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CTRI Number  CTRI/2017/09/009706 [Registered on: 11/09/2017] 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   A comparative study of Imatinib Mesylate Tablets 400 mg of CSPC Pharmaceutical, China and Gleevec® (Imatinib Mesylate) Tablets 400 mg of Novartis Pharma Stein AG, for Novartis Pharmaceuticals Corporation New Jersey in patients with cancer of white blood cells. 
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 CSPC Pharmaceutical, China to the reference drug Gleevec® (Imatinib Mesylate) Tablets 400 mg of Novartis Pharma Stein AG,for Novartis Pharmaceuticals Corporation New Jersey 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 
0860-16, Version: 1.1, Date: 19/07/2017  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mr Amin Dobaria 
Designation  Project manager 
Affiliation  Lambda Therapeutic Research Ltd  
Address  Lambda House, Plot No. 38, Survey No. 388
Near Silver Oak Club, S. G. Highway, Gota
Ahmadabad
GUJARAT
382481
India 
Phone  07940202362  
Fax  07940202021  
Email  aminkdobaria@lambda-cro.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ravi Alamchandani 
Designation  Assistant Manager 
Affiliation  Lambda Therapeutic Research Ltd 
Address  Lambda House, Plot No. 38, Survey No. 388
Near Silver Oak Club, S. G. Highway, Gota
Ahmadabad
GUJARAT
382481
India 
Phone  07940202358  
Fax  07940202021  
Email  ravialamchandani@lambda-cro.com  
 
Details of Contact Person
Public Query  
Name  Dr Ravi Alamchandani 
Designation  Assistant Manager 
Affiliation  Lambda Therapeutic Research Ltd 
Address  Lambda House, Plot No. 38, Survey No. 388
Near Silver Oak Club, S. G. Highway, Gota
Ahmadabad
GUJARAT
382481
India 
Phone  07940202358  
Fax  07940202021  
Email  ravialamchandani@lambda-cro.com  
 
Source of Monetary or Material Support  
CSPC Pharmaceutical Co. Ltd, No. 276, West Zhongshan Road, Shijiazhuang, Hebei, China. 
 
Primary Sponsor  
Name  CSPC Pharmaceutical Co Ltd 
Address  No. 276, West Zhongshan Road, Shijiazhuang, Hebei, China 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NA  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr M Gopichand  City Cancer Centre  # 33-25-33, Dept of Clinical Research, Room No. NA, Ch. Venkatakrishanyya Street, Suryavaopet, Vijayawada
Krishna
ANDHRA PRADESH 		 08662436661

mgopichand@yahoo.com 
Dr Pramod Kumar  J K Cancer Institute  Rawatpur corssing, Dept of Clinical Research, Room No. NA, Kanpur, 208005, UP India
Kanpur Nagar
UTTAR PRADESH 		 9838200265

drpramodsingh16@gmail.com 
Dr Shailesh Bondarde  Shatabdi Hospital Suyojit City Center  Opp Mahamarg Bus Stand, Dept of Clinical Research, Room No. NA, Mumbai Naka, Nashik, Maharashtra 422005 Nashik MAHARASHTRA
Nashik
MAHARASHTRA 		 02536639004

shaileshbondarde1971@gmail.com 
Dr Ankit Patel  Unique Hospital Multi Specialty and Research Institute  Opp. Kiran Motor, Dept of Clinical Research, Room No. NA, Near Canal, Civil Hospital Char Rasta Sosyo Circle Lane, Off Ring Road, Surat, Gujarat 395002 Surat GUJARAT
Surat
GUJARAT 		 9825404202

ankit_ahm@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Ethics committee,unique multispeciality hospital &research center, Dr Ankit Patel  Submittted/Under Review 
Institutional Ethics Committee, City Cancer Centre, Dr. M Gopichand  Approved 
J. K. Cancer Institute Ethics Committee, Dr. Pramod Kumar  Submittted/Under Review 
Shatabdi hospital ethic committee, Dr Shailesh Bondarde  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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 400mg of Novartis Pharma Stein AG, Stein, Switzerland for Novartis Pharmaceuticals Corporation, New Jersey   Dose: 400 mg, Frequency: everyday, Mode of Administration: oral, Duration of treatment: 7 days 
Intervention  Imatinib Mesylate Tablets 400 mg of CSPC Pharmaceutical Co., Ltd, China  Dose: 400 mg, Frequency: everyday, Mode of Administration: oral, Duration of treatment: 7 days  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients able to give informed consent for participation in the trial.
2. Male or female patients must be 18 to 65 years of age (both inclusive) at the
screening visit.
3. Patient must be on stable dose of 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.
7. Patient should be able to comply with study procedures in the opinion of the
investigator.
8. In case of female patient the serum pregnancy test at screening visit and urine
pregnancy test at day 1 (before dosing) must be negative.
9. Sexually active women, unless surgically sterile (at least 6 months prior to Study
drug administration) or postmenopausal for at least 12 consecutive months, must
use an effective method of avoiding pregnancy (including oral, transdermal, or
implanted contraceptives [any hormonal method in conjunction with a secondary
method], intrauterine device, female condom with spermicide, diaphragm with
spermicide, absolute sexual abstinence, use of condom with spermicide by sexual partner or sterile [at least 6 months prior to Study drug administration] sexual
partner) for at least 4 weeks prior to study drug administration, during study and
up to 30 days after the last dose of study drug. Cessation of birth control after this
point should be discussed with a responsible physician.
10. In case of Male patients: Either partner or patient must use an effective method of
avoiding pregnancy for at least 4 weeks prior to study drug administration, during
study and up to 30 days after the last dose of study drug. Cessation of birth control
after this point should be discussed with a responsible physician.
It is investigator’s responsibility to ensure that above points regarding an effective
method of avoiding pregnancy are discussed with patient in detail and patient
agreed for this and it is documented in source document. The investigator should
ensure that the patient is using an effective method of avoiding pregnancy as per
protocol. 
 
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. Patient is on drugs known to be inducer or inhibitor of CYP3A4 family.
7. Patient who have undergone Thyroidectomy.
8. Use of any recreational drugs or history of drug addiction.
9. Donation of blood (1 unit or 350 ml) within 90 days prior to receiving the first
dose of investigational medicinal product for the current study.
10. 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.
11. The receipt of an investigational medicinal product within a period of 30 days
prior to the first dose of investigational medicinal Product for the current study.
12. Patient with a history of difficulty in donating blood or difficulty in accessibility
of veins.
13. Patient with history of Hepatotoxicity 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To characterize and compare 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 and to assess the bioequivalence after multiple dose administration
under fed conditions. 		 Day 1 to Day 14 
 
Secondary Outcome  
Outcome  TimePoints 
To monitor the safety of the patients exposed to the Investigational Medicinal Product.  Day 1 to Day 14 
 
Target Sample Size   Total Sample Size="26"
Sample Size from India="26" 
Final Enrollment numbers achieved (Total)= "26"
Final Enrollment numbers achieved (India)="26" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/09/2017 
Date of Study Completion (India) 24/01/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
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. 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 tablets for atleast 30 days and having documented evidence of Philadelphia chromosome positive. The dosing and sampling regime is proposed to be built into the recommended treatment of such patients. 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.

In this study, Imatinib Mesylate 400 mg (Test and Reference) will be administered to patients at an interval of 24 hr for 14 days. Day 1 to day 7 will be considered period I and day 8 to day 14 will be considered as period II.

Following oral administration, the elimination half-life of Imatinib and its major active metabolite, the N-demethyl derivative, are approximately 18 and 40 hours, respectively. Therefore, this steady state multiple dose study will be performed in patients of Philadelphia chromosome positive Chronic Myeloid Leukaemia (CML), who are stabilized with Imatinib mesylate 400 mg for atleast 30 days.
 
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