针对瘤治疗和免疫瘤治疗的瘤组合剂量确定研究设计
Li Zhou1, Micaela B Reddy2, Rajendar K Mittapalli1
1Clinical Pharmacology, Oncology Research and Development, Pfizer Inc., San Diego, USA.
Clinical pharmacology and therapeutics
|October 26, 2023
概括
选择正确的临床试验设计对于评估组合癌症疗法至关重要. 本报告概述了不同设计的场景,以确保最佳剂量选择和患者安全.
科学领域:
- 在瘤学瘤学.
- 临床药理学 临床药理学
- 药物开发 药物开发
背景情况:
- 组合疗法是瘤学药物开发的组成部分.
- 评估新的研究药物与已批准或其他研究药物需要精心设计.
- 最初的步骤通常涉及组合剂量升级研究.
研究的目的:
- 为各种用于组合剂量升级的临床试验设计提出应用场景.
- 根据关键考虑,指导选择高效的试验设计.
- 支持瘤学中组合疗法的最佳剂量选择.
主要方法:
- 审查现有临床试验设计的组合剂量升级 (顺序,并行,单一疗法引入等). ) 的情况.
- 分析影响设计选择的因素:剂量反应,药物相互作用,益处/风险.
- 评估内部数据和已发表的研究,以确定应用场景.
主要成果:
- 针对不同的试验设计,提出了具体的应用场景.
- 设计效率取决于预测的剂量反应差异和潜在的相互作用.
- 考虑参与者的利益/风险在设计选择中至关重要.
结论:
- 适当的试验设计对于生成可靠的暴露-反应数据至关重要.
- 有效的设计有助于为组合疗法选择最佳剂量.
- 这项工作支持了Project Optimus对剂量优化的原则.
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