The main objective of this trial is to provide safety data in terms of drug-related adverse events (AE) for the recommendation of the dose for further trials in the development of BI 811283. Secondary objectives are the collection of antitumour efficacy data and the determination of the pharmacokinetic profile of BI 811283.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
124
1247.1.49002 Boehringer Ingelheim Investigational Site
Essen, Germany
1247.1.49001 Boehringer Ingelheim Investigational Site
Freiburg/Breisgau, Germany
Maximum tolerated dose
Time frame: 3-4 weeks
Safety profile: incidence and intensity of AEs graded according to the common terminology criteria for AEs, incidence of DLT
Time frame: throughout the study period
Progression free survival (PFS), Objective response, Response duration, Pharmacodynamic analysis, Basic pharmacokinetics
Time frame: throughout the study period
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.