Health Condition 1: C00-D49- Neoplasms
Conditions
Interventions
Intervention1: Doxorubicin pegylated liposomal
concentrate for solution for infusion 2
mg/mL- Test: Dose: 20 mg/10 mL vial,
Route of Administration: IV infusion,
Duration of Dose: 2 cycles.
Each cycle
Sponsors
Qilu Pharmaceutical (Hainan) Co., Ltd.
Lambda Therapeutic Research Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1) Must sign an ICF indicating that the participant understands the purpose of and procedures required for the study as described in Appendix 10.1.3 and in this protocol and is willing to participate in the study. 2) Female participant with an age of 18 (or the legal age of consent in the jurisdiction in which the study is taking place) to 75 years (completed years) of age (both inclusive), at the time of signing the informed consent. 3) Participant meeting one of the following criteria: a) Participant with documented advanced ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy AND who are already receiving or scheduled to start the monotherapy with doxorubicin pegylated liposomal at a dose of 50 mg per m2. b) Participants with documented metastatic breast cancer AND who are already receiving or scheduled to start the monotherapy with doxorubicin pegylated liposomal at a dose of 50 mg per m2. 4) Estimated life expectancy of greater than or equal to 03 months as assessed by the investigator 5) Body mass index (BMI) within the range of 18.5 to 30 kg per m2 (inclusive). 6) An Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2 at screening visit. ECOG PS of 2 must be due to disease and not due to comorbid conditions. 7) Participant should have recovered from any toxic effects of previous chemotherapy as judged by the Investigator. Participants who are already receiving doxorubicin pegylated liposomal at a dose of 50 mg per m2 should not require dose reduction(s) in next planned cycle in the study due to toxicity as per the Summary of Product Characteristics (SmPC). 8) Contraceptive use by participants or participants partners should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. A female participant is eligible to participate if she is not pregnant or breastfeeding and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP) as defined in Appendix 4 OR Is a WOCBP and agrees to remain on an acceptable contraceptive method that is highly effective (with a failure rate of less than 1 percentage per year), preferably with low user dependency when used consistently and correctly, as described in Appendix 4 during the intervention period and for at least 8 months after the last dose of the study intervention. The investigator should evaluate the effectiveness and the potential for contraceptive method failure (e.g., noncompliance, recently initiated) of the contraceptive method in relation to the first dose of the study intervention. A WOCBP agrees not to donate eggs (ova, oocytes), freeze them for future use for reproduction or retrieve them for their use during the recommended period of contraception. A WOCBP must have a negative highly sensitive pregnancy test (serum) during screening assessments and negative highly sensitive pregnancy test (urine) on day 1 before randomisation, but no more than 3 days before the first dose of study intervention. If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive. Additional
Exclusion criteria
Exclusion criteria: 1) Known allergies, hypersensitivity, or intolerance to any of the study interventions or components or excipients thereof (refer to the SmPC of Caelyx), or drug or other allergies that, in the opinion of the investigator, contraindicate participation in the study. 2) Current active systemic opportunistic infection based on clinical assessment. 3) Had major surgical procedure within 2 weeks before the screening, or will not have fully recovered from surgical procedure, or has surgical procedure planned during the time the participant is expected to participate in the study. Surgical implantation of a port catheter is not exclusionary. NOTE: Participants with any planned surgical procedure under local anaesthesia only may participate if they agree to seek prior approval from the investigator, and such planned procedure is not expected to prevent, limit, or confound the protocol-specified assessments as assessed by the investigator. 4) Presence of hepatitis B surface antigen (HBsAg) at screening or within 3 months prior to the first dose of investigational intervention. 5) Positive hepatitis C antibody test result at screening or within 3 months prior to starting the investigational intervention. NOTE: Participants with positive hepatitis C antibody due to prior resolved disease can be randomized only if a confirmatory negative hepatitis C RNA test is obtained. 6) Has known human immunodeficiency virus (HIV) seropositive status or positive HIV test at screening. For participants with unknown HIV status, HIV testing will be performed at screening unless prohibited by local regulations. 7) History of malignancy except disease under study within the past 3 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years; carcinoma in situ of the cervix; or malignancy, which is considered cured with minimal risk of recurrence. 8) Current or chronic history of liver disease. This includes but is not limited to hepatitis virus infections, drug- or alcohol-related liver disease, non-alcoholic steatohepatitis, autoimmune hepatitis, hemochromatosis, Wilsons disease, alpha-1 antitrypsin deficiency, primary biliary cholangitis, primary sclerosing cholangitis, or any other liver disease considered clinically significant by the investigator. Known hepatic or biliary abnormalities (with the exception of Gilberts syndrome or asymptomatic gallstones). 9) Participant with clinically significant current or recent (within the past 6 months before randomisation [unless otherwise specified below]) cardiac conditions as defined below: a) Acute coronary syndrome, stroke (including transient ischemic attack [TIA]) or other ischemic event or thromboembolic event (e.g., deep vein thrombosis [DVT], pulmonary embolism) b) Clinical risk assessment of cardiac function using the New York Heart Association Functional Classification of Class II or greater c) Serious cardiac arrhythmia not controlled by adequate medication, severe conduction abnormality d) Clinically significant pericardial disease e) Electrocardiographic evidence of clinically significant acute ischemic or active conduction system abnormalities at the screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To characterize the pharmacokinetic profile and to assess the bioequivalence of doxorubicin pegylated liposomal-Test relative to doxorubicin pegylated liposomal-Reference in participants with advanced ovarian cancer or metastatic breast cancerTimepoint: Pre-dose (0.000), 0.333, 0.667, 1.000 (end of infusion), 1.250, 1.500, 2.000, 2.500, 3.000, 5.000, 8.000, 12.000, 16.000, 24.000, 36.000, 48.000, 72.000, 120.000, 168.000, 216.000, 264.000, 312.000 and 360.000 hours. | — |
Secondary
| Measure | Time frame |
|---|---|
| To further characterize the pharmacokinetic profile of doxorubicin pegylated liposomal- Test relative to doxorubicin pegylated liposomal-Reference in participants with advanced ovarian cancer or metastatic breast cancerTimepoint: Pre-dose (0.000), 0.333, 0.667, 1.000 (end of infusion), 1.250, 1.500, 2.000, 2.500, 3.000, 5.000, 8.000, 12.000, 16.000, 24.000, 36.000, 48.000, 72.000, 120.000, 168.000, 216.000, 264.000, 312.000 and 360.000 hours. | — |
Countries
India
Contacts
Public ContactDr Jogesh Mahajan
Lambda Therapeutic Research Ltd
Outcome results
None listed