To investigate the maximum tolerated dose of BIBF 1120, safety and pharmacokinetics in escalating doses administered with Vinorelbine i.v. in elderly patients with advanced Non-Small Lung Cancer (Stage IV).
Patients older than 70 years could be enroled in this clinical trial. The trial is being carried out in two trial centres in Germany. For the planned sample size it is assumed that two different dosage groups are needed with 6 patients on each dosage group with the option to deescalate the first dosage. Altogether this leads to an estimated sample size of maximal 18 patients. * Duration of treatment/patient: up to 6 month * Follow Up: at least 6 month
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
2 x 150 mg capsules, oral, daily (Start dose)
25 mg/m2 i.v. on day 1 and 8 (three-week cycle)
Klinikum Kassel GmbH
Kassel, Hesse, Germany
LungenClinic Großhansdorf GmbH
Großhansdorf, Germany
Thoraxklinik Universitätsklinikum Heidelberg
Heidelberg, Germany
Klinikum der Universität München
München, Germany
To investigate the maximum tolerated dose of BIBF 1120
Time frame: Cycle 1 day 1, day 2, day 8, day 15; Cycle 2 day 1, day 2, day 8, day 15; Cycle 3 day 1, day 8, day 15; Cycle 4 day 1, day 8, day 15; day 84
Incidence of adverse events
Time frame: Cycle 1 day 1, day 2, day 8, day 15; Cycle 2 day 1, day 2, day 8, day 15; Cycle 3 day 1, day 8, day 15; Cycle 4 day 1, day 8, day 15; day 84
Pharmacokinetic parameters: Aerea Under Curve (AUC)
Time frame: 0,15, 0,50, 1, 1,50, 2, 3, 4, 6, 7, 24, 24,15, 24,50, 25, 25,5, 26, 27, 28, 30, 31, 48, 168 hours post dose
Pharmacokinetic parameters: C-max
Time frame: 0,15, 0,50, 1, 1,50, 2, 3, 4, 6, 7, 24, 24,15, 24,50, 25, 25,5, 26, 27, 28, 30, 31, 48, 168 hours post dose
Response Rate
Time frame: Day 43 (prior start of cycle 3), day 84
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.