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. Author manuscript; available in PMC: 2014 Jun 1.
Published in final edited form as: Invest New Drugs. 2012 Jul 31;31(3):685–695. doi: 10.1007/s10637-012-9863-1

Table 2.

Treatment by dose level

Dose Level Triapine 24-hours
i.v. Infusion (mg)		 Gemcitabine i.v.,
Fixed-Dose-Rate
(mg/m2) 		No. of
Patients		 No. with
DLTa 		No. with
DRb or DDc 		Description of DLTs
−2A 75 1000 1 1 1 Neutropenia, Thrombocytopenia
−1A 90 1000 5 2 4 Neutropenia, Leukopenia, Thrombocytopenia
1A 120 1000 5 2 4 Neutropenia, Leukopenia, Thrombocytopenia
2A 160 1000 2 2 2 Neutropenia, Fatigue & Dyspnea (Grade 3)
1B 75 1000 6 1 4 Neutropenia
2Bd 90 1000 15 1 8 Thrombocytopenia
3B 120 1000 2 2 1 Neutropenia, Leukopenia, Infection (Grade 3)
a

DLT: Dose limiting toxicity

b

DR: Dose reduction

c

DD: Dose delay

d

Including expansion cohort of 6 patients at this dose level

A: Arm A of the study, during which, both drugs were given on days 1 and 8 of a 21-day cycle regimen

B: Arm B of the study, during which, both drugs were given on days 1 and 15 of a 28-day cycle regimen