Table 1.
Characteristic | Total trials (n = 109), n (%) |
---|---|
Number of drugs | |
One drug | 66 (61) |
Two or more drugs | 43 (39) |
Type of tumor | |
Solid tumors (including CNS tumors) | 28 (26) |
CNS tumors only | 21 (19) |
Leukemia only | 19 (17) |
Solid tumors (excluding CNS tumors) | 16 (15) |
Neuroblastoma only | 15 (14) |
Other | 9 (8) |
Lymphoma only | 1 (1) |
Study design | |
3+3 | 63 (58) |
Rolling six | 24 (22) |
Adaptive/continual reassessment method | 8 (7) |
Other | 7 (6) |
Not reported | 7 (6) |
MTD/RP2D established | 94 (86) |
Number of dose levels, median (range) | 3 (1–9) |
Type of triala | |
Targeted | |
Group 1: Specific targeted agents with targeted agent dose escalation | 15 (14) |
Group 2: Nonspecific targeted agents with targeted agent dose escalation | 40 (36) |
Group 3: Specific targeted agents plus cytotoxic agents | 6 (6) |
Cytotoxic | |
Group 4: Nonspecific targeted agents plus cytotoxic agents with targeted agent dose escalation | 6 (6) |
Group 5: Nonspecific targeted agents plus cytotoxic agents with other dose escalation | 11 (10) |
Group 6: Cytotoxic agents only | 31 (28) |
For all trial groups (1–6), single agent or multiagent therapy combinations were included.
Abbreviations: CNS, central nervous system; MTD, maximum tolerated dose; RP2D, recommended phase II dose.