Table 2.
Phase I: dose escalation and DLTs.
| Nab-p (mg/m2) | Level | No. Pts | Nab-FOLFIRI (Arm A) | No. pts | Nab-FOLFOX (Arm B) |
|---|---|---|---|---|---|
| 90 | I | 3 | 3 | ||
| 100 | II | 3 | 3 | ||
| 110 | III | 6 | Liver toxicity G3 (1pt) | 3 | |
| 120 | IV | 6 | MTD | 3 | |
| 130 | V | 3 + 3 ↑↓ |
Neutropenia G4, leucopenia G3 (1 pt) anemia G3, neutropenia G4, thrombocytopenia G3, and mucositis G2 (1 pt) |
3 | |
| 140 | VI | 3 | Neutropenia G4, leucopenia G3, and thrombocytopenia G3 (1 pt) Fever G1, asthenia G3, and hospitalization (1 pt) DLT |
6 | Mucositis G3, diarrhea G3, and anorexia G3 (1 pt) |
| 150 | VII | NA | 6 | ||
| 160 | VIII | NA | 6 | Nausea G3 (1 pt) MTD |
|
| 170 | IX | NA * | 3 | Sepsis (1 pt) Febrile neutropenia G4 and leucopenia G3 (1 pt) DLT |
* NA = not applicable.