Table 2.
Comparison of the results of the three dacomitinib Phase I studies
| US18 | South Korea20 | Japan19 | |
|---|---|---|---|
| n | 121 | 12 | 13 |
| ClinicalTrials.gov NCT number | 00225121 | 00553254 | 00783328 |
| ARCHER | 1001 | 1003 | 1005 |
| Tumor types | Solid malignancies | KRAS WT NSCLC, prior erlotinib or gefitinib failure, more than one systemic regimen | Solid malignancies |
| NSCLC (45%) | NSCLC (69%) | ||
| Colorectal (22%) | Colorectal (15%) | ||
| Breast (6%) | Breast (8%) | ||
| Ovarian (5%) | |||
| Dose range | 0.5–60 mg | 30–45 mg | 15–45 mg |
| DLTs | Diarrhea, stomatitis, rash, palmar–plantar erythrodysesthesia | None | None |
| RP2D | 45 mg orally daily | 45 mg orally daily | 45 mg orally daily |
| Grade 4 toxicities (>5%) | None | None | None |
| Grade 3 toxicities (>5%) | Diarrhea (9.9%) | None | Diarrhea (28.6%) |
| Dermatitis acneiform (5.4%) | Decreased appetite (14.3%) | ||
| ALT increased (14.3%) | |||
| AST increased (14.3%) | |||
| Most common toxicities | Grade 1 diarrhea (39%) | Grade 2 dermatitis acneiform (50%) | Grade 1–3 rash (100%) |
| Grade 1 rash (27.0%) | Grade 1 diarrhea (42%) | Grade 1–3 diarrhea (92%) | |
| Grade 1 dry skin (26.2%) | Grade 1 paronychia (33.3%) | Grade 1–3 paronychia (69%) | |
| Grade 1 nausea (25.2%) | Grade 1 stomatitis (33.3%) | Grade 1–3 dry skin (62%) | |
| Grade 1–3 stomatitis (62%) | |||
| Food effect | None | Not investigated | Not investigated |
Abbreviations: NSCLC, non-small-cell lung cancer; WT, wild type; DLTs, dose limiting toxicities; RP2D, recommended Phase II dose; n, number of patients.