EUCTR2016-002240-17-GB进行中（未招募）1 期
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of ATR-101 for the Treatment of Cushing’s Syndrome
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 16
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
入选标准
- •1. Provision of signed and dated informed consent prior to any study-specific procedures
- •2. Men and women 18-80 years of age (inclusive) at screening
- •3. Subjects must have a confirmed diagnosis of endogenous Cushing’s syndrome as evidenced by
- •baseline UFC 1.3 to 10 × ULN (mean of all 24-hr UFC levels obtained during the screening period within 28 days of enrolment into the open-label dose-escalation period) AND documentation at any time of ONE of the following three criteria:
- •For subjects with a diagnosis of pituitary Cushing’s syndrome, either:
- •- Magnetic resonance imaging (MRI) confirmation of pituitary adenoma (greater than or equal to 0.6 cm), OR
- •- For subjects with a pituitary microadenoma less than 0.6 cm, bilateral inferior petrosal sinus sampling (BIPSS) showing an ACTH gradient > 2 before or > 3 after corticotropin-releasing hormone (CRH) or desmopressin (DDAVP) stimulation, OR
- •- For subjects who have had prior pituitary surgery: histopathology confirming an ACTH-staining adenoma
- •For subjects with a diagnosis of adrenal Cushing’s syndrome: MRI or computed tomography (CT) of the adrenal glands showing an adrenal tumor
- •For subjects with a diagnosis of ectopic ACTH as the cause of their Cushing’s syndrome: ACTH-dependent Cushing’s syndrome and either:
- •- MRI showing no pituitary adenoma, OR
- •- MRI showing only a small pituitary adenoma (< 0.6 cm) AND a negative BIPSS, OR
- •- For subjects who have had prior pituitary surgery: histopathology that is negative for an ACTH-staining adenoma
- •4. Subjects with a history of prior pituitary surgery must be at least 3 months post-surgery at the time of the screening visit
- •5. Body mass index (BMI) between 18 and 60 kg/m2, inclusive, at screening
- •6. Female subjects must be postmenopausal > 2 years OR must have been permanently surgically sterilized (bilateral salpingectomy or tubal occlusion) > 2 years OR male partner(s) has had a vasectomy > 2 years OR must consent to use two permitted medically-acceptable methods of contraception throughout the study during any sexual intercourse with a male partner. Permitted medically-acceptable methods of birth control for this study include oral contraceptives, contraceptive implants, Depo-Provera®, contraceptive patch, vaginal ring, male condom, female condom, spermicide, diaphragm with spermicide, cervical cap with spermicide, contraceptive sponge, or an intrauterine device (IUD) that does not contain steroid hormones; IUDs must have been in place for at least 28 days prior to first dose of study drug.
- •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 12
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4
排除标准
- •1. Pseudo-Cushing’s syndrome, cyclic Cushing’s syndrome or current iatrogenic Cushing’s syndrome
- •2. Subjects who are considered candidates for surgical treatment of Cushing’s syndrome, unless it is clearly
- •documented that the subject has refused such surgery or that surgery cannot be scheduled for at least the
- •anticipated duration of the study
- •3. Normal late night salivary cortisol value during screening, unless the subject’s history clearly demonstrates that he or she does not have pseudo-Cushing’s or cyclic Cushing’s. If the subject has a normal late night salivary cortisol, and the PI feels the subject does not have pseudo-Cushing’s or cyclic Cushing’s, the subject may be enrolled with approval of the medical monitor
- •4. Normal 24-hr UFC during screening (this would be suggestive of cyclic Cushing’s)
- •5. Radiotherapy of the pituitary within 6 months prior to or during screening
- •6. For subjects with pituitary Cushing’s syndrome, any compression of the optic chiasm or the presence of a tumor within 2 mm of the optic chiasm on the most recent pituitary MRI prior to or during screening
- •7. Use of or medical requirement for any of the following medications within the timeframes specified below prior to collection of the first 24-hr UFC during Screening and throughout study participation:
- •Inhibitors of steroidogenesis (ketoconazole, metyrapone): 1 week
- •Pituitary-directed agents: Dopamine agonists (bromocriptine, cabergoline) and PPAR? agonists (rosiglitazone or pioglitazone): 4 weeks
- •Octreotide LAR, Lanreotide SR and Lanreotide autogel: 14 weeks
- •Octreotide (immediate release formulation): 1 week
- •Pasireotide: 4 weeks
- •Mitotane: 26 weeks
- •Mifepristone: 3 weeks
- •8. Uncontrolled diabetes mellitus, as evidenced by HbA1c > 9.0% at screening
- •9. Uncontrolled hypertension, defined as systolic blood pressure > 160 mmHg or diastolic blood pressure > 90 mmHg during screening. Note: if appropriate, subjects may have blood pressure medications adjusted and blood pressure reassessed at an unscheduled visit prior to Visit T1.
- •10. Any history of gastric or small intestinal surgery or any current disease that causes malabsorption. Note: irritable bowel syndrome is acceptable for inclusion
- •11. Alcohol or substance abuse (cocaine, amphetamines and/or opioids) within the year prior to screening
- •12. Abnormal laboratory values as per the guidelines listed below or any other clinically significant, unexplained laboratory abnormality according to the Investigator:
- •Serum ALT or AST > 3 × ULN
- •Serum total bilirubin > 1.5 × ULN
- •Serum creatinine > 1.5 × ULN
- •Glomerular filtration rate < 60 mL/min/1.73m^2
- •13. Pregnant, breast-feeding, having conceived within the 6 months prior to screening, or having an intent to become pregnant during the study period
- •14. QTc > 470 msec on electrocardiogram at screening (subjects with a single QTc > 470 msec may have 2 additional ECGs taken during screening and the QTcs averaged; if the average QTc is > 470 msec then the subject is excluded)
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