| CTRI Number |
CTRI/2010/091/000136 [Registered on: 22/02/2010] |
| Last Modified On: |
22/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
Type of Study
Modification(s)
|
|
| Study Design |
Randomized, Crossover Trial |
Public Title of Study
Modification(s)
|
To evaluate the bioequivalence of two formulation of capecitabine Tablets 500 mg tablets in patients of Breast Cancer or Colorectal Cancer under fed condition |
Scientific Title of Study
Modification(s)
|
A multicentre, randomized, open label, two-period, two-treatment, two-way crossover, bioequivalence study comparing Capecitabine Tablets USP 500 mg (Manufactured by: Intas Pharmaceuticals Ltd., India) to the reference listed drug Xeloda® (capecitabine) Tablets 500 mg (Distributed by: Roche Laboratories Inc., New Jersey 07110) in patients of Breast Cancer or Colorectal Cancer under fed condition. |
| Trial Acronym |
NA |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| 333-09 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Mr Priyajeet Parekh |
| Designation |
|
| Affiliation |
|
| Address |
Lambda Therapeutic Research Limited, Near Gujarat High Court, S G Highway, Gota, Ahmedabad
Ahmadabad
GUJARAT
380061
India |
| Phone |
079-40202057 |
| Fax |
07940202021 |
| Email |
priyajeetparekh@lambda-cro.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Praveen Shetty |
| Designation |
|
| Affiliation |
NIL |
| Address |
Lambda Therapeutic Research Limited,
Near Gujarat High Court
Ahmadabad
GUJARAT
380061
India |
| Phone |
079-40202098 |
| Fax |
079-40202021 |
| Email |
praveenshetty@lambda-cro.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Mr Priyajeet Parekh |
| Designation |
|
| Affiliation |
|
| Address |
Lambda Therapeutic Research Limited, Near Gujarat High Court, S G Highway, Gota,
Ahmadabad
GUJARAT
380061
India |
| Phone |
079-40202057 |
| Fax |
079-40202021 |
| Email |
priyajeetparekh@lambda-cro.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Intas
Pharmaceuticals Ltd., India |
|
Primary Sponsor
Modification(s)
|
| Name |
Intas Pharmaceuticals Ltd India |
| Address |
Chinubhai Centre, Ashram Road, Off Nehru Bridge, Ahmedabad, Gujarat 380009 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 10 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr B R Shrivastav |
Cancer hospital & research institute |
Regional Centre for Cancer Research & Treatment, Cancer hill, Mandre ki mata-474 009
Gwalior
MADHYA PRADESH |
0751-2336502
br_shrivastav08@yahoo.com |
| Dr Ajay Mehta |
Central India Cancer Research Centre |
11 Shankarnagar, Nagpur-440011, India
Nagpur
MAHARASHTRA |
9823190192
ajayonco@gmail.com |
| Dr Chirmana Haritha |
Dept. of Medical Oncology, M S Patel Cancer Centre, Shree Krishna Hospital |
Gokal Nagar, Karamsad-388325
Anand
GUJARAT |
02692-223466
ritu80@rediffmail.com |
| Dr Krishnan S |
Dr.Rai Memorial Medical Centre |
No: 562 - Century Plaza, Teynampet,Chennai - 600018
Chennai
TAMIL NADU |
044-24349594
Krishnan_dr@yahoo.com |
| Dr GNPatel |
Jeevandeep Hospital |
302, 3rd floor, Ayush Doctor House, Station Road, Surat
388001
Surat
GUJARAT |
0261-2413131
gnonco@gmail.com |
| Dr J K Singh |
Mahavir Cancer Sansthan |
Phulwari Sharif, Patna-801505
Patna
BIHAR |
0612-2253956
drjksingh147@hotmail.com |
| Dr Raj Nagarkar |
Manvata Curie Cancer centre |
Opp. Mahamarg Bus stand, Mumbai Naka, Nashik, Maharashtra-422004
Nashik
MAHARASHTRA |
0253-2592666
drrajnagarkar@yahoo.co.in |
| DrKirushna Kumar |
Meeneakshi Mission Hospital |
Melur Road, Madurai - 625107
Madurai
TAMIL NADU |
0452-2588741
drkskk@yahoo.com |
| Dr Minish Jain |
Noble Hospital (Oncology Department) |
153, Magar patta, City Road-411013
Pune
MAHARASHTRA |
020-66285000
minishjain009@gmail.com |
| Dr Shailesh Bondarde |
Shatabdi Hospital |
Suyojit City Center,Mumbai Naka-422005
Nashik
MAHARASHTRA |
0253-2502105
shaileshbondarde@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 10 |
| Name of Committee |
Approval Status |
| Central India Cancer Research Institute Ethics Committee, Nagpur |
Approved |
| Ethical Review Board, Meeneakshi Mission Hospital and Rearch Centre, Madurai |
Approved |
| Ethics Committee, Mahavir Cancer Institute and Research Centre, Patna |
Approved |
| Ethics Committee, Shatabadi Hospital, Nasik |
Approved |
| Heart First Ethic Committee, Surat |
Approved |
| Human Research Ethics Committee of H.M. Patel Center for Medical Care & Education,Karamsad |
Approved |
| Institutional Ethics Committee, Cancer hospital & Research Institute, Cancer hill, Mandre Ki Mata, Gwalior - 474 009. |
Approved |
| Institutional Ethics Committee, Dr.Rai Memorial Cancer Institute, Chennai |
Approved |
| Manavata Clinical Research Institute, Professional Ethics Committee, Nasik |
Approved |
| Noble Hospital,Institutional Ethics Committee, 153, Magar patta, City Road,Pune-411013 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C189||Malignant neoplasm of colon, unspecified, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Capecitabine Tablets USP 500 mg,Each film -coated tablet contains: Capecitabine USP 500 mg,Manufactured by: Intas Pharmaceuticals Limited, India. |
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 |
| Comparator Agent |
Xeloda® (capecitabine) Tablets 500 mg,Each tablet contains: Capecitabine 500 mg,Distributed by: Roche Laboratories Inc., New Jersey 07110 |
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
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
82.00 Year(s) |
| Gender |
Both |
| Details |
1.Body Mass Index (BMI) at least 17 calculated as weight in kg / height in m2.
2.Patients must have/have had histopathologically /cytologically confirmed breast cancer or colorectal cancer.
3.Patients with BSA between 1.26-1.91 (Both inclusive) should be included.
4.Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
5.Patient with adequate bone marrow, renal and hepatic function.
6.Adequate Cardiac function (left ventricular ejection fraction [LVEF] ≥50%).
7.Patient should have recovered from any toxic effects of previous chemotherapy as judged by the Investigator
8.Patients with life expectancy of at least 3 months.
9.Able to comply with study requirement in opinion of Principal Investigator.
10.Able to give written informed consent for participation in the trial.
11.In case of female patient the serum pregnancy test at screening visit and urine pregnancy test at day 0 must be negative. |
|
| ExclusionCriteria |
| Details |
Prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to
5-fluorouracil, or known DPD (Dihydropyrimidine Dehydrogenase) deficiency.
2. Pregnant or breast-feeding female
3. Any of the following cardiac conditions:
a. Unstable angina
b. Myocardial infarction within the past 6 months
c. NYHA (New York State Heart Association) class II-IV heart failure
d. Severe uncontrolled ventricular arrhythmias
e. Clinically significant pericardial disease
f. Electrocardiographic evidence of acute ischemic or active conduction system
abnormalities
g. Any other cardiac illness that could lead to a safety risk to the patient in case of
enrolment in the study
4. History of drug/alcohol addiction
5. Known brain metastasis |
|
Method of Generating Random Sequence
Modification(s)
|
Other |
Method of Concealment
Modification(s)
|
Other |
Blinding/Masking
Modification(s)
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| To characterise the pharmacokinetic profile of the sponsors test formulation [Capecitabine Tablets USP 500 mg (Manufactured by: Intas Pharmaceuticals Ltd., India)] relative to that of reference formulation [Xeloda® (capecitabine) Tablets 500 mg (Distributed by: Roche Laboratories Inc., New Jersey 07110)] in patients of Breast Cancer or Colorectal Cancer under fed condition and to assess the bioequivalence |
NIL |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| To monitor the safety of the patients |
NIL |
|
Target Sample Size
Modification(s)
|
Total Sample Size="118"
Sample Size from India="118"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
12/05/2010 |
| 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
Modification(s)
|
Years="0"
Months="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This is a multicentre, randomized, open label, two-period, two-treatment, two-way crossover, bioequivalence study comparing Capecitabine Tablets USP 500 mg (Manufactured by: Intas Pharmaceuticals Ltd., India) to the reference listed drug Xeloda® (capecitabine) Tablets 500 mg (Distributed by: Roche Laboratories Inc., New Jersey 07110) in patients of Breast Cancer or Colorectal Cancer under fed condition. XELODA® (Capecitabine) is a fluoropyrimidine carbamate with antineoplastic activity In the present study, the relative bioavailability of test formulation [Capecitabine Tablets USP 500 mg (Manufactured by: Intas Pharmaceuticals Ltd., India)] in comparison to the reference formulation [Xeloda® (capecitabine) Tablets 500 mg (Distributed by: Roche Laboratories Inc.,New Jersey 07110)] will be assessed after single oral dose (3 x 500 mg tablets) in adult patients with Breast Cancer or Colorectal Cancer. Capecitabine is a cytotoxic drug. It would be unethical to do this study on healthy volunteers. Therefore the bioequivalence study is proposed to be carried out on patients of Breast Cancer or Colorectal cancer, who in the opinion of their treating physicians are candidate for Capecitabine therapy. Moreover, this is also in agreement with the current draft guidance on Capecitabine by OGD, USFDA Totally 110 patient will be enrolled.However, it may be possible that the actual intra-patient variability for the current formulation may differ. The intra-patient variability for the current formulation will be estimated using the data of first 30 patients (completing both the periods) by the biostatistician not involved in the actual statistical analysis of the study using SAS program (Version 9.1.3 or higher). The proboble date of enrollment of the first patient will be 15 May 2010 |