EUCTR2019-002954-21-FR进行中（未招募）1 期
Phase 2, Open-Label, Dose-Escalation and Dose-Expansion Study of Infigratinib, an FGFR 1-3-Selective Tyrosine Kinase Inhibitor, in Children with Achondroplasia: PROPEL 2 - PROPEL 2
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
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
- •- Signed informed consent by subject or parent(s) or legally authorized representative (LAR) and signed informed assent by the subject (when applicable).
- •- 3 to 11 years of age (inclusive) at screening.
- •- Diagnosis of ACH, documented clinically and confirmed by genetic testing.
- •- At least a 6-month period of growth assessment in the PROPEL study (Protocol QBGJ398 001) before study entry.
- •- Subjects and parent(s) or LAR are willing and able to comply with study visits and study procedures.
- •- Able to swallow oral medication.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 60
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Hypochondroplasia or short stature condition other than ACH
- •-Significant concurrent disease or condition that, in the view of the Investigator and/or Sponsor, would confound assessment of efficacy or safety of infigratinib, including but not limited to cardiac or vascular disease; severe sleep apnea, among others.
- •-Evidence of corneal or retinal disorder.
- •-History of malignancy.
- •- Currently receiving treatment with agents that are known strong inducers or inhibitors of CYP3A4 and medications which increase serum phosphorus and/or calcium concentration (including vitamin D analogues); medications that alter the pH of the gastrointestinal tract, including antacids, H2 antagonists (eg, ranitidine), and proton-pump inhibitors (eg, omeprazole); or enzyme-inducing anti-epileptic drugs, including carbamazepine, phenytoin, phenobarbital, and primidone.
- •- Current evidence of endocrine alterations of calcium/phosphorus homeostasis
- •- Treatment with growth hormone, insulin-like growth factor 1 (IGF-1), or anabolic steroids in the previous 6 months or long-term treatment (>3 months) at any time.
- •- Treatment with any other investigational product or investigational
- •medical device for the treatment of ACH or short stature.
研究者
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