EUCTR2012-000690-23-Outside-EU/EEA进行中（未招募）不适用
A Phase I Study of Sunitinib (SU11248), an Oral Multi-Targeted Tyrosine Kinase Inhibitor, in Children with Refractory Solid Tumors - Sunitinib in Treating Young Patients With Refractory Solid Tumors
ational Institution of Health (NCI)0 个研究点目标入组 60 人开始时间: 2012年2月29日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
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
- •- Patients must be = 2 years of age and = 21 years of age at the time of study entry
- •- Histologically confirmed solid tumor (not required for patients with intrinsic brain stem tumors or optic pathway gliomas). Patients with Recurrent or refractory disease are eligible including primary CNS tumors or known CNS metastases.
- •- Measurable or evaluable disease
- •- No known curative therapy or therapy proven to prolong survival with an acceptable quality of life.
- •- Karnofsky performance status (PS) 50-100% (> 10 years of age) OR Lansky PS 50-100% (= 10 years of age). Neurological deficits in pts with CNS tumor must have been relatively stable for = 1 week before study enrollment.
- •- Prior Therapy: Recovered from prior therapy
- •At least 3 weeks since prior myelosuppressive therapy (6 weeks for nitrosoureas).
- •At least 1 week since prior and no concurrent hematopoietic growth factors
- •At least 1 week since prior antineoplastic biologic agents
- •At least 2 weeks since prior local, palliative, small-port radiotherapy (at least 6 months for radiation to = 50% of pelvis). At least 6 weeks since other prior substantial bone marrow radiotherapy
- •At least 3 months since prior stem cell transplantation or rescue (without total-body irradiation) and no evidence of graft-vs-host disease
- •- Organ function requirements:
- •Absolute neutrophil count = 1,000/mm³
- •Platelet count = 100,000/mm³ (transfusion independent)
- •Hemoglobin = 8.0 g/dL (transfusions allowed)
- •Creatinine clearance or radioisotope glomerular filtration rate = 70 mL/min OR creatinine based on age/gender as follows:
- •No greater than 0.8 mg/dL (2 to 5 years of age)
- •No greater than 1 mg/dL (6 to 9 years of age)
- •No greater than 1.2 mg/dL (10 to 12 years of age)
- •No greater than 1.5 mg/dL (male) OR 1.4 mg/dL (female) (13 to 15 years of age)
- •No greater than 1.7 mg/dL (male) OR 1.4 mg/dL (female) (= 16 years of age)
- •Bilirubin = 1.5 times upper limit of normal (ULN)
- •ALT = 2.5 times ULN
- •Albumin = 2 g/dL
- •LVEF or shortening fraction normal
- •Corrected QT interval = 450 msec
- •Amylase = 1.5 times ULN
- •Lipase = 1.5 times ULN
- •Blood pressure within ULN
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 50
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Prior Therapy:
- •No prior anthracycline (any dose)
- •No prior radiotherapy to a radiation field that included the heart (including total body or craniospinal irradiation)
- •No prior sunitinib malate
- •- Not Pregnant or nursing women. Fertile patients must use effective contraception
- •- Concomitant Medications:
- •No other concurrent investigational drugs
- •No other concurrent anticancer agents, including chemotherapy, radiotherapy, immunotherapy, or biologic therapy
- •At least 12 days since prior and no concurrent CYP3A4 inducers, including any of the following: Rifampin, Rifabutin, Carbamazepine, Phenobarbital, Phenytoin, Hypericum perforatum (St. John's wort); Efavirenz; Tipranavir.
- •No concurrent antithrombotic or antiplatelet agents, including any of the following: Warfarin, Heparin, Low molecular weight heparin, Acetylsalicylic acid (aspirin), Ibuprofen, Other nonsteroidal anti-inflammatory drugs
- •At least 7 days since prior and no concurrent CYP3A4 inhibitors, including any of the following: Azole antifungals (e.g., itraconazole or ketoconazole), Clarithromycin, Erythromycin, Diltiazem, Verapamil, HIV protease inhibitors (e.g., indinavir, saquinavir, ritonavir, atazanavir, or nelfinavir), Delavirdine.
- •- No uncontrolled infection
- •- No tumors involving the pleural surface
- •- No pts with body surface area < 0.5 m² (for parts A and B) and < 0.4 m² (for Part C)
- •- Able to swallow sunitinib malate capsules (parts A and B only)
- •- No pre-existing thyroid abnormality (hyper- or hypothyroidism) with unstable thyroid function
- •- No history of allergic reaction attributed to sunitinib malate or component of sunitinib malate capsules
- •- No patients with known bone marrow metastasis
- •- No patients with prior allergy to both applesauce and yoghurt (Part C only).
- •- In pts with primary CNS tumors or known CNS metastases:
- •No evidence of new CNS hemorrhage on baseline MRI obtained within 14 days before study enrollment (ECHO gradient MRI sequences per institutional guidelines required for evaluation of CNS hemorrhage)
- •The presence of small punctuate CNS hemorrhage on these scans will exclude a patient from participation
研究者
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