euprorelin Acetate Injectable Suspension 11.25 mg in male subjects with metastatic prostate cancer

Not Applicable

• Conditions: Health Condition 1: C61- Malignant neoplasm of prostate

• Registration Number: CTRI/2019/08/020820
• Lead Sponsor: Daewoong Pharmaceutical Co Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Other (Terminated)
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Subjects must be able to provide voluntary written informed consent and to follow protocol requirements

2. Male subjects aged 18 to 75 years (both inclusive) having Body Mass Index (BMI) at least 17 calculated as weight in kg/height in m2.

3. Subjects with histologically/cytologically confirmed prostate cancer.

4. Newly diagnosed metastatic prostate cancer patients scheduled to receive their first dose of leuprorelin acetate as a part of their standard of care.

5. Subjects with Eastern Cooperative Oncology Group (ECOG) performance status <= 2 (Refer appendix A).

6. Acceptable hematology status:

a. Hemoglobin >= 9 g/dL

b. Absolute neutrophil count (ANC) >= 1500 cells/μL

c. Platelet count >= 75,000 cells/μLprior to dosing.

7. Acceptable liver function:

a. Alanine aminotransferase (ALT) <= 2X upper limit of normal (ULN)

b. Aspartate aminotransferase (AST) <= 2X ULN

c. Bilirubin < 1.2 mg/dL

d. Alkaline phosphatase <= 5X ULN

8. Subjects with creatinine clearance >= 60 mL/minute.

9. Subjects with HbA1c <= 7 %.

10. No history of addiction to any recreational drug or drug dependence or alcohol addiction.

11. Subjects who agree to use adequate male contraceptive methods while in the study

12. Subjects with life expectancy of > 180 days at the time of screening.

Exclusion Criteria

1. Known hypersensitivity or contraindication to GnRH, GnRH agonist or to any of the components of investigational product.

2. History or presence of any uncontrolled debilitating systemic disease (e.g. cardiovascular disease, hypertension, diabetes mellitus etc.).

3. Prior orchidectomy, hypophysectomy or adrenalectomy

4. Clinical indication of urinary tract obstruction

5. Subjects with major surgical procedure (including periodontal) within 28 days of first dose of Investigational Product.

6. Subjects with surgical or other non-healing wounds

7. Subjects with positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV)

8. Subjects with positive urine screen for drugs of abuse.

9. Subjects with positive alcohol breath test.

10. Smokers who smoke greater than or equal to 10 cigarettes or equivalent per day

11. Participation in any clinical study within 90 days prior to receiving the first dose of Investigational Product.

12. Donation of >= 350 mL blood within 90 days prior to receiving the first dose of investigational product for the current study.

13. 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.

14. Any other condition(s) which could significantly interfere with Protocol compliance including, but not limited to, dementia, psychosis, cognitive impairment, altered mental status, or other major psychiatric disorder.

15. Subjects with known CNS metastasis

16. Subjects with history of other malignancies in the last 5 years (except in situ cancer or basal or squamous cell skin cancer).

Study & Design

• Study Type: BA/BE
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To establish PK and PD bioequivalence of Luphere (Leuprorelin Acetate) depot Injection 11.25 mg of Daewoong Pharmaceutical Co. Ltd, South Korea and Leuplin depot 3M 11.25 mg S.C. Injection manufactured by Takeda, JapanTimepoint: Day01: Pre-dose blood sample (00.00) within 30 minutes prior to dosing. 00.25 hr, 00.50 hr. 01.00 hr. 01.50 hr, 02.00 hr. 02.50 hr. (± 05 minutes), 03.00 hrs, 04.00 hr, 06.00 hr, 08.00 hr, 12.00 hr (± 10 minutes), Day02: 24.00 hr (± 10 minutes), Day03: 48.00 hr, Day07:144.00 hr, Day14: 312.00 hr, Day21: 480.00 hr, Day28: 648.00 hr, Day35: 816.00 hr(± 4 hr), Day42: 984.00 hr, Day56: 1320.00 hr, Day 70 1656.00 hr, Day84: 1992.00 hr, Day98: 2328.00 hr, Day112: 2664.00 hr (± 1 Day)

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability of test product compared to reference product by monitoring adverse eventsTimepoint: Day01: Pre-dose blood sample (00.00) within 30 minutes prior to dosing. 00.25 hr, 00.50 hr. 01.00 hr. 01.50 hr, 02.00 hr. 02.50 hr. (± 05 minutes), 03.00 hrs, 04.00 hr, 06.00 hr, 08.00 hr, 12.00 hr (± 10 minutes), Day02: 24.00 hr (± 10 minutes), Day03: 48.00 hr, Day07:144.00 hr, Day14: 312.00 hr, Day21: 480.00 hr, Day28: 648.00 hr, Day35: 816.00 hr(± 4 hr), Day42: 984.00 hr, Day56: 1320.00 hr, Day 70 1656.00 hr, Day84: 1992.00 hr, Day98: 2328.00 hr, Day112: 2664.00 hr (± 1 Day)