CTRI/2019/08/020820 [Registered on: 21/08/2019] Trial Registered Prospectively
Last Modified On:
18/10/2021
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
Leuprorelin Acetate Injectable Suspension 11.25 mg in male subjects with metastatic prostate cancer
Scientific Title of Study
A randomized, open label, multi-center, two-treatment, single-period, parallel group, single dose, Pharmacokinetic - Pharmacodynamic study of Leuprorelin Acetate Injectable Suspension 11.25 mg of Daewoong Pharmaceutical Co. Ltd, South Korea with Leuplin depot 3M 11.25 mg S.C. Injection manufactured by Takeda, Japan in male subjects with metastatic prostate cancer undergoing initial therapy under fasting condition
CBCC/2019/007, Amendment Number 1.1 Dated 02/Jan/2020
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Sandeep Singh
Designation
Director Operations
Affiliation
CBCC Global Research LLP
Address
Clinical Operations Department, Room Number 2, East Wing, Second Floor Skoda House, Opposite L. J Campus, S. G. Highway, Sarkhej, Ahmedabad – 382210, India.
Ahmadabad GUJARAT 382210 India
Phone
9637555304
Fax
Email
sandeep.singh@cbccusa.com
Details of Contact Person Scientific Query
Name
Dr Sandeep Singh
Designation
Director Operations
Affiliation
CBCC Global Research LLP
Address
Clinical Operations Department, Room Number 2, East Wing, Second Floor Skoda House, Opposite L. J Campus, S. G. Highway, Sarkhej, Ahmedabad – 382210, India.
Ahmadabad GUJARAT 382210 India
Phone
9637555304
Fax
Email
sandeep.singh@cbccusa.com
Details of Contact Person Public Query
Name
Dr Sandeep Singh
Designation
Director Operations
Affiliation
CBCC Global Research LLP
Address
Clinical Operations Department, Room Number 2, East Wing, Second Floor Skoda House, Opposite L. J Campus, S. G. Highway, Sarkhej, Ahmedabad – 382210, India.
Ahmadabad GUJARAT 382210 India
Phone
9637555304
Fax
Email
sandeep.singh@cbccusa.com
Source of Monetary or Material Support
Daewoong Pharmaceutical Co. Ltd
72, Dugye- ro, Pogok-eup, Cheoin-gu, Yongin-si,
Gyeonggi-do, 17028, South Korea
Primary Sponsor
Name
Daewoong Pharmaceutical Co Ltd
Address
72, Dugye- ro, Pogok-eup, Cheoin-gu, Yongin-si,
Gyeonggi-do, 17028, South Korea
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.
ExclusionCriteria
Details
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).
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Pre-numbered or coded identical Containers
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
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, Japan
Total Sample Size="20" Sample Size from India="20" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
The Study is A randomized, open label, multi-center, two-treatment, single-period, parallel group, single dose, Pharmacokinetic - Pharmacodynamic study of Leuprorelin Acetate Injectable Suspension 11.25 mg of Daewoong Pharmaceutical Co. Ltd, South Korea with Leuplin depot 3M 11.25 mg S.C. Injection manufactured by Takeda, Japan in male subjects with metastatic prostate cancer undergoing initial therapy under fasting condition
Primary Objective: 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, Japan
Secondary Objective: Safety and tolerability of test product compared to reference product by monitoring adverse events