EUCTR2017-002985-28-BE进行中（未招募）1 期
Open-label, Phase I/II study to evaluate pharmacokinetics, pharmacodynamics, safety, and anticancer activity of avelumab in pediatric subjects from birth to less than 18 years of age with refractory or relapsed solid tumors and lymphoma - N/A
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Merck KGaA
- 入组人数
- 148
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
- •Male or female subjects 0 to < 18 years of age at the time of first treatment dose with histologically or cytologically confirmed solid malignant tumors or lymphoma; confirmed progression on or refractory to standard therapy or no standard therapy available; availability of archival formalinfixed, paraffin-embedded block containing tumor tissue, or slides, or a fresh/recent tumor biopsy prior to avelumab treatment; adequate bone marrow, kidney, and liver function.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 148
- •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
- •Prior therapy with any antibody or drug targeting T-cell coregulatory proteins; concurrent anticancer treatment or immunosuppressive agents; prior organ transplantation; significant acute or chronic infections; other significant diseases or conditions that might impair the subject’s tolerance of trial treatment.
研究者
相似试验
进行中（未招募）
1 期
Phase I/II study of avelumab in pediatric cancer subjectsSolid tumors (including central nervous system tumors) and lymphomaMedDRA version: 21.1Level: LLTClassification code 10065143Term: Malignant solid tumourSystem Organ Class: 100000004864MedDRA version: 21.0Level: LLTClassification code 10025632Term: Malignant lymphomaSystem Organ Class: 100000004864EUCTR2017-002985-28-DKMerck KGaA148
撤回
不适用
A phase I, open-label study to assess the pharmacokinetic profile, safety and tolerability of OBE001 after a single oral administration in pregnant women with medically indicated pregnancy terminatioNA (healthy volunteers)10010273NL-OMON40897ObsEva SA6
进行中（未招募）
不适用
TMC114-TiDP29-C228 – A safety study to evaluate the antiviral activity of darunavir (DRV) in combination with ritonavir (rtv) in HIV 1 infected children from 3 years to below 6 years of ageThe purpose of this Phase II trial is to evaluate the pharmacokinetics (blood levels), safety and antiviral activity to support dose recommendations by body weight of darunavir with low-dose ritonavir (DRV/rtv), in combination with other antiretroviral drugs (ARVs), in treatment-experienced HIV 1 infected children aged from 3 years to < 6 years and weighing between 10 kg and < 20 kg .MedDRA version: 16.1Level: LLTClassification code 10020192Term: HIV-1System Organ Class: 100000004862EUCTR2008-004630-25-Outside-EU/EEATibotec Pharmaceuticals24
进行中（未招募）
不适用
A safety study to evaluate the antiviral activity of darunavir in combination with ritonavir in HIV 1 infected adolescents between 12 and 18 years of age who have not received previous treatment with antiretroviral drugsHIV-1MedDRA version: 14.1Level: PTClassification code 10020161Term: HIV infectionSystem Organ Class: 10021881 - Infections and infestationsEUCTR2008-004631-37-Outside-EU/EEATibotec Pharmaceuticals12
进行中（未招募）
1 期
A Phase II, open-label trial, to evaluate pharmacokinetics, safety, tolerability and antiviral activity of DRV/rtv once daily in treatment-naïve HIV 1 infected adolescents aged between 12 and < 18 years.This trial will be referred to as DIONE.Estudio en Fase II, abierto, para evaluar la farmacocinética, seguridad, tolerabilidad y actividad antiviral de DRV/rtv una vez al día en adolescentes infectados por VIH-1 de entre 12 y < 18 años de edad no tratados. Nos referiremos a este estudio como DIONE. - DIONEHIV-1VIH-1MedDRA version: 9.1Level: LLTClassification code 10020161Term: HIV infectionEUCTR2008-004631-37-ESTibotec Pharmaceuticals12