NCT04871282
进行中（未招募）
2 期
RINGSIDE: A Phase 2/3, Randomized, Multicenter Study to Evaluate AL102 in Patients With Progressing Desmoid Tumors
概览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 198
- 试验地点
- 53
- 主要终点
- Progression free survival
概览
简要总结
The current study is designed to evaluate the efficacy and safety of AL102 in patients with progressive desmoid tumors.
详细描述
This is a Phase 2/3, randomized study in subjects with progressive desmoid tumors consisting of 2 parts. Phase2/Part A is an open-label, dose regimen finding study; Phase3/Part B is a double blind, placebo-controlled study and Open Label Extension utilizing the dose regimen selected in Phase2/Part A.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years of age (inclusive) at the time of signing the informed consent form (ICF).
- •Histologically confirmed desmoid tumor (aggressive fibromatosis) by local pathologist (prior to informed consent).
- •Disease progression, assessed locally by the investigator, defined as having at least one of the following:
- •Unidimensional growth of desmoid tumor(s) by ≥10%, using the sum of the largest diameters of target lesion(s), within 18 months of the screening MRI
- •Having desmoid tumor-related pain that is not adequately controlled with nonopioid medication
- •At least 1 measurable lesion amenable to volume measurements by MRI at screening (Part A only)
- •One of the following:
- •Treatment naïve subjects for whom, in the opinion of the investigator, the IP is deemed appropriate, OR
- •Recurrent/refractory disease following at least one line of therapy (including surgery, radiation, or systemic therapy)
- •Agrees to provide formalin-fixed paraffin embedded archival or fresh tumor tissue for re- confirmation of disease.
排除标准
- •Diagnosed with a malignancy in the past 2 years with some exceptions.
- •Current or recent (within 2 months of IP administration) GI disease or disorders that increase the risk of diarrhea, such as inflammatory bowel disease and Crohn's disease.
- •Evidence of uncontrolled, active infection, requiring systemic anti-bacterial, anti-viral or anti- fungal therapy ≤7 days prior to administration of IP such as known active infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) at Screening.
- •Myocardial infarction within 6 months prior to enrollment, greater than Class 1 angina pectoris, or has New York Heart Association (NYHA) Class III or IV heart failure, , symptomatic ventricular arrhythmias, sustained ventricular tachycardia, Torsade's de Pointes (TdP), the long QT syndrome, pacemaker dependence, or electrocardiographic evidence of acute ischemia.
- •Unstable or severe uncontrolled medical condition (e.g., unstable cardiac or pulmonary function or uncontrolled diabetes) or any important medical illness or abnormal laboratory finding that would, in the investigator's judgment, increase the risk to the subject associated with his or her participation in the study.
- •Pregnant or breastfeeding or expecting to conceive children within the projected duration of the study.
- •Eastern Cooperative Oncology Group (ECOG) performance status ≥2
- •Abnormal organ and marrow function at Screening defined as:
- •Neutrophils \<1000/mm3,
- •Platelet count \<100,000/mm3,
研究组 & 干预措施
Part A Main Study 1.2 mg daily
Experimental
AL102 1.2 mg
干预措施: AL102 (Drug)
Part A Main Study 2 mg Intermittent
Experimental
AL102 2 mg
干预措施: AL102 (Drug)
Part A Main Study 4 mg Intermittent
Experimental
AL102 4 mg
干预措施: AL102 (Drug)
Part B AL102
Experimental
AL102, recommended dose regimen from Part A, 1.2 mg daily
干预措施: AL102 (Drug)
Part B Placebo
Placebo Comparator
Placebo to match recommended dose regimen from Part A
干预措施: Placebo (Other)
Open Label Extension
Experimental
AL102, recommended dose regimen from Part A, 1.2 mg daily
干预措施: AL102 (Drug)
结局指标
主要结局
Progression free survival
时间窗: Approximately 2 years
Progression free survival (PFS) as defined as the time from randomization until the date of assessment of progression (as assessed by BICR based on RECIST v1.1) or death by any cause
次要结局
- Overall response rate(Approximately 2 years)
- Change in Tumor Volume(Approximately 2 years)
- Duration of response(Approximately 2 years)
- Progression Free Survival(Approximately 2 years)
- Patient reported outcome(Approximately 2 years)
- Safety and Tolerability(Approximately 2 years)
研究者
研究点 (53)
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