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.
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
CPL304110 is to be administered orally as hard gelatine capsules once daily in 28-day cycles.
Uniwersyteckie Centrum Kliniczne w Gdańsku
Gdansk, Poland
RECRUITINGBioResearch Group sp. z o.o.
Nadarzyn, Poland
RECRUITINGSP ZOZ MSWiA z Warmińsko-Mazurskim Centrum Onkologii w Olsztynie
Olsztyn, Poland
Maximum tolerated dose (MTD)
Maximum tolerated dose (MTD) of CPL304110 when administered orally once daily to adults with advanced solid malignancies. The MTD is the highest dose associated with the occurrence of dose-limiting toxicities (DLTs) in \<33% of patients.
Time frame: First cycle of 28 days
Safety profile
Overall safety profile of CPL304110, as assessed by the type, frequency, severity, timing, and relationship to study drug of any adverse events (AEs), serious adverse events (SAEs), and changes in vital signs, ECGs, and safety laboratory test.
Time frame: First cycle of 28 days
Recommended Phase 2 Dose (RP2D) determined on the base of the MTD.
The RP2D will be determined after review and discussion of the pharmacokinetics (PK) profile, type and severity of drug related toxicity and clinical suitability for long-term administration.
Time frame: Approximately up to 12 months
ORR, objective rate response
ORR, objective rate response defined as the rate of confirmed complete response (CR) or partial response (PR) by RECIST 1.1.
Time frame: Approximately up to 12 months
Maximum plasma concentration (Cmax)
Cmax defines the maximum concentration of the product in plasma during observation period.
Time frame: up to 24 hours after CPL304110 administration
Time to maximum plasma concentration (tmax)
tmax defines Time to reach maximum plasma concentration
Time frame: up to 24 hours after CPL304110 administration
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Klinika Onkologii, Europejskie Centrum Zdrowia
Otwock, Poland
NOT_YET_RECRUITINGCentrum Onkologii - Instytut im. Marii Skłodowskiej-Curie
Warsaw, Poland
RECRUITINGInstytut Gruźlicy i Chorób Płuc
Warsaw, Poland
RECRUITINGWojskowy Instytut Medyczny
Warsaw, Poland
NOT_YET_RECRUITINGArea under the plasma concentration versus time curve (AUC) from 0 up to the time of last quantifiable concentration (AUC0-t)
AUC(0-t) defines the area under the curve of plasma concentration vs time, from time point zero up to the time of last quantifiable concentration
Time frame: up to the time of last quantifiable concentration after CPL304110 administration
Area under the plasma concentration versus time curve AUC from 0 to infinity (AUC0-inf)
AUC0-inf defines the area under the curve of plasma concentration vs time, from time point zero extrapolated to infinity
Time frame: up to 24 hours after CPL304110 administration
Terminal half-life (t½)
Plasma elimination half-life
Time frame: up to 24 hours after CPL304110 administration
Kel: Terminal elimination rate constant
Terminal elimination rate constant
Time frame: up to 24 hours after CPL304110 administration