NCT00094328已完成2 期
An Open-label, Non-comparative, Multi-centre Study to Assess the Efficacy and Safety of Bicalutamide When Used in Combination With Anastrozole for the Treatment of Gonadotropin-independent Precocious Puberty in Boys With Testotoxicosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Change in Growth Rate (cm/Year)
研究概览
简要总结
The primary objective of this study is to investigate whether bicalutamide given in combination with anastrozole once daily for 12 months is effective in treating testotoxicosis in boys. Testotoxicosis is a condition that causes early puberty in boys including growth in height, and development of muscles and sexual organs .
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 13 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Provision of written informed consent of parent/legal guardian and subject assent (as needed by local requirements)
- •Male aged 2 years and over
- •Diagnosis of testotoxicosis based on the following:
- •Clinical features of Progressive sexual precocity documented by Tanner staging and evidence of symmetrical testicular enlargement
- •Clinical features of significantly advanced bone age (defined as bone age of at least 12 months beyond chronological age)
- •Pubertal levels of serum testosterone
- •Prepubertal levels of serum gonadotropins
- •Lack of an increase in serum gonadotropin levels following GnRH stimulation
- •Other pathology excluded by:
- •Undetectable plasma b human chorionic gonadotropin (bHCG). Samples with values below the LOQ will be reported as "<10 IU/L" which in the clinical setting equate to 'undetectable'.
- •Normal levels of 17-hydroxyprogesterone (17-OHP)
- •Normal levels of dehydroepiandrosterone sulphate (DHEAS)
- •Naive to anti androgen receptor therapy:
- •(Note: Ketoconazole and Spironolactone are considered acceptable as is prior use of anastrozole or other aromatase inhibitors)
- •A documented reliable height measurement taken > 6 months prior to study enrollment. Additionally for subjects who have previously received ketoconazole or spironolactone treatment, a documented reliable height measurement taken immediately prior to beginning this treatment.
- •(Note: for subjects who received such previous treatment only a single assessment is needed if it was taken immediately prior to beginning treatment and > 6 months prior to study entry)
- •Subjects should be free of endocrine or other effects of previous treatment for testotoxicosis prior to study entry: to ensure this there should be 15 days or 4 drug half lives (whichever is the longer) washout period from prior medication for testotoxicosis.
排除标准
- •Evidence of central precocious puberty as demonstrated by GnRH stimulation test
- •Serum concentration of total or direct bilirubin, GGT, AST or ALT greater than 1.5 times the upper limit of normal for age
- •Serum concentration of creatinine greater than 1.5 times the upper limit of normal for age
- •Any concomitant medical condition that, in the opinion of the investigator, may expose a subject to an unacceptable level of safety risk or that affects subject compliance
- •Known hypersensitivity to any of the study medications
- •Participation in a clinical study at the time of enrollment
研究组 & 干预措施
Bicalutamide with Anastrozole
Other
Bicalutamide in combination with Anastrozole
干预措施: Bicalutamide (Drug)
Bicalutamide with Anastrozole
Other
Bicalutamide in combination with Anastrozole
干预措施: Anastrozole (Drug)
结局指标
主要结局
Change in Growth Rate (cm/Year)
时间窗: Assessed after 12 months treatment
Change in growth rate after 12 months relative to the growth rate during the ≥6 month pre-study period, based on raw height data (cm/year).
Change in Growth Rate (SD Units)
时间窗: Assessed after 12 months treatment
Change in growth rate after 12 months relative to the growth rate during the ≥6 month pre-study period, calculated after adjustment for the chronological age of the patient (expressed as a standard deviation \[SD\] score).
次要结局
- Change in Growth Rate (SD Units)(Assessed after 6 months treatment)
- Change in Growth Rate (cm/Year)(Assessed after 6 months treatment)
- Change in Bone Age Maturation Rate (cm/Year)(Assessed after 6 and 12 months treatment)
- Change in Bone Age to Chronological Age Ratio(Assessed after 6 and 12 months of treatment)
- Number of Patients With Height Between 5th and 95th Percentile(Assessed after 3, 6, 9 and 12 months of treatment)
- Change in Predicted Adult Height (PAH)(Assessed after 12 months treatment)
- Change in Average Testicular Volume(Assessed after 6 and 12 months of treatment)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Efficacy and Toxicity of Bicalutamide and Dutasteride vs. Standard Care for Prostate Cytoreduction for BrachytherapyLower Urinary Tract SymptomsProstate CancerErectile DysfunctionNCT00866554CHU de Quebec-Universite Laval60
已完成
2 期
Bicalutamide and Ridaforolimus in Men With Prostate Cancer (MK-8669-002)Prostate CancerNCT00777959Merck Sharp & Dohme LLC22
终止
3 期
Bicalutamide in Treatment of Androgen Receptor (AR) Positive Metastatic Triple Negative Breast CancerMetastatic Triple Negative Breast CancerNCT03055312Sun Yat-sen University36
进行中（未招募）
2 期
Nivolumab, Ipilimumab, and Bicalutamide in Human Epidermal Growth Factor (HER) 2 Negative Breast Cancer PatientsBreast Neoplasm FemaleBreast CarcinomaBreast CancerBreast TumorNCT03650894Providence Health & Services30
招募中
1 期
Abemaciclib in Combination With Bicalutamide for Androgen Receptor-positive, HER2-negative Metastatic Breast CancerMetastasisBreast CancerNCT05095207Icahn School of Medicine at Mount Sinai42