Table 4.

Response outcomes for parts A and B

NENRPRCROverall response (PR + CR), n (%)
Part A (n = 12) 1* 4 3 7 (58) 
Part B (n = 4)  2 (50) 
Part A + B ORR     9 (75) 
 95% CI, %     42.8-94.5 
NENRPRCROverall response (PR + CR), n (%)
Part A (n = 12) 1* 4 3 7 (58) 
Part B (n = 4)  2 (50) 
Part A + B ORR     9 (75) 
 95% CI, %     42.8-94.5 

NE, not evaluable; NR, no response.

*

NE due to patient decision to withdraw from study after 4 cycles because of gastrointestinal toxicity.

Four patients from part A who had NR entered part B combination idasanutlin + IFN-α.

Residual splenomegaly likely resulting from known portal vein thrombosis in 1 patient, likely a CR (n = 1).

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