Maximum tolerated dose (MTD), safety, pharmacokinetics, efficacy of BIBF 1120, pharmacodynamics
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
Maximum tolerated dose (MTD)
Time frame: Up to 11 months
Incidence and intensity of adverse events according to Common Toxicity Criteria (CTC) associated with increasing doses of BIBF 1120
Time frame: Up to 11 months
Change from baseline in laboratory parameters
Time frame: Baseline, up to 11 months
Objective tumor response in surrogate markers
Time frame: Baseline, up to 11 month
Concentration at 2h (C2,1)
Time frame: 2 hours after first administration
Change from baseline in cellular protein tyrosine kinase inhibition
Time frame: Baseline, up to 11 months
Change from baseline in Eastern Cooperative Oncology Group (ECOG) performance score
Time frame: Baseline, up to 11 months
Change in vital signs
Time frame: up to 11 months
Change from baseline in electrocardiogram (ECG)
Time frame: Baseline, up to 11 months
Predose concentration immediately before administration of the Nth dose over the dosing interval τ (Cpre,N)
Time frame: Up to day 28
Area under the plasma concentration-time curve during the dosing interval τ (24 h) at steady state (AUCτ,ss)
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Time frame: Up to 11 months
Plasma concentration at the time point immediately before dosing at steady state (Cpre,ss)
Time frame: Up to 11 months
Minimum plasma concentration during the dosing interval τ at steady state (Cmin,ss)
Time frame: Up to 11 months
Maximum plasma concentration during the dosing interval τ at steady state (Cmax,ss)
Time frame: Up to 11 months
Time to reach minimum plasma concentration during the dosing interval τ at steady state (tmin,ss)
Time frame: Up to 11 months
Time to reach maximum plasma concentration during the dosing interval τ at steady state (tmax,ss)
Time frame: Up to 11 months
Terminal half-life at steady state (t1/2,ss)
Time frame: Up to 11 months
Apparent plasma clearance at steady state (CL/F,ss)
Time frame: Up to 11 months
Mean residence time at steady state (MRTpo,ss)
Time frame: Up to 11 months
Apparent volume of distribution during the terminal phase at steady state (Vz/F,ss)
Time frame: Up to 11 months
Tumor response assessed according to the European Group for Blood and Marrow Transplantation (EBMT) criteria
Time frame: Up to 11 months