This is a non-randomized multicenter phase 1b clinical trial of the safety and pharmacokinetics, as well as the preliminary efficacy of monotherapy with alofanib, an allosteric fibroblast growth factor receptor 2 inhibitor, in patients with advanced gastric cancer who have exhausted the resource of standard therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Five dose cohorts and expanded cohort will be included
N.N.Blokhin Russian Cancer Research Centre, Dept. of Clinical Pharmacology and Chemotherapy
Moscow, Russia
ACTIVE_NOT_RECRUITINGOmsk Regional Cancer Center
Omsk, Russia
RECRUITINGRostov Research Institute of Oncology
Rostov-on-Don, Russia
ENROLLING_BY_INVITATIONMaximum tolerated dose (MTD) or Recommended phase 2 dose (RP2D)
The highest dose of an alofanib that does not cause unacceptable side effects and recommended
Time frame: 6 months
Cmax
Peak Plasma Concentration (Cmax), the maximum concentration recorded
Time frame: 1 month
Tmax
Time of Maximum concentration observed
Time frame: 1 month
AUC
Area under the plasma concentration versus time curve
Time frame: 1 month
t1/2
Elimination half-life, the time taken for the plasma concentration to fall by half its original value
Time frame: 1 month
CL
blood clearance
Time frame: 1 month
Vd
Volume of distribution, the theoretical volume that would be necessary to contain the total amount of an alofanib at the same concentration that it is observed in the plasma
Time frame: 1 month
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Rate of AEs and SAEs according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: 12 months
Progression-free survival (PFS)
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St. Petersburg City Cancer Center
Saint Petersburg, Russia
ACTIVE_NOT_RECRUITINGPFS is defined as the time from treatment start to disease progression or death from any cause
Time frame: 12 months
Overall survival (OS)
OS is defined as the time from treatment start to death from any cause
Time frame: 12 months
Objective response rate (ORR)
ORR is the proportion of patients with tumor size reduction.
Time frame: 12 months