EUCTR2019-004441-33-BE进行中（未招募）1 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 - Lenvatinib for Pediatric Patients with Relapsed/Refractory Solid Tumors
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc0 个研究点目标入组 150 人开始时间: 2020年9月7日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
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
- •1. Has histologically or cytologically documented relapsed, or refractory pediatric solid malignancy excluding osteosarcoma. Participants with diffuse intrinsic pontine glioma, optic pathway glioma, or pineal tumors with elevated tumor markers do not require histological or cytological confirmation of diagnosis. Participants with diffuse intrinsic pontine glioma are not eligible for the HGG cohort and should only be enrolled in the other solid tumors cohort.
- •2. Has measurable disease as defined by RECIST 1.1 or RANO for HGG, meeting the criteria below:
- •- All tumor types except HGG and neuroblastoma: At least 1 lesion measuring =1.0 cm in the longest diameter for a non-lymph node or =1.5 cm in the short-axis diameter for a lymph node that is reproducibly measurable on CT or MRI scans.
- •- HGG: At least 1 contrast-enhancing lesion with clearly defined margins on T1-weighted MRI scan, measuring =1.0 cm in 2 perpendicular diameters, and visible on at least 2 axial slices.
- •- Participants with neuroblastoma who do not have measurable disease per RECIST 1.1 but have MIBG-positive evaluable disease may be enrolled.
- •- Tumor lesions situated in a previously irradiated area or in an area subjected to other locoregional therapy are considered measurable only if progression has been observed in such lesions since the completion of therapy.
- •3. Has a performance status as defined below:
- •- Lansky Play Score =50 for participants = 16 years of age.
- •- KPS =50 for participants >16 years of age.
- •- Neurologic deficits in participants with primary CNS tumors must have been stable for at least 7 days prior to study enrollment. Participants who are unable to walk because of paralysis, but who can perform ADL while wheelchair bound, will be considered ambulatory for the purpose of assessing the performance score.
- •4. Demonstrate adequate organ function as defined in the protocol.
- •5. Has urine dipstick <2+ for proteinuria. Participants who have =2+ proteinuria on dipstick urinalysis should undergo a spot P/C ratio that should be Grade <2 per CTCAE v5.0, and if possible, perform a 24-hour urine collection.
- •6. Has no clinical evidence of nephrotic syndrome.
- •7. Has adequate BP control with or without antihypertensive medications, as described in the protocol.
- •8. Has adequate cardiac function, as described in the protocol.
- •9. Has adequate neurologic function:
- •- Participants with seizure disorder may be enrolled if on anticonvulsants and seizure disorder is well controlled.
- •10. Has fully recovered to CTCAE v5.0 Grade =1 (except for alopecia, ototoxicity, and Grade =2 peripheral neuropathy) from the acute toxic effects of all prior anticancer therapy and must meet the minimum duration from prior anticancer-directed therapy prior to enrollment, as described in the protocol. If after the required timeframe, the numerical eligibility criteria are met, eg, blood count criteria, the participant is considered to have recovered adequately.
- •11. Male or female =2 years to = 21 years of age, on the day the main informed consent/assent is signed.
- •12. Male participants are eligible to participate if they agree to the following during the intervention period and for at least 7 days after the last dose of study intervention:
- •- Be abstinent from heterosexual intercourse as their preferred and usual lifestyle and agree to remain abstinent
- •- Must agree to use contraception unless confirmed to be azoospermic as detailed below:
- •Agree to use a male condom plus partner use of an addition
排除标准
- •1. Has had major surgery within 3 weeks prior to C1D1.
- •2. Has GI bleeding or active hemoptysis (bright red blood of at least half teaspoon) within 21 days prior to enrollment.
- •3. Has CNS tumors with a history of symptomatic tumor hemorrhage.
- •4. Has evidence of new intracranial hemorrhage of more than punctate size on MRI assessment obtained within 28 days prior to study enrollment.
- •5. Has radiographic evidence of encasement or invasion of a major blood vessel or of intratumoral cavitation.
- •6. Has evidence of untreated CNS metastases (exception: participants with primary CNS tumors and leptomeningeal disease).
- •7. Has GI malabsorption, GI anastomosis, or any other condition that in the opinion of the investigator might affect the absorption of lenvatinib.
- •8. Has preexisting =Grade 3 GI or non-GI fistula.
- •9. Has any active infection requiring systemic therapy.
- •10. Is known to be HIV positive.
- •11. Has known active viral hepatitis B virus (eg, HBsAg reactive) or Hepatitis C virus (eg, HCV RNA [qualitative] is detected) infection.
- •12. 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.
- •13. 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.
- •14. 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.
- •15. Has known hypersensitivity to any component of the investigational product (lenvatinib or ingredients).
- •16. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
研究者
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