Open label multicenter randomized parallel single-period single dose bio equivalence study of Leuprolide acetate 30 mg in adult male subjects with advanced prostaticcancer undergoing initial therapy.
- Conditions
- Health Condition 1: N429- Disorder of prostate, unspecified
- Registration Number
- CTRI/2020/10/028442
- Lead Sponsor
- Pharmathen SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 32
1. Male patients having a BMI of 18.5-30 kg/m2 (both inclusive).
2. Ability to understand and provide written informed consent prior to participation in the study and willing to comply with the study requirements as per protocol.
3. Patients who require Leuprolide Acetate Depot Injection, 30mg, every 16 weeks.
4. Patients with histologically/cytologically confirmed advanced carcinoma of prostate (Stage T(1b-4), N(any) , M(any)) who would be benefit from GnRH agonist.
5. Newly diagnosed advanced prostatic cancer patients that are scheduled to receive their first dose of leuprolide acetate as a part of their standard of care.
6. Testosterone levels >=1.5ng/mL at screening.
7. Patients with an ECOG Performance Status Score < 2
8. Patients with hemoglobin >= 9.0 g/dL.
9. No history of addiction to any recreational drug or drug dependence or alcohol addiction.
10. Patients with HbA1c <= 7 % at screening
11. Patients with life expectancy of at least 6 months at the time of enrolment as judged by Investigator.
12. Patients/ partner agreeing to use adequate contraceptive methods during the study.
1.Known hypersensitivity or contraindication to GnRH, GnRH agonist or to any of the components of investigational product.
2.History of prostatic surgery (e.g., radical prostatectomy, transurethral resection of the prostate [TUR-P]), orchiectomy, adrenalectomy and hypophysectomy.
3.History of radiotherapy, chemotherapy, immunotherapy, radiation therapy, cryotherapy, strontium, or biological response modifiers as prostate therapy within 8 weeks prior the screening visit.
4.Patients that received hormonal manipulation within 32 weeks prior the screening visit (i.e. GnRH analogues, estrogen, megace and phytotherapy)
5.Patients requiring additional treatment (i.e. radiotherapy)
6.History of hypogonadism
7.Received therapy with finasteride or ketoconazole within 1 week prior to the Screening Visit; dutasteride within 25 weeks prior to the Screening Visit.
8.Received therapy with a GnRH analog (1 year implant) within 60 weeks prior to the Screening Visit.
9.Positive tests for drug or alcohol abuse at screening or baseline.
10.Patient had major surgery (other than those specified in criteria 2) within 4 weeks prior to study entry, or who have not recovered from prior major surgery.
11.Patients with known positivity for human immunodeficiency virus (HIV), HBsAg or HCV.
12.Is either a non-smoker or ex-smoker who has not used any nicotine containing products in the last 6 months before day 1 of study treatment.
13.History of difficulty with donating blood or difficulty in accessibility of veins.
14.Donation of blood (1 unit or 350 ml) within 90 days prior to receiving the first dose of investigational medicinal product for the current study.
15.Clinical indication of urinary tract obstruction.
16.History or presence of any uncontrolled debilitating systemic disease (e.g. cardiovascular disease, hypertension, diabetes mellitus etc.)
17.Significant pre-existing cardiovascular co morbidities i.e.
• Myocardial infarction within 6 month
• Unstable angina
• Congestive cardiac failure
• Cardiac arrhythmia
• History of familial long QT syndrome
18.Known CNS metastasis.
19.Patients having history of convulsion, epilepsy, cerebrovascular disorders, central nervous system anomalies or tumors, and in patients on concomitant medications that have been associated with convulsions such as bupropion and SSRIs.
20.Concurrent medications that may prolong the QT/QTc interval.
21.A marked baseline prolongation of QTc interval (QTc interval >450 milliseconds (ms))
22.History of other malignancies in the last 5 years (except in situ cancer of cervix or basal or squamous cell skin cancer).
23.Participation in any clinical study within 90 days prior to receiving the first dose of Investigational Product.
24.Any condition/ abnormal baseline findings that in the investigatorâ??s judgment might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to obtain the objective of the study e.g. low expectation of compliance to dosing or expected changes in concomitant medication that may interfere in study.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the bioequivalence between Leuprolide acetate 30 mg of Pharmathen S.A., Greece and LUPRON DEPOT (leuprolide acetate for depot suspension) 30 mg of AbbVie Inc. North Chicago, IL 60064 in adult male subjects with advanced prostatic cancer undergoing initial therapy under fasting conditions.Timepoint: A total of 36 pharmacokinetic blood samples will be collected per patient the during study. All PK samples after 24.00hrs. will be ambulatory. Visit 3-21: Ambulatory PK sample collection visit (on days 3, 4, 7, 11, 15, 19, 23, 28, 35, 42, 49, 56, 63, 70, 77, 84, 91, 98, 105) Visit 22: End of study visit: Ambulatory PK sample collection visit (on day 112) and safety assessment.
- Secondary Outcome Measures
Name Time Method To monitor the adverse events and to ensure the safety of <br/ ><br>patients exposed Investigational Medicinal Product.Timepoint: Patients will be monitored for safety at screening period of 14 days and study duration post randomization for at least 112 days. Each patient will have 22 visits during the study. Visit 1: Screening visit (14 days prior to first day of dosing)Visit 2: Eligibility / Randomization visit (check in day 0) and Visit 22: End of study visit: Ambulatory PK sample collection visit (on day 112) and safety assessment.