Table 1.
Dosing schedule | 7 on/7 off in a 28-day cycle | 7 on/14 off in a 21-day cycle | Total | |||||||
---|---|---|---|---|---|---|---|---|---|---|
MK-8242 dose | 30 mg QD | 60 mg QD | 120 mg QD | 250 mg QD | 120 mg BID | 170 mg BID | 250 mg BID | 210 mg BID | 300 mg BID | |
Number enrolled | 1 | 1 | 3 | 1 | 4 | 3 | 3 | 6 | 4 | 26 |
Sex (male), no. (%) | 1 (100) | 1 (100) | 2 (66.7) | 1 (100) | 4 (100) | 2 (66.7) | 3 (100) | 3 (50) | 3 (75) | 20 (76.9) |
Age (years), mean ± SD | 63.0 | 74.0 | 72.3 ± 6.7 | 77.0 | 58.8 ± 18.5 | 63.3 ± 14.6 | 72.3 ± 12.5 | 63.5 ± 11.5 | 41.0 ± 14.3 | 62.2 ± 15.5 |
Race, no. (%) | ||||||||||
White | 1 (100) | 1 (100) | 3 (100) | 1 (100) | 4 (100) | 3 (100) | 3 (100) | 5 (83.3) | 3 (75) | 24 (92.3) |
Other | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (16.7) | 1 (25) | 2 (7.6) |
Primary Diagnosis | ||||||||||
Recurrent AML | 0 | 0 | 2 (66.7) | 1 (100) | 0 | 0 | 2 (66.7) | 3 (50) | 2 (50) | 10 (38.5) |
Refractory AML | 1 (100) | 1 (100) | 1 (33.3) | 0 | 4 (100) | 3 (100) | 1 (33) | 3 (50) | 2 (50) | 16 (61.5) |
WT p53 positive | 0 | 0 | 1 (33.3) | 0 | 0 | 1 (33.3) | 0 | 3 (50.0) | 2 (50.0) | 7 (26.9) |
WT p53 negative | 1 (100) | 1 (100) | 2 (66.7) | 1 (100) | 4 (100) | 2 (66.7) | 1 (33.3) | 3 (50.0) | 1 (25.0) | 16 (61.5) |
Genetic testing not performed | 0 | 0 | 0 | 0 | 0 | 0 | 2 (66.7) | 0 | 1 (25.0) | 3 (11.5) |