作者
Rastislav Bahleda, Antoine Italiano, Cinta Hierro, Alain Mita, Andres Cervantes, Nancy Chan, Mark Awad, Emiliano Calvo, Victor Moreno, Ramaswamy Govindan, Alexander Spira, Martha Gonzalez, Bob Zhong, Ademi Santiago-Walker, Italo Poggesi, Trilok Parekh, Hong Xie, Jeffrey Infante, Josep Tabernero
发表日期
2019/8/15
期刊
Clinical cancer research
卷号
25
期号
16
页码范围
4888-4897
出版商
American Association for Cancer Research
简介
Purpose
Here, we report results of the first phase I study of erdafitinib, a potent, oral pan-FGFR inhibitor.
Patients and Methods
Patients age ≥18 years with advanced solid tumors for which standard antineoplastic therapy was no longer effective were enrolled (NCT01703481). Parts 2 to 4 employed molecular screening for activating FGFR genomic alterations. In patients with such alterations, two selected doses/schedules identified during part 1 dose-escalation [9 mg once daily and 10 mg intermittently (7 days on/7 days off), as previously published (Tabernero JCO 2015;33:3401-8)] were tested.
Results
The study included 187 patients. The most common treatment-related adverse events were hyperphosphatemia (64%), dry mouth (42%), and asthenia (28%), generally grade 1/2 severity. All cases of hyperphosphatemia were grade 1/2 except for 1 grade 3 …
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R Bahleda, A Italiano, C Hierro, A Mita, A Cervantes… - Clinical cancer research, 2019