Phase 0 proof of concept study: a clinical pharmacokinetic microdosing trial with gemcitabine - N16GEM: Gemcitabine microdosing trial

Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 10 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

暂无简介。

•1. Age > 18 years.
•2. Indication for treatment with gemcitabine.
•3. Histologically or cytologically confirmed diagnosis of:
•a. Locally advanced or metastatic non-small cell lung cancer.
•b. Locally advanced or metastatic bladder cancer.
•c. Malignant mesothelioma
•4. Able and willing to give written informed consent.
•5. WHO performance status of 0 or 1.
•6. Able and willing to undergo blood sampling for PK analysis.
•7. All toxicities related to prior treatment should have resolved to CTCAE grade 1 or less.
•8. Willing and able to comply with study restrictions and to remain at the study center for the required duration.
•9. Adequate organ system function.

•1. Known hypersensitivity to gemcitabine.
•2. Prior treatment with gemcitabine within 30 days of the first dose.
•3. Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or that may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for the study.
•4. Active, uncontrolled systemic infection considered opportunistic, life threatening, or clinically significant at the time of treatment.
•5. Known positive test result for hepatitis B surface antigen (HBsAg) or hepatitis C antibodies (HC Ab) or has a known positive test result for human immunodeficiency virus (HIV) or a history of HIV disease.
•6. Serious medical or psychiatric condition that, in the opinion of the Investigator, should preclude the patient from participating in the study.

发起方

Antoni van Leeuwenhoek Ziekenhuis