Health Condition 1: C569- Malignant neoplasm of unspecifiedovary
Conditions
Interventions
Intervention1: Doxorubicin Hydrochloride Liposome Injection, 20 mg/10
mL (2 mg/mL) of Celerity Pharmaceuticals, USA: Dose: 50 mg/meter square
Frequency:every 4 weeks
(i.e.28 days)
Duration of treatment: 1 hour
Control Intervention1: Doxorubicin Hydrochloride Liposome Injection, 20 mg/ 10 mL (2 mg/mL) of Sun Pharmaceutical Ind. Ltd, India: Dose: 50 mg/meter square
Sponsors
Celerity Pharmaceuticals LLC
Eligibility
Inclusion criteria
Inclusion criteria: 1. Female patients between 18-75 years of age (both inclusive), BMI between 18 to 31 kg/meter square (both inclusive). 2. Patients must be able to understand the investigational nature of this study and to give written informed consent prior to the participation in the trial. 3.Patient with confirmed Ovarian Cancer whose disease has progressed or recurred after Platinum-based Chemotherapy and who are scheduled to start the therapy with Doxorubicin Hydrochloride Liposome Injection, 20 mg/ 10 mL (2 mg/mL) 4. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2. 5. Cardiac function (left ventricular ejection fraction [LVEF] greater than or equal to 50 percent and no other clinically significant findings on ECHO. 6. Patient should have recovered from any toxic effects of previous chemotherapy as judged by the Investigator. 7. Patients with life expectancy of at least 3 months. 8. Able to comply with study requirements in the opinion of Investigator. 9. Adequate hematologic status, renal and liver function. 10. Women of child bearing potential must not be pregnant or breastfeeding (as documented by a negative serum pregnancy test at screening and negative urine pregnancy test at baseline). 11. Women of child bearing potential must use an acceptable and effective method of avoiding pregnancy, starting at least four weeks before the first dose of study drug and continuing until at least six months after the last dose of study drug. Cessation of birth control after this point should be discussed with the responsible physician. 12. Adequate recovery from recent surgery. At least 1 week must have elapsed from the time of minor surgery; at least 4 weeks must have elapsed from the time of major surgery. 13. Non-smoker defined as non-smoker for at least 6 months (i.e. subject has not smoked or used any tobacco products for the 6 months prior to the screening visit).
Exclusion criteria
Exclusion criteria: 1. Pregnant or breast-feeding female. 2. Prior doxorubicin exposure that would result in a total lifetime exposure of 550 mg/meter square or more after four cycles of treatment 3. Active opportunistic infection with mycobacteria, cytomegalovirus, Toxoplasma gondii, P.carinii or other microorganism. 4. Presence of clinically significant cardiac, liver, or kidney disease. 5. Subjects with a history or presence of any illness, including psychiatric disorders that in the opinion of the Investigator, might confound the results of the trial or pose additional risk in administering the investigational products to the patient. 6. A history of severe hypersensitivity reactions, including anaphylaxis, to doxorubicin hydrochloride or the components of either of the two study medications. 7. Use of any recreational drugs (cocaine, amphetamines, barbiturates, benzodiazepines, cannabinoids and morphine) or history of drug or alcohol abuse within the past 1 year, as judged by the Investigator, or a positive result on the urine drug/alcohol screen. 8. Known brain metastasis. 9. Pre-existing motor or sensory neurotoxicity of a severity greater than or equal to grade 2 by NCI criteria. 10. Other serious illness or medical condition that would prevent the patient from understanding study requirements and providing informed consent. 11. A positive hepatitis screen including hepatitis B surface antigen or HCV antibodies. 12. Patients tested positive for HIV and/or syphilis. 13. The receipt of an investigational product, or participation in a drug research study within a period of 30 days prior Screening or 5 half-lives within the last dose of investigational product, whichever is longer. Current use of any drugs that are known to interfere with doxorubicin metabolism or to cause a drug-drug interaction. 14. Donation / loss of blood/plasma or blood product (without replenishment) (1 unit or 350 mL) within 90 days prior to receiving the first dose of study medicine. 15. Uncontrolled hypertension (systolic blood pressure [BP] greater than 140 or diastolic BP greater than 90mm Hg) or uncontrolled cardiac arrhythmias (Patients with hypertension controlled by antihypertensive therapies are eligible). 16. History of cerebrovascular accident (CVA) or venous thrombosis. 17. Patients who are smokers or tobacco users in any form. 18. Females of reproductive potential unwilling to use acceptable contraception (as defined in the protocol) throughout the trial and for six month after the last dose of study medication. 19. Past or current history of neoplasm other than the Ovarian Cancer and with the exception of treated non-melanoma skin cancer or carcinoma in situ of the cervix. 20. Patients must not have taken any potent CYP3A4 inhibitors/inducers less than or equal to 30 days prior to enrolment including but not limited to: ketoconazole, itraconazole, troleandomycin, clarithromycin, erythromycin, ritonavir, indinavir, nelfinavir, saquinavir, amprenavir, nefazodone, fluvoxamine, diltiazem, verapamil, mibefradil, cimetidine, cyclosporine, grapefruit juice and pomelo-containing food or fluids. 21. Patients with a mental incapacity, unwillingness, or language barrier that prevents the patient from understanding or cooperating with study procedures. 22. Presence of clinically significant findin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of the bioequivalence of the test product relative to that of the reference standardTimepoint: Pre-dose to 360.00 hours from start of infusion | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of the safety and tolerability of both the test and reference products in patients.Timepoint: During entire duration of the trial | — |
Countries
India
Contacts
Public ContactMr Prashant Modi
Lambda Therapeutic Research Ltd
Outcome results
None listed