Bioequivalence study of doxorubicin hydrochloride liposome injection 2mg/mL in ovarian cancer subjects under fasting conditions.
- Conditions
- Health Condition 1: C569- Malignant neoplasm of unspecifiedovary
- Registration Number
- CTRI/2020/05/025245
- Lead Sponsor
- Shanghai Jingfeng Pharmaceuticals Group Co Ltd China
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Willing and able to provide voluntary informed consent and to follow the protocol requirements
2. Female subjects between 18 and 75 years of age, both inclusive and having Body mass index BMI more than or equal to 17.00 calculated as weight in kg Per height in m2
3. Histopathologically confirmed ovarian cancer
4. Documented progressive or recurrent disease after treatment with platinum based chemotherapy
5. Able and clinically indicated to receive the recommended minimum 2 cycles of liposomal doxorubicin HCl
6. Eastern Cooperative Oncology Group ECOG performance status of less than or equal to 2
7. Life expectancy of more than 180 days at the time of enrollment
8. Acceptable hematology status
a. Hemoglobin more than or equal to 9 g Per dL
b. Absolute neutrophil count ANC more than or equal to 1500 cells Per Microlitre
c. Platelet count more than or equal to 1,00,000 cells Per Microlitre
9. Acceptable liver function
a. Alanine aminotransferase (ALT) less than or equal to 2X upper limit of normal ULN
b. Aspartate aminotransferase (AST) less than or equal to 2X ULN
c. Bilirubin less than 1.2 mg Per dL
d. Alkaline phosphatase less than or equal to 2.0 X ULN
10. Subjects with creatinine clearance more than or equal to 60 mL per minute.
11. Cardiac ejection fraction more than or equal to 50 percent by echocardiogram ECHO within 14 days prior to first dose of Investigational Product
12. Subjects with negative serum pregnancy test at screening and negative urine pregnancy test at Day 0
13. Women of child bearing potential, defined as women physiologically capable of becoming pregnant, unless they are using effective method of contraception during dosing of the investigational product practicing two acceptable methods of contraception
Acceptable methods of contraception are
A. Intrauterine device IUD or intrauterine system IUD or IUS
B. Double barrier method of contraception (Condom and occlusive cap or condom and spermicidal agent)
C. Male sterilization at least 6 months prior to the screening, should be the sole male partner for that subject
D. Female sterilization surgical bilateral oophorectomy) or tubal ligation at least 6 weeks prior to study participation
E. Total abstinence, partial abstinence is not acceptable
14. No history of addiction to any recreational drug or drug dependence or alcohol addiction
1. Known hypersensitivity or contraindication including anaphylaxis to conventional or liposomal formulations of doxorubicin, anthracycline therapy or to any of their components.
2. Subjects with prior doxorubicin exposure that would result in a total lifetime exposure of 550mg/m2 or more after four cycles of treatment
3. Received previous chemotherapy less than 4 weeks prior to dosing of Investigational Product.
4. Recent (6 month) history of myocardial infarction or severe arrhythmias prior to dosing of Investigational Product.
5. Received any prior mediastinal irradiation (as cardiac toxicity may occur at cumulative doses lower than 400mg/m2).
6. Receipt of trastuzumab within 24 weeks prior to dosing of Investigational Product and during the study.
7. Receipt of cyclophosphamide, calcium channel blockers, and other potential cardiotoxic drugs for 2 weeks prior to dosing of Investigational Product, and during the study.
8. Subjects taking inducers and inhibitors of CYP3A4, CYP2D6 or P-gp
9. Pregnant or lactating women.
10. History or presence of any uncontrolled debilitating systemic disease (e.g. cardiovascular disease, hypertension, diabetes mellitus etc.)
11. Active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, Pneumocystis carinii, or other microorganism if under treatment with myelotoxic drugs.
12. Known central nervous system metastasis.
13. Major surgical procedure (including periodontal) within 28 days of first dose of Investigational Product.
14. Surgical or other non-healing wounds.
15. Subjects with positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV).
16. History of other malignancies in the last 5 years. (except in situ cancer or basal or squamous cell skin cancer)
17. Has not recovered to Grade 0 or 1 toxicity from previous anticancer treatments or previous investigational agents. Exceptions are alopecia (any grade is acceptable), Hemoglobin more than or equal to 9.0 g/dL, 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).
18. 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.
19. Participation in any clinical study within 90 days before the first dose of Investigational Product.
20. Donation and/or loss of more than or equal to 350 ml (1 unit) of blood within 90 days before the first dose of Investigational Product.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the bioequivalence of doxorubicin hydrochloride liposome injection 2mg/mL of shanghai jingfeng pharmaceuticals group co., ltd., china with DOXOrubicin hydrochloride liposome injection 2mg/mL for intravenous infusion of sun pharmaceuticals ind. ltd. in ovarian cancer subjects whose disease has progressed or recurred after platinum-based chemotherapy and who are already receiving or scheduled to start therapy on doxorubicin hydrochloride (liposomal) under fasting conditions.Timepoint: A total of 19 PK blood samples will be collected in each period of the study. The sample will be collected on day 0, 1, 2, 3, 5, 8, 11 and 15 in period 01 and on day 28, 29, 30, 31, 33, 36, 39 and 43 in period 02 and during end of study.
- Secondary Outcome Measures
Name Time Method To monitor the adverse events and to ensure the safety of subjects.Timepoint: Safety assessment will be carried out during screening, on day 0, 1, 2, 3, 5, 8, 11 and 15 in period 01 and on day 28, 29, 30, 31, 33, 36, 39 and 43 in period 02 and during end of study.