| CTRI Number |
CTRI/2016/03/006741 [Registered on: 18/03/2016] 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
|
A Study Comparing Capecitabine Capsule 500 mg (Intas
Pharmaceuticals Ltd., India) To The Reference Listed Drug Xeloda®
(Capecitabine 500 mg; Roche Pharmaceuticals) In Patients Of Breast
Cancer Or Colorectal Cancer Under Fed Condition
|
|
Scientific Title of Study
|
A Multicentre, Randomized, Open Label, Two-Period, Two-Treatment,
Two-Way Crossover, Comparative Bioavailability Study At Steady State
Comparing Capecitabine Extended Release Capsule 500 mg (Intas
Pharmaceuticals Ltd., India) To The Reference Listed Drug Xeloda®
(Capecitabine 500 mg; Roche Pharmaceuticals) In Patients Of Breast
Cancer Or Colorectal Cancer Under Fed Condition
|
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 363-15, Version: 1.0, Date: 08/09/2015 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mr Srinivasa Rao |
| Designation |
Project Manager |
| Affiliation |
Lambda Therapeutic Research Ltd. |
| Address |
Plot No. 38, Near Silver Oak Club
S. G. Highway, Gota
Ahmadabad
GUJARAT
380061
India |
| Phone |
07940202570 |
| Fax |
07940202021 |
| Email |
srinivasarao@lambda-cro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjunath K |
| Designation |
GM |
| Affiliation |
Lambda Therapeutic Research Ltd |
| Address |
Plot No. 38, Near Silver Oak Club
S. G. Highway, Gota
Ahmadabad
GUJARAT
380061
India |
| Phone |
07940202290 |
| Fax |
07940202021 |
| Email |
manjunathk@lambda-cro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ankit Ranpura |
| Designation |
Manager |
| Affiliation |
Lambda Therapeutic Research Ltd |
| Address |
Plot No. 38, Near Silver Oak Club
S. G. Highway, Gota
Ahmadabad
GUJARAT
380061
India |
| Phone |
07940202074 |
| Fax |
07940202021 |
| Email |
ankitranpura@lambda-cro.com |
|
|
Source of Monetary or Material Support
|
| Intas Pharmaceuticals Ltd. 2nd Floor, Chinubhai Center, Ashram Road, Ahmedabad 380-009, Gujarat, India, Tel. No.: 07926576655,
Fax: 07926578862
|
|
|
Primary Sponsor
|
| Name |
Intas Pharmaceuticals Ltd |
| Address |
2nd Floor, Chinubhai Center, Ashram Road, Ahmedabad 380-009, Gujarat, India, Tel. No.: 07926576655, Fax: 07926578862 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Hari Goyal |
Artimis Hospitals |
Artimis Hospitals, Dept of oncology, Room Number - 1919, Sector: 51, Pin-122001
Gurgaon
HARYANA |
9958715678
drgoyalhari@hotmail.com |
| Dr Bala Murgan |
Guru Hospital |
Room No 5, Dept. of Clinical Research, Plot No. - 4/120-F, Pandikovil Ring Road, Mattuthavani, Madurai-625107
Madurai
TAMIL NADU |
9486467768
info@guruhospitals.com |
| Dr Anil Poddar |
Health Point A Multi Speciality Hospital |
Room No-12,Dept of oncology, OPD Section,
Health Point Multi Speciality Hospital, 21, Prannath pandit street (Opposite lansdown Padmapukur)- 700 025
Kolkata
WEST BENGAL |
9831004007
dranilpoddar@hotmail.com |
| Dr Nagesh Srinivas Mandoorkar |
Magnum Heart Institute |
Magnum Heart Institute, Chopda Medicare and Research Centre, 3rd Floor, Dept of oncology Room no. 5, Laxmi Nagar, Patil lane No. 1, Near KBH Vidyalay, Canada Corner- 422005
Nashik
MAHARASHTRA |
9822353986
nmadnoorkar@yahoo.co.in |
| Dr Shamsuddin Jalaluddin Virani |
Unique Hospital Multispeciality & Research Institute. |
Clinical Research Department,
Unique Hospital Multispeciality & Research Institute, Room No-4,
Opp. Kiran Motor, Near Canal,
Civil hospital Char Rasta - Sosyo Circle Lane,
Off Ring Road- 395002
Surat
GUJARAT |
9879855522
drsjvirani@gmail.com |
| Dr K B Akila |
VGM Cancer Care A Unit Of VGM hospital |
Dept of Surgical oncology,
Room no: 5,
4/120 F, PandiKovil Ring road- 625107
Madurai
TAMIL NADU |
9842270651
kbakila@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Artimis Health Science Institutional Ethics Committee, Dr. Hari Goyal |
Submittted/Under Review |
| Ethics Committee, Unique Hospital Multispeciality & Research Institute, Dr. Shamsuddin Jalaluddin Virani |
Submittted/Under Review |
| Health Point Ethics committee, Dr. Anil Poddar |
Submittted/Under Review |
| Institutional Ethics committee VGM Hospital, Dr. K B Akila |
Submittted/Under Review |
| Institutional Ethics committee, Guru Hospital, Dr. Bala Murgan |
Approved |
| Magna Care Ethics Committee, Dr. Nagesh Srinivas Mandoorkar |
Submittted/Under Review |
|
|
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
|
| Type |
Name |
Details |
| Intervention |
Capecitabine Extended Release Capsule 500 mg
(Intas Pharma)
|
Dose: 1250 mg/m2, Frequency: twice daily, Mode of Administration: orally, Duration of treatment: One week
|
| Comparator Agent |
Xeloda® (Capecitabine) film coated tablets
500 mg
(Roche Pharmaceuticals)
|
Dose: 1250 mg/m2, Frequency: twice daily, Mode of Administration: orally, Duration of treatment: One week |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or Female ≥18 to ≤ 65 years of age and having a 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
a. Metastatic colorectal carcinoma when treatment with fluoro pyrimidine therapy alone is preferred.
b. Metastatic breast cancer resistant to both paclitaxel and an anthracycline-containing chemotherapy regimen
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. Able to comply with study requirement in opinion of Principal Investigator.
9. Able to give written informed consent for participation in the trial.
|
|
| ExclusionCriteria |
| Details |
1.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. History of drug/alcohol addiction
4. Known brain metastasis
5. Pre-existing motor or sensory neurotoxicity of a severity ≥ grade 2 by NCI CTCAE criteria.
6. A positive hepatitis screen including hepatitis B surface antigen and HCV antibodies
7. Known case of HIV infection.
8. Any other condition that, in the investigator’s judgment, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| AUC |
Day 07 and Day 14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To monitor the safety of the patients who are exposed to the investigational medicinal product. |
Day 1 to Day 14 |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
23/03/2016 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The Sponsor has developed extended release formulation of capecitabine.
Capecitabine is a cytotoxic drug. It would be unethical to do this study in
healthy volunteers. Therefore the comparative bioavailability study is proposed
to be carried out on patients with Breast Cancer or Colorectal cancer, who in
the opinion of their treating physicians are candidates for Capecitabine
therapy
In current study, test formulation of capecitabine ER capsule 500 mg
will be administered as twice daily for one week and reference formulation of capecitabine
- Xeloda® (capecitabine) tablets 500 mg will be administered twice daily for
one week in a crossover manner in patients with breast cancer or colorectal
cancer under fed condition. Through this study, we will prospectively collect
the data from adult breast cancer or colorectal cancer patients who will be
randomly assigned to receive either capecitabine extended release capsule of
Intas Pharmaceuticals Limited, India or Xeloda®
(Capecitabine
500 mg; Roche Pharmaceuticals) for the pharmacokinetic profiling. |