Comparative study of Doxorubicin HCL Liposome Inj(2mg/mL)(10mL) with DoxilÂ®,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

Conditions: Ovarian Cancer

Registration Number: CTRI/2013/07/003829

Lead Sponsor: Onco Therapies Limited

Brief Summary: 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 DoxilÂ®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 19044 administered 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Other

Sex: Female

Target Recruitment: 48

Inclusion Criteria

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 â‰¤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 functionANC â‰¥ 1500/mm3, Platelet count â‰¥ 100,000/mm3 Haemoglobin â‰¥ 9.0 g/dl Renal functionSerum Creatinine < 1.5 times ULN Hepatic functionAST 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 investigatorâ€™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.

Exclusion Criteria

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 whoâ€™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 â‰¥ 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, etcâ€¦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 investigatorâ€™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.

Study & Design

Study Type: BA/BE

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 DoxilÂ®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 Measures

Name	Time	Method
To monitor the adverse events and to ensure the safety of Patient	N/A

Trial Locations

Locations (15): BIBI General Hospital & Cancer center
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Hyderabad, ANDHRA PRADESH, India
Cancer Clinic
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Nagpur, MAHARASHTRA, India
Central India Cancer Research Institute
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Nagpur, MAHARASHTRA, India
City Cancer centre
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Krishna, ANDHRA PRADESH, India
Curie Manavata cancer centre
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Nashik, MAHARASHTRA, India
Dr. G Vishwanathan Speciality Hospital
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Tiruchirappalli, TAMIL NADU, India
Erode Cancer center Velavan Nagaar
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Erode, TAMIL NADU, India
Kailash cancer hospital and Research centre,
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Vadodara, GUJARAT, India
Life Research center
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Surat, GUJARAT, India
Meenakshi mission hospital and research center
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Madurai, TAMIL NADU, India
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BIBI General Hospital & Cancer center
🇮🇳Hyderabad, ANDHRA PRADESH, India
Dr A V S Suresh
Principal investigator
9246243024
sureshattili@yahoo.com