Health Condition 1: C61- Malignant neoplasm of prostate
Conditions
Interventions
Intervention1: Leuprolide Depot Injection 7.5 mg of American Regent, Inc.: Dose:7.5 mg,
Frequency: Once in a Four weeks,
Route of Administration: Intramuscular,
Duration of Therapy: The duration fro
Sponsors
American Regent Inc
Eligibility
Inclusion criteria
Inclusion criteria: Subjects will be considered eligible for the study based on the following criteria: 1. Willing and able to provide voluntary informed consent prior commencement of any study-related activities, and the ability to follow protocol requirements 2. Male subjects aged 18 to 75 years (both inclusive) with body mass index (BMI) between 18.00 to 30.00 kg per m2 (both inclusive) 3. Males with histologically or cytologically confirmed carcinoma of the prostate 4. Subjects, newly diagnosed locally advanced and/or metastatic prostate cancer, scheduled to receive their first dose of leuprolide acetate as a part of their standard of care 5. Eastern Cooperative Oncology Group (ECOG) performance status Less than or equal to 2. 6. Acceptable hematology status: a. Hemoglobin Greater than or equal to 9 g pe dL b. Absolute neutrophil count (ANC) Greater than or equal to 1500 cells per mm3 c. Platelet count Greater than or equal to 100,000 cells/mm3 7. Acceptable liver function: a. Alanine aminotransferase (ALT) Less than or equal to 2 X ULN b. Aspartate aminotransferase (AST) Less than or equal to 2 X ULN c. Bilirubin Less than or equal to 1.2 mg per dL d. Alkaline phosphatase Less than or equal to 5 x ULN 8. Subjects with HbA1c Less than or equal to 7 % 9. Subjects with life expectancy of at least 6 (six) months at the time of enrolment 10. Young adult subjects who wish to bank their semen must agree for semen banking prior to 24 hours of receiving the first dose of Investigational Product 11. Subjects who agree to use adequate male contraceptive methods while in the study 12. No history of addiction to any recreational drug or drug dependence or alcohol addiction within 12 months before screening
Exclusion criteria
Exclusion criteria: Subjects will be excluded from the study based on the following criteria: 1. Known hypersensitivity or contraindication to gonadotropin-releasing hormone(GnRH), GnRH agonist or to any of the components of investigational product 2. Prior orchidectomy, hypophysectomy or adrenalectomy 3. Clinical indication of urinary tract obstruction 4. History of any major surgical procedure (including periodontal) within 28 days of dose of investigational product 5. Corrected QT interval [Bazetts formula (QTcB)] Greater than 450 msec at screening 6. History or presence of any uncontrolled systemic disease (e.g. cardiovascular disease, hypertension, diabetes mellitus etc.) 7. Known CNS metastasis 8. Surgical or other non-healing wounds 9. Subjects with positive serology for Hepatitis B virus (HBV), Hepatitis C virus (HCV),or Human immunodeficiency virus (HIV) 10. Subject with history or presence of seizures, epilepsy, cerebrovascular disorders, central nervous system anomalies or tumours or subjects who are on concomitant medications that have been associated with convulsions such as bupropion and Selective serotonin reuptake inhibitors (SSRIs) 11. Subjects with positive urine screen for drugs of abuse on day 0 12. Subjects with positive urine alcohol test on day 0 13. Smokers who smoke Greater than or equal to 10 cigarettes or equivalent per week 14. History of other malignancies in the last 5 years (except in situ cancer or basal or squamous cell skin cancer) 15. Have not recovered to Grade 0 or 1 toxicity from previous anticancer treatments or previous investigational agents. Exceptions are alopecia (any grade is acceptable),hemoglobin Greater than or equal to 9 g per 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], V 5.0) 16. Participation in any clinical study 90 days prior to receiving the investigational product (IP) of the current study 17. Loss of Greater than or equal to 350 mL blood 90 days prior to receiving the IP of the current study 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. Subjects with confirmed novel coronavirus infection (COVID-19) or subjects who have taken COVID-19 vaccine within 4 weeks prior to dosing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To establish bioequivalence of Leuprolide Depot Injection 7.5 mg of American Regent, Inc. with LUPRON Depot (leuprolide acetate for depot suspension) 7.5 mg of AbbVie Inc. North Chicago, IL 60064 in adult male subjects with locally advanced and/or metastatic prostate cancer undergoing initial therapy Timepoint: Upon randomization, subjects will receive either Test product or Reference product at the dose of 7.5 mg on Day 1 (Period 01), Day 29 (Period 02) and Day 57 (Period 03).Subjects will report to the study site on Days 4, 8, 15 and 22 (in Period 01), on Days 32,36, 43 and 50 (in Period 02) and on Day 60, 64, 71, 78 and 85 (in Period 03) for ambulatory PK and PD blood sample collection. | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the adverse events and to ensure the safety of subjects To assess the pharmacodynamics of leuprolide depot injection Timepoint: Subjects will report to the study site on Days 4, 8, 15 and 22 (in Period 01), on Days 32,36, 43 and 50 (in Period 02) and on Day 60, 64, 71, 78 and 85 (in Period 03) for ambulatory PK and PD blood sample collection. | — |
Countries
India
Contacts
Public ContactDr Sandeep Singh
CBCC Global Research LLP
Outcome results
None listed