Table 2. DLT and adverse events, irrespective of their relationship to study drug (n = 14).
| Dose of F50067 (mg/kg) | Single agent | F50067 Len-Dex | ||||
|---|---|---|---|---|---|---|
| 0.03 | 0.1 | 0.3 | 1 | 0.03 | 0.1 | |
| n = 1 | n = 4 | n = 3 | n = 2 | n = 1 | n = 3 | |
| DLT (Dose-Limiting Toxicities) | ||||||
| Neutrophils <0.5 × 109/L for >7 days | 0 | 0 | 0 | 0 | 0 | 1 |
| Febrile neutropenia grade ≥3 in arm A and grade 4 in arm B | 0 | 0 | 0 | 0 | 0 | 0 |
| Platelets <25 × 109/L for >7 days | 0 | 0 | 0 | 0 | 0 | 0 |
| Any grade 3 non-hematological toxicity* | 0 | 0 | 0 | 0 | 0 | 0 |
| Adverse events (AE) | ||||||
| At least one AE, all grades, n | 1 | 4 | 3 | 2 | 1 | 3 |
| At least one AE, grade 3–4, n | 1 | 1 | 3 | 2 | 1 | 3 |
| Hematological toxicities grade 3/4** | ||||||
| Anemia | 0 | 0 | 1 | 1 | 0 | 0 |
| Thrombocytopenia | 1 | 2 | 2 | 1 | 0 | 3 |
| Neutropenia | 1 | 3 | 2 | 1 | 0 | 3 |
| Febrile neutropenia | 0 | 0 | 0 | 0 | 0 | 0 |
| Non-hematological toxicities, grade 3–4 | ||||||
| Asthenia | 0 | 1 | 0 | 0 | 0 | 0 |
| Hyperhidrosis | 0 | 0 | 0 | 0 | 0 | 1 |
| Feeling cold | 0 | 0 | 0 | 0 | 0 | 1 |
| Pyrexia | 0 | 0 | 0 | 0 | 0 | 1 |
| Pneumonia influenza 1 | 0 | 0 | 0 | 1 | 0 | 0 |
| Chest pain | 0 | 0 | 1 | 0 | 0 | 0 |
| Electrocardiogram QT prolonged | 0 | 0 | 0 | 0 | 0 | 1 |
| Acute coronary syndrome | 0 | 0 | 0 | 0 | 1 | 0 |
| Hypertension | 0 | 0 | 0 | 0 | 0 | 1 |
| Dyspnea | 0 | 0 | 0 | 0 | 1 | 0 |
| Pulmonary embolism | 0 | 0 | 0 | 0 | 1 | 0 |
| Femoral neck fracture | 0 | 0 | 0 | 0 | 1 | 0 |
| Hyponatremia | 0 | 0 | 0 | 0 | 1 | 0 |
| Acute renal failure | 1 | 0 | 0 | 0 | 0 | 0 |
| Oliguria | 0 | 0 | 1 | 0 | 0 | 0 |
| Anuria | 0 | 0 | 0 | 1 | 0 | 0 |
| Rectal hemorrhage | 1 | 0 | 0 | 0 | 0 | 0 |
| Cholestasis | 0 | 0 | 1 | 0 | 0 | 0 |
| Multi-organ failure | 0 | 0 | 0 | 1 | 0 | 0 |
*Any grade 3 non-haematological toxicity according to NCI CTCAE criteria (version 4.03) except unpremedicated nausea, vomiting, diarrhea or infusion reaction; and only in arm B grade 3 sensory neuropathy and grade 3 thromboembolic event.
**All hematological changes were reported as hematological toxicities but only 6 of them in 5 patients 3 in single and 2 in combination arm were reported as adverse events.