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Also known as BIBW 2992, EGFR Inhibitor
Afatinib- 1A · 1 trial · 2 indications
The MTD for this combined treatment will be defined as either: 1. The highest dosage cohort in which six patients had been treated and there were less than two dose limiting toxicities (DLTs) or, 2. Afatinib at the highest tolerated dose investigated (40 mg by mouth \[PO\] daily) plus dasatinib at the highest tolerated dose investigated (cohort 3, 140 mg PO daily).
| Arm | Type | Description |
|---|---|---|
| Dose Escalation and Dose Expansion | EXPERIMENTAL | Dose escalation followed by dose expansion. Escalation cohort: Afatinib and Dasatinib. This study is divided into two parts. The first 8 - 18 people will be entered in the first part, called Phase 1A. Then this part will end. Expansion cohort:: Afatinib and Dasatinib. The next 20 people will enter into the second part, called Phase 1B. |
| Name | Type | Description |
|---|---|---|
| Dasatinib - 1A | DRUG | 1A: Begins Day 8. Level 1 - 100 mg, Level 2 - 100 mg, Level 3 - 140 mg. |
| Afatinib - 1A | DRUG | 1A: Begins Day 1. Level 1 - 30 mg, Level 2 - 40 mg, Level 3 - 40 mg. |
| Dasatinib - 1B | DRUG | In Phase 1B, a mutationally selected 20 participants (total) will be treated at the recommended dose to confirm tolerability and evaluate for early response signal. |
| Afatinib - 1B | DRUG | In Phase 1B, a mutationally selected 20 participants (total) will be treated at the recommended dose to confirm tolerability and evaluate for early response signal. |
Inclusion Criteria: * Pathologically or cytologically documented Stage IIIB/IV non-small cell lung cancer, or unresectable recurrent disease following locoregional treatment. * For Phase 1B Extension Only: * Either or both of the following: A tumor which harbors an activating Epidermal Growth Fa...
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