EUCTR2019-003142-32-GB进行中（未招募）1 期
A One Year, Randomized, Double-Blind, Placebo-Controlled Study of TBR-760 in Adult Patients with Non-Functioning Pituitary Adenomas
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
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
- All
入选标准
- •1. Male or female, =18 or =80 years of age;
- •2. Confirmed diagnosis of NFPA (defined as lack of clinical and biochemical evidence of adenohypophyseal hormone excess), and be status-post one TSS;
- •3. At the time of Screening, must have NFPA remnant following TSS of =10mm (maximum diameter) based on locally read MRI performed =24 months ago;
- •4. Female patients must not be pregnant and be highly unlikely to become pregnant. Male patients
- •must be unlikely to impregnate a partner. Male or female patients must meet at least one of the following criteria:
- •a. A female patient who is not of reproductive potential is eligible without requiring the use of contraception. A female patient who is not of reproductive potential is defined as one who: (1) has reached natural menopause (defined as 12 months of spontaneous amenorrhea without an alternative medical cause except if the medical cause is related to the NFPA or previous treatment of the NFPA including TSS); (2) is 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy; or (3) has undergone bilateral tubal ligation.
- •b. A male patient who is not of reproductive potential is eligible without requiring the use of contraception. A male patient who is not of reproductive potential is defined as one who has undergone a successful vasectomy or has hypogonadism and is on androgen replacement. A successful vasectomy is defined as (1) microscopic documentation of azoospermia, or (2) a vasectomy more than 2 years ago with no resultant pregnancy despite sexual activity post vasectomy.
- •5. A male or female patient who is of reproductive potential agrees to remain abstinent or use (or have their partner use) acceptable methods of highly effective contraception starting from the time of consent through 3 months after the completion of study therapy. True abstinence is defined as abstinence that is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of the study and withdrawal are not acceptable methods of contraception. Female patients must agree to two forms of birth control. Acceptable methods of highly effective birth control are combined or progestogen-only hormonal contraception that is associated with inhibition of ovulation, intrauterine device, and intrauterine hormone-releasing system. Female patients using a hormonal method of contraception must be accompanied with the use of a second, non-hormonal method of contraception (e.g. condom).
- •6. On a stable dose of hormone replacement therapy (i.e., growth hormone, thyroid hormone, corticosteroid, or sex hormone) for at least 3 months prior to Screening, if applicable.
- •7. Patients receiving treatment for hypertension must be controlled on a stable dose for at least one month, in the opinion of the Investigator, prior to Screening.
- •8. Be capable of giving informed consent and reading and signing the informed consent form after the nature of the study has been fully explained by the Investigator or Investigator designee.
- •9. Be willing and able to complete all study assessments and procedures and to communicate effectively with the Investigator and site staff.
- •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 105
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4
排除标准
- •1. Has undergone more than one TSS, or had TSS <6 months prior to screening, or is anticipated to require TSS within 6 months of Screening;
- •2. Is likely to, in the opinion of the Investigator, require TSS or radiation during the course of the study due to location of (i.e., remnant anatomically impinging upon the optic chiasm), or growth rate of the remnant;
- •3. Is known to have silent corticotroph, somatotroph or thyrotroph adenoma;
- •4. Has undergone radiation therapy to the head for any reason, or is already planned to have or anticipated to require radiation therapy during the study period;
- •5. Prior treatment with any dopamine receptor agonist or somatostatin analog (administration of single doses for testing purposes is acceptable);
- •6. Has been or is currently being treated for psychotic disorder and/or requires neuroleptic antipsychotic/prokinetic (antiemetic) drugs (i.e., butyrophenones, phenothiazines, metoclopramide), due to antagonism of neuroleptic and dopaminergic agonists;
- •7. Any contraindications to magnetic resonance imaging including allergy or intolerance to gadolinium or gadolinium-based contrast;
- •8. Any history of clinically severe cardiac valvular disease;
- •9. Has history of clinically significant orthostatic hypotension or severe hypotension.
- •10. Positive for human immunodeficiency virus (HIV), hepatitis C (HCV) antibodies (unless the patient has successfully completed drug therapy that results in cure/clearance of HCV), and hepatitis B surface antigen (HBsAg);
- •11. For female patients of childbearing potential, a positive serum human chorionic gonadotropin (hCG) test or a positive urine hCG test on Screening or Day 1;
- •12. Planning to become pregnant or to breastfeed during the study or is currently breastfeeding;
- •13. Has clinically significant hepatic abnormalities in the opinion of the investigator or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3x the upper limit of normal (ULN); total bilirubin > 2x the upper limit of normal. Patients with Gilbert’s syndrome are excluded.
- •14. Has clinically significant renal disease in the opinion of the Investigator or estimated glomerular filtration rate (eGFR) < 60 mL/min.
- •15. Has uncontrolled diabetes (glycosylated haemoglobin (HbA1c) >8%);
- •16. Body Mass Index (BMI) <17.5 or >40 kg/m2;
- •17. A history of drug or alcohol abuse within the past one year as judged by the Investigator.
- •18. A cancer that has not been in complete remission for at least 5 years. Patients with squamous cell or basal cell carcinoma of the skin, localized cervical cancer, or localized prostate cancer are eligible if, in the opinion of the Investigator, the condition has been adequately diagnosed, and is determined to be clinically in remission, and the patient’s participation in the study would not represent a safety concern.
- •19. A history of a clinically significant allergic reaction or hypersensitivity, as judged by the Investigator, to any drug or any component of the study drug formulations used in the study.
- •20. On electrocardiogram (ECG), a corrected QT interval, Fridericia’s formula (QTcF) >450 ms in men and >470 ms in women or the presence of clinically significant abnormalities as determined by the investigator.
- •21. A history of major surgery within 4 weeks or minor surgery within 2 weeks of Day 1.
- •22. Any flu-like syndrome or other respiratory infection within 2 weeks of Day 1 or vaccination with attenuated live virus within 4 weeks of Day 1.
研究者
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