Table 7

Overall response by UC

UC
All patients (N = 25), % (95% CI)Patients in expansion phase (at MTD) (N = 15), % (95% CI)
Response     
    sCR n = 0 0 (0-22) n = 0 0 (0-22) 
    CR n = 2 8 (1-26) n = 1 7 (0-32) 
    VGPR n = 7 28 (12-49) n = 4 27 (8-55) 
    PR n = 6 24 (9-45) n = 3 20 (4-48) 
    Stable disease n = 5 20 (7-41) n = 4 27 (8-55) 
    PD n = 1 4 (0-20) n = 1 7 (0-32) 
    Not evaluable* n = 4 16 (5-36) n = 2 13 (2-40) 
Overall response (sCR + CR + VGPR + PR) n = 15 60 (39-79) n = 8 53 (27-79) 
UC
All patients (N = 25), % (95% CI)Patients in expansion phase (at MTD) (N = 15), % (95% CI)
Response     
    sCR n = 0 0 (0-22) n = 0 0 (0-22) 
    CR n = 2 8 (1-26) n = 1 7 (0-32) 
    VGPR n = 7 28 (12-49) n = 4 27 (8-55) 
    PR n = 6 24 (9-45) n = 3 20 (4-48) 
    Stable disease n = 5 20 (7-41) n = 4 27 (8-55) 
    PD n = 1 4 (0-20) n = 1 7 (0-32) 
    Not evaluable* n = 4 16 (5-36) n = 2 13 (2-40) 
Overall response (sCR + CR + VGPR + PR) n = 15 60 (39-79) n = 8 53 (27-79) 

sCR indicates stringent CR; and PD, progressive disease.

*

Patients came off study prior to the first scheduled assessment prior to cycle 3.

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