| CTRI Number |
CTRI/2017/07/009123 [Registered on: 27/07/2017] Trial Registered Prospectively |
| Last Modified On: |
17/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Comparative evaluation of two formulations of Imatinib Mesylate Tablet 400 mg in Adult Patients Suffering from Cancer under Fed Conditions |
|
Scientific Title of Study
|
A Randomized, Open Label, Two-Treatment, Multiple Dose, Steady State, Two-period, Cross-over, Multi-Centre Comparative Bioequivalence Study of Imatinib Mesylate Tablet 400 mg of Qilu Pharmaceutical (Hainan) Co.,Ltd. with gleevec®(Imatinib Mesylate) Tablet 400 mg Distributed by Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936 in Adult Patients Suffering from Chronic Myeloid Leukemia or Gastrointestinal Stromal Tumor under Fed Conditions |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| ARL/CT/16/010 Version No. 00 Amendment 00 Dated 17 May 2017 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ajaykumar B Malle |
| Designation |
General Manager Clinical Trials |
| Affiliation |
Accutest Research Laboratories (I) Pvt Ltd |
| Address |
A 77, Khairne MIDC, TTC Industrial Area,
Khairne, Navi Mumbai
Mumbai
MAHARASHTRA
400709
India |
| Phone |
02227780718 |
| Fax |
02227780720 |
| Email |
ajay.malle@accutestglobal.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajaykumar B Malle |
| Designation |
General Manager Clinical Trials |
| Affiliation |
Accutest Research Laboratories (I) Pvt Ltd |
| Address |
A 77, Khairne MIDC, TTC Industrial Area,
Khairne, Navi Mumbai
Mumbai
MAHARASHTRA
400709
India |
| Phone |
02227780718 |
| Fax |
02227780720 |
| Email |
ajay.malle@accutestglobal.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hiren Gandhecha |
| Designation |
Manager - Clinical Operations |
| Affiliation |
Accutest Research Laboratories (I) Pvt Ltd |
| Address |
Opp. The Grand Bhagwati,
S.G. Highway,
Bodakdev, Ahmedabad 380059,
Gujarat
Ahmadabad
GUJARAT
380059
India |
| Phone |
07940231600 |
| Fax |
07940029317 |
| Email |
hiren.gandhecha@accutestglobal.com |
|
|
Source of Monetary or Material Support
|
| Qilu Pharmaceutical Co Ltd, No.243 Gong Ye Bei Road, Jinan,
Shandong Province, P.R. China, 250100
|
|
|
Primary Sponsor
|
| Name |
Qilu Pharmaceutical Co Ltd |
| Address |
No.243 Gong Ye Bei Road, Jinan,
Shandong Province, P.R. China, 250100
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
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 M Gopichand |
City Cancer Centre |
Department of Oncology, Clinical Reseaerch Room City Cancer Center, 33-25-33, CH. Venkata krishnayya street suryarao pet, Vijayawada-520002, AndhraPradesh, India
Krishna
ANDHRA PRADESH |
09885256059
mgopichand@yahoo.com |
| Dr Kartikeya Jain |
Kailash Cancer Hospital & Research Centre |
Kailash Cancer Hospital & Research Centre, Muni Seva Ashram, Goraj, Ta: Waghodia, Vadodara - 391760, Gujarat, India
Vadodara
GUJARAT |
07042519274
kartikeya.jain@greenashram.org |
| Dr Jyothi N |
Karnataka Cancer Hospital & Research Centre |
No-99, Jharakabande kaval, Krishnadanagar, Nandim layout, Bangalore, 560096
Bangalore
KARNATAKA |
09448051964
jyothichinnali@yahoo.com |
| Dr Dyaneshwar Upase |
Lifepoint Multispeciality Hospital |
Lifepoint Research LLP Lifepoint Multispeciality Hospital, 145/1, Mumbai Bangalore Highway, Near Hotel Sayaji, Wakad, Pune -411 057, Maharashtra, India
Pune
MAHARASHTRA |
09623707572
upase.dnyneshwar111@gmail.com |
| Dr K C Lakshmaiah |
Srinivasam Cancer Care Multispeciality Hospitals India Private Limited |
36 1st A Main, 5th Cross (Nethravati Street), Maruthinagar, Nagarbhavi main road, Banglore-560072
Bangalore
KARNATAKA |
09448055949
kcluck@gmail.com |
| Dr Keyur Bhatt |
Surat Institute of Digestive Science |
Vijay Nagar Gate No-3, Besides Nirman Bhavan, Opp. Gandhi College, Majura Gate, Surat, Gujarat 395002
Surat
GUJARAT |
09712939693
drkeyurbhatt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, City Cancer Centre |
Approved |
| Institutional Ethics Committee, Karnataka Cancer Hospital & Research Centre |
Approved |
| Kailash Cancer & Medical Centre,IEC |
Approved |
| LPR Ethics Committee |
Approved |
| Srinivasam Cancer Care Multispeciality IEC |
Approved |
| Surat Institute of Digestive sciences, ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Adult Patients Suffering from Chronic Myeloid Leukemia or Gastrointestinal Stromal Tumor under Fed Conditions, (1) ICD-10 Condition: C921||Chronic myeloid leukemia, BCR/ABL-positive, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Gleevec®(Imatinib Mesylate) Tablet 400 mg |
400 mg once a day for 7 Days |
| Intervention |
Imatinib mesylate tablets is 400 mg |
400 mg once a day for 7 Days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Age 18 to 55 years (both inclusive) and either sex.
2.Diagnosed case of Philadelphia chromosome positive (Ph+) CML patients in chronic phase or GIST and presently being treated with imatinib 400 mg tablets
3.Eastern Cooperative Oncology Group (ECOG) performance status of 0–2.
4.Willing to give written informed consent for participation in the study as well as willing and able to comply with study visit schedule and other protocol requirements.
5.Patient’s screening laboratory assessments are clinically non-significant as per the discretion of the Investigator.
6.Female patients of child bearing potential (except for those who have completed one year since menopause or have gone through hysterectomy or bilateral tubal ligation) must have negative serum pregnancy test at the screening, negative urine pregnancy test on check in to housing, must be non-lactating at screening and must agree to use effective contraception (barrier or hormonal) for the study period.
|
|
| ExclusionCriteria |
| Details |
1.History of hypersensitivity to imatinib mesylate or to any of the excipients as judged by investigator.
2.Patient of CML receiving treatment in Myeloid Blast Crisis or Accelerated Phase
The Patients with any of the following criteria should be excluded:
3.Abnormal laboratory results as below:
Absolute neutrophils count < 1 x 109/L or < 1000/ mm3
Platelet Count < 50 x 109/L or 50,000/mm3
SGOT &/or SGPT > 5 times upper limit of normal (ULN)
Serum total Bilirubin > 3 times ULN
Serum TSH > 10 μIU/mL
Serum Uric Acid > 12 mg/dL
Reactive for HIV antibody, HBsAg or HCV antibody
4.History of a heart failure, renal insufficiency, hypereosinophilic syndrome (HES), myelodysplastic syndrome (MDS)/ myeloproliferative disease (MPD) or acute systemic mastocytosis (ASM).
5.Alcohol or any drug dependence within past one year.
6.Blood donation/ loss exceeding 200 mL within last 60 days.
7.History of therapy with any of the following as per timelines before randomization:
Inducers of CYP3A4 activity within 14 days
Inhibitors of CYP3A4 activity within 14 days.
Investigational product/ device within last one month
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To characterize pharmacokinetic profile of test product – Imatinib Mesylate tablets compared to that of the corresponding reference product– gleevec® (imatinib mesylate) tablets 400 mg who are diagnosed to have CML or GIST and are presently receiving stable dose of imatinib mesylate tablets 400 mg, and assess their bioequivalence. |
On days 5 and 12, 1st pre-dose blood sampling within 10 minutes before IP dose will be done
On days 6 and 13, 2nd pre-dose blood sampling within 10 minutes before IP dose will be done
On days 7 and 14, 3rd pre-dose sample will be taken within 10 minutes before IP dose and thereafter post dose sampling will be done at 00.25, 00.50, 01.00, 01.50, 02.00, 02.33, 02.67, 03.00, 03.33, 03.67, 04.00, 04.50, 05.00, 05.50, 06.00, 06.50, 07.00, 08.00, 10.00, 12.00, 16.00, and 24.00 hrs post-dose.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To monitor the safety and tolerability of a multiple doses of imatinib mesylate tablets 400 mg in adult patients, who are diagnosed to have CML or GIST and are presently receiving stable dose of imatinib mesylate tablets 400 mg. |
Monitoring and Reporting of Adverse Events. |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
Final Enrollment numbers achieved (Total)= "48"
Final Enrollment numbers achieved (India)="48" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
07/08/2017 |
| 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="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The present
study is being conducted in adult
patients, who are diagnosed to have CML or GIST and are presently
receiving stable dose of imatinib mesylate tablets
400 mg, to avoid the risk of
adverse effects in healthy volunteers.
Present protocol is randomized, open label, two-treatment,
multiple dose, steady state, two-period, cross-over, multi-centre comparative
bioequivalence study under fed condition.
|