CTRI/2013/07/003829 [Registered on: 23/07/2013] Trial Registered Prospectively
Last Modified On:
02/03/2017
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
Study Design
Randomized, Crossover Trial
Public Title of Study
Comparative study of Doxorubicin HCL Liposome Inj(2mg/mL)(10mL) with Doxil®,20mg in 10mL(2mg/mL)Manf.for:Janssen Products, LP Horsham,PA 19044 administer in female patient with progressed/recurred ovarian cancer after platinum based chemo under fed condition
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 Injection (2mg/mL) (10mL) of Onco Therapies Limited, Bangalore, India with Doxil®Doxorubicin HCl liposome injection, 20mg in 10mL (2 mg/mL) Manufactured by: Ben Venue Laboratories, Inc., Bedford, OH 44146 Manufactured for: Janssen Products, LP Horsham, PA 19044 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
12-VIN-274 Version 01 dated 9th July 2012
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Brijesh Wadekar
Designation
Head of Department
Affiliation
Veeda Clinical Research Pvt. Ltd.
Address
Veeda Clinical Research Pvt. Ltd.Insignia, Sindhu Bhavan Road, Bodakdev Road, S.G.highway.
Ahmedabad
Ahmadabad GUJARAT 380059 India
Phone
07930013000
Fax
07930013010
Email
brijesh.wadekar@veedacr.com
Details of Contact Person Scientific Query
Name
Dr Brijesh Wadekar
Designation
Head of Department
Affiliation
Veeda Clinical Research Pvt. Ltd.
Address
Veeda Clinical Research Pvt. Ltd.Insignia, Sindhu Bhavan Road, Bodakdev Road, S.G.highway.
Ahmedabad
Ahmadabad GUJARAT 380059 India
Phone
07930013000
Fax
07930013010
Email
brijesh.wadekar@veedacr.com
Details of Contact Person Public Query
Name
Dr Brijesh Wadekar
Designation
Head of Department
Affiliation
Veeda Clinical Research Pvt. Ltd.
Address
Veeda Clinical Research Pvt. Ltd.Insignia, Sindhu Bhavan Road, Bodakdev Road, S.G.highway.
Ahmedabad
Ahmadabad GUJARAT 380059 India
Phone
07930013000
Fax
07930013010
Email
brijesh.wadekar@veedacr.com
Source of Monetary or Material Support
Onco Therapies Limited.
Primary Sponsor
Name
Onco Therapies Limited
Address
Bilekahalli, Bannerghatta Road
Bangalore 560076, India
Cancer Clinic, 208 Shreewardhan Complex, Wardha Road, Ramdaspeth AND Cancer Clinic and Nursing Home, block 4B, Hyatt Medicare, Dr. N.B.Khare Marg, Dhantoli
Nagpur MAHARASHTRA
09373107176
cancerclinic9@gmail.com
Dr Ajay mehta
Central India Cancer Research Institute
11, Shankr Nagar,
West High Court, Nagpur, 440010
Maharastra
Nagpur MAHARASHTRA
09823190192
ajayonco@hotmail.com
DrGopichand
City Cancer centre
33-25-33, Venkta Krishnayya street suryaraopet, Vijaywada-520002
Krishna ANDHRA PRADESH
9642611888
mgopichand@yahoo.com
Dr Rajinesh Nagarkar
Curie Manavata cancer centre
Opp:Mhamarg Bus Stand,Mumabi,Nasik, Maharastara-422002,INDIA Nashik MAHARASHTRA
09823258862
drraj@manavatacancercentre.com
Dr K N Srinivasan
Dr. G Vishwanathan Speciality Hospital
No. 27, Babu Road, Trichy-620008
Tiruchirappalli TAMIL NADU
9443337230
kns68@yahoo.com
Dr K velavan
Erode Cancer center Velavan Nagaar
Thindal (PO),Peruindurai Road,Erode-12 Erode TAMIL NADU
09629760276
velavandoctor@gmail.com
Dr Niraj Bhatt
Kailash cancer hospital and Research centre,
kailash cancer hospital and Research centure,Muni seva asharm,Goraj-391760,Ta.Waghodia,Dist. Vadodara
Vadodara GUJARAT
09687623125
medonc12@gmail.com
Dr SP Shrivastav
Life Research center
Life Research center,401-Param Doctor House,station lal darwaja road,Surat-395003
Surat GUJARAT
0261-224862
crconcolrc@yahoo.com
Dr K S Kirushnakumar
Meenakshi mission hospital and research center
Meenakshi mission hospital and research center,Lake area,Merul road,Madurai,Tamilnadu,625107
Madurai TAMIL NADU
0452-2586353
drkskk@yahoo.com
Dr Yatish Kumar
N R R Hospital
Hessaragatta Main Road, Near Chikanbanvara Railways Station, Bangalore, Bangalore KARNATAKA
9986873824
dryathish@hotmail.com
Dr Rakesh Neve
Nandadeep Multispeciality Hospital
119511,FC Road,Shivaji Nagar, Pune 41105 Pune MAHARASHTRA
9881143140
drdipalin@gmail.com
DrMinish Jain
Noble Hospital Pvt ltd.
153, Magarpatta city road,
Hadapsar, Pune 411013
Maharastra
Pune MAHARASHTRA
09823133390
minishjain009@gmail.com
Dr S S Nirni
Omega Hospital,
Road No 12, Banjara Hill, HCA Colony Road, Hyderabad, AndhraPradesh Hyderabad ANDHRA PRADESH
040-23551034
nirni2002@rediffmail.com
Dr Pradeep Shah
Shreyas Medical Clinic and Hospital
2 Premal Apartment Raopura, Near GPO, Vadodara, Gujarat-390001
Vadodara GUJARAT
Nandadeep Hospital Independent Ethics Committee/Pune/Dr.Rakesh Neve
Submittted/Under Review
Nobel Hospital Institutional Ethics Committee/pune/Dr.Minish Jain
Approved
Research Independent Ethics Committee, Surat /surat/Dr.S.P.Shrivastav
Submittted/Under Review
Regulatory Clearance Status from DCGI
Status
No Objection Certificate
Health Condition / Problems Studied
Health Type
Condition
Patients
Ovarian Cancer ,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Doxil®Doxorubicin HCl liposome injection, 20mg in 10mL (2 mg/mL).Dose of 50 mg/meter square will be administered once in every 4 weeks by Intra Venous Infusion.
Manufactured by: Ben Venue Laboratories, Inc., Bedford, OH 44146 Manufactured for: Janssen Products, LP Horsham, PA 19044
Intervention
Doxorubicin Hydrochloride Liposome Injection. Dose of 50 mg/meter square will be administered once in every 4 weeks by Intra Venous Infusion for four to six cycles.
Onco Therapies Limited, Bangalore, India
Inclusion Criteria
Age From
18.00 Year(s)
Age To
75.00 Year(s)
Gender
Female
Details
1.Female 18 to 75 years of age (both inclusive) and having a Body Mass Index (BMI) at least 17 calculated as weight in kg / (height in meter)square.
2.Patients with Ovarian Cancer whose disease has progressed or recurred after Platinum-based Chemotherapy and requiring Doxorubicin HCl liposomal injection 50 mg/meter square dose as monotherapy.
3.Patient should have recovered from any toxic effects of previous chemotherapy as judged by the Investigator.
4.Patients with life expectancy of at least 3 months.
5.ECOG performance status ≤2
6.Patients can be on stable concomitant medication, as long as drugs and their dose have not been changed for the last 3 months prior to first day of dosing.
7.Adequate Hemopoeitic, Renal and Liver function
Body system Parameters
Bone marrow function ANC ≥ 1500/mm3,
Platelet count ≥ 100,000/mm3
Haemoglobin ≥ 9.0 g/dl
Renal function Serum Creatinine < 1.5 times ULN
Hepatic function AST and ALT < 2.5 times ULN
Alkaline phosphatase < 2 times ULN
Bilirubin < 2.5 times ULN
8.Sexually active women, unless surgically sterile (at least 6 months prior to Study drug administration) or postmenopausal for at least 12 consecutive months, must use an effective method of avoiding pregnancy (including oral, transdermal, or implanted contraceptives [any hormonal method in conjunction with a secondary method], intrauterine device, female condom with spermicide, diaphragm with spermicide, absolute sexual abstinence, use of condom with spermicide by sexual partner or sterile [at least 6 months prior to Study drug administration] sexual partner) for at least 4 weeks prior to study drug administration, during study and up to 30 days after the last dose of study drug. Cessation of birth control after this point should be discussed with a responsible physician.
It is investigator’s responsibility to ensure that above points regarding an effective method of avoiding pregnancy are discussed with patient in detail and patient agreed for this and it is documented in source document. The investigator should ensure that the patient is using an effective method of avoiding pregnancy as per protocol.
9.Subject or his/her legal representative has signed the informed consent.
10.Patients should preferably be on monotherapy. However, cancer patients receiving concomitant drug(s) are allowed to participate, provided:
a.The concomitant medication with dosing regimen is the same for both study period and clearly documented and clearly stated in the protocol.
b.The concurrent medications do not interfere with the assay for measuring the drug in plasma.
ExclusionCriteria
Details
1.History of allergy or hypersensitivity to Doxorubicin HCl Liposome Injection or any related compound at any dose.
2.Positive pregnancy test at screening (Serum) and prior to dosing (Urine) in each period.
3.Patient who’s total cumulative dose of doxorubicin HCl approaches 550 mg/meter square
4.Patient having active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, P. carinii or other microorganism if under treatment with myelotoxic drugs.
5.Abnormal baseline findings considered by the investigator to indicate conditions that might affect study endpoints.
6.Any clinically significant concomitant disease
7.Alcohol or drug abuse or drug dependence within the preceding year
8.The receipt of an investigational product or participation to another clinical trial within 60 days prior to first day of dosing. of investigational Product (Elimination half-life of the study drug should be taken into consideration for inclusion of the patient in the study).
9.Pregnant or breastfeeding female
10.Patients with a prior history of coronary artery disease or any of the following cardiac conditions:
a.Unstable angina
b.Myocardial infarction within the past 6 months
c.NYHA (New York State Heart Association) class II-IV heart failure
d.Severe uncontrolled ventricular arrhythmias
e.Clinically significant pericardial disease
f.Electrocardiographic evidence of acute ischemic or active conduction system abnormalities.
g.Any other cardiac illness that could lead to a safety risk to the patient in case of enrolment in the study
11.Patients with clinically significant liver or renal disease as judged by the investigator.
12.Known brain metastasis
13.Presence of active infections
14.Pre-existing motor or sensory neurotoxicity of a severity ≥ grade 2 by NCI CTCAE criteria.
15.Patients with hepatic impairment and severe renal impairment
16.A positive hepatitis screen including hepatitis B surface antigen, HCV or HAV (IgM) antibodies
17.Donation of blood (1 unit or 350 ml) within 90 days prior to receiving the first dose of investigational medicinal product for the current study.
18.Known, existing uncontrolled coagulopathy
19.Physiological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
20.Patients must not have taken any potent CYP3A4 inhibitors including but not limited to: ketoconazole, itraconazole, troleandomycin, clarithromycin, erythromycin, ritonavir, indinavir, nelfinavir, saquinavir, amprenavir, nefazodone, fluvoxamine, diltiazem, verapamil, mibefradil, cimetidine and cyclosporine within 30 days prior to day of first dosing and/or use of drug metabolism enzymes such as phenytoin, cabamazepin, phenobarbital, etc…during the study and within 30 days prior to day of first dosing.
21.Patients with another primary malignancy except if the other primary malignancy is neither currently clinically significant or requiring active intervention.
22.Any other condition that, in the investigator’s judgment, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.
Method of Generating Random Sequence
Other
Method of Concealment
An Open list of random numbers
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Compare and evaluate the single dose,comparative bioavailability study of Doxorubicin HCL Liposome Injection (2 mg/mL)(10mL)of Onco Therapies Limited, Bangalore, India with Doxil®Doxorubicin HCl liposome injection,20mg in 10mL(2 mg/mL) Manufactured by: Ben Venue Lab, Inc., Bedford, OH 44146 Manufactured for: Janssen Products, LP Horsham, PA 19044 administered in female patients with ovarian cancer whose disease has progressed or recurred after platinum based chemotherapy under fed condition.
Total 18 blood samples collected during each period. Pre-infusion blood sample of 3.5 mL(00.00)will be collected within 1 hr prior to dosing. post-dose blood samples of 3.5 mL each will be drawn at During IV infusion:Blood samples(1 x 3.5 ml)will be collected at0.250,0.500,0.750 and 1 hr after start of IV. After completion of the IV
Post-dose blood samples(1 x 3.5 ml)collected at0.083,0.25 ,0.500,1.00,3.00,5.00,8.00,24.00,48.00,96.00,168.00,240.00,336.00hr after completion of the IV.
Secondary Outcome
Outcome
TimePoints
To monitor the adverse events and to ensure the safety of Patient
N/A
Target Sample Size
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"
This study is a multicenter, open label, randomized, balanced, two treatment, two period, two sequence, two way crossover, single dose, bioequivalence study of Doxorubicin Hydrochloride Liposome Injection (2mg/mL) (10mL) of Onco Therapies Limited, Bangalore, India with Doxil®Doxorubicin HCl liposome injection, 20mg in 10mL (2 mg/mL) Manufactured by: Ben Venue Laboratories, Inc., Bedford, OH 44146 manufactures for: Janssen Products, LP Horsham, PA 19044administered in female patients with ovarian cancer whose disease has progressed or recurred after platinum based chemotherapy under fed condition
Treatments will be allocated to patient by carrying out randomization using statistical techniques. Total number of subjects will be enrolled in to the study in order to complete the study with 48 subjects
The dose of doxorubicin HCl for individual patient will be calculated according to body surface area and same dose will be administered in both the periods.There will be a washout period of 28 days, between two successive dosing (two successive periods).
Patients will be randomized to receive intravenous infusion of either test or reference product of doxorubicin hydrochloride injection 2mg/mL (10mL) by IV infusion after dilution over 60 minutes period as per randomization schedule.
Total expected duration of the study will be of at least 43 days from the first day of IMP administration in period I till the end of study sample collection in period II.
All the Adverse events and serious adverse events will be recorded from the signing of the Informed consent form till 30 days after the last dose of study drug administration.
The study was not initiated and no subjects were enrolled hence to update and close the CTRI from the sponsors end the study status was updated to terminated.