Table 2.
DLTs by cohort and DL
| Cohort | DL | No. of patients entered and eligible | Evaluable for dose-escalation decisions | Patients with DLT in course 1* | Patients with DLT in course 2* | Patients with DLT in other courses |
|---|---|---|---|---|---|---|
| A1 | DL1 (45 mg/m2) | 3 | 3 | 0 | 0 | 0 |
| DL2 (60 mg/m2) | 3 | 3 | 0 | 0 | 0 | |
| DL3 (75 mg/m2) | 3 | 3 | 0 | 0 | 0 | |
| DL4 (95 mg/m2) | 10 | 5a | 0 | 0 | 0 | |
| DL5 (115 mg/m2) | 6 | 6 | 1b | 0 | 1b | |
| A2 | 100 mg | 5 | 5 | 0 | 0 | 2c |
| 150 mg | 10 | 10 | 1d | 2e,f | 3e,f,g | |
| B2 | DL4 (95 mg/m2) | 3 | 3 | 0 | 0 | 0 |
| DL5 (115 mg/m2) | 6 | 6 | 0 | 0 | 1h |
a. Five patients were not evaluable for dose-escalation decisions (Fig. 1).
b. Grade 3 diarrhea in course 1 in one patient; grade 2 hallucinations/insomnia in course 3 in another patient.
c. Grade 3 hyperglycemia in course 3 in one patient; grade 2 memory impairment in course 7 in another patient.
d. Grade 2–4 agitation/anxiety/mania in course 1.
e. Grade 2–4 delusions/psychosis/suicide attempt in course 2 that recurred in course 3 despite dose reduction.
f. Grade 3 agitation/neuropathy in course 2 that recurred in course 3 despite dose reduction.
g. Grade 2 edema limbs and neuropathy in course 4.
h. Grade 2 anxiety/depression/somnolence/hypersomnia in course 3.
*DLTs used for dose escalation include all DLTs occurring in course 1 and any CNS DLT through course 2.