NCT04419623已完成1 期
A Phase 1/2, Double-Blind, Randomized, Placebo-Controlled Study of TL-895 With Standard Available Treatment Versus Standard Available Treatment for the Treatment of COVID-19 in Patients With Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Recommended dose of TL-895
研究概览
简要总结
This study evaluates TL-895, a tyrosine kinase inhibitor (TKI). This is a study comprising a Phase 1 safety assessment. TL-895 open-label will be administered orally at an assigned dose continuously in 7-day cycles for 2 cycles. Up to 3 dose levels will be evaluated.
Only Phase 1 of the study was enrolled and the study did not proceed into Phase 2.
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
- •Known diagnosis of active cancer that is not considered cured or disease free.
- •Confirmed COVID-19 infection as per World Health Organization (WHO) criteria with suspected pneumonia requiring hospitalization and oxygen saturation < 94% on room air or requires supplemental oxygen.
- •Adequate hematological, hepatic and renal function as would be medically expected of a cancer patient population.
- •Able to swallow and absorb oral medications.
排除标准
- •Current active treatment with medications contraindicated for receipt of investigational product.
- •Require chemotherapy or urgent systemic therapy for active cancer that cannot be withheld.
- •No remaining available therapies for advanced or metastatic malignancies.
- •Participation in another clinical study with therapeutic intent for COVID-19
- •Require artificial ventilation at screening.
- •Life expectancy less than 6 months.
- •Medical conditions that make it unsafe to receive investigational product (for example, heart attack in the last 6 mos, unstable angina, uncontrolled arrhythmia, heart failure class 3/4, QTC interval > 480 msec; known bleeding disorders, stroke or intracranial hemorrhage in the last 6 mos; active HBV, HCV or history of HIV; GI malabsorption syndrome, small bowel resection, poorly controlled IBS; untreated/actively progressing known CNS lesions).
- •Receipt of radiation therapy to the lung or mediastinum for treatment of COVID-19
研究组 & 干预措施
Dose Finding - 200mg BID
Experimental
200mg TL-895 orally BID taken continuously in 7-day cycles for 2 - 4 cycles with SAT for COVID-19 (14 - 28 days of treatment).
干预措施: TL-895 (Drug)
结局指标
主要结局
Recommended dose of TL-895
时间窗: After the day 14 of the 6th subject per dose level
To determine the recommended dose of TL-895 to be based on the observed dose limiting toxicity
次要结局
未报告次要终点
研究者
研究点 (2)
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