A phase I study to determine the maximum tolerable dose (MTD) of weekly carboplatin with the Wee1 inhibitor AZD1775 in patients with p53 mutated solid tumors. - N18WEE

Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 30 人开始时间: 待定最近更新: 2024年4月15日

试验速览

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•1. Histological or cytological proof of advanced p53 mutated cancer, pre-treated with maximally one line of systemic chemotherapy in the advanced setting and any line of hormonal or immunotherapy for advanced disease, and potentially benefitting from carboplatin-AZD1775 combination therapy (prior (neo-)adjuvant chemotherapy is accepted and does not count as one line, since administered in early stage disease);
•5. Able and willing to undergo blood sampling for PK and PD analysis;
•6. Able and willing to undergo a tumor biopsy (if p53 status is already known, tumor biopsy is still mandatory)
•8. Evaluable disease according to RECIST 1.1 criteria;

•1. Any treatment with investigational drugs within 28 days prior to receiving the first dose of investigational treatment; or 21 days for standard (neo-)adjuvant chemotherapy, hormonal and immunotherapy;
•6. Unresolved (> grade 1) toxicities of previous chemotherapy, excluding alopecia.
•8. Patient has had prescription or non-prescription drugs or other products known to be metabolized by CYP3A4, or to inhibit or induce CYP3A4 that cannot be discontinued two weeks prior to Day 1 of dosing and withheld throughout the study until 1 week after the last dose of study medication.
•17. Any of the following cardiac diseases currently or within the last 6 months as defined by New York Heart Association (NYHA) >= Class 2.
•o Unstable angina pectoris
•o Congestive heart failure
•o Acute myocardial infarction
•o Conduction abnormality not controlled with pacemaker or medication

发起方

Antoni van Leeuwenhoek Ziekenhuis