Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Intervention1: Doxorubicin Hydrochloride (Pegylated Liposomal) 20
mg/10 mL (2 mg/mL) of Celerity Pharmaceuticals, LLC, Rosemont, Illinois, USA: Dose: 50 mg/meter square
Duration of treatment: 1 hour
Control Intervention1: CAELYX (Doxorubicin hydrochloride (pegylated liposomal)), 20 mg/ 10 mL (2
mg/mL) of Janssen-Cilag International NV, Beerse, Belgium: Dose: 50 mg/me
Sponsors
Celerity Pharmaceuticals LLC
Eligibility
Inclusion criteria
Inclusion criteria: 1. Female patients age greater than or equal to 21 to less than or equal to 75 years of age, BMI between 18 to 31 kg per meter square. 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 metastatic breast cancer who are scheduled to start therapy with doxorubicin hydrochloride (pegylated liposomal) injection 2mg per ml 4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 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, with the exception of alopecia, as judged by the Investigator. 7. Patients with a life expectancy of at least 3 months. 8. Able to comply with the study requirements in the opinion of the Investigator. 9. Adequate haematologic 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, hormonal therapy (other than replacement therapy), chemotherapy (6 weeks for nitrosoureas or mitomycin C), or radiotherapy, and the patient has recovered. 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 450 mg per meter square or more after four cycles of treatment. 3. Active opportunistic infection with mycobacteria, cytomegalovirus,Toxoplasmagondii, 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 investigation products to the patient. 6. A history of intolerance (including Grade 3 or 4 infusion reaction) or severe hypersensitivity reactions, including anaphylaxis, to doxorubicin hydrochloride or the components of either of the two study medications. 7. Use of amiodarone during the study and for at least 6 months prior 8. Patient requiring any other anticancer therapies apart from study drug during the course of study. 9. Previous radiotherapy for the treatment of unresectable, locally advanced or metastatic breast cancer is not allowed if the last fraction of radiotherapy has been administered within 28 days prior to study drug administration. 10. 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. 11. Known brain metastasis. 12. Pre-existing motor or sensory neurotoxicity of a severity greater than or equal to grade 2 by NCI criteria. 13. Other serious illness or medical condition that would prohibit the understanding and giving of informed consent. 14. A positive hepatitis screen including hepatitis B surface antigen or HCV antibodies. 15. Patients who test positive for HIV and/or syphilis. 16. 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. 17. 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. 18. 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). 19. History of cerebrovascular accident (CVA) or venous thrombosis 20. Patients who are smokers or tobacco users in any form. 21. 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. 22. Past or current history of neoplasm other than the Breast Cancer and with the exception of treated non-melanoma skin cancer or carcinoma in situ of the cervix. 23. Patients must not
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of the bioequivalence of the test product relative to that of the reference medicinal productTimepoint: 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 listed drug in patients.Timepoint: During entire duration of the trial | — |
Countries
India
Contacts
Public ContactMr Prashant Modi
Lambda Therapeutic Research Ltd
Outcome results
None listed