Health Condition 1: null- (a) Metastatic Breast Cancer (b) Advanced Ovarian Cancer
Conditions
Interventions
Intervention1: Pegylated Liposomal Doxorubicin Hydrochloride: Pegylated Liposomal Doxorubicin Hydrochloride for Injection 2mg/mL at a dose of 50mg/m2 of Emcure Pharmaceuticals Ltd., India
Control Inte
Sponsors
Emcure Pharmaceuticals Ltd India
Eligibility
Inclusion criteria
Inclusion criteria: Female patients will be considered eligible for the study based on the following criteria: 1.Willing and able to provide voluntary informed consent and to follow the protocol requirements. 2.Females aged 18 to 65 years (both inclusive) having Body Mass Index (BMI) at least 17.00 calculated as weight in kg/height in m2. 3.Patients with histopathologically / cytologically confirmed advanced ovarian cancer requiring Doxorubicin as monotherapy and who have failed a first-line platinum- or paclitaxel- based chemotherapy regimen. Or Patients with histopathologically/cytologically confirmed metastatic breast cancer requiring Doxorubicin as monotherapy. 4.Able and clinically indicated to receive liposomal doxorubicin HCl 50mg/m2, as specified in the product monograph, without exceeding a lifetime cumulative dosage of 450mg/m2. Prior use of conventional or liposomal doxorubicin formulations, in addition to the use of other anthracyclines or anthracenediones should be included in calculations of total lifetime cumulative dose. 5.Able and clinically indicated to receive the recommended minimum 2 cycles of liposomal doxorubicin HCl. 6.Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2. 7.Life expectancy of at least 6 months at the time of enrolment. 8.Non-smokers 9.Acceptable hematology status: a.Hemoglobin greater than or equal to 9.0 g/dL b.Absolute neutrophil count (ANC) greater than or equal to 1500 cells/mm3 c.Platelet count greater than or equal to 75,000 cells/mm3 10.Acceptable liver function: a.Alanine aminotransferase (ALT) less than or equal to 2.5 X ULN b.Aspartate aminotransferase (AST) less than or equal to 2.5 X ULN c.Bilirubin less than or equal to 1.5 X ULN d.Alkaline phosphatase less than or equal to 2.5 X ULN 11.Patients with Creatinine clearance greater than or equal to 60 mL/minute 12.Cardiac ejection fraction greater than or equal to 50% by echocardiogram (ECHO) within 14 days prior to first dose of Investigational Product. 13.Patients with negative serum pregnancy test at screening and negative urine pregnancy test at Day 0. 14.Patients who agree to use adequate contraception (eg, hormonal, chemical, double-barrier, or abstinence) while in the study and for 6 months after study participation is discontinued. 15.No history of addiction to any recreational drug or drug dependence or alcohol addiction.
Exclusion criteria
Exclusion criteria: Female patients will be excluded from the study based on the following criteria: 1.Known hypersensitivity or contraindication to conventional or liposomal formulations of doxorubicin, anthracycline therapy or to any of their components. 2.Received liposomal doxorubicin HCl in the past and had a required dose reduction to below 50mg/m2, or whose disease has progressed or recurred after treatment with liposomal doxorubicin. 3.Received previous chemotherapy less than 4 weeks prior to dosing of Investigational Product. 4.Received any prior mediastinal irradiation (as cardiac toxicity may occur at cumulative doses lower than 400mg/m2). 5.Receipt of cyclophosphamide, calcium channel blockers, and other potential cardiotoxic drugs for 2 weeks prior to dosing of Investigational Product, and during the study. 6.History or presence of any uncontrolled debilitating systemic disease (e.g. cardiovascular disease, hypertension, diabetes mellitus etc.). 7.Known CNS metastasis. 8.Major surgical procedure (including periodontal) within 28 days of first dose of Investigational Product. 9.Surgical or other non-healing wounds. 10.Patients with positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV). 11.Patients with positive urine screen for Drugs of Abuse. 12.History of other malignancies in the last 5 years (except in situ cancer or basal or squamous cell skin cancer). 13.Has not recovered to Grade 0 or 1 toxicity from previous anticancer treatments or previous investigational agents. Exceptions are alopecia (any grade is acceptable), fatigue (Grade 2 is acceptable), and peripheral neuropathy (stable Grade 2 is acceptable) (Per National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], V5.0). 14.Participation in any clinical study within 90 days before the first dose of Investigational Product. 15.Donation of blood (1 unit or 350 ml) within 90 days prior to receiving the first dose of investigational product for the current study. 16.Any other medical condition or serious intercurrent illness that, in the opinion of the Investigator, may make it undesirable for the subject to participate in the study including but not limited to cirrhosis or psychiatric illness/social situations that would limit adherence to study requirements. 17.Pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To establish bioequivalence between Pegylated Liposomal Doxorubicin Hydrochloride for Injection 2mg/mL at a dose of 50mg/m2 of Emcure Pharmaceuticals Ltd., India and PrCAELYX® (Pegylated Liposomal Doxorubicin Hydrochloride for Injection) 2mg/mL at a dose of 50mg/m2 of Janssen Inc., 19 Green Belt Drive, Toronto, Ontario, M3C 1L9Timepoint: The pre-infusion blood sample (00.00) will be drawn within one hour prior to the scheduled dosing time and at 00.17 (10 min), 00.33 (20 min), 00.50 (30 min), 00.67 (40 min), 00.83 (50 min), 01.00, 01.08 (1 hr 05 min), 01.25 (1 hr 15 min), 01.50 (1 hr 30 min), 01.75 (1 hr 45 min), 02.00, 03.00, 04.00, 06.00, 08.00, 12.00, 24.00, 48.00, 96.00, 144.00, 192.00, 240.00, 288.00 and 336.00 hours after the start of infusion in each period. | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the adverse events and to assess safety and tolerability in patientsTimepoint: NA | — |
Countries
India
Contacts
Public ContactDr Sandeep Singh
Emcure Pharmaceuticals Limited
Outcome results
None listed