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临床试验/NL-OMON50304
NL-OMON50304招募中2 期

A Phase I/II study of Brigatinib in pediatric and young adult patients with ALK+ Anaplastic Large Cell Lymphoma, Inflammatory Myofibroblastic Tumors or other solid tumors - BrigaPED

Prinses Máxima Centrum voor Kinderoncologie0 个研究点目标入组 5 人开始时间: 待定最近更新:
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适应症

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
5
研究概览入排标准研究者记录与标识符相似试验

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

  • •1. Patients must be >=1 and < 26 years of age at the time of enrollment, and
  • •able to swallow brigatinib tablets
  • •Note 1: for phase 1 only patients < 18 years old will be eligible, note a
  • •liquid formulation for children who cannot swallow tablets is in development.
  • •Note 2: for the Netherlands only, minimum age is >= 5 years.
  • •Note 3: for the Czech Republic only, minimum age is >= 4 years.
  • •2. Patients must have a histologically confirmed diagnosis of cancer at baseline
  • •3. Patients are required to provide prior results showing an activating ALK
  • •aberration in the tumor per local laboratory results, and material needs to be
  • •available for central laboratory confirmation of ALK status
  • •4. For Phase 1:
  • •Patients with ALCL must be relapsed/refractory or intolerant to standard
  • •therapies. Refractory disease for ALCL is defined as:
  • •o no response to at least one course of ALCL99/other standard of care
  • •chemotherapy (SD or PD ), and/or
  • •o MRD-positivity by qualitative PCR for NPM-ALK after at least one course
  • •ALCL99/other standard of care chemotherapy (before the second course of
  • •chemotherapy).
  • •Patients with relapsed/refractory (R/R) or newly diagnosed IMT must not be
  • •suitable for curative surgical resection without causing severe mutilation or
  • •risk associated with organ involvement, or have metastatic disease.
  • •Patients with other solid tumors (excluding IMT) must have relapsed or
  • •refractory disease .
  • •Only patients >=1 and < 18 years will be eligible for phase 1. For the
  • •Netherlands only, minimum age is >= 5 years
  • •5. For Phase 2, patients must have measurable and/or evaluable disease:
  • •Patients with ALCL must be relapsed/refractory as defined.
  • •o No response to at least one course of ALCL99/other standard of care
  • •chemotherapy (SD or PD), and/or
  • •o MRD-positivity by qualitative PCR for NPM-ALK after at least one course of
  • •ALCL99/other standard of care chemotherapy (before the second course of
  • •chemotherapy).
  • •Patients with R/R IMT Relapsed/refractory IMT, or newly diagnosed, including
  • •locally advanced and metastatic IMT which cannot be surgically resected without
  • •causing mutilation.
  • •6. Performance Status:
  • •Karnofsky performance status >=40% for patients >=16 years of age or Lansky
  • •Play Scale >=40% for patients <16 years of age for ALCL patients in phase 2.
  • •Karnofsky performance status >=50% for patients >=16 years of age or Lansky
  • •Play Scale >=50% for patients <16 years of age, for IMT and other solid tumors
  • •and for ALCL patients in phase 1.
  • •7. Patients must not be receiving other investigational medications within 30
  • •days of first dose of study drug or while on study.
  • •9. Patients must have recovered to Grade <2 NCI CTCAE v5.0 or to baseline, from
  • •any nonhematologic toxicities
  • •10. Patients must meet the organ function and system function requirements as
  • •stated below:
  • •Patients must have adequate renal and hepatic function
  • •No clinical, radiological or laboratory evidence of pancreatitis
  • •Absolute neutrophil count: >=0.75 × 10 9/L, except in case of macrophage
  • 另有 6 项未显示

排除标准

  • •1. Patients receiving systemic treatment with strong or moderate CYP3A
  • •inhibitors or inducers within 14 days or five half-lives, whichever the less,
  • •prior to the first dose of study drug (refer to Section 5.2 for a list of
  • •example medications).
  • •2. Diagnosis of another concurrent primary malignancy.
  • •3. Clinically significant cardiovascular disease, including any of the
  • •Myocardial infarction or unstable angina within 6 months of study entry.
  • •History of or presence of heart block, and/or clinically significant
  • •ventricular or atrial arrhythmias.
  • •Uncontrolled hypertension defined as persistent elevation of systolic and/or
  • •diastolic blood pressures to >=95th percentile based on age, sex, and height
  • •percentiles despite appropriate antihypertensive management.
  • •4. Planned non-protocol chemotherapy, radiation therapy, another
  • •investigational agent, or immunotherapy while patient is on study treatment.
  • •5. Any illness that affects gastrointestinal absorption.
  • •6. Ongoing or active systemic infection, active seropositive HIV, or known
  • •active hepatitis B or C infection.
  • •7. Any pre-existing condition or illness that, in the opinion of the
  • •investigator or sponsor, would compromise patient safety or interfere with the
  • •evaluation of the safety or efficacy of brigatinib.
  • •8. Patients with rare hereditary problems of galactose intolerance, total
  • •lactase deficiency or glucose-galactose malabsorption.
  • •9. Patients with a history of cerebrovascular ischemia/hemorrhage with residual
  • •deficits are not eligible (patients with a history of cerebrovascular
  • •ischemia/hemorrhage remain eligible provided all neurologic deficits and
  • •causative have resolved).
  • •10. Uncontrolled seizure disorder (patients with seizure disorders that do not
  • •require antiepileptic drugs, or are well controlled with stable doses of
  • •antiepileptic drugs are eligible).
  • •11. Patients with electrolytes imbalances >= grade 2 NCI CTCAE v5.0 are not
  • •eligible (supplementation or medical intervention is allowed to correct
  • •electrolyte imbalance before inclusion).
  • •12. Patients with uncontrolled diabetes, i.e. patients with persistent
  • •hyperglycemia >= grade 2 NCI CTCAE v5.0 despite well conducted treatment with
  • •either oral anti glycemic agent and/or insulin are not eligible (patients with
  • •well controlled diabetes with either insulin or oral anti glycemic agents are

研究者

发起方
Prinses Máxima Centrum voor Kinderoncologie

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