The main objective of this trial is to provide safety data in terms of drug-related adverse events for the recommendation of the dose for further trials in the development of BI 831266. Secondary objectives are the collection of antitumour efficacy data and the determination of the pharmacokinetic and pharmacodynamic profile of BI 831266.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
1257.1.4303 Boehringer Ingelheim Investigational Site
Linz, Austria
1257.1.4302 Boehringer Ingelheim Investigational Site
Salzburg, Austria
1257.1.4301 Boehringer Ingelheim Investigational Site
Vienna, Austria
Maximum tolerated dose
Time frame: 3-4 weeks
Safety parameters (incidence and intensity of AEs graded according to the common terminology criteria for AEs and incidence of DLT)
Time frame: throughout the study period
Pharmacokinetic parameters
Time frame: throughout the study period
Pharmacodynamic analysis
Time frame: 3-4 weeks
Efficacy data (progression free survival, objective response rate, response duration)
Time frame: throughout the study period
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