EUCTR2019-004016-58-PL进行中（未招募）1 期
A Phase 1, Multicenter, Open-label, Dose EscalationStudy of the Safety and Pharmacokinetics ofIntravenously Infused Berubicin® in Pediatric Patientswith Progressive, Refractory, or Recurrent High GradeGliomas
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 35
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.Written informed consent of the patient’s LAR, and assent when
- •appropriate based on the patient’s age and institutional guidelines, prior
- •to any study-related procedure.
- •2. Patients must have progressive, refractory, or recurrent HGG (WHO
- •Grade III or IV).
- •3. Age =2 to <18 years at the tiem of the first Berubicin dose.
- •4. Performance status score =50 (Lansky for research patients aged
- •=16 years and Karnofsky for patients ?16 years). Patients who are
- •unable to walk because of paralysis but who are up in a wheelchair will
- •be considered ambulatory for the purpose of assessing the performance
- •5. Patients must have completed at least 1 line of prior therapy.
- •6. Before the projected start of scheduled study treatment, the following
- •time periods must have elapsed:
- •a. 5 half-lives from any investigational agent.
- •b. 4 weeks from cytotoxic therapy (except 23 days from
- •temozolomide and 6 weeks from nitrosoureas).
- •c. 6 weeks from antibody therapies.
- •d. 4 weeks (or 5 half-lives, whichever is shorter) from other antitumor
- •e. Patients who have received radiation therapy must be =6 weeks
- •post the completion of local palliative radiation therapy (reirradiation
- •for progressive disease or upfront radiation therapy at
- •initial diagnosis).
- •7. Adequate organ function defined as:
- •a. Bone marrow:i. Peripheral absolute neutrophil count =1000/mm3
- •ii. Hemoglobin =8 g/dL (may have received packed red blood cell
- •transfusion)
- •iii. Platelet count =100,000/mm3 (transfusion-independent, defined
- •as not receiving platelet transfusions for at least 7 days prior to
- •enrollment)
- •b. Renal function:
- •i. Creatinine clearance or radioisotope glomerular filtration rate
- •=70 mL/min/1.73 m2 or normal serum creatinine based on age
- •as shown below:
- •? Age <5 years: 0.8 mg/dL maximum
- •? Age =5 to <10 years: 1.0 mg/dL maximum
- •? Age =10 to <15 years: 1.2 mg/dL maximum
- •? Age =15 years: 1.5 mg/dL maximum
- •c. Hepatic function:
- •i. Total bilirubin (sum of conjugated + unconjugated) =1.5 × the
- •upper limit of normal (ULN) for the institution
- •ii. Alanine aminotransferase =3 × ULN for the institution
- •iii. Serum albumin =2 g/dLd. Neurologic function:
- •i. Patients with seizure disorder may be enrolled if the seizure
- •disorder is well controlled, as determined by the investigator.
- •e. Cardiac function (left ventricular ejection fraction [LVEF]):
- •i. Fractional shortening =27% or LVEF =50% by echocardiogram
- •or multigated radionuclide study (MUGA)
- •8. All adverse events (AEs) Grade >1 related to prior therapies
- •(chemotherapy, radiation therapy, and/or surgery) must be resolved to
- •Grade 1 or baseline level, except for alopecia and sensory neuropathy
- 另有 13 项未显示
排除标准
- •1. Evidence of diffuse leptomeningeal disease or evidence of
- •cerebrospinal fluid (CSF) dissemination.
- •2. Known additional malignancy that is progressing or has required active
- •treatment within 3 years of start of study drug.
- •3. History of allergic reactions attributed to compounds of similar
- •chemical or biologic composition to Berubicin or its excipients.
- •4. Patients with any clinically significant, unrelated systemic illness (eg,
- •significant pulmonary, hepatic [including Gilbert’s syndrome], or other
- •organ dysfunction) or psychiatric illness/social situations that would
- •compromise the patient’s ability to tolerate the study drug or study
- •procedures or would likely interfere with the study procedures or
- •5. Any known clinically significant active bacterial, fungal, or viral
- •infection including hepatitis B or hepatitis C, or any underlying disease
- •in the recent past that could compromise enrollment and the safety of
- •the patient.
- •6. Patient with a history of clinically significant, uncontrolled heart
- •disease and/or repolarization abnormalities as documented by a
- •standard 12-lead electrocardiogram (ECG).
- •7. Known history of cardiac arrhythmias including atrial fibrillation,
- •tachyarrhythmias, or bradycardia, unless arrhythmia is controlled and
- •after a cardiology consultation has cleared the patient to receive
- •Berubicin. Patients receiving therapeutic agents known to prolong QTinterval will be excluded; however, the use of ondansetron is permitted.
- •Patients with a history of congestive heart failure, myocardial
- •infarction, or stroke in the last 3 months will be excluded.
- •8. Congenital long QT syndrome or QTc >460 ms.
- •9. Patients receiving any other anticancer or investigational drug therapy.
- •10. Prior treatment with bevacizumab.
- •11. Current or planned participation in a study of another investigational
- •agent or using an investigational device.
- •12. Requirement for cytochrome P450 3A4 (CYP3A4)-inducing or
- •inhibiting agents, with the exception of corticosteroids.
- •Patients unable to return for follow-up visits or undergo follow-up
- •procedures required to assess toxicity of therapy.
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