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. 2017 Dec 1;7(12):2350–2394.

Table 4.

DE-310/DE310

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]