EUCTR2019-000309-64-NL进行中（未招募）1 期
A Phase 2, Open-Label, Multi-Center Study of AL101 in Patients With Adenoid Cystic Carcinoma (ACC) Bearing Activating Notch Mutations - ACCURACY Study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 87
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Age = 18 years old.
- •2. Histologically confirmed ACC with known NOTCH 1/2/3/4 activating mutation that is recurrent or metastatic, not amenable to potentially curative surgery or radiotherapy.
- •3. Evidence of radiographic or clinical disease progression within 6-months of signing informed consent; newly diagnosed metastatic patients will be allowed.
- •4. Patients must have FFPE tissue available (please refer to laboratory manual for number of slides required). Archived (within 3 years) or fresh core or punch needle biopsied are acceptable.
- •5. Must have at least 1 target lesion that is measurable per RECIST v1.1 for patients with nodal or visceral metastasis. Patients with bone exclusive disease will also be eligible after consultation and approval with Sponsor's Medical Monitor and only if bone lesions are evaluable by CT or MRI as per modified MDA Criteria.
- •6. Resolution of clinically significant toxicities related to prior therapy to CTCAE v5.0 = Grade 1, except for sensory neuropathy with resolution to = Grade 2 and alopecia.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 72
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •1. Diagnosed with a malignancy in the past 2 years.
- •2. Current or recent gastrointestinal disease. Nonchronic conditions that are completely resolved for at least 2 weeks prior to starting investigational product are not exclusionary
- •3. Evidence of uncontrolled, active infection, requiring systemic anti-bacterial, anti-viral or anti-fungal therapy =7 days prior to administration of investigational product at Screening.
- •4. Symptomatic central nervous system (CNS) metastases. Patients with asymptomatic CNS metastases as well as those with previously treated CNS metastases are eligible for enrolment in the study if at least four weeks has elapsed since last whole brain radiation treatment or at least two weeks has elapsed since last focal radiation treatment, steroid therapy is not required, and the patient is deemed clinically stable by the Investigator.
- •5. Unstable or severe uncontrolled medical condition or any important medical illness or abnormal laboratory finding that would, in the investigator’s judgement, increase the risk to the patient associated with his or her participation in the study.
- •6. Female patients who are pregnant or breastfeeding.
- •7. Completed palliative radiation therapy < 7 days prior to initiating study drug.
- •8. Prior treatment with gamma secretase inhibitors. .
- •9. Last chemotherapy, biologic, or investigational therapy agent <4 weeks or 5 half-lives (whichever is shorter) prior to initiating investigational product; 6 weeks if the last regimen included BCNU or mitomycin C.
- •10. Eastern Cooperative Oncology Group (ECOG) performance status =2.
- •11. Abnormal organ and marrow function defined as:
- •a. neutrophils <1500/mm3,
- •b. platelet count <100,000/mm3,
- •c. hemoglobin <9 g/dL,
- •d. total bilirubin >1.5 x upper limit of normal (ULN) (except known
- •Gilbert's syndrome),
- •e. aspartate aminotransferase (AST) and alanine aminotransferase (ALT) >2.5 x ULN OR >5 x ULN for patients with liver metastases,
- •f. serum creatinine > ULN and creatinine clearance <50 mL/min (Calculation of CrCl will be based on acceptable institution standard),
- •g. uncontrolled triglyceride =Grade 2 elevations per CTCAE v5.0 (>300 mg/dL or >3.42 mmol/L)
- •12. Myocardial infarction within 6 months prior to enrollment or has NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled
- •ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
- •13. Mean QT interval corrected for heart rate using Fridericia’s formula (QTcF) =480 msec.
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