Advanced prostate cancer treatment MedDRA version: 21.1 Level: PT Classification code 10036909 Term: Prostate cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10060862 Term: Prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Teverelix TFA
Product Code: Teverelix TFA
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Teverelix
CAS Number: 790299-79-5
Current Sponsor code: Teverelix TF
Sponsors
Antev Ltd.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Is male, aged 80 years or younger at beginning of treatment period (Day 0) 2. Has histologically proven advanced adenocarcinoma of the prostate (metastatic or non-metastatic, hormone-sensitive, non-curative), suitable for androgen deprivation therapy. 3. mlIs fulfilling any of the following treatment conditions: • Is treatment naïve. • Has not received treatment with any of the following within 1 year prior to screening, and has treatment history of these treatments for less than 6 months: • gonadotropin-releasing hormone (GnRH) analogs, androgen receptor antagonist • androgen synthesis inhibitors (e.g. abiraterone) 4. Agrees to practice contraception during the entire study treatment period and through 3 months after the last dose of IMP: • Either by using double barrier contraception , • or, is ruly sexually abstinent, when this is in line with the preferred and usual lifestyle of the participant Note: Periodic abstinence [e.g. calendar, ovulation, symptothermal, postovulation methods for the female partner with childbearing potential] and withdrawal are not acceptable methods of contraception. 5. Has provided written (personally signed IMPHas provided written (personally signed and dated) informed consent before completing any study-related procedure, which means any assessment or evaluation that would not have formed a part of his normal medical care. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: The participant: 1. Has abnormal screening and/or baseline laboratory values that suggest a clinically significant underlying disease, or the following laboratory values: • Liver function test (aspartate aminotransferase [ASAT/SGOT], alanine aminotransferase [ALAT/SGPT]), or total bilirubin exceeding twice the upper limit of the normal range, unless the elevation is attributed to hepatic metastases • Creatinine twice the upper limit of the normal range • Uncontrolled diabetes (Haemoglobin A1c [HbA1c] >7.5%) or previously undiagnosed diabetes mellitus with HbA1c >6.5% 2. Has any contraindication to the use of teverelix TFA 3. Has life expectancy of less than 1 year 4. Has testosterone levels below 2.0 ng/mL at screening 5. Has a medical history of bilateral orchidectomy 6. Using any of the following prohibited treatments: a. Within 25 weeks prior to screening: dutasteride b. Within 12 weeks prior to screening: finasteride c. Current use of any of the following:: i. Anti-androgen therapy, including testosterone replacement therapy and 5a-reductase inhibitor treatment etc. ii. Gonadotropin-releasing hormone (GnRH) analogues, androgen receptor antagonists iii. Androgen synthesis inhibitors (e.g. abiraterone) iv. Any other medication or herbal product that may affect hormone levels and might, therefore, confound interpretation of the study results (e.g. St. John’s wort) 7. Has neurological disease, psychiatric disease, drug or alcohol abuse, which could interfere with the participant’s proper compliance 8. Has a history of myocardial infarction, unstable symptomatic ischemic heart disease, any ongoing cardiac arrhythmias of grade >2 (chronic stable atrial fibrillation on stable anticoagulant therapy is allowed), thromboembolic events (e.g. deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events), or any other significant cardiac condition (e.g. pericardial effusion, restrictive cardiomyopathy) within 6 months before screening 9. Has congenital long QT syndrome or ECG abnormalities at screening of: • Q-wave infarction, unless identified =6 months before screening • Heart rate-corrected QT interval millisecond (msec) (QTcF interval) >480 msec. If QTcF is prolonged in a participant with a pacemaker, the participant may be enrolled in the study upon discussion with the project clinician • If the QTcF interval is 450-480 msec, inclusive, in a participant with current use of medications with known effects on QT interval, the participant may be enrolled in the study following discussion with the Medical Lead 10. Has known or suspected severe renal impairment 11. Has a medical history of diagnosis of, or treatment for, another malignancy within 2 years before the first dose of IMP, or previous diagnosis of another malignancy with evidence of residual disease. Participants with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection 12. Is currently using Class IA (e.g. quinidine, procainamide) or Class III (e.g. amiodarone, sotalol) antiarrhythmic medications 13. Has uncontrolled hypertension despite appropriate medical therapy (sitting blood pressure [BP] of greater than 180 millimetres of mercury (mmHg) systolic and greater than 95 mmHg diastolic at 2 separate measurements taken no more than 60 minutes apart during the Screening visit). Participants with isolated systolic BP measurements >180 mmHg may be rescreened. Participants with isolated systolic BP measureme
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of teverelix TFA in terms of ability to suppress serum testosterone (T) levels to below castration level (<0.5 ng/ml or 1.73 nmol/L) at Day 28 ;Secondary Objective: • To assess the efficacy of teverelix TFA in terms of ability to suppress serum testosterone levels to below castration level (<0.2 ng/ml or 0.6934nmol/L) at Day 28 • To assess the efficacy of teverelix TFA in terms of ability to suppress serum testosterone levels to below castration level (<0.5 ng/dl or 1.73 nmol/L) at Day 168 • To assess the efficacy of teverelix TFA in terms of ability to suppress serum testosterone levels to below castration level (<0.2 ng/ml or 0.6934nmol/L) at Day 168 • To assess the efficacy of teverelix TFA in terms of ability to maintain suppression of serum testosterone levels below castration level (<0.5 ng/ml or 1.73 nmol/L) over time during Stage II (maintenance dosing period) To assess the efficacy of teverelix TFA in terms of ability to maintain suppression of serum testosterone levels below castration level (<0.2 ng/ml or 0.6934nmol/L) over time during Stage II (maintenance dosing period) *and other from protocol;Primary end point(s): Primary Endpoint: Proportion of Participants achieving castration level with serum testosterone < 0.5 ng/ml or 1,73 nmol/L at Day 28 ;Timepoint(s) of evaluation of this end point: Every 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Every 12 weeks;Secondary end point(s): 1. Proportion of Participants achieving castration level with T=50% reduction at Day 168 visit. 11. Number of Participants with PSA response of >=120% reduction at Day 168 visit. 12. Percent Change from Baseline in Serum PSA Concentration at each visit. 13. Mean Serum PSA Concentration at each visit. 14. Mean Serum LH Concentration at each visit. 15. Mean serum T Concentration at each visit 16. Mean Serum FSH Concentration at each visit. 17. Mean Serum Sex Hormone-Binding Globulin (SHBG) Concentration at each visit | — |
Countries
Lithuania
Contacts
Public ContactCarol MacLean
Antev Ltd.
Outcome results
None listed