| CTRI Number |
CTRI/2013/07/003836 [Registered on: 24/07/2013] Trial Registered Prospectively |
| Last Modified On: |
23/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Comparison of two Imatinib Mesylate tablets in patients of Philadelphia chromosome positive Chronic Myeloid Leukaemia stabilized on Imatinib Mesylate tablets 400mg |
|
Scientific Title of Study
|
A multicentre, randomized, open label, single dose, two treatment, two period, two sequence, crossover, bioequivalence study under fed conditions comparing of Imatinib Mesylate 400 mg tablets (Ranbaxy Laboratories Limited, India) to the reference listed drug Gleevec® (Imatinib Mesylate) Tablets 400 mg (Novartis Pharmaceuticals Corporation, East Hanover, New Jersey-07936) in patients of Philadelphia chromosome positive Chronic Myeloid Leukaemia stabilized on Imatinib Mesylate tablets 400mg |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| 361-12 ; Version Number: 03; Date: 01 Aug 2013 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mr Saravanan Gurumurthy |
| Designation |
Project Manager |
| Affiliation |
Lambda Therapeutic Research Ltd, |
| Address |
Plot No. 38, Near Silver Oak Club, S. G. Highway, Gota
Ahmadabad
GUJARAT
380 061
India |
| Phone |
09962559022 |
| Fax |
07940202022 |
| Email |
Saravanangurumurthy@lambda-cro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ankit Ranpura |
| Designation |
Assistant Manager |
| Affiliation |
Lambda Therapeutic Research Ltd, |
| Address |
Plot No. 38, Near Silver Oak Club, S. G. Highway, Gota
Ahmadabad
GUJARAT
380 061
India |
| Phone |
07940202074 |
| Fax |
07940202022 |
| Email |
ankitranpura@lambda-cro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Praveen Shetty |
| Designation |
Manager |
| Affiliation |
Lambda Therapeutic Research Ltd, |
| Address |
Plot No. 38, Near Silver Oak Club, S. G. Highway, Gota
Ahmadabad
GUJARAT
380 061
India |
| Phone |
07940202098 |
| Fax |
07940202022 |
| Email |
praveenshetty@lambda-cro.com |
|
|
Source of Monetary or Material Support
|
| Ranbaxy Laboratories Limited |
|
|
Primary Sponsor
|
| Name |
Ranbaxy Laboratories Limited |
| Address |
Plot No. GP-5, Sector 18, HSIDC Old Delhi – Gurgaon Road, Gurgaon 122 015, Haryana India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 9 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrDipti Rani Samanta |
Acharya Hari Har regional Cancer Centre |
Medical Road, Mangalabag, -753007
Cuttack
ORISSA |
9437032728
diptiranisamanta@rediffmail.com |
| Dr Sandip Bartakke |
Aditya Birla Memorial Hospital |
Aditya Birla hospital Marg,
Chinchawad, Pune - 411033
Pune
MAHARASHTRA |
9763164057
spbartakke@rediffmail.com |
| DrKrishnan |
Dr.Rai memorial Medical Centre |
Dr.Rai Memorial Medical Centre-IRB,No 526,Century Plaza,Annasalai,Teynampet-600018
Chennai
TAMIL NADU |
9952833735
krishnan_dr@yahoo.com |
| Dr Avatar Ganju |
Ganju Heamatology Clinic & Hospital |
Midas Height, Central Bazar Road,Ramdas peth, Nagpur-440010
"
Nagpur
MAHARASHTRA |
9422110765
avatarganju@yahoo.com |
| Dr S P Shrivastav |
Life Research Centre & Lions cancer Research centre |
401, Param Doctor House,
Station to Lal Darwaja Road- 395 003
Surat
GUJARAT |
8866400075
drspvarma@liferesearchcentre.in |
| Dr Vijay Ramanan |
Oyster and Pearl Hospital |
1671-75, Ganeshkhind Road
ShivajiNagar,Pune - 411005
Pune
MAHARASHTRA |
020-30205050
mvijayr@gmail.com |
| Dr J K Singh |
S S Hospital |
Malahi Pakri Chowk,Doctors Colony,Kankarbagh,Patna- 800020,India
Patna
BIHAR |
9006330804
drjksingh147@hotmail.com |
| DrCTSathish |
Sri Venkateshwara Hospital |
No-86,Hosur Main Road, Madiwala,Bangalore-560068
Bangalore
KARNATAKA |
9819411987
drsatheeshct@gmail.com |
| DrLakshmaiah |
Srinivasam Cancer Care Hospitals India Private Limited |
No236/1,Vijayashree Layout,Arekere,Bannerghatta Main Road, Bangalore-560076
Bangalore
KARNATAKA |
9448055949
kcluck@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 9 |
| Name of Committee |
Approval Status |
| Acharya Hari Har regional Cancer - Institutional Ethics Committee, Cuttack |
Approved |
| Dr.Rai Memorial Medical Centre-IRB Teynampet |
Approved |
| Institutional Ethics committee S S Hospital & Research Centre Patna |
Approved |
| Nagpur Independent Ethics Committee Nagpur |
Approved |
| O & P institutional Ethics Committee Pune |
Approved |
| Royal Pune Independent Ethics committee Pune |
Approved |
| SCCH-Institutional Ethics Committee Bangalore |
Approved |
| South Gujarat Independent Ethics Committee |
Approved |
| Sri Venkateshwara Hospital Ethics Committee Bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C921||Chronic myeloid leukemia, BCR/ABL-positive, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Gleevec® (Imatinib Mesylate) |
400 mg OD orally on Day 01 and Day 08 |
| Intervention |
Imatinib Mesylate tablets |
400 mg OD orally on Day 01 and Day 08 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient able to give written informed consent for participation in the trial
2.Male or female patients must be ≥ 18 years of age at the screening visit.
3.Patient must be on stable dose of Imatinib Mesylate 400 mg tablets.
4.Patients of Chronic Myeloid Leukemia in chronic phase with documented evidence of Philadelphia chromosome positive (Ph+ CML).
5.Patient must have an ECOG performance status of 0-2.
6.Patient must have an adequate bone marrow, renal and hepatic function |
|
| ExclusionCriteria |
| Details |
1.Known Hypersensitivity to the active substance or to any of the excipients of Imatinib tablets.
2.Patients with known human immunodeficiency virus (HIV) infection.
3.A positive hepatitis screen including hepatitis B surface antigen, HCV and HAV antibodies.
4.Patients of Ph+ CML in Accelerated Phase (AP) or Blast Crisis (BP).
5.If the patient have previously undergone hematopoietic stem cell transplantation.
6.Significant bleeding disorder unrelated to CML.
7.Use of any recreational drugs or history of drug addiction.
8.Any other condition or abnormal baseline findings that, in the investigator’s judgement, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.
9.Patient with a history of difficulty in donating blood or difficulty in accessibility of veins. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To characterize the pharmacokinetic profile and assess bioequivalence of the sponsor’s test formulation (Imatinib Mesylate 400 mg tablets) relative to that of reference formulation (Gleevec® 400 mg tablets) in adult patients of philadelphia chromosome positive chronic myeloid leukemia stabilized with Imatinib mesylate 400 mg |
PK sample-
0.500,3.000,5.000,20.000 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To monitor the safety of the patients exposed to the Investigational Medicinal Products |
End of the study |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
03/09/2013 |
| 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="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Imatinib mesylate (Imatinib) is a selective inhibitor of the protein tyrosine kinase associated with bcr-abl and specifically inhibits proliferation of Ph expressing cells.
As per available guidance on Imatinib Mesylate, US FDA recommends to conduct a single dose study in patients already receiving a stable dose of Imatinib tablets, 400 mg and recruitment efforts should be targeted at patients for whom a titration away from the 400 mg dose is unlikely, such as patients with gastrointestinal stromal tumors and patients in their first three months of treatment for chronic myeloid leukemia (CML).
The recommended dosing regime is Imatinib Mesylate 400 mg tablet daily for adult patients of Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. Treatment may be continued as long as there is no evidence of progressive disease or unacceptable toxicity
|