Event | Phase I | Phase II | |||
---|---|---|---|---|---|
Dalotuzumab 5mg/kg plus erlotinib | Dalotuzumab 10 mg/kg plus erlotinib | Erlotinib | Dalotuzumab 10 mg/kg plus erlotinib | ||
N = 4 | N = 16 | N = 38 | N = 37 | ||
Diarrhea | |||||
AE | 1 (25%) | 12 (75%) | 27 (71%) | 30 (81.1%) | |
SAE | 0 | 2 (12.6%) | 0 | 0 | |
Drug-related AE | 1 (25%) | 10 (62.5%) | 18 (47.3%) | 16 (43.2%) | |
g3-5 | 0 | 2 (12.5%) | 1 (2.6%) | 3 (8.1%) | |
Nausea | |||||
AE | 0 | 5 (31.2%) | 17 (44.7%) | 17 (45.9%) | |
SAE | 0 | 0 | 0 | 0 | |
Drug-related AE | 0 | 3 (18.7%) | 4 (10.5%) | 6 (16.2%) | |
g3-5 | 0 | 0 | 0 | 0 | |
Stomatitis | |||||
AE | 2 (50%) | 5 (31.2%) | 3 (7.9%) | 4 (10.8%) | |
SAE | 0 | 0 | 0 | 0 | |
Drug-related AE | 1 (25%) | 3 (18.5%) | 2 (5.3%) | 3 (8.1%) | |
g3-5 | 0 | 0 | 0 | 0 | |
Asthenia | |||||
AE | 1 (25%) | 10 (62.5%) | 14 (36.8%) | 14 (37.8%) | |
SAE | 0 | 0 | 1 (2.6%) | 0 | |
Drug-related AE | 0 | 1 (6.2%) | 7 (18.4%) | 3 (8.1%) | |
g3-5 | 0 | 1 (6.2%) | 2 (5.3%) | 2 (5.4%) | |
Hepatobiliary disorders | |||||
AE | 0 | 0 | 4 (10.5%) | 4 (10.8%) | |
SAE | 0 | 0 | 0 | 2 (5.4%) | |
Drug-related AE | 0 | 0 | 1 (2.6%) | 0 | |
g3-5 | 0 | 0 | 0 | 2 (5.4%) | |
Hyperglycemia | |||||
AE | 0 | 8 (50%) | 5 (13.1%) | 7 (18.9%) | |
SAE | 0 | 1 (6.2%) | 1 (2.6%) | 2 (5.4%) | |
Drug-related AE | 0 | 2 (12.5%) | 2 (5.3%) | 4 (10.8%) | |
g3-5 | 0 | 5 (31.2%) | 4 (10.5%) | 4 (10.8%) | |
Dehydration | |||||
AE | 0 | 0 | 2 (5.3%) | 1 (2.7%) | |
SAE | 0 | 0 | 1 (2.6%) | 0 | |
Drug-related AE | 0 | 0 | 0 | 1 (2.7%) | |
g3-5 | 0 | 0 | 1 (2.6%) | 0 | |
Rash | |||||
AE | 1 (25%) | 9 (56.2%) | 24 (63.1%) | 28 (75.7%) | |
SAE* | 3 (75%) | 14 (87.5%) | 28 (73.7%) | 25 (67.6%) | |
Drug-related AE | 1 (25%) | 8 (50%) | 19 (50%) | 20 (54%) | |
g3-5 | 1 (25%) | 0 | 2 (5.26%) | 2 (5.4%) | |
Acneiform dermatitis | |||||
AE | 2 (50%) | 8 (50%) | 11 (28.9%) | 4 (10.8%) | |
SAE* | 3 (75%) | 14 (87.5%) | 28 (73.7%) | 25 (67.6%) | |
Drug-related AE | 2 (50%) | 6 (37.5%) | 9 (23.7%) | 3 (8.1%) | |
g3-5 | 0 | 0 | 1 (2.6%) | 0 | |
Paronychia | |||||
AE | 1 (25%) | 1 (6.2%) | 8 (21.05%) | 6 (16.2%) | |
SAE | 0 | 0 | 0 | 0 | |
Drug-related AE | 0 | 1 (6.2%) | 5 (13.1%) | 4 (10.8%) | |
g3-5 | 0 | 0 | 0 | 0 | |
Related deaths | 0 | 0 | 1 (2.6%)** | 0 | |
Treatment discontinuations*** | 0 | 1 (6.25%) | 2 (5.26%) | 1 (2.7%) |