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104142

How Adequate is the Adequate Kidney Function for Clinical Trial Enrollment of Novel Anticancer Drugs?

Article

Last updated: 01 Jan 2025

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Tags

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Abstract

Excessively restrictive eligibility criteria hinder the enrollment of cancer patients to clinical trials. Those patients are supposed to represent the range of characteristics of the overall population with particular cancer. This, in turn, affects the generalizability of results and efficiency of the drug development process in oncology. Recent guidelines from the American Society of Clinical Oncology recommend broadening the eligibility criteria for early and late phase trials. A clearly defined rationale is essential for excluding patients. They selected specific items that commonly lead to the exclusion of patients from clinical trials, namely brain metastases, the minimum age for enrollment, human immunodeficiency virus infection, prior and concurrent malignancies, and organ dysfunction. We reviewed the clinical trials of abemaciclib and tucatinib, two novel anticancer agents, to investigate the eligibility criteria used in their ongoing trials and how the cut-offs for adequate kidney functions were defined. We provided recommendations to allow for enrollment of otherwise eligible patients.

DOI

10.21608/resoncol.2020.33223.1100

Keywords

Abemaciclib, Clinical trials, Eligibility criteria, Kidney function, Tucatinib

Authors

First Name

Nehal

Last Name

Gamal

MiddleName

-

Affiliation

Medical Student, Kasr Al-Ainy School of Medicine, Cairo University, Cairo, Egypt

Email

n.metwally@students.kasralainy.edu.eg

City

-

Orcid

-

First Name

Kyrillus

Last Name

Shohdy

MiddleName

S.

Affiliation

Hematology and Medical Oncology Division, Department of Medicine, Weill Cornell Medical College, New York, NY, USA

Email

kss4001@med.cornell.edu

City

New York

Orcid

0000-0001-8627-3605

Volume

16

Article Issue

2

Related Issue

18448

Issue Date

2020-12-01

Receive Date

2020-06-19

Publish Date

2020-12-01

Page Start

31

Page End

34

Print ISSN

2357-0687

Online ISSN

2357-0695

Link

https://resoncol.journals.ekb.eg/article_104142.html

Detail API

https://resoncol.journals.ekb.eg/service?article_code=104142

Order

1

Type

Mini Review

Type Code

811

Publication Type

Journal

Publication Title

Research in Oncology

Publication Link

https://resoncol.journals.ekb.eg/

MainTitle

How Adequate is the Adequate Kidney Function for Clinical Trial Enrollment of Novel Anticancer Drugs?

Details

Type

Article

Created At

22 Jan 2023