Phase 1 Study of the Safety and Tolerability of ATR-101 in Adrenocortical Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 5
- 主要终点
- Frequency of dose-limiting toxicity and determination of maximum tolerated dose
研究概览
简要总结
This first-in-human study is designed to establish the safety and tolerability of ATR-101 in patients with advanced adrenocortical carcinoma whose tumor has progressed on standard therapy. Information will also be collected to determine how long ATR-101 stays in the blood, and if any effect on tumor progression is seen. Biomarkers (blood and urine tests) will determine if any effects on production of steroid hormones (cortisol, aldosterone, estrogen and testosterone) are seen.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical confirmation of adrenocortical carcinoma that is locally advanced or metastatic and not amendable to surgical resection;
- •Failed or declined mitotane (adjuvant or therapeutic) therapy or a platinum-based chemotherapy regimen;
- •Able to understand and comply with the protocol requirements;
- •Willing and able to provide informed consent.
排除标准
- •Mitotane level > 5
- •Use of contraindicated concomitant medications
- •Unstable medical condition that, in the judgment of the investigator, could interfere with study procedures or data interpretation.
研究组 & 干预措施
ATR-101
ATR-101 will be administered as capsules or tablets by mouth once or twice per day to ascending dose cohorts
干预措施: ATR-101 (Drug)
结局指标
主要结局
Frequency of dose-limiting toxicity and determination of maximum tolerated dose
时间窗: Occurrence of DLT at 28 days
Adverse events will be recorded and tabulated by grade and system organ class according to CTCAE v 4.03. Laboratory measures and ECGs will be assessed.
次要结局
- Change in plasma cortisol levels(Baseline and day 22)
- Area under the plasma concentration versus time curve (AUC) of ATR-101(Day 1 and Day 22)
- Change in objective measurement of tumor size(Baseline and 8 weeks)