CTRI/2024/03/064636 [Registered on: 21/03/2024] Trial Registered Prospectively
Last Modified On:
11/03/2024
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
Study Design
Randomized, Crossover Trial
Public Title of Study
This is a drug concentration assessment study of Azacitidine 300 mg tablets in patients with Blood Cancer (Acute Myeloid Leukemia).
Scientific Title of Study
A multicenter, randomized, open label, two treatment, two period, single-dose, crossover, bioequivalence study of Azacitidine Tablets 300 mg manufactured by Teva, Czech Industries s.r.o. with ONUREG (Azacitidine) Tablets 300 mg manufactured by Celgene Distribution B.V., Netherlands under fasting condition in patients with a confirmed diagnosis of Acute Myeloid Leukemia in remission phase.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
CT/AZAC/2103 (Version 1.0) dated 22/Aug/2023
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Ward No 90 (Ground Floor) Clinical Trial Room, Oncology Department,Alwarpuram, Madurai, Tamilnadu 625020, India Madurai TAMIL NADU
9442619775
jjebasingh@gmail.com
Dr Madatha Vijay Ramanan
Grant Medical Foundation Ruby Hall Clinic
Room No 103,
01st Floor, Hematology Department
40, Sassoon Road, Pune 411001, Maharashtra India Pune MAHARASHTRA
9822240022
mvijayr@gmail.com
Dr Senthilkumar KS
Harshamitra Super SpecialityCancer hospital & Reasearch Institute
Room No 02 Ground Floor Onoclogy Department
Mathur Panchayat Road, Trichy-Madurai Highway, Nagamangalam, Trichy-620012 Tamilnadu India Tiruchirappalli TAMIL NADU
93631288840
drsenthilkumarresearchunit@gmail.com
Dr Sanketh Kotne
HCG Cancer Centre
Room No 02 (Ground Floor), Oncology Department, Plot No 10, Survey No 13P,APIIC health city,Chinagadili,Arilova ,Visakhapatnam, Andhra Pradesh - 530040 Visakhapatnam ANDHRA PRADESH Visakhapatnam ANDHRA PRADESH
7013222831
drsanketh.k@hcgel.com
Dr Toshniwal Manoj Murlidhar
Ishwar Institute of Health Care
Room No 107, First Floor,Ishwar Institute of Health Care, Ishwar Heights, 01st Floor Plot No 07, Gut No 06/1, Beside Punjabi Bhawan, padegoan, Aurangabad 431002 Maharashtra India Aurangabad MAHARASHTRA
9225300842
drmanojtoshniwal.iicr@gmail.com
Dr Chandran K Nair
Malabar Cancer Centre
Room No 212A Department of Clinical Hematology & Medical Oncology Moozhikkara P.O Kodiyeri
Thalassery Kannur Kerala 670103 India Kannur KERALA
9496048808
cknair09@gmail.com
Dr Pandidurai
Meridian Hospital
Room No: 613 Department of Medical Oncology
46D, Jawaharlal Nehru Road, 200 Feet Ring Rd, Kolathur, Chennai, Tamil Nadu 600099 Chennai TAMIL NADU
8248461542
pandi19@gmail.com
Dr PKChaithanya
MNJ Institute of Oncology & Regional Cancer Centre
Room No 03 Consultation Room, Ground Floor, NANO Hospitals,79, Sir M Visveswaraya Rd, Nyanappana Halli, Hulimavu, DLF City Road, Near Arekere Saibaba Temple, Bengaluru, Karnataka 560076 Bangalore KARNATAKA Bangalore KARNATAKA
9844685166
saldanhasmitha@gmail.com
Dr Anuj Kumar Bansal
Punjab Cancer Care Multispeaciality Hospital
Room No 05, Ground Floor, Punjab Cancer Care Multispeaciality Hospital, Z-3-03570, Goniana Road, Opp Dayal Kidney Hospital, Near Tinkoni, Bathinda-151001, Punjab India Bathinda PUNJAB
9868964152
anujkumarbansal2003@gmail.com
Dr Vikas TTalreja
Regency Hospital Ltd
Room No 02, First Floor, Medical Haemato Oncologist, Regency Hospital Ltd Cancer & Gastro Care Centre, A4, Tower 02 Sarvodaya Nagar Kanpur-208005 (U.P) India Kanpur Nagar UTTAR PRADESH Kanpur Nagar UTTAR PRADESH
9769890961
vikasttalreja@gmail.com
Dr Sanjeev
Sanjay Gandhi Postgraduate Institute of Medical Science
I Block Ground floor Department of Hematology(Clinical/BMT)
Raebareli Road, Lucknow 226014 UP India Lucknow UTTAR PRADESH
9670187769
dr.sanjeev.ranchi@gmail.com
Dr Susanta Kumar Paikaray
Utkal Hospital
Basement 02 Room No 06 Medical Oncology Department
Plot No-C/3, Niladri Vihar Chandrasekharpur, Bhubaneswar 751021 India Khordha ORISSA
9780731393
drskppgi@gmail.com
Dr Riya Ballikar
Wockhardt Hospital
OPD No – 18
Hematology Department
13, Ambazari Rd, opp. New Wochardt Hospital, Shankar Nagar, Shivaji Nagar, Nagpur, Maharashtra 440010 Nagpur MAHARASHTRA
8334988584
riabalikar@rediffmail.com
Details of Ethics Committee
No of Ethics Committees= 14
Name of Committee
Approval Status
Ethics Committee of Ishwar Institute of HealthCare Ishwar Institute of Health Care 3rd Floor, Plot No.07, Gut No. 6/1 Padhegaon,Beside Panjabi Bhavan Jaysingpura Aurangabad Maharashtra - 431002 India
Submittted/Under Review
Ethics Committee Wockhardt Hospitals Ltd Nagpur Wockhardt Hospitals Limited Napur, 1643 Shankar Nagar North Ambazari Road Nagpur (India)-440010 India
Submittted/Under Review
IEC,Punjab Cancer Care Multispeaciality Hospital, Z-3-03570, Goniana Road, Opp Dayal Kidney Hospital, Near Tinkoni, Bathinda-151001, Punjab India
Submittted/Under Review
IEC-Malabar Cancer Centre Malabar Cancer Centre Moozhikkara P.O Kodiyeri Thalassery Kannur Kerala 670103 India
Submittted/Under Review
Institutional Ethics Committee Harshamitra Superspeciality Cancer Centre No. 41 Nachiyar Kovil Street, Woraiyur Tiruchirappalli Tamil Nadu - 620003 India
Approved
Institutional Ethics Committee HCG Cancer Centre HCG Cancer Centre Plot No 10, APIIC Health, Arilova Chinnagadili, Mudasarlova Road Visakhapatnam Andhra Pradesh-530040 India
Approved
Institutional Ethics Committee Madurai Medical College and Govt. Rajaji Hospital Madurai Medical College Panagal Road Madurai Madurai Tamil Nadu - 625020 India
Submittted/Under Review
INSTITUTIONAL ETHICS COMMITTEE Sanjay Gandhi Postgraduate Institute of M Sciences Raebareli Road Lucknow LUCKNOW Lucknow Uttar Pradesh - 226014 India
Submittted/Under Review
Institutional Ethics Committee Sparsh Hospitals and Critical Care Private Limited Plot No-A/407, Saheed Nagar, Bhubaneswar Khordha, Orissa - 751007 India
Submittted/Under Review
KVT Speciality Hospital-IEC KVT Speciality Hospital Plot No.1, 2, 3 And 10 Ethirajsamy Salai, Erukanchery Chennai, Chennai, Tamil Nadu - 600118 India
Approved
Medstar Speciality Hospital Ethics Committee Medstar Speciality Hospital N0 614, 17/1/3, Kodigehalli Main Road sahakarnagar Post Bangalore Bengaluru (Bangalore) Urban Karnataka - 560092 India
Approved
MNJIORCC Ethics Committee MNJ Institute of Oncology and RCC Lakdikapool Red Hills Hyderabad Hyderabad Telangana - 500004 India
Submittted/Under Review
Poona Medical Research Foundation Ruby Hall Clinic 40,Sassoon road Pune pune Pune Maharashtra - 411001 India
Submittted/Under Review
Regency Hospital Ethics Committee Regency Hospital A 2, Sarvodaya Nagar KANPUR 208005 Kanpur Kanpur Nagar Uttar Pradesh - 208005 India
During each of the study periods, patients will receive a single oral dose with 150 mL of water.
Comparator Agent
ONUREG (Azacitidine) 300mg
During each of the study periods, patients will receive a single oral dose with 150 mL of water.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1. Male or female patients of 18 years of age and above at the time of signing the informed consent form.
2. Able to understand and voluntarily sign an informed consent form prior to any study related assessments and procedures.
3. Patients with documented diagnosis of acute myeloid leukemia who achieved complete remission or complete remission with incomplete blood count recovery following induction chemotherapy with or without consolidation treatment and who are not candidates for, including those who choose not to proceed to, hematopoietic stem cell transplantation.
4. Patients who are scheduled to be initiated on maintenance therapy with azacitidine tablets 300mg or already on a stable dose of azacitidine tablets 300mg (for these patients a washout period of 14 days to be maintained prior to the dosing in period I).
5. As per investigator discretion, patients must not be eligible for therapy of higher curative potential where an alternative treatment has been shown to prolong survival in an analogous population.
6. Have an Eastern Cooperative Oncology Group performance status of 0-2, inclusively.
7. Have a life expectancy of more than 3 months based on the clinical judgement of the Investigator.
8. Have stable renal function without dialysis for at least 2 months prior to Investigational Medicinal Product administration.
9. Have adequate bone marrow function at the screening and randomization visits.
10. Have adequate hepatic function at the screening visit.
11. Have a 12-lead Electrocardiogram with no clinically significant findings at screening, as determined by the investigator.
12. Women of childbearing potential must be non-pregnant or non-lactating.
13. Able to adhere to the study visit schedule and other protocol requirements.
ExclusionCriteria
Details
1. Gastrointestinal tumors, tumors that have originated or metastasized to the liver, or other tumors known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
2. Patients requiring any concurrent chemotherapy, hormonal therapy, immunotherapy, therapy with biologicals or radiotherapy for the disease.
3. Have been treated with an investigational agent within 4 weeks prior to the first day of IMP administration.
4. Patients treated with proton pump inhibitors like esomeprazole, lansoprazole, omeprazole, pantoprazole and rabeprazole.
5. A positive test result for HIV, HBsAg and HCV.
6. Have ongoing clinically significant adverse event(s) due to prior treatments administered as determined by the investigator
7. Significant active cardiac disease within the previous 6 months.
8. Have known or suspected hypersensitivity to azacitidine or any other ingredient used in the manufacturing of azacitidine.
9. Uncontrolled systemic fungal, bacterial, or viral infection.
10. Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
11. Any condition that confounds the ability to interpret data from the study.
12. Impaired ability to swallow oral medication.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
To demonstrate the
bioequivalence between Test
product Azacitidine 300mg
tablets and Reference product
ONUREG® (Azacitidine)
300mg tablets in patients with
Acute Myeloid Leukemia
Total Sample Size="48" Sample Size from India="48" 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)
15/04/2024
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="6" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Closed to Recruitment of Participants
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
The purpose of the proposed study is to evaluate
bioavailability of Azacitidine Tablets 300 mg and establish bioequivalence
between Test product (Azacitdine Tablets 300 mg manufactured by Teva, Czech
Industries s.r.o.) and Reference product (ONUREG (Azacitidine) tablets 300mg
manufactured by Celgene Distribution B.V., Netherlands) in patients with
confirmed diagnosis of Acute Myeloid Leukemia in remission phase.