Table 2.
Treatment‐related adverse events occurring in >30% of patients in either the PF‐3512676 monotherapy phase or entire study (both monotherapy and combination therapy phases)
| Level† (evaluable patients, n) | Patients, n (%) | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Entire study (monotherapy phase + combination therapy phase) | Monotherapy phase | |||||||||||||||
| Level 1 (n = 3) | Level 2 (n = 6) | Level 3 (n = 3) | All levels (n = 12) | Level 1 (n = 3) | Level 2 (n = 6) | Level 3 (n = 3) | All levels (n = 12) | |||||||||
| All grades | ≥Grade 3 | All grades | ≥Grade 3 | All grades | ≥Grade 3 | All grades | ≥Grade 3 | All grades | ≥Grade 3 | All grades | ≥Grade 3 | All grades | ≥Grade 3 | All grades | ≥Grade 3 | |
| Adverse events, hematologic | ||||||||||||||||
| Leukopenia | 3 | 2 | 6 | 3 | 3 | 2 | 12 (100) | 7 (58.3) | 2 | 0 | 1 | 0 | 1 | 0 | 4 (33.3) | 0 |
| Neutropenia | 3 | 3 | 6 | 5 | 3 | 3 | 12 (100) | 11 (91.7) | 1 | 0 | 1 | 0 | 1 | 0 | 3 (25.0) | 0 |
| Lymphocytopenia | 2 | 2 | 6 | 1 | 3 | 1 | 11 (91.7) | 4 (33.3) | 2 | 0 | 3 | 0 | 1 | 1 | 6 (50.0) | 1 (8.3) |
| Anemia | 3 | 1 | 5 | 1 | 3 | 1 | 11 (91.7) | 3 (25.0) | 1 | 0 | 2 | 0 | 1 | 0 | 4 (33.3) | 0 |
| Thrombocytopenia | 2 | 0 | 2 | 2 | 3 | 0 | 7 (58.3) | 2 (16.7) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Monocytopenia | 1 | 0 | 1 | 0 | 3 | 0 | 5 (41.7) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Adverse events, non‐hematologic | ||||||||||||||||
| Injection‐site reactions | 3 | 0 | 6 | 0 | 3 | 1 | 12 (100) | 1 (8.3) | 3 | 0 | 6 | 0 | 3 | 0 | 12 (100) | 0 |
| Flu‐like symptoms | 2 | 0 | 6 | 0 | 3 | 1 | 11 (91.7) | 1 (8.3) | 2 | 0 | 6 | 0 | 3 | 0 | 11 (91.7) | 0 |
| Anorexia | 1 | 1 | 4 | 0 | 2 | 1 | 7 (58.3) | 2 (16.7) | 0 | 0 | 2 | 0 | 0 | 0 | 2 (16.7) | 0 |
| Malaise | 2 | 0 | 3 | 0 | 2 | 0 | 7 (58.3) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| ALT increased | 1 | 0 | 3 | 0 | 2 | 0 | 6 (50.0) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Constipation | 0 | 0 | 3 | 0 | 2 | 0 | 5 (41.7) | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 (8.3) | 0 |
| Diarrhea | 1 | 0 | 4 | 0 | 0 | 0 | 5 (41.7) | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 2 (16.7) | 0 |
| AST increased | 0 | 0 | 2 | 0 | 2 | 0 | 4 (33.3) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Nausea | 1 | 0 | 3 | 0 | 0 | 0 | 4 (33.3) | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 (8.3) | 0 |
†Level 1: (Mono) PF‐3512676 0.1 mg/kg → (Combo) PF‐3512676 0.1 mg/kg + carboplatin AUC 6 + paclitaxel 200 mg/m2; Level 2: (Mono) PF‐3512676 0.2 mg/kg → (Combo) PF‐3512676 0.2 mg/kg + carboplatin AUC 6 + paclitaxel 200 mg/m2; Level 3: (Mono) PF‐3512676 0.4 mg/kg → (Combo) PF‐3512676 0.2 mg/kg + carboplatin AUC 6 + paclitaxel 200 mg/m2. ALT, alanine‐aminotransferase; AST, aspartate‐aminotransferase; Combo, combination therapy; Mono, monotherapy.