Health Condition 1: C61- Malignant neoplasm of prostate
Conditions
Interventions
Intervention1: Leuprolide acetate for depot suspension 7.5 mg: Dose: 7.5 mg
Frequency: Once every 4 weeks
Route of Administration: Intramuscular Injection
Duration of Therapy: 04 Months
Control Inte
Sponsors
American Regent Inc.
CBCC Global Research
Eligibility
Inclusion criteria
Inclusion criteria: Subjects who meet the following criteria will be eligible to participate in the study: 1. Willing and able to provide voluntary informed consent prior to commencement of any study-related activities, and able to follow protocol requirements. 2. Male subjects aged eighteen years and older, with a body mass index (BMI) between eighteen point zero zero to thirty point zero zero kilograms per square metre (both inclusive). 3. Male subjects with histologically or cytologically confirmed carcinoma of the prostate. 4. Subjects newly diagnosed with locally advanced and/or metastatic prostate cancer and scheduled to receive their first dose of leuprolide acetate as part of their standard of care. Or Subjects receiving a stable regimen of leuprolide acetate for depot suspension via intramuscular injection route. 5. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to two. 6. Acceptable haematology status: a. Haemoglobin greater than or equal to nine grams per decilitre b. Absolute neutrophil count greater than or equal to one thousand five hundred cells per cubic millimetre c. Platelet count greater than or equal to one hundred thousand cells per cubic millimetre 7. Acceptable liver function: a. Alanine aminotransferase (ALT) less than or equal to two times the upper limit of normal (or less than or equal to five times the upper limit of normal if liver metastases are present) b. Aspartate aminotransferase (AST) less than or equal to two times the upper limit of normal (or less than or equal to five times the upper limit of normal if liver metastases are present) c. Bilirubin less than or equal to one point five times the upper limit of normal d. Alkaline phosphatase less than or equal to two times the upper limit of normal, and less than or equal to five times the upper limit of normal if bone metastasis is present 8. Subjects with glycated haemoglobin (HbA1c) less than or equal to eight percent. 9. Subjects with a life expectancy of at least nine months at the time of enrolment, as per the investigator s clinical judgement. 10. Subjects who wish to bank their semen must agree to semen banking prior to twenty-four hours before 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, drug dependence, or alcohol addiction within twelve months before screening.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria will be excluded from the study: 1. Known hypersensitivity or contraindication to gonadotropin-releasing hormone (GnRH), GnRH agonist, or to any of the components of the investigational product. 2. Prior orchidectomy, hypophysectomy, or adrenalectomy. 3. Indication of clinically significant urinary tract obstruction or spinal cord compression. 4. History of any major surgical procedure (including periodontal) within twenty-eight days of receiving the first dose of the investigational product. 5. Corrected QT interval using Fridericia formula (QTc) greater than four hundred fifty milliseconds at screening. 6. Presence of any uncontrolled systemic disease (for example, cardiovascular disease, hypertension, diabetes mellitus, etc.). 7. Known central nervous system (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 One. 12. Subjects with positive urine alcohol test on Day One. 13. Smokers who smoke ten or more cigarettes or equivalent per week. 14. History of other malignancies in the last five years (except in situ cancer or basal or squamous cell skin cancer). 15. Subjects who have not recovered to Grade Zero or Grade One toxicity from previous anticancer treatments or previous investigational agents used to treat cancer other than locally advanced and/or metastatic prostate cancer. Exceptions are alopecia (any grade is acceptable), haemoglobin greater than or equal to nine grams per decilitre, fatigue (Grade Two is acceptable), and peripheral neuropathy (stable Grade Two is acceptable), as per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version Five Point Zero. 16. Participation in any clinical study within ninety days prior to receiving the investigational product of the current study. 17. Loss of three hundred fifty millilitres or more of blood within ninety days prior to receiving the investigational product of the current study. 18. Any other medical condition or serious inter-current 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 history of severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome or toxic epidermal necrolysis (SJS/TEN).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To establish leuprolide pharmacokinetics based bioequivalence between American Regent Inc. s test formulation of Leuprolide acetate for depot suspension(7.5 mg 1 monthor4 weeks) and the reference listed drug (RLD) Lupron Depot 7.5 mg for 1 month (4weeks) of AbbVie Inc. North Chicago, IL 60064 administered as an intramuscular injection in adult male prostatic carcinoma patients.Timepoint: Total 22 samples between 0.00 (Day 1) to 672.00 hours (Day 29) in each period on Day 1,2,6,7,8,10, 13,15,17,20,22,26,29 | — |
Secondary
| Measure | Time frame |
|---|---|
| Qualitative assessment of the pharmacodynamic markers (testosterone, prostate specific antigen (PSA), luteinizing hormone (LH) & follicle-stimulating hormone (FSH)) for the two formulations of leuprolide acetate for depot suspension 7.5 mg for 1 month (4-weeks) administered via intramuscular injection route (Test & RLD) in the study participant population. To monitor the general safety & tolerability of the leuprolide acetate for depot suspension administered via intramuscular injection route in the study participant population. Timepoint: Total 13 samples between -72.00 (Day -2) to 672.00 (Day 29) hours in each period on Day -2, 1, 2, 6, 7, 8, 15, 22, 26, 29 | — |
Countries
India
Contacts
Public ContactMr. Ankit Parikh
REV Clinical, previously CBCC Global Research
Outcome results
None listed