EUCTR2020-000543-31-LT进行中（未招募）1 期
An Adaptive Phase II, Open-Label, Multicentre Study Investigating the Pharmacokinetics, Pharmacodynamics, Efficacy and Safety of Teverelix Trifluoroacetate, a GnRH antagonist, in Participants with Advanced Prostate Cancer - TEACh (Teverelix Evaluated in Advanced prostate Cancer)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Antev Ltd.
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •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
排除标准
- •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
- •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
- 另有 3 项未显示
研究者
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