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Study to determine the maximum tolerated dose (MTD) for various treatment durations of BIBW 2992 when administered in combination with docetaxel as determined by drug-related adverse events (AEs) as well as Pharmacokinetics, overall safety and antitumor efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Docetaxel + BIBW 2992 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIBW 2992 | Drug | continuous daily dosing for 20 or 13 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and intensity of AdverseEvents according to Common Terminology Criteria (CTCAE version 3) | up to 32 months | |
| Maximum tolerated dose (MTD) of BIBW 2992 | up to 126 days |
| Measure | Description | Time Frame |
|---|---|---|
| Objective tumor response | up to 32 months | |
| Correlation of EGFR (epidermal growth factor receptor), HER2, estrogen receptor (ER) and progesterone receptor (PrR) immunohistochemical status as based on tumor biopsies, or excisions obtained prior to this trial, with objective tumor responses |
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Inclusion Criteria:
Exclusion Criteria:
The patient may be eligible for re-treatment after the previous course is finished. The patient will not be eligible if any of the following conditions are met:
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077716 | Afatinib |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Docetaxel |
| Drug |
single infusion on day 1 |
|
| up to 32 months |
| Area under the plasma concentration-time curve (AUC) for several time points | up to 48 hours after administration |
| The percentage of AUC0-∞ that is obtained by extrapolation (%AUCtz-∞) | up to 48 hours after administration |
| Predose plasma concentration (Cpre) for several time points | predose on day 10 and 21 |
| Plasma concentration at 24 hours (C24) | 24 hours after the first and the last adminstration of study drug |
| Maximum measured plasma concentration (Cmax) for several time points | up to 48 hours after administration |
| Time from dosing to the maximum plasma concentration (tmax) for several time points | up to 48 hours after administration |
| Terminal half-life (t1/2) for several time points | up to 48 hours after administration |
| Mean residence time (MRT) for several time points | up to 48 hours after administration |
| Apparent clearance (CL/F) for several timt points | up to 48 hours after administration |
| Apparent volume of distribution during the terminal phase (Vz/F) for several time points | up to 48 hours after administration |
| Terminal rate constant in plasma (λz) | up to 48 hours after administration |
| Accumulation ratio between day 1 and day 21 with respect to Cmax (Ra1) and AUC (RA2) | up to day 21 |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |