CTRI/2011/12/002288 [Registered on: 23/12/2011] 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 Ltd., 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, THREE PERIOD, THREE SEQUENCE, SINGLE DOSE, REFERENCE-REPLICATED CROSSOVER, BIOEQUIVALENCE STUDY OF CAPECITABINE 500MG TABLETS OF SUN PHARMACEUTICAL INDUSTRIES LIMITED, INDIA AND Xeloda (CAPECITABINE) 500MG TABLETS OF ROCHE LABORATORIES INC., 340 KINGSLAND STREET NUTLEY, NEW JERSEY 07110-1199, IN 54 CANCER PATIENTS UNDER FED CONDITIONS.
Asirvatham Speciality
hospital,Oncology
Department, Medical
Oncology Division, 22,Rajaji street,Gandhi road,
Madurai-625020,Tamil Nadu,India. Madurai TAMIL NADU
919442619775 04523061971 jjebasingh@gmal.com
Dr V Satya Suresh Attili
BIBI GENERAL HOSPITAL & CANCER CENTER
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 04024528144 sureshattili@yahoo.com
Dr KVelavan
Erode Cancer Center
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
04242339704 04242339705 Kvels@rediffmail.com
Dr N Sudhakar
KOVAI MEDICAL CENTER & HOSPITAL LTD
Oncology department, Medical Oncology Division, Room No:02, 3209, Avanashi road,
Coimbatore-641014.
Tamil Nadu, India
Coimbatore TAMIL NADU
Institutional ethics commitee, Jaipur affiliated to Manu Hospital & Research Center for Dr. Pinakin Patel
Approved
Institutional ethics commitee, Jaipur for Dr. Utam Soni
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 & 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
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.
Comparator Agent
Capecitabine (Xeloda) tablets
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
60.00 Year(s)
Gender
Both
Details
i. Availability of patients for the entire study period and willingness to adhere to protocol
requirements.
ii. Subjects between 18 to 60 years of age.
iii. Patients whose body surface area is equal to or less than 1.25 m2 , between 1.52 to 1.65 m2 , between 1.92 to 2.05 m2 and dose is to be given in multiples of 500 mg tablet.
iv. Subjects 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.
v. 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.
vi. Patients who are taking Capecitabine as first-line treatment for metastatic colorectal
carcinoma when treatment with fluoropyrimidine therapy alone is preferred.
vii. 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).
viii.Patients should not take any adjuvant chemotherapeutic agent except capecitabine
throughout the study and 4 weeks before the study.
ix. Patients whose life expectancy of greater than or equal to 6 months.
x. Patients having histologically proven Cancer.
xi. Patients having no brain metastasis.
xii.Patients with Performance less than or equal to 2 on the ECOG performance scale.
xiii.Subjects whose screening laboratory values are within normal limits or considered by the
Investigator/sub-Investigator to be of no clinical significance.
xiv.Informed consent form given in written form according to section 9.3 of the protocol.
xv.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
1. History or presence of significant:
i. Allergy or Significant history of hypersensitivity or idiosyncratic reactions to Capecitabine
and/or any related compounds etc.
ii. Cardiovascular (including coronary artery disease), pulmonary, hepatic impairment, renal
(including severe renal impairment), hematological (including leucopenia, thrombocytopenia),
gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological, or
psychiatric disease.
iii.Cancer patients with a prior history of coronary artery disease, receiving concomitant therapy of
warfarin.
iv.Cancer patients with a history of dihydropyrimidine dehydrogenase deficiency.
v.Presence of infections which reduce life expectancy.
vi. Alcohol dependence, alcohol abuse or drug abuse or addiction with any recreational drug within
past one year.
vii.Undergoing concomitant oncologic treatment.
viii.Smoking (more than or equal to 10 cigarettes/day) or consumption of tobacco products ( more than or equal to 4 chews/day).
ix. History of difficulty in swallowing or coming for follow up.
x. Clinically significant illness (except Dukes’ C colon cancer/ metastatic colorectal
carcinoma/metastatic breast cancer) within 4 weeks before the start of the study.
xi. Subjects who have been on an abnormal diet (for whatever the reason) during the four weeks
preceding the study.
xii. Female subject who is pregnant, lactating or likely to become pregnant or have a positive
pregnancy test at screening and prior to check in.
xiii. Positive result to HIV, HCV, RPR and HbsAg.
xiv. Use of enzyme-modifying drugs (like Phenytoin, Carbamazepine, Barbiturates, Gresiofulvine) in the previous 30 days before day 1 of this study.
xv. Abnormal 12 lead ECG, X-ray.
2. Donation of 350 mL or more of blood in the previous 90 days before day 1 of this study.
3. Participation in another clinical trial within the preceding 90 days of study starts.
4. 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.
The pre-dose blood sample (1 x 6 ml) will be collected within 1 hour prior to dosing. The post-dose blood samples (1 x 2ml 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.
Secondary Outcome
Outcome
TimePoints
NA
NA
Target Sample Size
Total Sample Size="54" Sample Size from India="54" 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, multi center,
open label, two treatment, three period, three sequence, single dose,
reference-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.