| CTRI Number |
CTRI/2012/08/002940 [Registered on: 31/08/2012] Trial Registered Retrospectively |
| Last Modified On: |
26/09/2012 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
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 USP 500 mg (Manufactured by: Hetero Labs Ltd, India) and the reference listed drug Xeloda® (Capecitabine) Tablets 500 mg (Distributed by Genentech USA, Inc., A Member of the Roche Group, South San Francisco, CA 94080) in locally advanced or Metastatic Breast Cancer or Colorectal 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-001, Version Number 00, dated 16 May 2012 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr SP Shrivastav |
| Designation |
Surgical Oncologist |
| Affiliation |
Life Research Centre |
| Address |
Life Research Centre, # 401-Param Doctor House, Station-Lal Darwaja Road,Surat, Gujarat
# 401-Param Doctor House, Station-Lal Darwaja Road, Surat – 395 001, Gujarat
Surat
GUJARAT
395 001
India |
| Phone |
0261-2242862 |
| Fax |
0261-2400075 |
| Email |
liononco@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSuresh Kamireddy |
| Designation |
Medical Monitor |
| Affiliation |
ClinSync Clinical Research Pvt. Ltd |
| Address |
#4-1-1, Hayathnagar, Hyderabad
#4-1-1, Hayathnagar, Hyderabad-501505
Hyderabad
ANDHRA PRADESH
501505
India |
| Phone |
040-24203000 |
| Fax |
040-24203000 |
| Email |
suresh@clinsynccro.com |
|
Details of Contact Person
Public Query
|
| Name |
DrChinna Babu |
| Designation |
Medical Monitor |
| Affiliation |
Clinsync Clinical Research Pvt.Ltd |
| Address |
#4-1-1, Hayathnagar, Hyderabad
#4-1-1, Hayathnagar, Hyderabad-501505
Surat
GUJARAT
501505
India |
| Phone |
040-24203000 |
| Fax |
040-24203000 |
| 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
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mallik S |
Bibi General Hospital and Cancer Centre |
H.No-16-3-991/ 1/ C, Govt Printing Press Road, Malakpet, Hyderabad- 500 024
Hyderabad
ANDHRA PRADESH |
040-24528122
040-24410792
drmallik.onco@gmail.com |
| DrSPShrivastav |
Life Research Centre |
# 401-Param Doctor House, Station-Lal Darwaja Road, Surat – 395 001, Gujarat
Surat
GUJARAT |
0261-2242862
0261-2400075
liononco@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Bibi Institutional Ethics Committee, H.No-16-3-991/1/C,Govt Printing Press Road,Malakpet, Hyderabad- 500 024. |
Approved |
| Research Independent Ethics committee,Lions cancer research centre,New civil hospital campus,Majure gate, Surat,Gujarat |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
locally advanced or Metastatic Breast Cancer or Colorectal Cancer adult subjects. , |
|
|
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) Tablets 500 mg (Distributed by Genentech USA, Inc., A Member of the Roche Group, South San Francisco, CA 94080) |
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 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)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/08/2012 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a multicentre, randomized, open label, two-treatment, two-period, two sequence, single dose, crossover, study in locally advanced or metastatic Breast cancer or Colorectal cancer adult subjects |