EUCTR2013-003595-12-FR进行中（未招募）1 期
A Phase II Study of Pazopanib (GW786034, NSC# 737754) inChildren, Adolescents and Young Adults with Refractory SolidTumors
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
- 154
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: Patients must be at least 1 year and less than or equal to 18 years of age at the time of study entry.
- •Diagnosis: Patients must have had histologic verification of one of the malignancies listed below at original diagnosis or at relapse.
- •1.Rhabdomyosarcoma
- •2.Non-rhabdomyosarcomatous Soft Tissue Sarcoma (including desmoplastic small round cell tumor)
- •3.Ewing Sarcoma/Peripheral PNET
- •4.Osteosarcoma
- •5.Neuroblastoma (Measurable)
- •6.Neuroblastoma (Evaluable)
- •7.Hepatoblastoma
- •Patient must have disease that has either relapsed or is refractory to prior therapy
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 154
- •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
- •Pregnant or breast-feeding women are not eligible for this study
- •Concomitant Medications
- •1.Corticosteroids: Patients requiring corticosteroid who have not been on a stable or decreasing dose of corticosteroid for the 7 days prior to enrollment are not eligible.
- •2.Investigational Drugs: Patients who are currently receiving another investigational drug are not eligible.
- •3.Anti-Cancer Agents or Radiation Therapy: Patients who are currently receiving other anti-cancer agents or radiation therapy are not eligible.
- •4.Anti-hypertensive: Patients who are currently receiving more than one anti-hypertensive medication (Grade 3) or whose blood pressure is not controlled (i.e. as defined in Section 3.2.8.) are not eligible for study enrollment.
- •5.Anti-coagulation: Patients must not be on therapeutic anticoagulation. ((Warfarin (coumadin®) and/or low molecular weight heparin are prohibited.) Prophylactic anticoagulation (ie intraluminal heparin) of venous or arterial access devices is allowed.
- •6.CYP3A4 Substrates and drugs causing QTc prolongation: Patients receiving drugs with a known risk of torsades de pointes are not eligible. See Appendices IIIA and IIIB and Section 4.8 for a list of enzyme inducing, enzyme inhibiting and other adversely interacting drugs and the appropriate washout periods required prior to study enrollment
- •Note: This list includes the prohibition of grapefruit juice for 14 days prior to enrollment and while receiving pazopanib.
- •7.Thyroid Replacement Therapy: Patients who require thyroid replacement therapy are not eligible if they have not been receiving a stable replacement dose for at least 4 weeks prior to study enrollment
- •Patients who are unable to swallow tablets or liquid are not eligible. Pazopanib cannot be administered via NG tube or G-tube
研究者
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