CTRI

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CTRI Number

CTRI/2022/10/046909 [Registered on: 31/10/2022] Trial Registered Prospectively

Last Modified On:

20/01/2023

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Drug

Study Design

Other

Public Title of Study

PK study of Leuprolide acetate for depot suspension 30 mg with LUPRON DEPOTÂ® (leuprolide acetate for depot suspension) 30 mg in adult male subjects with locally advanced and/or metastatic prostate cancer undergoing initial therapy.

Scientific Title of Study

A comparative pharmacokinetic study of Leuprolide acetate for depot suspension 30 mg for 4-month (16-weeks) of American Regent, Inc. with LUPRON DEPOTÂ® (leuprolide acetate for depot suspension) 30 mg for 4-month (16-weeks) of AbbVie Corporation, 8401 Trans-Canada Highway, St-Laurent, QC H4S 1Z1 in adult male subjects with locally advanced and/or metastatic prostate cancer undergoing initial therapy.

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
CBCC/2020/030, Version 1.0 dated 28/Jun/2022	Protocol Number

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Sandeep Singh
Designation	Vice President - Clinical Operations
Affiliation	CBCC Global Research LLP
Address	2nd Floor, Skoda House Opp. LJ Campus, S. G. Highway Sarkhej, Ahmedabad - 382210, Gujarat, India. Bodakdev Ahmadabad GUJARAT 382210 India
Phone	9637555304
Fax
Email	sandeep.singh@cbccusa.com

Details of Contact Person
Scientific Query

Name	Dr Sandeep Singh
Designation	Vice President - Clinical Operations
Affiliation	CBCC Global Research LLP
Address	2nd Floor, Skoda House Opp. LJ Campus, S. G. Highway Sarkhej, Ahmedabad - 382210, Gujarat, India. Bodakdev Ahmadabad GUJARAT 382210 India
Phone	9637555304
Fax
Email	sandeep.singh@cbccusa.com

Details of Contact Person
Public Query

Name	Dr Sandeep Singh
Designation	Vice President - Clinical Operations
Affiliation	CBCC Global Research LLP
Address	2nd Floor, Skoda House Opp. LJ Campus, S. G. Highway Sarkhej, Ahmedabad - 382210, Gujarat, India. Bodakdev Ahmadabad GUJARAT 382210 India
Phone	9637555304
Fax
Email	sandeep.singh@cbccusa.com

Source of Monetary or Material Support

American Regent, Inc 6610 New Albany Rd E,New Albany, OH43054

Primary Sponsor

Name	American Regent, Inc.
Address	6610 New Albany Rd E, New Albany, OH 43054
Type of Sponsor	Pharmaceutical industry-Global

Details of Secondary Sponsor

Name	Address
NA	NIL

Countries of Recruitment

India

Sites of Study
Modification(s)

No of Sites = 12
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Lovenish Goyal	Aadhar Health Institute	Tosham Road, Near South Bypass Crossing, Hisarâ€“ 125005, Haryana, India. Hisar HARYANA	9896539142 drlovenish@gmail.com
Dr Parashant Darakh	Darakh Nursing Home and Kidney Stone Centre	Raghuveer Nagar, Jalna Road, Aurangabad-431001, Maharashtra, India Aurangabad MAHARASHTRA	9972590000 drprashantdarakh@gmail.com
Dr K Velavan	Erode Cancer Centre	1/393,velvan nagar, perundurai road, Thindal, Erode-638012 Tamil Nadu , India Erode TAMIL NADU	9842334222 kvels@rediffmail.com
Dr Chakor Vora	Grant Medical Foundation Ruby Hall Clinic	40,Sassoon road, Pune-411001 Maharashtra, India Pune MAHARASHTRA	9823584609 chakor.vora@gamil.com
Dr Rashmi A Gudur	Krishna Institute of Medical Science (Deemed to be university)	NH-4 Pune-Bangalore Highway, Malkapur, Karad-415539 Maharashtra, India Pune MAHARASHTRA	9860249027 rashmigudur@gmail.com
Dr Anil Kumar M R	Oncoville Cancer Hospital & Research Center	No. 4, 80 Ft. Road, 7th Block, Nagarbhavi, 2nd Stage, Bangalore- 560072, Karnataka, India. Bangalore KARNATAKA	9739808502 dranil.onco@gmail.com
Dr Mukesh C Arya	S. P. Medical College & A. G. of Hospitals	Dept. of Urology, Uro-Science Center, Bikaner -334001, Rajasthan, India Bikaner RAJASTHAN	9414138782 mcarya@yahoo.co.in
Dr Satheesh C T	Spandana Oncology Center	28 th Main Road, jaynagar, Bengaluru -560069, Karnataka , India Bangalore KARNATAKA	9242698750 drsatheeshct@gmail.com
Dr Gurpreet Singh Bhangu	Sri Guru Ram Das Institute of Medical Sciences and Research	VPO Vallah, Mehta Road, Amritsar-143501, Punjab, India Amritsar PUNJAB	9915272884 drbhangu@hotmail.com
Dr Anil Goel	SSG Hospital	Jail Road, Indira Avenue, Vadodara, Gujarat-390001, India. Vadodara GUJARAT	9227132025 ssghospital.ct@spearsmind.com
Dr Rajendra Singh Arora	Sujan Surgical Cancer Hospital and Amravati Cancer Foundation	52/B Shankar Nagar, Main Road, Amravati-444606, Maharashtra, India Amravati MAHARASHTRA	9823097573 drrsarora@rediffmail.com
Dr Deepak Kumar Singh	Swami Harshankaranand Ji Hospital and Research Center	N 8/237, BHU Rd, Near Bhikaripur Crossing, Opposite Union Bank of India,B.H.U, Sundarpur, Newada, Varanasi,-221005, Uttar Pradesh, India Varanasi UTTAR PRADESH	9450428608 deepakbhu@gmail.com

Details of Ethics Committee
Modification(s)

No of Ethics Committees= 12
Name of Committee	Approval Status
Aadhar Institutional Ethics Committee	Approved
Amravati Ethics Committee	Approved
Ethics Committee Ajanta Superspeciality Hospital	Approved
Ethics Committee, S.P. Medical College, Bikaner	Approved
IEC KIMS	Approved
Independent EC Namaste Integrated Services	Approved
Institutional Ethics Committee BGS Global Institute of Medical Sciences	Approved
Institutional Ethics Committee ERODE Cancer Centre	Approved
Institutional Ethics Committee for Human Research Medical College, Baroda	Submittted/Under Review
Institutional Ethics Committee of OCH and RC	Approved
Institutional Ethics Committee SGRDIMSAR	Not Applicable
Poona Medical Research Foundation Ruby Hall Clinic	Approved

Regulatory Clearance Status from DCGI

Status

Approved/Obtained

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: C61\|\|Malignant neoplasm of prostate,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Leuprolide acetate for depot suspension 30 mg for 4-month (16-weeks) of American Regent, Inc.	Dose:30 mg, Frequency: Once in a Four Months, Route of Administration: Intramuscular, Duration of Therapy: The duration from the screening visit until the end of study assessment
Comparator Agent	LUPRON DEPOTÂ® (leuprolide acetate for depot suspension) 30 mg for 4-month (16-weeks) Manufactured for AbbVie Corporation, 8401 Trans-Canada Highway, St-Laurent, QC H4S 1Z1	Dose:30 mg, Frequency: Once in a Four Months, Route of Administration: Intramuscular, Duration of Therapy: The duration from the screening visit until the end of study assessment.

Inclusion Criteria

Age From	18.00 Year(s)
Age To	75.00 Year(s)
Gender	Male
Details	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 with 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 per 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 per 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 one year 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

ExclusionCriteria

Details

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 (Ex. 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 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 per social situations that would limit adherence to study requirements
19. 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.
20. Subjects with confirmed novel coronavirus infection (COVID-19) or subjects who have taken COVID-19 vaccine within 4 weeks prior to dosing

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Centralized

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
To compare the bioavailability of Leuprolide acetate when two leuprolide acetate for depot suspension 30 mg for 4-month (16-weeks) injection dosage forms of American Regent, Inc. (Test) and a reference comparator product LUPRON DEPOTÂ® of AbbVie Corporation, St-Laurent, QC H4S 1Z1, Canada are administered to adult prostate cancer patients.	Subjects will report to the study site on Days 4, 8, 15, 22, 29, 36, 43, 57, 71, 85 and 99 of Randomized Study Period for ambulatory, PK and PD blood sample collection and on Day 116, 120, 127, 134, 141, 148, 155, 169, 183, 197 and 211 of Non-randomized Study Period for ambulatory PK and PD blood sample collection.

Secondary Outcome

Outcome	TimePoints
To monitor the adverse events and to ensure the safety of subjects. To assess the pharmacodynamics of leuprolide depot injection.	Subjects will report to the study site on Days 4, 8, 15, 22, 29, 36, 43, 57, 71, 85 and 99 of Randomized Study Period for ambulatory, PK and PD blood sample collection and on Day 116, 120, 127, 134, 141, 148, 155, 169, 183, 197 and 211 of Non-randomized Study Period for ambulatory PK and PD blood sample collection.

Target Sample Size

Total Sample Size="32"
Sample Size from India="32"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

N/A

Date of First Enrollment (India)

15/11/2022

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="0"
Months="9"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Not Applicable

Recruitment Status of Trial (India)

Open to Recruitment

Publication Details

NONE

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

American Regent, Inc. has developed a generic product of the LUPRON Depot (leuprolide acetate for depot suspension) 30 mg of AbbVie Inc. American Regent, Inc. wants to conduct the study to characterize the pharmacokinetic profile of test product in adult.

male subjects with locally advanced and/or metastatic prostate cancer undergoing initial therapy. In order to assess steady-state bioequivalence.

The study has been designed at a dose of 30 mg (Depot Injection of 30 mg) in line with the applicable USFDAâ€™s Guidance.