Study to determine the Maximum Tolerated dose of BIBW 2992 given in combination with Herceptin®
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Load: 4mg/kg-maintain:2mg/kg/week
Increased dose cohorts from low dose to MTD
1200.68.44001 Boehringer Ingelheim Investigational Site
Brighton, United Kingdom
1200.68.44003 Boehringer Ingelheim Investigational Site
Cambridge, United Kingdom
1200.68.44005 Boehringer Ingelheim Investigational Site
Guildford, United Kingdom
1200.68.44004 Boehringer Ingelheim Investigational Site
Newcastle upon Tyne, United Kingdom
Number of Participants With Dose Limiting Toxicities (DLT)
Number of participants with DLT in the first cycle (28 days) for the determination of the maximum tolerated dose (MTD). Important Limitations and Caveats are provided in the respective section.
Time frame: 28 days
Maximum Tolerated Dose (MTD) of Afatinib in Combination With Herceptin(R)
The MTD was defined as the highest dose at which no more than 1 of 6 patients experienced DLT. It was determined using a standard 3 + 3 dose escalation cohort design. To confirm the MTD, the MTD cohort was to be expanded to 18 patients with no more than 3/18 patients experiencing a DLT. Please refer to CAVEATs and Limitations.
Time frame: 28 days
Number of Patients With Objective Response (OR)
Objective tumor response based on response evaluation criteria in solid tumors (RECIST) version 1.1. OR is defined as complete response (CR) or partial response (PR).
Time frame: Tumor assessment was performed at screening and every 2nd cycle until earliest time of progression, death or end of treatment.
Number of Patients With Best Overall Response
Best overall response based on response evaluation criteria in solid tumors (RECIST) version 1.1. Best overall response is defined as complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD) or not evaluable.
Time frame: Tumor assessment was performed at screening and every 2nd cycle until earliest time of progression, death or end of treatment.
Progression Free Survival (PFS)
PFS is defined as time from randomisation to disease progression or death whichever occurs first. Assessed by central independent review according to the response evaluation criteria in solid tumors (RECIST 1.1). Median time results from unstratified Kaplan-Meier estimates.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
1200.68.44002 Boehringer Ingelheim Investigational Site
Truro, United Kingdom
Time frame: Baseline until disease progression, death or data cut-off.
Summary of Concentration of Afatinib in Plasma
Pre-dose Concentrations of Afatinib in Plasma at Steady State on Days 8, 15 and 29 (Cpre,ss,8, Cpre,ss,15 and Cpre,ss,29) and Maximum Concentration of Afatinib in Plasma at Steady State (Cmax,ss).
Time frame: 0.05 hours (h) before dosing and 0.5-1h, 2h, 3h, 4h, 5h, 6h, 8h after dosing
Time From Dosing to the Maximum Concentration of Afatinib in Plasma at Steady State (Tmax,ss)
tmax,ss represents the time from dosing to the maximum concentration of afatinib in plasma at steady state
Time frame: 0.05 hours (h) before dosing and 0.5-1h, 2h, 3h, 4h, 5h, 6h, 8h after dosing
Summary of Concentration of Herceptin in Plasma
Pre-dose Concentrations of Herceptin in Plasma on Days 8, 15 and 29 (Cpre,8, Cpre,15 and Cpre,29) and Maximum Concentration of Herceptin in Plasma on Days 1, 15 and 29 (Cmax,1, Cmax,15 and Cmax,29).
Time frame: 0.05 hours (h) before dosing and 0.5-1h, 2h, 3h, 4h, 5h, 6h, 8h after dosing