EUCTR2015-005437-53-ES进行中（未招募）1 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
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 82
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
入选标准
- •Histologically or cytologically confirmed diagnosis of ALCL
- ••Target gene aberration as defined as:
- •oThe t(2;5) translocation or other translocation encoding for ALK aberrations (e.g. (1;2), t(2;3), inv(2), t(2;22)) This should be apparent in all tumor cells
- •?This can be proven by either ALK- immunohistochemistry, FISH or PCR
- •Disease involvement:
- •o For dose escalation measurable and non measurable disease is allowed
- •o For does expansion measurable disease is mandated
- •o Measurable disease is defined as at least one nodule with a longest diameter
- •greater than 1.5 cm
- •Histologically or cytologically confirmed diagnosis NBL or RMS
- •Target gene aberration as defined as:
- •o A point mutation in the kinase domain of ALK that results in an amino-acid
- •change, and is not a known polymorphism
- •o An amplification of the ALK gene, defined as =9 copies per cell, or 4 copies
- •per haploid genome. When assessed by FISH, ALK amplification must be
- •observed in focal clusters of tumor cells (not only single cells) or in more than
- •one-third of the tumor cells
- •o A translocation in >15% of the tumor cells (by break apart FISH-assay)
- •o An amplification of the MET-gene, defined as of =5 MET signals per tumor
- •cell (by break apart FISH)
- •o A MET mutation, defined as the presence of a somatic mutation (Direct, bidirectional
- •sequencing of exon 16-19 of MET)
- •o TFE3 rearrangement, define as at least 15% of cells rearranged (FISH homemade
- •break-apart TFE3 probe set: RP11-344N17 and RP11-552J9)
- •Disease involvement:
- •o For dose escalation measurable and non-measurable disease is allowed
- •o For does expansion measurable disease is mandated, except for
- •neuroblastomas where MIBG disease is sufficient
- •o For RMS: Measurable disease defined as per RECIST 1.1 with a target lesion
- •of at least 10 mm
- •o For NBL: Measurable disease defined as per RECIST 1.1 or evaluable disease
- •(I123 MIBG uptake with or without bone marrow metastases)
- •Histologically or cytologically confirmed diagnosis of other solid tumor or lymphomas
- •other than ALCL (at initial diagnosis) that is relapsed or refractory to standard therapy. Or
- •patients with newly diagnosed IMT in whom radical surgery is deemed infeasible or will
- •result in significant morbidity/mutilation
- •Target gene aberration as defined as:
- •o A point mutation in the kinase domain of ALK that results in an amino-acid
- •change, and is not a known polymorphism
- •o An amplification of the ALK gene, defined as =9 copies per cell, or 4 copies
- •per haploid genome. When assessed by FISH, ALK amplification must be
- •observed in focal clusters of tumor cells (not only single cells) or in more than
- •one-third of the tumor cells
- •o A translocation in
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 known 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 as
- •well as medication with known QT-prolongation
- •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.
- •Plus for stratum 1:
- •Patients with ALCL and skin lesions only, are excluded
- •Plus for stratum 2:
- •Patients with neuroblastoma and bone marrow disease only, are excluded.
研究者
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