2024-512135-80-00已完成2 期
An Open-Label, Multicenter Phase 2 Basket Study to Evaluate the Antitumor Activity and Safety of Lenvatinib in Children, Adolescents, and Young Adults with Relapsed or Refractory Solid Malignancies
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 10
- 主要终点
- 1. Objective Response Rate (ORR) At Week 16 per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) or Response Assessment in Neuro-Oncology (RANO) Criteria (for High Grade Glioma [HGG] only), by Investigator Assessment
研究概览
简要总结
To determine the Objective Response Rate (ORR) at Week 16, by each tumor type, per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) or Response Assessment in Neuro-Oncology (RANO) (for High Grade Glioma [HGG] only) as assessed by the investigator.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 years 至 64 years（18-64 Years, 0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Has histologically or cytologically documented relapsed, or refractory pediatric solid malignancy excluding osteosarcoma
- •Male participants must agree to use approved contraception during the treatment period and for at least 7 days after the last dose of study intervention and refrain from donating sperm during this period
- •Has measurable disease as defined by Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) or Response Assessment in Neuro-Oncology (RANO) for High Grade Glioma (HGG)
- •Has a performance status defined as follows: 1) Lansky Play Score ≥50 for participants up to and including 16 years of age 2) Karnofsky performance status (KPS) ≥50 for participants >16 years of age 3) Neurologic deficits in participants with primary central nervous system (CNS) tumors must have been stable for at least 7 days prior to study enrollment
- •Demonstrate adequate organ function
- •No clinical evidence of nephrotic syndrome.
- •Has adequate blood pressure (BP) control with or without antihypertensive medications
- •Has adequate cardiac function
- •Has adequate neurologic function
- •Participant must have fully recovered to Common Terminology Criteria for Adverse Events, Version 5.0 (CTCAE v5.0) Grade ≤1 (except for alopecia, ototoxicity, and Grade ≤2 peripheral neuropathy) from the acute toxic effects of all prior anticancer therapy
排除标准
- •Has had major surgery within 3 weeks prior to Cycle 1 Day 1 (C1D1)
- •Known to be Human immunodeficiency virus (HIV) positive
- •Known active viral hepatitis (B or C) as demonstrated by positive serology. Testing for hepatitis B or hepatitis C is required at screening only when mandated by local health authority
- •Is currently participating and receiving study therapy, or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the date of allocation
- •Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
- •Has known hypersensitivity to any component of the investigational product (lenvatinib or ingredients)
- •Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the stud
- •Has clinically significant cardiovascular disease within 6 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability
- •Has non-healing wound, tumor ulceration, unhealed or incompletely healed fracture, or a compound (open) bone fracture at the time of enrollment
- •Has gastrointestinal (GI) bleeding or active hemoptysis (bright red blood of at least half teaspoon) within 21 days prior to enrollment
- •Has CNS tumors with a history of symptomatic tumor hemorrhage
- •Has evidence of new intracranial hemorrhage of more than punctate size on MRI assessment obtained within 28 days prior to study enrollment
- •Has radiographic evidence of encasement or invasion of a major blood vessel or of intratumoral cavitation
- •Has evidence of untreated CNS metastases (exception: participants with primary CNS tumors and leptomeningeal disease.
- •Has GI malabsorption, GI anastomosis, or any other condition that in the opinion of the investigator might affect the absorption of lenvatinib
- •Has preexisting ≥Grade 3 GI or non-GI fistula
- •Has any active infection requiring systemic therapy
结局指标
主要结局
1. Objective Response Rate (ORR) At Week 16 per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) or Response Assessment in Neuro-Oncology (RANO) Criteria (for High Grade Glioma [HGG] only), by Investigator Assessment
1. Objective Response Rate (ORR) At Week 16 per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) or Response Assessment in Neuro-Oncology (RANO) Criteria (for High Grade Glioma [HGG] only), by Investigator Assessment
次要结局
- 1. ORR per RECIST 1.1 or RANO Criteria (for HGG only), by Investigator Assessment
- 2. Progression Free Survival (PFS) per RECIST 1.1 or RANO (for HGG only), by Investigator Assessment
- 3. Best Overall Response (BOR) per RECIST 1.1 or RANO (for HGG only), by Investigator Assessment
- 4. Duration of Response (DOR) per RECIST 1.1 or RANO (for HGG only), by Investigator Assessment
- 5. Disease Control Rate (DCR) per RECIST 1.1 or RANO (for HGG only), by Investigator Assessment
- 6. Clinical Benefit Rate (CBR) per RECIST 1.1 or RANO (for HGG only), by Investigator Assessment
- 7. Number of Participants who Experience an Adverse Event (AE)
- 8. Number of Participants who Discontinue Study Treatment Due to an AE
- 9. Palatability Questionnaire Score For Lenvatinib Suspension Formulation
- 10. Area Under the Concentration-Time Curve of lenvatinib From Time 0 to Infinity (AUC 0-inf)
研究者
Behzad Bidadi
Scientific
Merck Sharp & Dohme LLC
研究点 (10)
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