A Phase 2, Open-Label, Single-Arm, Multicentre Study Investigating the Pharmacokinetics, Pharmacodynamics, Efficacy and Safety of Teverelix DP, a Gonadotropin-releasing Hormone (GnRH) Antagonist, in Participants with Advanced Prostate Cancer
- Conditions
- Advanced prostate cancerMedDRA version: 20.0Level: PTClassification code: 10060862Term: Prostate cancer Class: 100000004864Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-509255-14-01
- Lead Sponsor
- Antev Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- Male
- Target Recruitment
- 44
(1) Is male, aged =85 years (=18 years) at the beginning of the treatment period (Day 1) (2) Has histologically proven advanced adenocarcinoma of the prostate (metastatic or non- metastatic, hormone-sensitive, non-curative), suitable for androgen deprivation therapy (3) Is treatment naïve for GnRH analogues
(1) Has abnormal screening and/or baseline laboratory values that suggest a clinically significant underlying disease, or the following laboratory values: (a) Liver function test (aspartate aminotransferase [ASAT/SGOT], alanine aminotransferase [ALAT/SGPT]), exceeding >2X the upper limit of the normal (ULN) range (b) Total bilirubin exceeding >1.5X the upper limit of the normal (ULN) range (c) Creatinine twice the ULN range (d) Uncontrolled diabetes (HbA1c >7.5%) or previously undiagnosed diabetes mellitus with HbA1c >6.5% (e) An estimated glomerular filtration rate (eGFR) < 30 mL/min, based on creatinine clearance calculation by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation normalized to an average surface area of 1.73m2, at the screening visit. (2) Has any contraindication to the use of teverelix DP (3) Has a life expectancy of less than 1 year (4) Has T levels <1.5 ng/mL at screening (5) Has a medical history of bilateral orchidectomy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of a dosing regimen of teverelix DP in attaining by Day 29 and sustaining to Day 155 castration rate defined as the cumulative probability of testosterone suppression to < 0.5 ng/mL with the lower bound of the 95% confidence interval (CI) being > 90%;Secondary Objective: To evaluate the ability of a dosing regimen of teverelix DP in attaining by Day 29 and sustaining to Day 155 profound castration rate defined as the cumulative probability of testosterone suppression to < 0.2 ng/mL;Primary end point(s): The sustained castration rate defined as the cumulative probability of achieving testosterone suppression to castrate levels of = 0.5 ng/mL (1.7 nmol/L) while on study treatment from Study Day 29 through Study Day 155
- Secondary Outcome Measures
Name Time Method Secondary end point(s):The sustained castration rate, defined as the cumulative probability of testosterone suppression to = 0.2 ng/mL (0.7 nmol/L) while on study treatment from Study Day 29 through Study Day 155