A Study Of AL101 In Patients With Adenoid Cystic Carcinoma (ACC) Bearing Activating Notch Mutations

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追踪信息

首次提交日期 ^ICMJE

September 22, 2018

首次发布日期e ^ICMJE

October 1, 2018

最后更新发布日期

October 1, 2018

预计研究开始日期 ^ICMJE

October 2018

预计主要完成日期

April 2021 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

Objective response rate (ORR; complete response [CR] and partial response [PR]) by RECIST v1.1[ Time Frame: Up to 36 month ]

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

Frequency, duration and severity of adverse events (AEs) and serious adverse events (SAEs);[ Time Frame: Up to 36 month ]

描述性信息

简略标题 ^ICMJE

A Study Of AL101 In Patients With Adenoid Cystic Carcinoma (ACC) Bearing Activating Notch Mutations

正式标题 ^ICMJE

A Phase 2, Open-Label, Single-Arm, Multi-Center Study Of AL101 (BMS-906024) In Patients With Adenoid Cystic Carcinoma (ACC) Bearing Activating Notch Mutations

简要概况

This is a Phase 2, Simon 2-Stage optimal design, non comparative, open label, single-arm, multicenter study of AL101 in patients with recurrent or metastatic ACC who harbor NOTCH 1,2,3,4 activating mutations.

详细说明

研究类型 ^ICMJE

Interventional

研究阶段

Phase 2

研究设计 ^ICMJE

分配:
干预模型: Single Group Assignment
干预模型描述: Open label
盲法: Interventional
盲法描述:
主要目的: Treatment

适用条件 ^ICMJE

干预项目 ^ICMJE

Drug: AL101
AL101 is a small-molecule that inhibits gamma secretase, an enzyme which plays a key role in the activation of the Notch signaling pathway by releasing the Notch intracellular domain (NICD) of all four Notch receptors from the membrane. In patients with aberrant Notch signaling, AL101 may inhibit Notch signaling and potentially impede tumor growth.The drug is administered intravenous.

研究工具

Experimental: SINGLE-ARM
AL101 is an inhibitor of gamma secretase-mediated Notch signaling.

招募信息

招募状态 ^ICMJE

Not yet recruiting

预计入组 ^ICMJE

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

July 2021

预计主要完成日期

April 2021 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Inclusion Criteria: 1. Confirmed Adenoid Cystic Carcinoma with known NOTCH 1/2/3/4 activating mutation that is recurrent or metastatic, not amenable to potentially curative surgery or radiotherapy. 2. Evidence of radiographic or clinical disease progression within 6-months of signing informed consent; newly diagnosed metastatic patients will be allowed. 3. Patients must have Formalin-fixed, Paraffin-embedded tissue available . 4. Must have at least 1 target lesion that is measurable for patients with nodal or visceral metastasis. Exclusion Criteria: 1. Diagnosed with a malignancy in the past 2 years. 2. Infection 3. Gastrointestinal (GI) disease with increased risk of diarrhea [e.g. inflammatory bowel disease (IBD)] 4. Symptomatic central nervous system (CNS) metastases. 5. Unstable or severe uncontrolled medical condition 6. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1. 7. Abnormal organ and marrow function

性别

参与研究的性别:

All

年龄

最小年龄：18 Years ，最大年龄：N/A

接受健康的志愿者

没有

可入组国家 ^ICMJE

管理信息

数据检测委员会

Yes

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: Yes
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

责任方

，

研究赞助商 ^ICMJE

Ayala Pharmaceuticals, Inc,

合作者 ^ICMJE

研究员 ^ICMJE

PRS 账户

验证日期

September 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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