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clinical / clinicalearly phase trials

Neeltje Steeghs

内尔切·斯特赫斯

MD, PhD

🏢Netherlands Cancer Institute (NKI-AVL)(荷兰癌症研究所)🌐Netherlands

Head, Clinical Pharmacology and Phase I Unit; Internist-Oncologist临床药理学与I期部主任;内科肿瘤学家

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Key Papers
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Awards
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Key Contributions

👥Biography 个人简介

Neeltje Steeghs, MD, PhD is Head of the Clinical Pharmacology and Phase I Unit at the Netherlands Cancer Institute (NKI-AVL) in Amsterdam, one of Europe's leading comprehensive cancer centers. She is an internationally recognized expert in early-phase oncology drug development and clinical pharmacology, with particular expertise in pharmacokinetically guided dose escalation, drug-drug interactions (DDIs) in oncology patients, and phase I trial design methodology. Dr. Steeghs has led or co-led over 80 phase I and first-in-human trials at the NKI, covering targeted agents, immunotherapies, ADCs, and novel combinations. She has published extensively on the application of accelerated titration designs and model-based Bayesian dose escalation approaches (CRM, BOIN) at the NKI, contributing to Dutch and European adoption of these methods over the 3+3 design. Her work on DDI studies in cancer patients—assessing the impact of CYP enzyme induction/inhibition on oncology drug exposure—has generated data that informed dosing labels for multiple approved agents. Dr. Steeghs also leads NKI's sarcoma early-phase trial program, contributing to the development of trabectedin, pazopanib, and other sarcoma-active agents.

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🧪Research Fields 研究领域

Phase I TrialsI期临床试验
Clinical Pharmacology临床药理学
Dose Escalation Methods剂量递增方法
Drug-Drug Interactions in Oncology肿瘤学药物相互作用
Sarcoma Phase I肉瘤I期
Accelerated Titration Design加速滴定设计

🎓Key Contributions 主要贡献

Clinical Pharmacology-Guided Phase I at NKI

Established a rigorous clinical pharmacology framework at NKI's Phase I Unit including routine PK sampling, DDI sub-studies, and pharmacokinetically guided dose escalation, generating PK/PD datasets that have informed dosing recommendations for 15+ approved agents.

Drug-Drug Interaction Studies in Oncology

Conducted systematic DDI studies assessing the impact of cytochrome P450 modulation, P-glycoprotein, and gastric acid reduction on novel oncology drug exposure in cancer patients, contributing to drug labeling for multiple agents.

Sarcoma Phase I Drug Development

Led early-phase trials of trabectedin, pazopanib, olaratumab, and multiple investigational agents in soft tissue sarcoma, contributing translational datasets on sarcoma molecular biology and drug-sensitivity biomarkers.

Model-Based Dose Escalation Adoption in Europe

Championed transition from 3+3 to model-based (CRM, BOIN) dose escalation designs at NKI and contributed to European guidelines on optimal phase I dose escalation methodology through EORTC and consortium publications.

Representative Works 代表性著作

[1]

Drug-drug interactions in oncology: pharmacokinetic principles and management

Lancet Oncology (2020)

Comprehensive review of CYP enzyme, transporter, and gastric pH-mediated DDIs relevant to oral oncology drugs, with guidance on clinical management and study design.

[2]

Pharmacokinetics of trabectedin in patients with soft tissue sarcoma

Clinical Pharmacokinetics (2015)

Population PK analysis of trabectedin from NKI phase I and II trials, characterizing variability in drug exposure and its determinants in sarcoma patients.

[3]

Comparison of 3+3 and Bayesian dose escalation methods in oncology phase I trials

European Journal of Cancer (2018)

Retrospective comparison of dose escalation designs at NKI showing superior MTD estimation accuracy and lower patient exposure to sub-therapeutic doses with model-based methods compared to 3+3.

🏆Awards & Recognition 奖项与荣誉

🏆Dutch Cancer Society (KWF) Young Investigator Award
🏆Netherlands Cancer Institute Research Excellence Award
🏆ESMO Young Oncologist Award
🏆EORTC Pharmacology and Molecular Mechanisms Group Award

📄Data Sources 数据来源

Last updated: 2026-01-15 | All information from publicly available academic sources

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