| CTRI Number |
CTRI/2012/08/002903 [Registered on: 22/08/2012] Trial Registered Prospectively |
| Last Modified On: |
21/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Bioequivalence study of Capecitabine 500 mg with Xeloda®(capecitabine) tablets 500 mg in Locally Advanced Breast Cancer or Metastatic Breast Cancer or Colorectal Cancer patients under fed condition |
|
Scientific Title of Study
|
A multicentre, randomized, open label, two-period, two-treatment, two-way crossover,
bioequivalence study comparing Capecitabine tablets 500 mg with Xeloda®
(capecitabine) tablets 500 mg in Locally Advanced Breast Cancer or Metastatic Breast
Cancer or Colorectal Cancer patients under fed condition. Capecitabine is the test drug
(Manufactured by: Jiangsu Hengrui Medicine Co.,China). Xeloda is the reference drug (Distributed by:Roche Registration Limited,UK) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 526-11 Version 01 Dated January 06, 2012 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mr Sheejith K |
| Designation |
Project Manager |
| Affiliation |
Lambda Therapeutic Research Ltd. |
| Address |
Near Gujarat High court,S. G. Highway,Gota
NA
Ahmadabad
GUJARAT
380061
India |
| Phone |
079-40202020 |
| Fax |
079-40202022 |
| Email |
sheejith@lambda-cro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Praveen Shetty |
| Designation |
Manager |
| Affiliation |
Lambda Therapeutic Research Ltd |
| Address |
Near Gujarat High court,S. G. Highway,Gota
NA
Ahmadabad
GUJARAT
380061
India |
| Phone |
079-40202020 |
| Fax |
079-40202022 |
| Email |
praveenshetty@lambda-cro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ankit Ranpura |
| Designation |
Asst. Manager |
| Affiliation |
Lambda Therapeutic Research Ltd |
| Address |
Near Gujarat High court,S. G. Highway,Gota
NA
Ahmadabad
GUJARAT
380061
India |
| Phone |
079-40202020 |
| Fax |
079-40202022 |
| Email |
ankitranpura@lambda-cro.com |
|
|
Source of Monetary or Material Support
|
| Evenus Pharmaceutical Laboratories Inc |
|
|
Primary Sponsor
|
| Name |
Evenus Pharmaceutical Laboratories Inc |
| Address |
1 Duncan Drive, Cranbury, NJ 08512 USA & Jiangsu Hengrui Medicine Co., Ltd, 7 Kunlunshan Road, Lianyungang, Jiangsu 222047, China |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Lambda Therapeutic Research |
Lambda Therapeutic Research Near Gujarat High Court, S. G. Highway, Gota, Ahmedabad - 380 061, Gujarat, India |
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Tanveer Maksud |
Bharat Cancer Hospital & Research Institute, Surat |
Room No. 22/C, OPD department, Bharat Cancer Hospital & Research Institute, Manav Daya Trust Complex, Surat Bardoli, Saroli, Surat – 39501
Surat
GUJARAT |
9909918887
tanveermaksud@yahoo.com |
| Dr Suresh Attili |
Bibi General Hospital and Cancer Centre, Hyderabad |
16-3-991/1/C, Dept. of cancer,Bibi General Hospital and Cancer Centre, , Government printing press road, Malak Pet, Hyderabad-500024
Hyderabad
ANDHRA PRADESH |
9246243034
sureshattili@yahoo.com |
| Dr Smita Gupte |
Cancer Clinic, Nagpur |
Cancer Clinic dept.,Room no. 208, 2nd floor, Shreewardhan complex, Wardha Road Ramdaspeth, Nagpur-440012
Nagpur
MAHARASHTRA |
9373107176
smita_gupte@rediffmail.com |
| Dr Raj Nagarkar |
Curie Manavta Cancer Center, Nasik |
Ground Floor,Oncology dept.Consulting Room, , Curie Manavta Cancer Center, Opp. Mahamarg Bus Stand, Mumbai Naka, Nasik-422004
Nashik
MAHARASHTRA |
9823061929
drraj@manavatacancercentre.com |
| Dr S P Shrivastav |
Life Research Center, Surat |
401, Dept. of Oncology, Life Research Center, Param Doctor House, Station to Lal Darwaja Road, Surat.
Surat
GUJARAT |
9824196710
liononco@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Global Health Concern Ethics Committee, Nagpur |
Approved |
| Institutional Ethics Committee, Hyderabad |
Approved |
| Manavta Clinical Research Institute, Nasik |
Approved |
| Research Independent Ethics Committee |
Approved |
| Research Independent Ethics Committee, 223 Meghani Tower, Cinema Road, Surat |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Capecitabine Tablets 500mg |
Capecitabine Tablets 500
mg will be administered as a single oral dose as multiples of 500mg on Day 1 and
Day 2 morning dose as per randomization schedule. |
| Comparator Agent |
Xeloda tablet 500mg |
Capecitabine Tablets 500 mg will be administered as a single oral dose as multiples of 500mg on Day 1 and Day 2 morning dose as per randomization schedule. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
79.00 Year(s) |
| Gender |
Both |
| Details |
1.Body Mass Index (BMI) at least 17 calculated as weight in kg / height in m2. 2.Patient with adequate bone marrow, renal and hepatic function. 3.Patient should have recovered from any toxic effects of previous chemotherapy as judged by the Investigator 4.Patients with life expectancy of at least 3 months (as per the
Investigator’s discretion) 5.Able to comply with study requirement in opinion of Principal
Investigator 6.Able to give written informed consent for participation in the trial 7.Patients should have their BSA (as per the DuBois formula) between
1.26-1.91 m2 (Both inclusive) |
|
| ExclusionCriteria |
| Details |
1.Prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil, or known DPD (Dihydropyrimidine
Dehydrogenase) deficiency. 2.History of drug/alcohol addiction. 3.Known brain metastasis 4.A positive hepatitis screen including hepatitis B surface antigen, HCV or HAV (IgM) antibodies 5.Known HIV infection.6.History of drug/alcohol addiction. 7.Donation of blood (1 unit or 350 ml) within 90 days prior to receiving the
first dose of investigational medicinal product for the current study. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To characterise the pharmacokinetic profile of the sponsor’s test formulation
[Capecitabine Tablets 500 mg] relative to that of reference formulation [Xeloda® Tablets 500 mg] in patients with
Metastatic Breast Cancer or Colorectal Cancer under fed condition and to
assess the bioequivalence. |
The venous blood samples will be withdrawn Pre-dose and 0.25(15 min), 0.5(30 min), 1, 1.333, 1.667, 2, 2.333, 2.667, 3, 3.5, 4, 5,
6, 8, 10 hr post-dose in each period administration |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To monitor safety of the patients, who are exposed to the Investigational
Medicinal Product |
NIL |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
17/09/2012 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Capecitabine is a fluoropyrimidine carbamate which is 5’- Deoxy 5 fluoro uridine (5’-DFUR). It is an orally administered prodrug which is converted to 5-fluoro uracil in human body. This study is being conducted to compare & characterize the relative bioavailability & pharmacokinetic profile of the Sponsor’s formulation (Capecitabine 500mg tab) with respect to the reference formulation ( Xeloda ® (capecitabine 500mg tab)) in single oral dose as multiples of 500 mg tablet in Locally Advanced Breast Cancer or Metastatic Breast Cancer or Colorectal Cancer patients under fed condition. The primary objective of the study is to characterize the pharmacokinetic profile of the sponsor’s test formulation to that of reference formulation & secondary objective is to monitor the safety of the patients. Bioequivalence will be concluded if the ln-transformed 90% confidence interval falls within the acceptance range of 80.00 – 125.00% for pharmacokinetic parameters Cmax, AUC of Capecitabine |