An Open Label, Multicentre Study to Assess the Pharmacokinetics, Pharmacodynamics, Efficacy and Safety of Teverelix Trifluoroacetate in patients with Advanced Prostate Cancer

Phase 1

Active, not recruiting

• Conditions: Advanced prostate cancer treatment; MedDRA version: 21.1Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10060862Term: Prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-000543-31-LT
• Lead Sponsor: Antev Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-11
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 25

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified