EUCTR2015-002184-42-Outside-EU/EEA进行中（未招募）不适用
A Phase 1-2 Dose Finding, Safety and Efficacy Study of Cabazitaxel inPediatric Patients with Refractory Solid Tumors Including Tumors of theCentral Nervous System
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 57
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
- •Phase 1 Part (dose escalation):
- •Patients with a histologically confirmed
- •solid tumor including tumors of the central nervous system that is
- •recurrent or refractory and for which no further effective standard
- •treatment is available. All patients must have measurable disease.
- •Patients with diffuse pontine glioma are eligible without a biopsy after
- •evidence of progressive disease post radiation therapy.
- •Phase 2 Part (safety and activity):
- •Patients with recurrent or refractory
- •high grade glioma or diffuse intrinsic pontine glioma for whom no
- •further effective therapy is available. All patients must have
- •measurable disease. Patients with diffuse pontine glioma are eligible
- •without a biopsy after evidence of progressive disease post radiation
- •therapy. Patients with a grade III or grade IV glioma must have
- •pathologic conformation either at the time of initial diagnosis or at the
- •time of recurrence.
- •Patients aged =2 years and =18 years
- •Patients should meet the body surface area (BSA) requirements to be
- •a) Minimal BSA requirements for a particular dose level;
- •b) During the Phase 1 part patients must have a BSA <2.1 m² at the
- •time of enrollment
- •c) During the Phase 2 part patients with a BSA =2.1 m² will be eligible,
- •however the actual dose of cabazitaxel for these patients will be
- •adjusted to a maximum dose calculated with (capped at) the BSA of 2.1
- •Performance status by:
- •a) Lansky score =60 (patients =10 years of age)
- •b) Karnofsky score =60% (patients >10 years of age)
- •Patients who are unable to walk because of paralysis, but who are
- •mobile in a wheelchair, will be considered ambulatory for the purpose
- •of assessing the performance score
- •Patients must have adequate liver, renal and marrow function as
- •defined below:
- •a) Total bilirubin =1.0 x the upper limit of normal (ULN) for age
- •b) AST (SGOT) and ALT (SGPT) =2.5 x ULN
- •c) Serum creatinine =1.5 x ULN for age or creatinine clearance =60
- •mL/min/1.73 m²
- •d) Absolute neutrophil count =1.0x10^9 /L
- •e) Platelets =75x10^9/L (transfusion independent)
- •f) Hemoglobin =8.0 g/dL (can be transfused)
- •Female patients of child-bearing potential must have a negative
- •pregnancy test =7 days before starting cabazitaxel treatment.
- •Male and female patients of reproductive potential must agree to use
- •adequate contraception prior to study entry, for the duration of study
- •participation and for 6 months following the last dose of cabazitaxel.
- •Written informed consent/assent prior to any study-specific
- •procedures. Consent must be obtained from the patient and/or
- •parent(s) or legal guardian(s) and the signature of at least one parent or guardian will be required. Investigators will also obtain assent of
- •patients according to local, regional or national guidelines.
- •Patients must have recovered from the acute toxic effects of all prior
- •therapy to = grade 1before entering the study
- 另有 6 项未显示
排除标准
- •Prior treatment within the following timeframes:
- •a) Systemic anti-cancer treatment within 3 weeks (6 weeks for
- •nitrosourea, mitomycin and monoclonal antibodies including
- •bevacizumab)
- •b) Surgery or smaller field radiation therapy within 4 weeks
- •c) Treatment with an investigational agent within 4 weeks or within 5
- •half-lives of the agent, whichever is longer
- •Craniospinal or other large field radiation therapy (defined as >25% of
- •bone marrow irradiated) within 6 months prior to the first dose.
- •Prior systemic radioisotope therapy (this does not include diagnostic
- •imaging or radioimmunoconjugates lacking myelosuppressive
- •properties) or total body irradiation.
- •Prior bone marrow or stem cell transplant
- •Patients with any clinically significant illness that, in the investigator's
- •opinion, cannot be adequately controlled with appropriate therapy,
- •would compromise a patient's ability to tolerate cabazitaxel or result in
- •inability to assess toxicity. This includes, but is not limited to
- •uncontrolled intercurrent illness including ongoing or active infection,
- •cardiac disease, renal impairment, planned surgery or psychiatric
- •illness/social situations that would limit compliance with study
- •requirements.
- •Known human immunodeficiency virus (HIV) infection or acquired
- •immunodeficiency-syndrome (AIDS)-related disease
- •Known history of hepatitis C or known active hepatitis B infection.
- •Pregnant or breast feeding women
- •Treatment with strong inhibitors or strong inducers of CYP3A4 or
- •enzyme inducing anti-epileptic drugs (EIAED) within 14 days prior to
- •first dose of cabazitaxel and for the duration of study. Non-EIAEDs are
- •Known history of hypersensitivity to taxanes or polysorbate 80 or GCSF.
- •Participation in another interventional clinical trial and/or concurrent
- •treatment with any investigational drug.
- •Patients not able to comply with scheduled visits, treatment plans,
- •laboratory tests, and other study procédures.
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