| CTRI Number |
CTRI/2026/03/105187 [Registered on: 02/03/2026] Trial Registered Prospectively |
| Last Modified On: |
28/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Crossover Oral Bioequivalence
Study Comparing Imatinib Mesylate 400 mg Tablets of Natco Pharma Limited, with Gleevec (Imatinib Mesylate) Tablet 400 mg of Novartis Pharmaceuticals, USA in adult Patients with CML and/or Gastrointestinal Stromal Tumor under fed conditions. |
|
Scientific Title of Study
|
A Multicenter, Open Label, Balanced, Randomized, Steady State, Two-
Treatment, Two-Sequence, Two-period, Crossover Oral Bioequivalence
Study Comparing (Test Product) Imatinib Mesylate 400 mg Tablets of Natco
Pharma Limited, India with (Reference Product) Gleevec® (Imatinib
Mesylate) Tablet 400 mg of Novartis Pharmaceuticals Corporation, East
Hanover, New Jersey 07936 in adult Human Patients with Chronic Myeloid
Leukemia and/or Gastrointestinal Stromal Tumor stabilized on Imatinib
Mesylate 400 mg under fed conditions. |
| Trial Acronym |
CNR-012-25 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CNR-012-25 |
DCGI |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Radhika Inapakolla |
| Designation |
Overall Trial Coordinator |
| Affiliation |
CliNovi Research Pvt. Ltd. |
| Address |
Survey No. 81/7 and 8, Mithran Mall, Mumbai-Bangalore Highway, Tathawade, Pune Maharashtra, India
Survey No. 81/7 and 8, Mithran Mall, Mumbai-Bangalore Highway, Tathawade, Pune Maharashtra, India
Pune
MAHARASHTRA
411033
India |
| Phone |
09765800495 |
| Fax |
|
| Email |
radhika@clinovi.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Radhika Inapakolla |
| Designation |
Overall Trial Coordinator |
| Affiliation |
CliNovi Research Pvt. Ltd. |
| Address |
Survey No. 81/7 and 8, Mithran Mall, Mumbai-Bangalore Highway, Tathawade, Pune Maharashtra, India
Survey No. 81/7 and 8, Mithran Mall, Mumbai-Bangalore Highway, Tathawade, Pune Maharashtra, India
Pune
MAHARASHTRA
411033
India |
| Phone |
09765800495 |
| Fax |
|
| Email |
radhika@clinovi.com |
|
Details of Contact Person
Public Query
|
| Name |
Radhika Inapakolla |
| Designation |
Overall Trial Coordinator |
| Affiliation |
CliNovi Research Pvt. Ltd. |
| Address |
Survey No. 81/7 and 8, Mithran Mall, Mumbai-Bangalore Highway, Tathawade, Pune Maharashtra, India
Survey No. 81/7 and 8, Mithran Mall, Mumbai-Bangalore Highway, Tathawade, Pune Maharashtra, India
Pune
MAHARASHTRA
411033
India |
| Phone |
09765800495 |
| Fax |
|
| Email |
radhika@clinovi.com |
|
|
Source of Monetary or Material Support
|
| Natco Pharma Limited India
Natco House, Road No-2, Banjara Hills, Road No. 2, Hyderabad, Telangana 500034 |
|
|
Primary Sponsor
|
| Name |
Natco Pharma Limited |
| Address |
Natco House
Road No.2, Banjara Hills
Hyderabad-500 034, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| CliNovi Research Pvt Ltd |
Plot No. 81/7&8, Mumbai-Bangalore Highway, Tathawade, Pune, Maharashtra - 411033, India. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Minish Jain |
CIMETS Inamdar Multispeciality Hospital |
Sr No.15, Behind KPTC Mall, Fatima Nagar, Wanowrie, Pune - 411040
Pune
MAHARASHTRA |
9823133390
dr.minishjainimhtrials@gmail.com |
| Dr Lakshmi Priyadarshini K |
HCG Curie City Cancer Centre |
33-25-25,ch.venkatakrishnayya street, Suryaraopeta, Vijayawada - 520002
Krishna
ANDHRA PRADESH |
9966030988
priyadarshini006@gmail.com |
| Dr Dnyaneshwar Pralhadrao Upase |
Life point Multi specialty Hospital |
Sr no 145/1, Bangalore- Mumbai High way, Near Sayajji Hotel , Wakad, Pune - 411057
Pune
MAHARASHTRA |
9224640845
upase.dnyaneshwar111@gmail.com |
| Dr Rajendersingh Arora |
Sujan surgical cancer Hospital and Amravati Cancer Foundation |
52/B shankar Nagar, Main Road, Amravati - 444606,
Amravati
MAHARASHTRA |
9823097573
0721257868
rsaroradr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| AMRAVATI ETHICS COMMITTEE |
Approved |
| Ethics Committee Inamdar Multispeciality Hospital |
Approved |
| INSTITUTIONAL ETHICS COMMITTEE HCG Curie City Cancer Centre |
Approved |
| Lifepoint Research Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| 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 Tablet 400 mg |
Novartis Pharmaceuticals Corporation East Hanover New Jersey 07936 |
| Intervention |
Imatinib Mesylate
400 mg |
Natco Pharma Limited India |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Men and women of age in between 18 years to 65 years both inclusive
Ability to provide written informed consent prior to participation in the study
Chronic phase Chronic Myeloid Leukemia CML patients with documented evidence of Philadelphia positive chromosome who are on stable dose regimen of 400 mg once daily dose of Imatinib mesylate And Or
Kit CD117 positive Gastrointestinal Stromal Tumor GIST with documented evidence who are on a stable dose regimen of 400 mg once daily dose of Imatinib mesylate
Adequate organ function defined as the following
Hemoglobin 9 mg dL
Total bilirubin 1.5 upper limit of normal ULN
SGOT and SGPT 2.5 ULN
Serum Creatinine 1.5 ULN
Absolute neutrophil count ANC 1.5 109 L
Platelets 100 109 L
HbA1c 9 percent
Females of child-bearing potential FOCP must have negative pregnancy test at screening and must agree to use an acceptable method of birth control such as sexual abstinence or at least 2 reliable modes of contraception one of which must be a double-barrier method condom with spermicidal gel or diaphragm with spermicidal gel or IUD or vaginal spermicidal suppository from screening until 14 days after last dose of study drug Note Use of hormonal contraception pills hormonal intrauterine device etc is not allowed Patients agree to accept the risk that pregnancy could still result despite using birth control devices
Or
Post menopausal females defined as 12 consecutive months of amenorrhea
Surgically sterilized females with documented evidence of hysterectomy
bilateral salpingectomy bilateral oophorectomy Females without documented evidence of surgery and those who has undergone tubal ligation will be considered of childbearing potential
Male patient must agree to use an acceptable method of birth control such as sexual abstinence or barrier method of contraception condom from screening until 14 days after last dose of study drug Patients agree to accept the risk that pregnancy in female partner could still result despite using birth control devices No history of participation in any clinical study within the past 90 days Patients should be screened for hepatotoxicity prior to enrollment and the protocol should include procedures to monitor hepatotoxicity during the course of the study
|
|
| ExclusionCriteria |
| Details |
The patient will be excluded based on the following criteria
Patients in accelerated phase or blast crisis phase
Patients for whom a titration away from 400 mg dose is likely during the entire study period as per Investigators judgement
Patient received any treatment for CML prior to study entry for longer than 2 weeks with the exception of hydroxyurea and or anagrelide and or imatinib mesylate
History of patient with another primary malignancy except if the primary malignancy is neither currently clinically significant or requiring active intervention
Patients having history of major surgery within 4 weeks prior to study entry or who have not recovered from prior major surgery
Patients with an ECOG Eastern Cooperative Oncology group Performance Status Score 3
Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent
Patients with identified sibling donors where allogeneic bone marrow transplant is elected as first line treatment
Patients who are on or may require concomitant medications which are known to be inhibitors and or inducers of CYP3A4 family
History of hematopoietic stem cell transplantation
History of Hypersensitivity to imatinib mesylate or any of its excipient or related group of drugs
Patients who are eligible and willing to undergo transplantation during the entire study period
History of patients taking certain medications that are accepted to have a risk of causing Torsades de Pointes
History of patients taking medications that irreversibly inhibit platelet function or anticoagulants
History of uncontrolled diseases such as thyroidal dysfunction diabetes mellitus angina pectoris heart failure neuropsychiatric disorders
Patients who are at clinically high risk of developing Tumor Lysis Syndrome as per the investigator evaluation
Patients who have undergone thyroidectomy or patients receiving levothyroxine
Patients with history of bullous dermatologic reaction including erythema multiforme and Stevens Johnson syndrome during the prior therapy with imatinib mesylate or any other drug Recent history within 6 months of alcohol and/or drug addiction
Patients who are human immunodeficiency virus and HCV Antibody positive
History of ascites and rapid weight gain with or without superficial edema
History of prior radiotherapy to bone marrow
Use of other concurrent anticancer agents other than Imatinib mesylate including chemotherapy or biological agent
Positive results for drugs of abuse benzodiazepines opioids amphetamines cannabinoids cocaine and barbiturates in urine
Positive results for alcohol in urine
History of difficulty with donating blood or difficulty in accessibility of veins
An unusual or abnormal diet for whatever reason religious fasting
High caffeinemore than 5 cups of coffee or tea day or tobacco more than cigarettes beedis cigars per day consumption
History of patient for whom oral administration of drug is not possible
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the rate and extent of absorption of Test Product Imatinib Mesylate 400 mg Tablets of Natco Pharma Limited India with Reference Product Gleevec Imatinib Mesylate Tablet 400 mg of Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936 in adult Human Patients with Chronic Myeloid Leukemia and or Gastrointestinal Stromal Tumor stabilized on Imatinib Mesylate 400 mg under fed conditions |
0.50, 1.00, 1.50,
2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 6.00, 8.00, 10.00, 12.00, 18.00 and
24.00 hrs. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the safety and tolerability of Imatinib Mesylate 400 mg tablets |
6 Months safety |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
11/03/2026 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A Multicenter Open Label Balanced Randomized Steady State Two Treatment Two Sequence Two period Crossover Oral Bioequivalence Study Comparing Test Product Imatinib Mesylate 400 mg Tablets of Natco Pharma Limited India with Reference Product Gleevec Imatinib Mesylate Tablet 400 mg of Novartis Pharmaceuticals Corporation East Hanover New Jersey 07936 in adult Human Patients with Chronic Myeloid Leukemia and or Gastrointestinal Stromal Tumor stabilized on Imatinib Mesylate 400 mg under fed conditions CNR 012 25 |