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Brief Title: Safety, Tolerability and Pharmacokinetics of Oral CPL304110, in Adult Subjects With Advanced Solid Malignancies
Official Title: A Phase I, Open-label, Multicentre, Dose Escalation Study to Assess Safety, Tolerability and Pharmacokinetics of Oral CPL304110, in Adult Subjects With Advanced Solid Malignancies
Study ID: NCT04149691
Brief Summary: The purpose of the study is to determine to evaluate safety and tolerability of CPL304110 when administered once daily to adults with advanced solid malignancies.
Detailed Description: 01FGFR2018 is an Open-label, Multicentre, Dose Escalation Study to Assess Safety, Tolerability and Pharmacokinetics of Oral CPL304110, in Adult Subjects with Advanced Solid Malignancies. The study consists of 3 parts: initial dose escalation (Part 1 - without FGFR, fibroblast growth factor receptor, molecular aberrations), dose escalation (Part 2 - with FGFR molecular aberrations) and dose extension (Part 3 - with FGFR molecular aberrations).
Minimum Age: 25 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Uniwersyteckie Centrum Kliniczne w Gdańsku, Gdańsk, , Poland
BioResearch Group sp. z o.o., Nadarzyn, , Poland
SP ZOZ MSWiA z Warmińsko-Mazurskim Centrum Onkologii w Olsztynie, Olsztyn, , Poland
Klinika Onkologii, Europejskie Centrum Zdrowia, Otwock, , Poland
Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie, Warsaw, , Poland
Instytut Gruźlicy i Chorób Płuc, Warsaw, , Poland
Wojskowy Instytut Medyczny, Warsaw, , Poland