NL-OMON54812招募中2 期
A phase 1B of crizotinib either in combination or as single agent in pediatric patients with ALK, ROS1 or MET positive malignancies;Study ITCC 053 - CRISP
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 64（—）
入选标准
- •Inclusion criteria
- •1b en 2:Histologically or cytologically confirmed diagnosis of
- •relapsed/refractory ALCL, including first relapse, NBL or RMS
- •3: Histologically confirmed diagnosis of other solid tumor or lymphomas other
- •than ALCL that is relapsed or refractory to standard therapy, or patients with
- •newly diagnosed IMT for whom surgery may not be feasible for close proximity to
- •vital structures, without prior tumor-shrinkage and no other feasible options
- •are available as per local standard of care.when stratum 1b is completed, ALCL
- •patients will be eligible to enroll into stratum 3
- •Age at enrolment >=1 year of age and <= 21 years
- •Lansky play score > 60%; or Karnofsky performance status > 60%.
- •Target gene aberration as defined as:
- •o stratum 1b: The t(2;5) translocation or rearrangement t(1;2), t(2;3), inv(2),
- •t(2;22). proven by ALK- immunohistochemistry, FISH or NGS
- •stratum 2: A point mutation in the kinase domain of ALK, An amplification of
- •the ALK gene,rearrangement in >15% of the tumor cells or An amplification of
- •the MET-gene,MET mutation, TFE3 rearrangement,
- •o A point mutation in the kinase domain of ALK, or MET mutation
- •o An amplification of the ALK or MET gene,
- •o A ROS1 or TFE3 rearrangement in > 15% of the tumor cells
- •Life expectancy >= 12 weeks
- •Disease involvement :
- •o stratum 1b Measurable disease defined as at least one nodule with a longest
- •diameter greater than 1.5 cm (pediatric NHL response criteria)
- •stratum 2: For dose escalation measurable and non-measurable disease is
- •allowed; For dose expansion measurable disease is mandated, except for
- •neuroblastomas where MIBG or FDG avidity is sufficient
- •stratum 3:Measurable disease according to RECIST 1.1
- •Or, measurable disease as defined as at least one nodule with a longest
- •diameter greater than 1.5 cm
- •Any previous systemic anticancer therapy must have been completed at least 2
- •weeks prior to initiation of study medication
- •No prior therapy directly targeting ALK or ROS1 or MET
- •No treatment with any other investigational drug within the past 2 weeks or
- •major surgery
- •Male and female patients of child-bearing potential must agree to use an
- •effective method for males and a highly effective method for females
排除标准
- •Other serious illnesses or medical conditions, • Current uncontrolled
- •infection, • History of allergic reactions to the compounds or their solvents,
- •Patients with untreated CNS metastases and/or primary CNS tumors and/or
- •meningeal, lymphoma involvement, defined as CNS3 status (patients with CNS2 are
- •eligible), • Concurrent use of drugs or foods that are known potent CYP3A4
- •inducers or inhibitors CYP3A4 substrates with narrow therapeutic indices as
- •well as medication with known QT*prolongation, •• Any of the following within
- •the 3 months prior to starting study treatment: myocardial infarction,
- •severe/unstable angina, coronary/peripheral artery bypass graft, congestive
- •heart failure or cerebrovascular accident including transient ischemic attack.
- •Use of live vaccines within 30 days of first dosing
- •* Impairment of gastrointestinal (GI) function or GI disease that may
- •significantly alter the, absorption of crizotinib (e.g., ulcerative diseases,
- •uncontrolled nausea, vomiting, diarrhea,, or malabsorption syndrome), • Not
- •able to comply with scheduled follow*up and with management of toxicity., • A
- •cardiac shortening fraction < 29%, • Ongoing cardiac dysrhythmias of NCI
- •CTCAE Grade >=2, uncontrolled atrial fibrillation of any, grade, or QTcF
- •interval >470 msec., • History of extensive disseminated/bilateral or known
- •presence of grade 3 or 4 interstitial, fibrosis or interstitial lung disease,
- •including a history of pneumonitis, hypersensitivity, pneumonitis, interstitial
- •pneumonia, interstitial lung disease, obliterative bronchiolitis, and,
- •pulmonary fibrosis, but not history of prior radiation pneumonitis., • No
- •evidence of active graft*vs*host disease (GVHD) and at least 3 months post*
- •allogeneic, HSCT. Must not receive GVHD prophylaxis., • For patients with
- •childbearing potential, a negative test for pregnancy and agreement to use,
- •effective contraceptive measures is required before entry on study.,• Spinal
- •cord compression unless treated with the patient attaining good pain control
- •and stable or recovered neurologic function.
- •Prior malignancy (other than current malignancy): patients will not be
- •eligible if they have evidence of active malignancy (other than non-melanoma
- •skin cancer or localized cervical cancer, or localized and presumed cured
- •prostate cancer) within the last 3 years.
- •Carcinomatous meningitis or leptomeningeal disease
- •Plus for stratum 2:, • Patients with neuroblastoma and bone marrow disease
- •only, are excluded.
研究者
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