| CTRI Number |
CTRI/2018/04/013185 [Registered on: 11/04/2018] Trial Registered Prospectively |
| Last Modified On: |
10/12/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Bioequivalence study of Doxorubicin Hydrochloride Liposome Inj(20mg/10mL) administered in female patients with ovarian cancer. |
|
Scientific Title of Study
|
A multicenter, open label, randomized, balanced, two treatment, two period, two sequence, two way crossover, single dose, bioequivalence study of Doxorubicin Hydrochloride Liposome Injection20mg/10mL of Mylan Laboratories Ltd India with Doxorubicin Hydrochloride Liposome injection for intravenous infusion20mg/10mlManufactured by SUN pharmaceutical Ind Ltd Halol Baroda Highway halol 389350 Gujarat India administered in female patients with ovarian cancer whose disease has progressed or recurred after platinum based chemotherapy under fed condition. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 13-VIN-443 Version 6 Amd 04 Dated 31 Oct 2017 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashoka Kumar Singh |
| Designation |
Head - Clinical Operations |
| Affiliation |
Veeda Clinical Research Pvt. Ltd. |
| Address |
Veeda Clinical Research Pvt. Ltd. Shivalik Plaza-A, Near IIM,
Ambawadi
Ahmadabad
GUJARAT
380015
India |
| Phone |
07930013000 |
| Fax |
07930013010 |
| Email |
Ashoka.Singh@veedacr.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yogesh Patel |
| Designation |
Senior Manager- Medical Monitor |
| Affiliation |
Veeda Clinical Research Pvt. Ltd |
| Address |
Veeda Clinical Research Pvt. Ltd. Shivalik Plaza-A, Near IIM,
Ambawadi
Ahmadabad
GUJARAT
380015
India |
| Phone |
07930013000 |
| Fax |
07930013010 |
| Email |
Yogesh.AP@veedacr.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashoka Kumar Singh |
| Designation |
Head - Clinical Operations |
| Affiliation |
Veeda Clinical Research Pvt. Ltd. |
| Address |
Veeda Clinical Research Pvt. Ltd. Shivalik Plaza-A, Near IIM,
Ambawadi,
Ahmadabad
GUJARAT
380015
India |
| Phone |
07930013000 |
| Fax |
07930013010 |
| Email |
Ashoka.Singh@veedacr.com |
|
|
Source of Monetary or Material Support
|
| Mylan Laboratories Limited, Bilekahalli,Bannerghatta road, Banglore-560076, India |
|
|
Primary Sponsor
|
| Name |
Mylan Laboratories Limited |
| Address |
Bilekahalli, Bannerghatta Road,
Bangalore 560076, India.
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 10 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr G N Patel |
Apple hospital |
Oncology Department, Division Oncology, Room. Clinical research deprtment, Udhana darwaja, Ring road 395002
Surat
GUJARAT |
9376913131
0261-6696078
drgnpatelonco@gmail.com |
| Dr Krishna Kamble |
Government Medical College & Hospital, Dept. of Radiation therapy & oncology |
Dept. of Radiation therapy and oncology, Division Oncology, Ward no. 85, Medical college square 440003
Nagpur
MAHARASHTRA |
9850246275
drkmkamble@yahoo.co.in |
| Dr Mahesh Kaloli |
KLEs Dr. Prabhakar Hospital & Medical Research Centre |
Clinical Research Room Second Floor, Nehru Nagar, Belgaum 590010, Karnataka, India.
Bangalore
KARNATAKA |
9945014996
mahesh.kalloli@gmail.com |
| Dr Kirushna Kumar |
Meenakshi Mission hospital and reserch centre |
Oncology Department, Division Oncology, Clinical Research Room,Lake area, Melur road, Near Mattuthavani bus stand, 625107
Madurai
TAMIL NADU |
9787713004
0452-2586353
drkskk@yahoo.com |
| Dr Mukta Srinivasulu |
MNJ Institute of Oncology & Regional Cancer Centre |
Red Hills, Hyderabad-500004, Telangana, India
Hyderabad
ANDHRA PRADESH |
9849044816
muktasrinivasulu@yahoo.co.in |
| Dr Tushar Patil |
Sahyadri hospital |
Department Oncology, Clinical Research Road, Plot No. 30-C, Karve Road, Erandawane, Deccan Gymkhana 411004
Pune
MAHARASHTRA |
8805002590
020-25459315
tussipats@hotmail.com |
| DrSatheesh CT |
Shetty’s Hospital |
Plot No: 11&12, Department of Oncology, Room Clinical Research, 12th “F†Main, Kaveri Nagar,
Kodichikkanahalli,
Bommanhalli, Bangalore 560068
Bangalore
KARNATAKA |
9242698756
drsatheeshct@gmail.com |
| Dr Rajesh Makadia |
Shree Giriraj Multi speciality hospital |
Oncology department, Division Oncology, Room. Clinical Research Room, 27, Navjyot park corner, 150 feet ring road 360005
Rajkot
GUJARAT |
9824255668
281-2587222
makadiarajesh@rocketmail.com |
| Dr Ghanshyam Biswas |
Sparsh Hospital |
A/407, Oncology Division, Department of Medical Oncology, Back Side of Kalyan Jewellers, Sahid Nagar, Bhubaneswar, Odisha 751007
Khordha
ORISSA |
9937500878
0674-2545860
drgbiswas@gmail.com |
| Dr Rajeshwar |
Srikara Hospital |
Plot No: 50, LB Nagar Ring Road, Hyderabad - 500074, Telangana, India.
Hyderabad
ANDHRA PRADESH |
9949148484
rajeshavancha@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 10 |
| Name of Committee |
Approval Status |
| Apple Hospital Ethics committee |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee - Government Medical College & Hospital, Nagpur |
Approved |
| Institutional Ethics Committee - Sparsh Hospital |
Approved |
| Institutional Ethics Committee Belgavi |
Approved |
| Institutional Ethics committee MNJ Institutie of Oncology and regional cancer center |
Approved |
| Sahyadri Hopsitals Ethics Committee |
Approved |
| Shettys Hospital Ethics Committee |
Approved |
| Shree Giriraj Hospital Ethics Committee |
Approved |
| SNR Galaxy Hospital Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Ovarian cancer, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Doxorubicin Hydrochloride Liposome Injection (20mg/10mL) |
Manufactured by Mylan Laboratories Limited, India
Dosing:Subjects will receive 50 mg/m2 dose of Doxorubicin Hydrochloride liposomal Injection for intravenous infusion (either test or reference product as per the randomization sequence either in period I or period II) |
| Comparator Agent |
Doxorubicin Hydrochloride Liposome Injection for intravenous infusion 20 mg/10 mL |
Manufactured By: Sun Pharmaceutical Ind. Ltd., India
Dosing:Subjects will receive 50 mg/m2 dose of Doxorubicin Hydrochloride liposomal Injection for intravenous infusion (either test or reference product as per the randomization sequence either in period I or period II) |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Female |
| Details |
1 Non-smoker, female, having a Body Mass Index (BMI) atleast 17
2 Patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy and who are already receiving or scheduled to start Doxorubicin Hydrochloride liposomal injection.
3 Patients with life expectancy of at least 3 months.
4 Adequate hemopoeitic, renal and liver function.
5 Sexually active women, unless surgically sterile or postmenopausal.
|
|
| ExclusionCriteria |
| Details |
1 History of allergy or hypersensitivity reactions to Doxorubicin Hydrochloride or the components of Doxorubicin Hydrochloride Liposome Injection or any related compound at any dose or other anthracycline drugs, or granisetron or dexamethasone.
2 Patients who require a dose reduction to below 50mg/m2.
3 Prior history of acute infusion related reaction.
4 Prior Doxorubicin exposure that would result in a total lifetime exposure of 550 mg/m2 or more after four cycles of treatment.
5 Patient having active opportunistic infection or other clinically significant infection
6 Patients with history of other clinically significant concomitant disease.
7 Participation in another clinical trial within 60 days prior to first day of dosing of Investigational Medicinal Product.
8 Pregnant or breastfeeding female.
9 Patients with any cardiac risks.
10 Patients with hepatic impairment and severe renal impairment.
11 A positive HIV and hepatitis screen.
12 Donation of blood within 90 days prior to receiving the first dose of Investigational Medicinal Product for the current study.
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare and evaluate the single dose,comparative bioavailability of Doxorubicin Hydrochloride Liposome Inj.(20mg/10mL) |
Total 25 blood samples in each period. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To monitor the adverse events and to ensure the safety of patients |
Physical examination will be done at screening and during study period. |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="125" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
17/04/2018 |
| Date of Study Completion (India) |
10/10/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="7"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
A multicenter, open label, randomized, balanced, two treatment, two period, two sequence, two way crossover, single dose, bioequivalence study of Doxorubicin Hydrochloride Liposome Injection (20 mg/10 mL) administered in female patients with ovarian cancer whose disease has progressed or recurred after platinum based chemotherapy under fed condition. The total study duration will be 43 days from the first day of Investigational medicinal product administration. Patients with Ovarian Cancer whose disease has progressed or recurred after Platinum-based chemotherapy and who are already receiving or scheduled to start Doxorubicin Hydrochloride liposomal injection 50 mg/m2 dose as monotherapy will be enrolled in the study. Patients with prior Doxorubicin exposure that would result in a total lifetime exposure of 550 mg/m2 or more after four cycles of treatment will be excluded from the study. Total 25 blood samples will be collected during each period.
Dr.Aseem kumar Samar(Malpani multispeciality hospital, Jaipur),Dr.Nirmal Raut(Bhaktivedanta hospital & research institute, Thane), Dr.Rakesh Neve(PDEA’s Ayurved Rugnalay & sterling multispeciality hospital, Pune), Dr.Tanveer Maksud (Unique multispeciality hospital, Surat),Dr.Gopichand M(City cancer centre,Vijaywada), Dr.Chinmay Kumar Basu(Netaji subhashchandra bose cancer research institute, Kolkata), Dr.Mukesh Singhal (Acharya Tulsi Regional Cancer centre, Bikaner),Dr.Pramod Patil(Kailash cancer hospital and research centre,Goraj, Vadodara), Dr.Sapna Datta(Surya superspeciality hospital, Varanasi),Dr.Rajeev L K(Shree venketshwar hospital, Banglore), Dr. Rajnish Nagarakar (Curie Manavta Cancer centre, Nashik). Following sites have started enrolling patients. First patient was screened on 1st Jan 2018 and first patient randomized was 17th Jan 2018. |