Table 4.
Key | Route & dose | Formulation | Cancer type and key clinical trial outcome | Refs |
---|---|---|---|---|
2005 Phase I | 3 h iv at 1-2 mg/m2, 2 wk/c or at 6-9 mg/m2, 6 wk/c (86c/24 pts) | Lyophilized drug w maltose diluted in saline | 27 pts w advanced solid tumors; DLT: NP, TCP, veno-occlusive hepatotoxicity; CR: 1 pt; PR: 1 pt; SD: 14 pts; Phase II: 7.5 mg/m2, 6 wk/c | No 1 [237] |
2005 Phase I | 3 h iv at 6 mg/m2; one time for PK studies | Lyophilized drug w maltose diluted in saline | 6 pts w solid tumors; preferential accumulation of DE-310, DX-8951 and G-DX-8951 in human tumor tissues was not observed | No 2 [238] |