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Table 2 Dose escalation scheme

From: A phase I dose-escalation study of PEP02 (irinotecan liposome injection) in combination with 5-fluorouracil and leucovorin in advanced solid tumors

Dose Level

PEP02 (mg/m2)

No. patients

No. patients with DLT

I

60

3

0

II

80

3 + 3

0 + 0

III

100

3 + 2

0 + 2

IV

120

2

2

  1. Abbreviation: DLT dose-limiting toxicity