CTRI/2024/09/074455 [Registered on: 26/09/2024] Trial Registered Prospectively
Last Modified On:
14/02/2025
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
Study Design
Other
Public Title of Study
Bioequivalence Study of Test Product Leuprolide Acetate for Depot Suspension 7.5 mg in Adult Male Patients with Prostate Carcinoma Undergoing Initial Therapy of Leuprolide Acetate.
Scientific Title of Study
An Open-Label, Multiple Dose, Multicenter, Randomized, Two Sequence, Two-Treatment, fully Replicate, Cross-Over, Steady State, Bioequivalence Study of Test Product Leuprolide Acetate for Depot Suspension 7.5 mg of Pharmathen S.A. Greece with Reference Product Lupron Depot® 7.5 mg, Manufactured for AbbVie Inc. in Adult Male Patients with Prostate Carcinoma Undergoing Initial Therapy of Leuprolide Acetate.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
Protocol No.: C2A03320 Version: 02 Date: 28 Jun 2024
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Dharmesh Domadia
Designation
Vice President - Global Clinical Operations
Affiliation
Cliantha Research limited
Address
Cliantha Research Limited, Cliantha Corporate, TP 86, FP 28/1, Off S.P. Ring Road, Sarkhej, Ahmedabad - 382210, Gujarat, India
Ahmadabad GUJARAT 382210 India
Phone
07966219555
Fax
07966219549
Email
ddomadia@cliantha.com
Details of Contact Person Scientific Query
Name
Dr Ankesh Barnwal
Designation
Associate Director- II– Clinical Trial Medical Services
Affiliation
Cliantha Research limited
Address
Cliantha Research Limited, Cliantha Corporate, TP 86, FP 28/1, Off S.P. Ring Road, Sarkhej, Ahmedabad - 382210, Gujarat, India
Ahmadabad GUJARAT 382210 India
Phone
07966219555
Fax
07966219549
Email
abarnwal@cliantha.com
Details of Contact Person Public Query
Name
Mr Jitendra Panda
Designation
Project Manager - Clinical Trials
Affiliation
Cliantha Research limited
Address
Cliantha Research Limited, Cliantha Corporate, TP 86, FP 28/1, Off S.P. Ring Road, Sarkhej, Ahmedabad - 382210, Gujarat, India
Department of Medical Oncology & Haematology, Ground Floor, G-Block, OPD Building, Sijua, Patrapada, Bhubaneswar, Odisha - 751019, India Khordha ORISSA
7008651823
drskmishra.trial@gmail.com
Dr Jitendra Amlani
B.T. Savani kindney Hospital
University Rd, Near University Main Gate, Shiv Shakti Colony, Alap Avenue, Sadguru Nagar, Rajkot-360005
Rajkot GUJARAT
9825077701
jcamlani@yahoo.com
Dr Mahantesh G Todakar
Belagavi Institute of Medical Sciences
Belagavi, 3rd Floor, BIMS Building, Clinical Research Department, Dr B R Ambedkar Road, Belagavi - 590001, Karnataka, India Belgaum KARNATAKA
9449335213
drmahanteshgt@gmail.com
Dr Kuntal Ray
Charnock Hospital Pvt. Ltd.
BMC 195, Biswa Bangla Sarani, Dhalipara, Tegharia, Newtown, Kolkata- 700157, West Bengal, India Kolkata WEST BENGAL
HCG Manavata Cancer Centre, Clinical Research Department, 1st floor MCRI new building, Behind Shivang Auto, Mumbai Naka, Nashik - 422002, Maharashtra Nashik MAHARASHTRA
9823061929
drraj@manavatacancercentre.com
Dr Prakash S S
K R Hospital Mysore Medical College and Research Institute
Room no. 23, Ground Floor, CRD Department, Department of Surgical Oncology, Next to Department of Radiology, K R Hospital, Mysore Medical College & Research Institute, Mysore - 570001, Karnataka Mysore KARNATAKA
9901000559
prakashyesyes@yahoo.com
Dr Nilesh Dhamne
Kolhapur Cancer Center
Third Floor, Clinical Research Department, RS No 238, Opposite Mayur petrol-pump, Gokul Shirgaon, Kolhapur, Maharashtra - 416234 Kolhapur MAHARASHTRA
7738245698
dr.nilesh.gmc@gmail.com
Dr Satish Sonawane
Maccare Superspeciality Hospital
Clinical Research Department, 4th Floor, Behind Zopadi Canteen, Opp. Saint Monica D.ed College, Savedi, Ahmednagar - 414003, Maharashtra
Ahmadnagar MAHARASHTRA
9730099999
satishujjwal@yahoo.com
Dr Kapil Thakkar
Nirmal Hospital Pvt. Ltd.
1st Floor, Adult OPD, Nirmal Hospital Pvt. Ltd., Ring road, Surat - 395002, Gujarat Surat GUJARAT
9825276278
kapilthakkar@gmail.com
Dr Anilkumar MR
Oncoville Cancer Hospital And Research Centre
Department of Radiation Oncology, Clinical Trial Division, Third Floor, No. 04, 80 Ft. Road, 7th Block, 2nd Stage, Nagarbhavi, Bangalore - 560072, Karnataka Bangalore KARNATAKA
9739808502
dranil.onco@gmail.com
Dr Mukesh Arya
S P Medical College and AG Hospital
Room no. 27, First Floor, Dept. of Urology, Uro - Sciences Centre, Sarder Patel Medical College and Associated Group of Hospital, Bikaner - 334003, Rajasthan Bikaner RAJASTHAN
9414138782
mcarya@yahoo.com
Dr Nikhil Shirsi
Sangvi Multispeciality Hospital
Oncology Department, Ground Floor, Survey No 71/1/2/189, City Survey No 2387, Shirode Road, Lane No. 2, Near Krishna Chowk, Krishna Nagar, New Sanghavi, Pune - 411027, Maharashtra Pune MAHARASHTRA
Institutional Ethic Committee Belagavi Institute of Medical Science
Approved
Institutional Ethic Committee MLN Medical College
Approved
Institutional Ethics Committee - HCG Cancer Centre
Approved
Institutional Ethics Committee Erode Cancer Centre
Approved
Institutional Ethics Committee K R Hospital Mysore Medical College and Research Institute
Approved
Institutional Ethics Committee Maccare Hospital
Approved
Institutional Ethics Committee Oncoville Cancer Hospital And Research Centre
Approved
Kolhapur Cancer Center Institutional Ethics Committee
Approved
Manavata Clinical Research Institute Ethics Committee
Approved
Nirmal Hospital Pvt Ltd Ethics Committee
Approved
Parth Hospital Ethics Committee
Approved
Signus Hospital Ethics Committee
Approved
Treat Me Hospital Institutional Ethics Committee
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 7.5 mg for 1-month administration
7.5 mg intramuscular injection, to be administer at a dosing interval of 28 (±2 days) for period of 4 months (Consecutive 4 dose of Test product)
Comparator Agent
Lupron Depot® 7.5 mg for 1- month administration for intramuscular injection
7.5 mg intramuscular injection, to be administer at a dosing interval of 28 (±2 days) for period of 4 months (Consecutive 4 dose of Reference product)
Inclusion Criteria
Age From
18.00 Year(s)
Age To
85.00 Year(s)
Gender
Male
Details
Patient will be eligible for inclusion in this study only if all of the following criteria apply:
1. Male of age 18-85 years with histologically proven carcinoma of the prostate (undergoing initial therapy of leuprolide acetate), who require leuprolide treatment as per investigator judgement.
2. Life expectancy of at least 1 year at the time of screening as judged by the investigator.
3. Patient with Body Mass Index (BMI) ≥ 18.5 to ≤ 32 kg/m2 at screening and randomization visit.
4. PSA level should be greater than 4 mg/mL.
5. Patient having adequate hematologic reserve.
a. Hemoglobin ≥ 9 gm/dL
b. WBC (white blood cells) ≥4000/mm3
c. Absolute neutrophils count ≥1500/mm3
d. Platelets ≥1,00,000/mm3 (Patient who is on coumarin anticoagulants must have Platelets count ≥1,50,000/mm3)
6. World Health Organization/Eastern Cooperative Oncology Group (WHO/ECOG) performance status of 0, 1, or 2.
7. Adequate renal function at screening as defined by serum creatinine ≤ 1.6 times the ULN (Upper Limit of Normal) for the clinical laboratory.
8. Adequate and stable hepatic function as defined by bilirubin ≤ 1.5 times the ULN (upper limit of normal) and transaminases (i.e., SGOT, SGPT) ≤ 2.5 times the ULN (upper limit of normal) for the clinical laboratory at screening.
Note: For patient with liver metastasis, bilirubin ≤ 2 times the ULN (upper limit of normal) and transaminases (i.e., SGOT, SGPT) ≤ 5 times the ULN (upper limit of normal) is allowed.
9. Patient agrees to use acceptable contraceptive methods during study.
10. Patient with adequate muscle mass to receive the intramuscular injection according to the investigator.
11. Patient willing and able to comply with the protocol for the duration of the study including undergoing treatment, scheduled visits and examinations.
12. Patient willing to provide informed consent to participate in the study.
13. Non-smoker or ex-smoker who has not used any nicotine containing products in the last 6 months before Day 0 of study treatment.
ExclusionCriteria
Details
Patient will not be eligible for inclusion in this study if any of the following criteria apply:
1. Patient with hypersensitivity to GnRH, GnRH agonist analogs including any LHRH analogues, or any excipients of the study formulation.
2. Patient with anaphylactic reactions to synthetic GnRH or GnRH agonist analogs.
3. Patient with history or presence of hypogonadism, or receipt of exogenous testosterone supplementation within 6 months of screening visit.
4. Patient requiring additional treatment for prostatic cancer (i.e. radiotherapy).
5. Participated in any other clinical investigation using experimental drug/donated blood or plasma of one unit (about 450 mL whole blood or 220 mL plasma) in past 90 days before screening visit.
6. Consumption of any grapefruit juice and its products (pomelos, exotic citrus fruits, grapefruit hybrids, or fruit juices), red wine, seville oranges, and seville orange juice and its products within 07 days prior to randomization (Day 0) to throughout the study duration.
7. Patient with evidence of brain metastases, in the opinion of the Investigator, taking into account medical history, clinical observations and symptoms.
8. Patient with evidence of spinal cord compression, in the opinion of the Investigator, taking into account medical history, clinical observations and symptoms.
9. Patient with evidence of severe urinary tract obstruction with threatening urinary retention, in the opinion of the Investigator, taking into account medical history, clinical observations and symptoms.
10. Patient with excruciating, severe pain from extensive osseous deposits, in the opinion of the Investigator, taking into account medical history, clinical observations and symptoms.
11. Testosterone levels less than 1.5 ng/mL at screening and randomization visit.
12. Patient with previous orchiectomy, adrenalectomy or hypophysectomy.
13. Patient with previous prostatic surgery (e.g., radical prostatectomy, transurethral resection of the prostate [TUR-P]) within 2 weeks from screening visit or not recovered from any undesirable or harmful effects of surgery.
14. Patient with previous cancer systemic therapy such as chemotherapy, immunotherapy (e.g., antibody therapies, tumor-vaccines), biological response modifiers (e.g., cytokines) within 2 months from screening visit.
15. Patient who has received prior hormonal therapy for treatment of prostate cancer, such as luteinizing hormone-releasing hormone (LHRH) analogues (e.g., Leuprorelin acetate, Goserelin etc.) [No washout allowed].
16. Patient who has received anti-androgen treatment (i.e., androgen receptor antagonist like Bicalutamide, Flutamide, Megestrol, cyproterone acetate) [No washout allowed].
17. Administration of 5-alpha-reductase inhibitors (Proscar®, Avodart®, Propecia®) within 6 months before screening visit.
18. Over-the-counter (OTC) or alternative medical therapies which have an estrogenic or antiandrogenic effect (i.e., PC-SPES, saw palmetto, Glycyrrhiza®, Urinozinc®, dehydroepiandrosterone [DHEA]) within the 3 months before randomization visit.
19. Patient with co-existent malignancy, according to the Investigators opinion.
20. Patient with abnormal or prolonged QTc interval (Bazetts formula greater than 450 msec, Appendix II), uncontrolled congestive heart failure, myocardial infarction or a coronary vascular procedure (e.g. balloon angioplasty, coronary artery bypass graft) or significant symptomatic cardiovascular disease(s) within 6 months before check-in resting uncontrolled hypertension (≥ 160/100 mmHg) or symptomatic hypotension within 3 months before randomization visit.
21. Patient with venous thrombosis within 6 months from randomization visit.
22. Patient with Insulin-dependent diabetes mellitus or uncontrolled type 2 diabetes mellitus (HbA1c greater than 7 percentage).
23. History of difficulty with donating blood or difficulty in accessibility of veins.
24. Patient who is institutionalized.
25. A positive test result for Hepatitis (includes subtypes B and C) or HIV.
26. Patient with history of drug and/or alcohol abuse within 6 months from randomization visit.
27. Patient with serious concomitant illness(es) or disease(s) [e.g., hematological, renal, hepatic, respiratory, endocrine, psychiatric] that may interfere with, or put patients at additional risk for, their ability to receive the treatment outlined in the protocol.
28. Patient receiving anticoagulants who have prothrombin and partial thromboplastin times outside of the normal range for the laboratory assays; patients who are on anticoagulation or antiplatelet medications (e.g. dipyridamole, ticlopidine, warfarin derivatives) who are not receiving a stable dose for 3 months before randomization visit; patients who are receiving
warfarin-derivative anticoagulants who do not have an International Normalized Ratio (INR) in the therapeutic range for the clinical indication for which the anticoagulant has been prescribed.
29. Any other condition that, in the investigator’s judgment, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
To evaluate the bioequivalence between Leuprolide acetate for depot suspension 7.5 mg 1- month administration of Pharmathen S.A. Greece and Lupron Depot® 7.5 mg for 1-month administration in adult male patients with prostate carcinoma undergoing initial therapy of Leuprolide Acetate.
35 Weeks
Secondary Outcome
Outcome
TimePoints
To evaluate the safety and tolerability of the patients.
35 Weeks
Target Sample Size
Total Sample Size="60" Sample Size from India="60" 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)
29/11/2024
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="1" Months="4" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Open to Recruitment
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
An Open-Label, Multiple Dose, Multicenter,
Randomized, Two Sequence, Two-Treatment, fully Replicate, Cross-Over, Steady
State, Bioequivalence Study of Test Product Leuprolide Acetate for Depot
Suspension 7.5 mg of Pharmathen S.A. Greece with Reference Product Lupron
Depot® 7.5 mg, Manufactured for AbbVie Inc. in Adult Male Patients with
Prostate Carcinoma Undergoing Initial Therapy of Leuprolide Acetate.
Objective:
a. To evaluate the bioequivalence between Leuprolide
acetate for depot
suspension 7.5 mg for 1-month administration of Pharmathen S.A. Greece and
Lupron Depot® 7.5 mg for 1-month
administration in adult male patients with prostate carcinoma undergoing
initial therapy of Leuprolide Acetate.
b. To evaluate the safety and tolerability of the
patients.