EUCTR2020-004239-25-DK进行中（未招募）1 期
A PHASE I/II, OPEN-LABEL, MULTICENTER STUDY EVALUATING THE SAFETY, PHARMACOKINETICS, AND EFFICACY OF ALECTINIB IN PEDIATRIC PATIENTS WITH ALK FUSION POSITIVE SOLID OR CNS TUMORS FOR WHOM PRIOR TREATMENT HAS PROVEN TO BEINEFFECTIVE OR FOR WHOM THERE IS NO SATISFACTORY TREATMENT AVAILABLE
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 42
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
- •Age at study entry <18 years old
- •Histologically confirmed diagnosis of CNS or solid tumors with documented evidence of ALK gene fusions as assessed centrally through the use of the investigational F1CDx assay or based on pre-existing NGS test results
- •Participants with prior treatment proven to be ineffective (relapsed or refractory), or for whom there is no satisfactory treatment available
- •Participants with tumor tissue availability for submission to the Sponsor from active disease, obtained subsequent to last anti-cancer therapy regimen administered and obtained prior to study enrollment (preferred option), or willing to undergo a core or excisional biopsy sample collection prior to enrollment
- •Life expectancy >=8 weeks, in the investigator's judgment
- •Adequate performance status (For participants < 16 years old: Lansky Performance Status should be >= 50% and for participants >= 16 years old: Karnofsky Performance Status should be >= 50%)
- •Participants with adequate end-organ function
- •Females of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating eggs during the treatment period and for at least 3 months after the final dose of study drug
- •Females of childbearing potential must have a negative serum pregnancy test during screening and be neither breastfeeding nor intending to become pregnant during study participation
- •Males who are not surgically sterile must agree to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating sperm, during the treatment period and for at least 3 months after the final dose of study drug
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 42
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Medical history of prior use of ALK inhibitors, any gastrointestinal (GI) disorder that may affect absorption of oral medications, organ transplant, recent stem cell infusions (with or without traumatic brain injury)
- •Diagnosis of Anaplastic Large Cell Lymphoma (ALCL)
- •History of hypersensitivity to any of the additives in the alectinib drug formulation to be used in the study
- •Substance abuse within 12 months prior to screening, in the investigator's judgment
- •Familial or personal history of congenital bone disorders, bone metabolism alterations or osteopenia
- •Treatment with investigational therapy 28 days prior to initiation of study drug
- •Liver disease
- •Abnormal levels of creatinine or glomerular filtration rate (GFR)
- •National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0) Grade >=3 toxicities attributed to any prior therapy such as radiotherapy (excluding alopecia), which have not shown improvement and are strictly considered to interfere with alectinib
- •Co-administration of anti-cancer therapies other than those administered in this study
- •Active hepatitis B or C virus (HBV, HBC) or known human immunodeficiency virus (HIV) positivity or Acquired immunodeficiency syndrome (AIDS)-related illness
- •Any clinically significant concomitant disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study or the absorption of oral medications or that would, in the opinion of the Principal Investigator, pose an unacceptable risk to the participants in this study
- •Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol requirements and/or follow-up procedures
- •Planned procedure or surgery during the study except as permitted treatment
- •Infection considered by the investigator to be clinically uncontrolled or of unacceptable risk to the participant upon induction of neutropenia such as fungal infection or bacterial infection or neutropenic fever or participants who have received <5 days of appropriate therapeutic antibiotic therapy for an identified infection
- •Pregnant or breastfeeding women, or intending to become pregnant during the study or within 3 months after the final dose of alectinib
研究者
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