NL-OMON49242已完成2 期
A Phase 2, Open-Label, multi-center Study of AL101 in patients with adenoid cystic carcinoma (ACC) bearing activating Notch mutations - ACCURACY
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •In order to be eligible for participation in this study, the patient must meet
- •all of the following:
- •1. Age >18 years old.
- •2. Histologically confirmed ACC with known NOTCH 1/2/3/4 activating mutation
- •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). Archived5 (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. (see Table 9 in
- •Appendix C).
- •6. Resolution of clinically significant toxicities related to prior therapy to
- •National Cancer
- •Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE v5.0)
- •<= Grade 1, except for sensory neuropathy with resolution to <= Grade 2 and
排除标准
- •The patient must be excluded from participating in the study if meet any of the
- •Medical Conditions
- •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
- •enrollment 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
- •judgment, 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
- •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
- •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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