| CTRI Number |
CTRI/2016/08/007155 [Registered on: 05/08/2016] Trial Registered Prospectively |
| Last Modified On: |
19/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
BA/BE study of Imatinib Mesylate 400 mg Tablets |
Scientific Title of Study
Modification(s)
|
A Multi Center Open Label Balanced Randomized Two Treatment Two Sequence Two Period Crossover SteadyState Bioequivalence Study of Imatinib Mesylate Tablets 400 mg Test of Eugia Pharma Specialities Limited India A joint venture of Aurobindo Pharma Limited and Celon Laboratories Limited and Gleevec® Imatinib Mesylate 400 mg Tablets Reference of Novartis Pharmaceuticals Corporation USA in 36 adult patients with Chronic Myeloid Leukemia and or Gastro Intestinal Stromal Tumors already receiving Imatinib Mesylate Tablets 400 mg under fed conditions |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CR050-14, Version 1.1 Dated 09.03.2015 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Subhra Lahiri |
| Designation |
Associate Vice President |
| Affiliation |
AXIS Clinicals Limited |
| Address |
1-121/1 Miyapur Hyderabad
Hyderabad
ANDHRA PRADESH
500049
India |
| Phone |
04040408064 |
| Fax |
04040408003 |
| Email |
subhra.l@axisclinicals.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Subhra Lahiri |
| Designation |
Associate Vice President |
| Affiliation |
AXIS Clinicals Limited |
| Address |
1-121/1 Miyapur Hyderabad
Hyderabad
ANDHRA PRADESH
500049
India |
| Phone |
04040408064 |
| Fax |
04040408003 |
| Email |
subhra.l@axisclinicals.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Subhra Lahiri |
| Designation |
Associate Vice President |
| Affiliation |
AXIS Clinicals Limited |
| Address |
1-121/1 Miyapur Hyderabad
Hyderabad
ANDHRA PRADESH
500049
India |
| Phone |
04040408064 |
| Fax |
04040408003 |
| Email |
subhra.l@axisclinicals.com |
|
|
Source of Monetary or Material Support
|
| Eugia Specialities Limited ( A JV of Aurobindo Pharma and Celon Lab)
Sy No 555 Kolthur Village Shameerper Manadal RR District Telengana 500078, India |
|
|
Primary Sponsor
|
| Name |
Eugia Pharma Specialities Limited A JV of Aurobindo Pharma Limited and Celon Laboratories Limited |
| Address |
Sy No 550 551 and 552 Kolthur (Village) Shameerpet (Mandal) RR District TS India 500078 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| AXIS Clinicals Limited |
1-121/1 Miyapur Hyderabad 500049 India |
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr M Gopichand |
City Cancer Centre, Vijaywada |
33-25-33, Ch.Venkata Krishnaiah Street , Suryaraopeta , Vijaywada 520002
Krishna
ANDHRA PRADESH |
9885256059
mgopichand@yahoo.com |
| Dr Velavan |
Erode Cancer Centre |
1/393,Velavan Nagar,Perundurai road,Thindal 638012
Erode
TAMIL NADU |
9842334222
kvels@rediffmail.com |
| Dr Jayanthi S |
Gleneagles Global Hospital |
6-1-1070/1 to 4 Lakadikapool Hyderabad-500004
Hyderabad
ANDHRA PRADESH |
9866020074
jayanthi_srirambhatla@yahoo.com |
| Dr Rohan Bhise |
KLEs Dr Prabhakar kore Hospital and MRC |
KLES Dr.Prabhakar Kore Hospital and MRC
NH 4A, Belgaum, Nehru nagar, 590010
Belgaum
KARNATAKA |
9448866712
rohanbhise30@gmail.com |
| Dr Vikas Goyal |
Sanjeevani Cancer Hospital |
Infront of Jain Mandir Dawada Colony Pachpedi Naka 492001
Raipur
CHHATTISGARH |
9320144215
drvikas20@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee -City Cancer Centre Dr. Gopichand |
Approved |
| Institutional Ethics Committee Erode Cancer Centre Dr. Velavan |
Approved |
| Institutional Ethics Committee Gleneagles Global Hospital Dr. Jayanthi S |
Approved |
| Institutional Ethics Committee, KLE Academy of Higher education & Research Dr. Rohan Bhise |
Approved |
| Sanjeevani Cancer Hospital Institutional Ethics Committee Dr. Vikas Goyal |
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, (2) ICD-10 Condition: C269||Malignant neoplasm of ill-definedsites within the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Gleevec(R) -Imatinib Mesylate 400mg
Distributed by Novartis Pharmaceuticals Corporation, USA. |
This study will consists of two periods and is multiple dose study. Eligible patients will be administered with test (Imatinib Mesylate 400mg ) or reference (Gleevec® (Imatinib Mesylate) Tablets 400 mg;)for 7 consecutive days in each period crossed over without washout. |
| Intervention |
Imatinib Mesylate 400mg
Manufactured by Eugia Pharma Specialities Limited, India |
This study will consists of two periods and is multiple dose study. Eligible patients will be administered with test (Imatinib Mesylate 400mg ) or reference (Gleevec® (Imatinib Mesylate) Tablets 400 mg;)for 7
consecutive days in each period crossed over without washout. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Male or female subject aged between 18 and 65 years of age (both inclusive) at the time of informed consent and should have BMI ≥ 18.5 to ≤ 30 kg/m2.
2.Subject with chronic phase Ph+ CML (Philadelphia chromosome positive Chronic Myeloid Leukemia) in their first three months of treatment and /or Gastro Intestinal Stromal Tumors (GIST) who are on stable dose regimen of Imatinib Mesylate 400 mg daily dose
3.Subject with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase
OR
Subject with GIST diagnosed histologically with expressing CD117+ or with documented mutation of the KIT or PDGFRA gene
4.Female subject of childbearing potential should be willing to use a reliable method of birth control
5.Female subject must have a negative pregnancy test at Screening.
6.Subject should be otherwise healthy as determined by general and systemic examination, medical history and have no significant abnormality in any of the laboratory parameters including ECG and Chest X-ray.
7.Subject with ECOG (Eastern Cooperative Oncology Group) performance status 0-2
8.Subject with no history of addiction to any recreational drug or drug dependence
9.Subject must be able to adhere to the study visit schedule and other protocol requirements and must have given informed consent prior to any screening procedures.
|
|
| ExclusionCriteria |
| Details |
1.Subject with history of accelerated or blast phase CML
2.Subject with history of ascites and rapid weight gain with or without superficial edema
3.Subject had uncontrolled diabetes mellitus at the discretion of Principal Investigator
4.Subject with history of hematopoietic stem cell transplantation.
5.Subject had prior radiotherapy to bone marrow
6.Subject undergone major surgery within 4 weeks of enrolment.
7.Subject use of other concurrent anticancer agents, including chemotherapy or biologic agents.
8.Subject had history of hypersensitivity or idiosyncratic reactions to any drug product or its excipients etc
9.History of difficulty with donating blood or difficulty in swallowing the drug or difficulty in accessibility of veins.
10.High caffeine (more than 5 cups of coffee or tea/day) or tobacco (more than 9 cigarettes/ beedies/ cigars per day) consumption.
11.Subject diagnosed to be HIV 1 and 2 or Hepatitis B (HBs Ag) or Hepatitis C (HCV) virus reactive/positive.
12.Female subject who is pregnant or currently breast-feeding.
13.Subject donated blood ≥ 350 mL within 90 days of screening.
14.Subject participation in another clinical trial within the preceding 90 days of study starts.
15.Use of concomitant medication with drugs known to be inhibitors and/or inducers of CYP3A4 family and acetaminophen (paracetamol)
16.Subject with history of arterial thrombosis or deep vein thrombosis within the past year
17.Subject had significant pre-existing co-morbidities
a. Cardiovascular
• Congestive heart failure
• Uncontrolled hypertension
b. Pulmonary
• pleural effusion, pulmonary edema
c. Neurologic and psychiatric
• History of significant neurologic or psychiatric disorder that would preclude study compliance or ability to give informed consent
d. Gastrointestinal
• Severe Diarrhea and Vomiting
• Inflammatory bowel diseases
Liver or Kidney disease
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
AUC0-ï´ -: Area under the plasma concentration – time curve over the steady state dosing interval.
Cmax-ss: Maximum concentration over the steady state dosing interval.
|
Day 1, 5, 6, 8, 12 and 13: Venous blood samples will be withdrawn 5 minutes prior to morning dosing to confirm steady state condition. ( 3 days/ 12 mL/ period)
Day 7 and 14: Venous blood samples will be withdrawn at 0.00 (pre-dose) and 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 18.00 and 24.00 hours of post dose in each period.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Css-avg: Average concentration over the steady state dosing interval. |
Day 1, 5, 6, 8, 12 and 13: Venous blood samples will be withdrawn 5 minutes prior to morning dosing to confirm steady state condition. ( 3 days/ 12 mL/ period)
Day 7 and 14: Venous blood samples will be withdrawn at 0.00 (pre-dose) and 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 18.00 and 24.00 hours of post dose in each period.
|
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="38" |
|
Phase of Trial
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
17/05/2018 |
| Date of Study Completion (India) |
21/08/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a multicentre study and the Primary objective will be to determine clinical Bioequivalence of Imatinib Mesylate 400mg ( Eugia Specialities-Test ) with Gleevec (R) -Reference of Novartis Pharamaceutcals Corporation , USA . The study will be done in 36 adult evaluable subjects with Chronic Myeloid Leukemia or Gastrointestinal Stromal Tumor . The secondary object of this study is to asses safety and tolerability as asseses by the reported adverse events . |