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The primary objective of this trial is to determine the MTD of the combination of BIBW 2992/BIBF 1120 therapy administered concomitantly in a 28-day cycle schedule.
Secondary objectives are the collection of antitumor efficacy data, the determination of pharmacokinetic parameters of BIBF 1120 and BIBW 2992, and if data allow the determination of the pharmacokinetic influence of BIBW 2992 on BIBF 1120 and vice versa.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIBW 2992 | Drug |
| ||
| BIBF 1120 |
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint of this trial is the safety of the combination of BIBW 2992/BIBF 1120 when administered concomitantly, and this is assessed by the dose limiting toxicity | Until undue toxicity or progressive disease. |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics, Objective tumor response. | Until undue toxicity or progressive disease. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1239.1.3 Boehringer Ingelheim Investigational Site | Scottsdale | Arizona | United States | |||
| 1239.1.1 Boehringer Ingelheim Investigational Site |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077716 | Afatinib |
| C530716 | nintedanib |
| ID | Term |
|---|---|
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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|
| Tampa |
| Florida |
| United States |
| 1239.1.2 Boehringer Ingelheim Investigational Site | Detroit | Michigan | United States |
| 1239.1.4 Boehringer Ingelheim Investigational Site | Omaha | Nebraska | United States |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |