurai TAMIL NADU
919442619775
ijebasingh@gmail.com
Dr V Satya Suresh Attili
BIBI General Hospital & Cancer Center
Clinical Research Department(3rd Floor), 16-3-991/1/c,Govt.Printing Press Road,Malakpet,
Hyderabad-500024
India Hyderabad ANDHRA PRADESH
919246243034
sureshattilli@yahoo.com
Dr K Velavan
Erode Cancer Institute
Erode Cancer Center, Department of Oncology, Radiology Division, Ground Floor, Room Number 1,
Velavan nagar
Perundurai Road. thindal
Erode-638 012, Tamil nadu.
Erode TAMIL NADU
04242330135
kvels@rediffmail.com
DrKNSrinivasan
GVN hospitals
Dr.G.Viswanathan Speciality Hospital,Department of Oncology, Radiology Division, Ground floor, Consulting room number 2, # 27 Babu Road, Trichy - 620 008, TN, India.
Tiruchirappalli TAMIL NADU
9443337230
kns68@yahoo.com
Dr N SUDHAKAR
KOVAI MEDICAL CENTER & HOSPITAL LTD
Oncology Department; Medical Oncology Division; Room Number 2; 3209, Avanashi road,
Coimbatore-641014
Tamil Nadu, India Coimbatore TAMIL NADU
Hospital Ethics Committee, Trichy affiliated to Dr.G.Viswanathan Specialty Hospital for Dr.K.N.Srinivasan
Approved
Institutional Ethics Committee Erode Cancer Center, Erode affiliated to Erode Cancer Institute for Dr.K.Velavan
Approved
Institutional ethics committee NRR Hospital, Bangalore affiliated to NRR Hospital for Dr Yathish Kumar H.M.
Approved
Institutional Ethics Committee, Hyderabad affiliated to BIBI GENERAL HOSPITAL AND CANCER CENTER for Dr. V. Satya Suresh attili
Approved
Institutional review board, Madurai affiliated to Asirvatham Speciality hospital for Dr. Jebasingh
Approved
KMCH Ethics Committee, Coimbatore affiliated to Kovai Medical Center & Hospital for Dr. N. Sudhakar
Approved
Virtuous Independent Ethics Committee, Hydrabad for Dr. Ravi Kumar Saxena
Submittted/Under Review
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
Cancer,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Capecitabine
1250 mg/m2 administered twice daily orally :BD (morning and evening; equivalent to 2500 mg/m2 total daily dose) for 14 days followed by a 7-day rest period.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
80.00 Year(s)
Gender
Both
Details
i. Patients at least 18 years or older.
ii. Patients whose body surface area is less than or equal to 1.26 m2, between 1.53 to 1.66 m2, between 1.93 to 2.06 m2 dose is to be given in multiples of 500 mg tablet
iii. Patients who have no evidence of underlying disease (except Dukes C colon cancer,
metastatic colorectal carcinoma, metastatic breast cancer) during screening medical history and whose physical examination is performed within 21days prior to commencement of the study.
iv. Patients who are taking Capecitabine as a single agent for adjuvant treatment for Dukes C
colon cancer who have undergone complete resection of the primary tumor when treatment
with fluoropyrimidine therapy alone is preferred.
v. Patients who are taking Capecitabine as first-line treatment for metastatic colorectal
carcinoma when treatment with fluoropyrimidine therapy alone is preferred.
vi. Patients who are taking Capecitabine for the treatment of metastatic breast cancer resistant
to both paclitaxel and an anthracycline containing chemotherapy regimen or resistant to
paclitaxel and for whom further anthracycline therapy is not indicated, eg, patients who have
received cumulative doses of 400 mg/m2 of doxorubicin or doxorubicin equivalents.(only
capecitabine as chemotherapeutic agent).
vii. Patients should not take any adjuvant chemotherapeutic agent except capecitabine
throughout the study and 4 weeks before the study.
viii. Patients whose life expectancy of greater than or equal to 6 months.
ix. Patients having histologically proven Cancer.
x. Patients having no brain metastasis.
xi. Patients with Performance less than or equal to 2 on the ECOG performance scale (listed in Appendix III).
xii. Patients whose screening laboratory values are within normal limits or considered by the
Investigator/sub-Investigator to be of no clinical significance.
xiii. The subject must sign the written consent form (subject Information and Consent Form)
prior to study entry.
xiv. The subject must have clinically acceptable results from the screening procedure including
blood pressure, heart rate, 12 lead ECG, X-Ray, physical exam, medical history, hematology,
biochemistry, urinalysis, and infection screen (Hepatitis B Antigen, Hepatitis C Antibody,
HIV, VDRL/RPR)
xv. Availability of subject for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent.
xvi. Female subjects
of child bearing potential practicing an acceptable method of birth control for the
duration of the study as judged by the investigator(s), such as condoms, foams, jellies,
diaphragm, intrauterine device (IUD), or abstinence.
OR
Postmenopausal for at least 1 year.
OR
Surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy has
been performed on the Subject).
ExclusionCriteria
Details
i. Subjects with a history of clinically significant Cardiovascular, pulmonary, hepatic, renal,
hematological (including leucopenia, thrombocytopenia), gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological, or psychiatric disease, in the last 12
months.
ii. Allergy or Significant history of hypersensitivity or idiosyncratic reactions to Capecitabine
or any related compounds etc.
iii. Cancer patients with a prior history of coronary artery disease, receiving concomitant
therapy of warfarin.
iv. Cancer patients with a prior history of dihydropyrimidine dehydrogenase deficiency.
v. Presence of infections which reduce life expectancy.
vi. Undergoing concomitant oncological treatment.
vii. History of difficulty in swallowing or coming for follow up.
viii. Clinically significant illness (except Dukes C colon cancer, metastatic colorectal carcinoma,
metastatic breast cancer) within 4 weeks before the start of the study.
ix. Females who are pregnant, breastfeeding, or are likely to become pregnant.
x. Subjects with a history of alcohol, drug or substance abuse in the past 12 months.
xi. Subjects who have used enzyme inducing or inhibiting drugs (like Phenytoin, Carbamazepine,
Barbiturates, Gresiofulvine etc.) within 30 days of day 1 dosing of the study or
any other prescription or over-the-counter medication within 14 days of day 1 dosing of the
study.
xii. Subjects who have used hormonal methods of contraception (including oral and transdermal
contraceptives, injectable progesterone, progestin sub-dermal implants, progesteronereleasing
IUDs, post-coital contraception methods) or hormone replacement therapy within
30 days of day 1 dosing of the study.
xiii. Subjects deemed uncooperative or non compliant.
xiv. Smoking or consumption of any nicotine products.
xv. Subjects who have consumed alcohol within 48 hours prior to day 1 dosing of the study.
xvi. Subjects who have consumed xanthine-containing products (including caffeine, theobromines,
etc.) within 24 hours prior to day 1 dosing of the study.
xvii. Subjects who have consumed grapefruit, pomelo or grapefruit- or pomelo-containing products
within 72 hours prior to day 1 dosing of the study.
xviii. Subjects who have had an abnormal diet within 30 days prior to day 1 dosing of the study.
xix. Subjects who have received an investigational product within the last 2 months prior to day 1
dosing of the study.
xx. Abnormal 12 lead ECG
xxi. Subjects who have donated a total of 100 mL to 499 mL of whole blood within 30 days prior
to day 1 dosing or Subjects who have donated a total of more than 499 mL of whole blood
within 56 days prior to day 1 dosing of the study.
xxii. Positive result to HIV, HCV, RPR and HBsAg.
xxiii. Subjects who have:
Systolic blood pressure less than 90 mm of Hg or more than 140 mm of Hg
Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg
Minor deviations (2-4mm Hg) at check-in may be acceptable at the discretion of the Investigator.
Pulse rate below 60/min. or above 100/min.
Method of Generating Random Sequence
Permuted block randomization, fixed
Method of Concealment
Centralized
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
1)To characterize the rate and extent of bioavailability of the test products in comparison with the reference product after single dose administration under fed conditions
2)Monitor the safety of the subjects participating in the study and the tolerability of the test products in comparison with the reference considering adverse events.
Pre-dose blood sample: (1 x 6 mL) will be collected within 1 hour prior to dosing.
Post-dose blood samples (1 x 2 mL each) will be collected at 0.167, 0.333, 0.500, 0.667, 0.833, 1.000, 1.167, 1.333, 1.500, 1.667, 1.833, 2.000, 2.250, 2.500, 3.000, 3.500, 4.000, 4.500, 5.000 and 6.000 hours after administration of morning dose in each period.
Secondary Outcome
Outcome
TimePoints
NA
NA
Target Sample Size
Total Sample Size="44" Sample Size from India="44" Final Enrollment numbers achieved (Total)= "" Final Enrollment numbers achieved (India)=""
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
This study isa randomized, multicenter, open label, two treatment, four period, two sequence, single dose, replicated crossover study for monitoringthe safety of the Patients participating in the study and to assess the bioequivalence of Capecitabine 500mg tablets of Sun Pharmaceutical Industries Limited, India, and Xeloda® (Capecitabine) 500mg of Roche Registration Ltd. in Cancer patients under fed conditions.