| CTRI Number |
CTRI/2013/09/004026 [Registered on: 27/09/2013] 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, steady state, two treatment, two period, two-way crossover,
bioequivalence study under fed conditions comparing Imatinib Mesylate Tablets 400 mg of Dr. Reddy’s Laboratories Limited, India to the reference listed drug Gleevec® (Imatinib Mesylate)
Tablets 400 mg of Novartis Pharma Stein AG, Stein, Switzerland for Novartis Pharmaceuticals
Corporation East Hanover, New Jersey 07936 in patients of Philadelphia chromosome positive Chronic Myeloid Leukaemia (CML), stabilized on Imatinib Mesylate 400 mg. |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 339-13; Version Number: 01; Date: 25 June 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 |
917940202074 |
| 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 |
917940202098 |
| Fax |
07940202022 |
| Email |
praveenshetty@lambda-cro.com |
|
|
Source of Monetary or Material Support
|
| Dr. Reddy’s Laboratories Ltd. |
|
|
Primary Sponsor
|
| Name |
Dr Reddys Laboratories Ltd |
| Address |
Integrated Product Development Organization
Bachupally, Qutubullapur, Mandal,Hyderabad – 500090, India |
| 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 Suresh Atilli |
BIBI General Hospital & Cancer Centre |
Department of Medical Oncology, 16-3-991/1/C, Government Printing Press Road,
Malakpet.
Hyderabad
ANDHRA PRADESH |
09246243034
sureshatilli@yahoo.com |
| DrKrishnan |
Dr.Rai memorial Medical Centre |
Department of Radiology,Dr.Rai Memorial Medical Centre-IRB, No 526, Century Plaza, Annasalai, Teynampet-600018
Chennai
TAMIL NADU |
09444896010
krishnan_dr@yahoo.com |
| Dr R K Saxena |
Global Hospital |
Department of Medical Oncology,6-1-1070/1 to 4,Lakdi-ka-pool,Pin-500 004
Hyderabad
ANDHRA PRADESH |
09949385000
ravikumar1960@rediffmail.com |
| Dr S P Shrivastav |
Life Research Centre & Lions cancer Research centre |
Room No. 401, Param Doctor House,Station to Lal Darwaja Road,Surat - 395 003
Surat
GUJARAT |
09824196710
drspvarma@liferesearchcentre.in |
| Dr Kirushna Kumar |
Meenakshi Mission Hospital & Research Centre |
Oncology Department,Lake Area, Melur Road, Madurai-625107
Madurai
TAMIL NADU |
09787713004
drkskk@yahoo.com |
| Dr Anitha Ramesh |
Sri Ramachandra Hospital |
Oncology Department, Room No. E-1,No. 1, Ramachandra Nagar, Porur, Pin- 600 116
Chennai
TAMIL NADU |
09840758567
anitachandra100@hotmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Dr.Rai Memorial Medical Centre-IRB,Dr.Krishnan |
Approved |
| Institutional Ethics Committee,Dr. Anitha |
Submittted/Under Review |
| Institutional Ethics Committee,Dr. Kirushna |
Submittted/Under Review |
| Institutional Ethics Committee,Dr. Suresh |
Approved |
| Institutional Ethics Committee,Dr.Saxena |
Approved |
| South Gujarat Independent Ethics Committee,Dr. S. P. Shrivastav |
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
|
| Type |
Name |
Details |
| Comparator Agent |
Gleevec® (Imatinib Mesylate) Tablets |
400 mg OD daily orally for 14 days |
| Intervention |
Imatinib Mesylate Tablets |
400 mg OD daily orally for 14 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient and /or LAR or impartial witness 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 stabilised with Imatinib Mesylate 400 mg for at least 30 days prior to dosing.
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 hyper sensitivity to Imatinib or any of its excipients or related group of drugs.
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. Have previously undergone hematopoietic stem cell transplantation.
6. Use of any recreational drugs or history of drug addiction.
7. Any other condition or abnormal baseline findings 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.
8. Patient with a history of difficulty in donating blood or difficulty in accessibility of veins |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To characterize the pharmacokinetic profile of the sponsor’s test formulation (Imatinib Mesylate Tablets 400 mg) relative to that of reference formulation (Gleevec® (Imatinib Mesylate) Tablets 400mg) in adult philadelphia chromosome positive chronic myeloid leukemia patients stabilized with Imatinib mesylate 400 mg |
PK sample 0.500, 1.000,1.500 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To monitor the safety of the patients exposed to the Investigational Medicinal Product. |
End of study |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
15/10/2013 |
| 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="7"
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
|
Imatinib mesylate (Imatinib) is a selective inhibitor of the protein tyrosine kinase associated with bcr-abl and specifically inhibits proliferation of Ph expressing cells. To prevent healthy volunteers from adverse events and as per Guidance on the conduct of bioequivalence study with Imatinib Mesylate4, this study is proposed to be carried out on patients of Chronic Myeloid Leukaemia (CML) in chronic Phase who are stabilized with Imatinib Mesylate 400 mg for atleast 30 days and having documented evidence of Philadelphia chromosome positive. The recommended dosing regime is Imatinib 400 mg 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. |