Study to determine the maximum tolerated dose of BIBW 2992 when combined with backbone chemotherapies consisting in cisplatin plus paclitaxel or cisplatin plus 5 FU. The overall safety, the pharmacokinetics and the anti-tumour efficacy will also be assessed.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
47
In each arm, BIBW 2992 dose will be escalated to determine MTD. Starting dose will be 20mg daily followed by 40 mg (with the option of an intermediary dose of 30 mg) then 50mg daily. Dose escalation will stop at 50 mg. No intra patient dose escalation.
low to high dose, daily
1200.37.3202 Boehringer Ingelheim Investigational Site
Brussels, Belgium
1200.37.3201 Boehringer Ingelheim Investigational Site
Edegem, Belgium
1200.37.3203 Boehringer Ingelheim Investigational Site
Ghent, Belgium
Number of Participants With Dose Limiting Toxicities (DLT) in the First Cycle for the Determination of the Maximum Tolerated Dose (MTD)
Number of participants with DLT in the first cycle (21 days) for the determination of the MTD.
Time frame: 21 days
Maximum Tolerated Dose (MTD) for Regimen A and Regimen B
The MTD was determined using a standard 3 +3 dose escalation cohort design. The sample size and the number of patients who receive each dose in this design depends on the frequency of DLT at each dose level in cycle 1.
Time frame: 21 days
Number of Patients With Objective Response
Objective tumor response based on response evaluation criteria in solid tumors (RECIST) version 1.0. Objective response is defined as complete response (CR) and partial response (PR).
Time frame: Tumor assessment were performed at screening and every 2nd cycle until end of follow up (=end of treatment + 30 days +/- 7 days)
Maximum Concentration of Afatinib in Plasma at Steady State (Cmax,ss)
Cmax,ss represents the maximum concentration of afatinib in plasma at steady state
Time frame: 0.05hours (h) before administration and 1h, 2h, 2h 55 minutes (min), 4h, 4h 30min, 5h, 6h, 8h, 10h, 24h, 48h, 216h, 480h after administration
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.