NCT04644315终止2 期
A Phase II, Open-Label, Single Arm Decentralized Home-Based Approach Study to Evaluate the Efficacy and Safety of Alectinib in Locally-Advanced or Metastatic ALK-Positive Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 7
- 主要终点
- Confirmed Objective Response Rate (ORR) as Determined by the Investigator Per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
研究概览
简要总结
This study will evaluate the efficacy and safety of alectinib in participants with Anaplastic Lymphoma Kinase (ALK)-positive locally advanced or metastatic solid tumors other than lung cancer.
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
- •Histologically confirmed ALK-positive locally-advanced or metastatic solid tumor excluding lung cancer
- •ALK-positive tumor as per Foundation Medicine, Inc (FMI) next-generation sequencing (NGS) (NGS F1CDx, F1LCDx, or F1HEME) or per local accredited laboratory using validated NGS testing of tumor tissue or peripheral blood
- •No alternative effective standard therapy available, or standard therapy considered unsuitable or intolerable to the participant
- •Other cancer therapies are allowed, including investigational drugs, if any treatment-related toxicities (excluding alopecia) have resolved to grade </= 1 or to laboratory values as defined by the protocol
- •Measurable disease at baseline as assessed by the Investigator per RECIST v1.1 or RANO criteria (for participants with primary CNS tumors)
- •Life expectancy of at least 12 weeks
- •Eastern cooperative oncology group (ECOG) performance status of 0-2
- •Adequate hemataologic, hepatic, and renal function
- •Participants with primary central nervous system (CNS) tumors are available
- •Participants with brain or leptomeningeal metastasis are allowed in the study if asymptomatic and if they meet additional criteria as defined by the protocol
- •Willingness to comply with study procedures
- •Willingness to comply with home-base approach and visits by Mobile Nurses
- •Ability to swallow alectinib capsules intact
- •Women of childbearing potential must test negative for pregnancy at screening and prior to the first dose of study drug
- •Women of childbearing potential must agree to remain abstinent or use contraceptive methods as defined by the protocol and refrain from donating eggs during the treatment period and for at least 90 days after the last dose of alectinib
- •Men must agree to remain abstinent or use contraceptive methods as defined by the protocol and refrain from donating sperm during the treatment period and for at least 90 days after the last dose of alectinib
排除标准
- •Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of alectinib
- •Lung Cancer
- •Patients with one of the following ALK point mutations: I1171X, G1202R, V1180L
- •Prior therapy with an ALK inhibitor
- •Liver disease as described in the protocol
- •Known HIV, hepatitis B, or hepatitis C (HCV) infection
- •Patients with symptomatic bradycardia
- •Patients with symptomatic or unstable brain metastasis; patients with primary CNS tumors are allowed
- •Malabsorption syndrome or any other condition that would interfere with enteral absorption
- •Incomplete recovery from any surgery prior to treatment
- •Any other malignancies within 5 years prior to enrollment, except for those described in the protocol
- •Any serious medical condition or abnormality in clinical laboratory tests that, in the Investigator's judgment, precludes the patient's safe participation in and completion of the study
- •History of hypersensitivity to any of the ingredients in the alectinib drug formulation
研究组 & 干预措施
ALK-positive Solid Tumors
Experimental
Participants with locally advanced or metastatic ALK-positive tumors will receive alectinib twice daily (BID) until disease progression, unacceptable toxicity, death, or withdrawal from the study for any reason.
干预措施: Alectinib (Drug)
结局指标
主要结局
Confirmed Objective Response Rate (ORR) as Determined by the Investigator Per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
时间窗: Approximately 1 year
次要结局
- Plasma Concentration of Alectinib(Baseline up to 5 years)
- Confirmed ORR as Determined by Blinded Independent Center Review (BICR) Per RECIST v1.1(0 days)
- Central Nervous System (CNS) ORR by BICR Per RECIST v1.1(Baseline up to 5 years)
- CNS DOR by BICR Per RECIST v1.1(From the first observation of CNS response to the first observation of CNS progression or death from any cause (up to 5 years))
- Overall Survival (OS)(From the first dose of study drug to death from any cause (up to 5 years))
- Percentage of Participants With Adverse Events (AEs)(Approximately 1 year)
- Duration of Response (DOR) as Determined by Both the Investigator and by BICR Per RECIST v1.1(From first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to 5 years))
- Progression-Free Survival (PFS) as Determined by Both the Investigator and by BICR Per RECIST v1.1(From first dose of alectinib to disease progression or death from any cause, whichever occurs first (up to 5 years))
- Percentage of Participants With Serious Adverse Events (SAEs)(Approximately 1 year)
- ORR in Participants With Primary CNS Tumors as Determined by Both BICR and the Investigator Per Response Assessment in Neuro-Oncology (RANO) Criteria(Up to 5 years)
- DOR in Participants With Primary CNS Tumors as Determined by Both BICR and the Investigator Per RANO Criteria(From first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to 5 years))
- PFS in Participants With Primary CNS Tumors as Determined by Both BICR and the Investigator Per RANO Criteria(From first dose of alectinib to disease progression or death from any cause, whichever occurs first (up to 5 years))
- OS in Participants With Primary CNS Tumors(From the first dose of study drug to death from any cause (up to 5 years))
研究者
研究点 (7)
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