| CTRI Number |
CTRI/2012/07/002778 [Registered on: 09/07/2012] Trial Registered Retrospectively |
| Last Modified On: |
07/02/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Other |
|
Public Title of Study
|
To assess the safety and tolerability of a single oral dose of the Capecitabine test and reference formulations. |
|
Scientific Title of Study
|
A multicentre, randomized, open label, two-treatment, two-period, two sequence, single dose, crossover, bioequivalence study comparing Capecitabine Tablets 500 mg (Manufactured by: Hetero Labs Ltd, India) and the reference listed drug Xeloda® (Capecitabine) 500 mg film coated tablets (Manufactured by Roche Pharma AG, Emil-Barell – Str I, D-79639 Grenzach-Wyhlen, Duitsland) in locally advanced or Metastatic Breast Cancer or colorectal Cancer or advanced gastric cancer adult subjects already receiving a stable twice-daily dosing regimen as prescribed by the reference product label under fed condition. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| C-HET-CAP-002 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S Mallik |
| Designation |
Principal Investigator |
| Affiliation |
Bibi General Hospital and Cancer Center |
| Address |
BIBI general hospital and cancer centre
Malakpet, Hyderabad
Hyderabad
ANDHRA PRADESH
500024
India |
| Phone |
|
| Fax |
|
| Email |
drmallik.onco@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chinnababu |
| Designation |
Medical Monitor |
| Affiliation |
Clinsync Clinical Research Pvt Ltd |
| Address |
#4-1-1,Hayathnagar,Hyderabad
Hyderabad
ANDHRA PRADESH
501505
India |
| Phone |
|
| Fax |
|
| Email |
chinnasunkavalli@clinsynccro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chinnababu |
| Designation |
|
| Affiliation |
|
| Address |
#4-1-1,Hayathnagar,Hyderabad
Hyderabad
ANDHRA PRADESH
501505
India |
| Phone |
|
| Fax |
|
| Email |
chinnasunkavalli@clinsynccro.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Hetero Labs Ltd |
| Address |
7-2-A2
Hetero Corporate
Sanathnagar Industrial Estate
Hyderabad - 500018
Andhra Pradesh India
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Clinsync Clincal research Pvt Ltd |
#4-1-1
Hayathnagar
Hyderabad-501505
India |
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr S Mallik |
BIBI general hospital and cancer centre |
Dept. of Radiation Oncology
H. No 16-3-991/1/C Govt.Printing Press Road Malakpet Hyderabad-500024
Hyderabad
ANDHRA PRADESH |
040-24528422
040-24410792
drmallik.onco@gmail.com |
| Dr Hemanth Vudayaraju |
ClinSync Hospitals |
#4-1-1 Hayathnagar Hyderabad-501505
Hyderabad
ANDHRA PRADESH |
9704064455
040-24203000
drhemanthv@gmail.com |
| Dr Shrikant Suryavanshi |
Curie Manavata cancer centre |
Opposite Mahamarg Bus Stand Mumbai Naka Nashik-422004
Nashik
MAHARASHTRA |
982257417
0253-2595666
drshrikant@mcrinasik.com |
| DrCTSatheesh |
Dr .C. T. Satheesh |
Sri Venkateshwara Hospital
#86 Hosur Main Road
Madiwala
Bangalore 560068
Bangalore
KARNATAKA |
91-9242698750
drsatheeshct@gmail.com |
| Dr SP Shrivastav |
Life Research Centre |
# 401, Param Doctor House, Station to Lal Darwaja Road, Surat-395003
Surat
GUJARAT |
91-9824196710
91-261-2400075
liononco@gmail.com |
| Dr Niti Raizada |
Vikram Hospitals Bengaluru Pvt. Ltd. |
#71/1 Millers Road
Bengaluru 560052
Bangalore
KARNATAKA |
91-9901205647
nitiraizada@yahoo.co.uk |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Bangalore Ethics |
Approved |
| Bibi Institutional Ethics Committee |
Approved |
| IEC Consultants |
Approved |
| Maarg Independent Ethics Committee |
Approved |
| Manavata Clinical Research Institute Professional Ethics Committee |
Approved |
| Research independent Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
advanced or Metastatic Breast Cancer or colorectal Cancer or advanced gastric cancer, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Capecitabine Tablets 500 mg, manufactured by Hetero labs ltd. |
The recommended dose of capacitabine is 1250 mg/m2 administered orally twice daily (morning and evening; equivalent to 2500 mg/m2 total daily dose) for 2 weeks followed by a 1-week rest period given as 3 week cycles |
| Comparator Agent |
Xeloda® (Capecitabine) 500mg film coated tablet, manufactured by Roche Pharma AG, Emil-Barell – Str I, D-79639 Grenzach-Wyhlen, Duitsland |
The recommended dose of XELODA® is 1250 mg/m2 administered orally twice daily (morning and evening; equivalent to 2500 mg/m2 total daily dose) for 2 weeks followed by a 1-week rest period given as 3 week cycles |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Established cases of advanced breast cancer or metastatic breast cancer or colo-rectal cancer or advanced gastric cancer (in combination with a platinum based regimen), who are already receiving a stable twice-daily dosing regimen in multiples of 500 mg tablet.
2.Life expectancy of at least 3 months
3.Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
|
|
| ExclusionCriteria |
| Details |
1. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of study drug, or which may jeopardize the subject in case of participation in the study.
2. Positive alcohol or drug abuse test at baseline.
3. Diagnosis of AIDS, Hepatitis B, Hepatitis C infection defined as a positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests, respectively.
4. Have received any live or live attenuated vaccines within 2 months prior to randomization. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Establishing the bioequivalence between test and reference |
Day 1 and Day 2 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| AUClast AUCinf Cmax λz Tmax and T1/2 and other parameters as appropriate from plasma concentration time |
Day 1 and Day 2 |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/06/2012 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
-- |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is an open-label, randomized, single dose, and two treatment periods, two sequence cross-over study in locally advanced breast cancer or metastatic breast cancer or colo rectal cancer or advanced gastric cancer. |