NCT03420508进行中（未招募）2 期
A Phase 2 Study of the ALK Inhibitor Ensartinib for Patients With Melanomas Harboring ALK Alterations or Aberrant ALK Expression
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 18
- 试验地点
- 4
- 主要终点
- clinical benefit rate (CBR)
研究概览
简要总结
The purpose of this study is to test the effects of the study drug, ensartinib, on the patient and the cancer. Ensartinib is a new, investigational type of treatment for melanoma with a particular type of abnormality.
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
- •For Screening Phase:
- •Patients ≥18 years of age
- •Histologically confirmed advanced malignant melanoma, regardless of subtype
- •For Treatment Phase, as above and in addition:
- •Progression following PD-1 based checkpoint inhibitor therapy, with or without ipilimumab. Tumors harboring BRAF V600 alterations must also have received prior therapy with BRAF inhibitors (with or without a MEK inhibitor). Patients with uveal melanoma are exempt from PD-1 based progression since there is no accepted standard frontline therapy.
- •Tumors must harbor an alteration in ALK using a CLIA-certified laboratory, including, but not limited to, ALKATI, ALK fusions, or ALK mutations.
- •Disease must be measurable according to RECIST 1.
- •Disease that has undergone local therapy in the past 30 days is not considered measurable unless the investigator has documented progression despite the local therapy.
- •° If a patient has consented to the pre-screening portion, has been determined to have ALK alterations, but has no measurable disease, the trial may be favored later, and the patient should be consented (or re-consented) to the treatment portion of the trial at the discretion of the investigator.
- •Asymptomatic untreated brain metastases are allowed. Symptomatic metastases that have undergone local therapy with RT or surgery and have not required an increase in steroid dose in prior 2 weeks are allowed. Disease that has undergone local therapy is not considered measurable.
- •Patients must have an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-2
- •Acceptable liver, renal, and hematological function:
- •total bilirubin ≤1.5x upper limit of normal (ULN); patients with Gilbert's Syndrome must have bilirubin ≤3x ULN
- •Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤3 x ULN (≤5x if liver metastases are present)
- •Estimated glomerular filtration rate (GFR) ≥ 30 mL/min using a cancer-specific GFR Model; the calculator found at: http://tavarelab.cruk.cam.ac.uk/JanowitzWilliamsGFR/
- •Hemoglobin ≥9 g/dL
- •Neutrophils ≥1.5 x 10^9/L
- •Platelets ≥100 x 10^9/L
- •Prothrombin time, international normalized ratio [INR], and/or activated partial thromboplastin time within ≤1.5 x ULN
- •Prothrombin time, international normalized ratio [INR], and/or activated partial thromboplastin time within ≤1.5 x ULN
排除标准
- •For Screening Phase:
- •Any prior ALK inhibition.
- •For Treatment Phase, as above and in addition:
- •Prior therapy with immune-activating agents within less than 1 cycle length prior to first day of study treatment (e.g. 3 weeks for ipilimumab or pembrolizumab; 2 weeks for nivolumab).
- •Prior therapy with BRAF/MEK agents within 3 weeks prior to first day of study treatment.
- •Any other systemic or regional anticancer therapy (cytotoxic chemotherapy, embolization) within 3 weeks or 1 cycle length, whichever is shorter, prior to first day of study treatment
- •Prior RT or clinically relevant major surgery (e.g. craniotomy, metastasectomy) within 2 weeks prior to first day of study treatment.
- •Any other active malignancy other than melanoma that, in the opinion of the investigator, would interfere with study participation.
- •Receipt of any other systemic anticancer therapy except for hormonal therapy for a hormonally sensitive (e.g. breast or prostate) cancer.
- •Receipt of strong CYP3A inhibitors or inducers per Appendix A.
- •Clinically significant cardiovascular disease, including:
- •QTc interval by Bazett's formula >480 ms
- •Symptomatic bradycardia <45 beats per minute
- •Other clinically significant ECG abnormalities (e.g. bundle branch block) may be eligible after discussion with the Principal Investigator
- •Clinically uncontrolled hypertension in the investigator's opinion.
- •The following within 6 months prior to Cycle 1 Day 1:
- •Congestive heart failure (New York Heart Class III or IV).
- •Cardiomyopathy.
- •o Arrhythmia or conduction abnormality requiring medication. Note: patients with atrial fibrillation/flutter adequately controlled by medication in the opinion of the treating physician and arrhythmias controlled by pacemakers are eligible.
- •Severe/unstable angina, coronary artery/peripheral bypass graft, or myocardial infarction.
- •Cerebrovascular accident or transient ischemia.
- •Any serious, active infection at the time of treatment such as bacteremia
- •Interstitial lung disease or pneumonitis that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity. Patients with prior pneumonitis that has resolved are eligible.
- •Patients must not be pregnant or breast feeding, or unable or unwilling to use proper contraception during the study and up to 3 months following study completion.
研究组 & 干预措施
ensartinib
Experimental
The screening portion of the trial will test archival tumor material for the presence of ALKATI using a Nanostring-based RNA assay for any patients deemed to be current or future candidates for this trial. This will require approximately 5 formalin-fixed paraffin- embedded (FFPE) slides of 5-8 micron thickness. For the treatment portion of the study, all patients will receive ensartinib orally at a dose of 225mg daily.
干预措施: ALKATI by Customized Nanostring Assay (Diagnostic Test)
ensartinib
Experimental
The screening portion of the trial will test archival tumor material for the presence of ALKATI using a Nanostring-based RNA assay for any patients deemed to be current or future candidates for this trial. This will require approximately 5 formalin-fixed paraffin- embedded (FFPE) slides of 5-8 micron thickness. For the treatment portion of the study, all patients will receive ensartinib orally at a dose of 225mg daily.
干预措施: Ensartinib (Drug)
结局指标
主要结局
clinical benefit rate (CBR)
时间窗: up to 24 weeks
CBR is defined as any confirmed objective response by Response Evaluation in Solid Tumor (RECIST) 1.1, or stable disease until the 24 week assessment.
次要结局
未报告次要终点
研究者
研究点 (4)
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