| CTRI Number |
CTRI/2022/04/041602 [Registered on: 04/04/2022] Trial Registered Prospectively |
| Last Modified On: |
02/11/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Bioequivalence Study of Leuprolide Depot Injection 7.5 mg of with LUPRON Depot (leuprolide acetate for depot suspension) 7.5 mg in subjects with locally advanced and/or metastatic prostate cancer undergoing initial therapy.
|
|
Scientific Title of Study
|
An open label, multi-center, randomized, two-treatment, three-period, three-sequence, single-dose, reference replicate, pharmacokinetic bioequivalence study 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.
|
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CBCC/2021/022, version No. 1.0 dated 29/Dec/2021 |
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, 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, 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, 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,
OH43054
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 11 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| 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 Rajnish Nagarkar |
HCG Manavata Cancer Centre |
Behind Shivang auto, Mumbai Naka,Nashik-422002, Maharashtra, India
Nashik
MAHARASHTRA |
9823061929
drraj@manavatacancercentre.com |
| Dr Koushik Chatterjee |
Health Point Hospital |
21, Prannath Pandit Street, Opp: Lansdown, Paddapukur, Bhowanipore, Kolkata-700025, West Bengal, India
Kolkata
WEST BENGAL |
9874357580
drkoushik.chatterjee@gmail.com |
| Dr Kumar Saurabh |
Health Point Hospital |
Next to RIMS, Near Medical Chowk, Bariatu, Ranchi – 834009, Jharkhand, India
Ranchi
JHARKHAND |
9122030242
ksaurabhoncology@gmail.com |
| Dr Anupam Datta |
Netaji Subhash Chandra Bose Cancer Hospital |
3081,Nayabad New Garia, Kolkata-700094, West Bengal, India
Kolkata
WEST BENGAL |
9894487928
dranuapmdatta@gmail.com |
| Dr B Ravi Shankar |
Omega Hospital |
Plot.No4 Chinnagadali, Arilova Section Visakhapatnam-530040, Andhra Pradesh, India
Visakhapatnam
ANDHRA PRADESH |
9849123256
dr.bellalaravishankar@gmail.com |
| Dr Mukesh C Arya |
Sardar Patel Medical College & AG of Hospital |
SP Medical College Road, Bikaner, Rajasthan-334001
Bikaner
RAJASTHAN |
9782300231
mcarya@yahoo.com |
| Dr Neeraj Jain |
Sri Guru Ram Das Institute of Medical Sciences and Research |
VPO Vallah Mehta Road Amritsar-143006, Punjab, India
Amritsar
PUNJAB |
9814299045
neer1967@yahoo.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 |
| Dr V Arumugam |
Tirunelveli Government Medical College and Hospital |
North High Ground road, Tirunelveli-627011, Tamil Nadu, India
Tirunelveli
TAMIL NADU |
9842913301
arumugamonco@gmail.com |
| Dr Ankit Patel |
Unique Hospital Multispeciality and Research Institute |
Civil Hospital-Char Rasta, Sosyo Circle, Canal Rd, opp. Kiran Motor, Surat-395002, Gujarat, India
Surat
GUJARAT |
9825404202
drankitoncologist@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 11 |
| Name of Committee |
Approval Status |
| Ethics Committee N S C B C Research Institute |
Approved |
| Ethics Committee Unique Hospital |
Approved |
| ETHICS COMMITTEE, S.P.MEDICAL COLLEGE, BIKANER |
Approved |
| Health Point Ethics Committee |
Approved |
| Health Point Ranchi Ethics Committee |
Approved |
| Independent EC Namaste Integrated Services |
Approved |
| Institutional Ethics Committee ERODE Cancer Centre |
Approved |
| Institutional Ethics Committee Omega Hospitals |
Approved |
| Institutional Ethics Committee SGRDIMSAR |
Approved |
| Institutional Ethics Committee Tirunelveli Government Medical College and Hospital |
Approved |
| Manavata Clinical Research Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 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 from the screening visit until the end of study assessment.
|
| Comparator Agent |
LUPRON Depot (leuprolide acetate for depot suspension) 7.5 mg of AbbVie Inc. North Chicago, IL 60064
|
Dose: 7.5 mg,
Frequency: Once in a Four weeks,
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 |
Both |
| Details |
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
|
|
| 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 (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
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
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
|
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 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 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. |
|
|
Target Sample Size
|
Total Sample Size="33"
Sample Size from India="33"
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)
|
08/04/2022 |
| 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="3"
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) 7.5 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 7.5 mg (Depot Injection of 7.5 mg) in line with the applicable USFDA’s Guidance |