Table 5.
Best response in patients with neuroblastoma, by accession number
| Dose level (mg/m2 per dose) | Part | Measurable or evaluable disease | ALK status | Best response (cycle maximum response observed) | Total cycles | |
|---|---|---|---|---|---|---|
|
Neuroblastoma ALK positive (n=11)
| ||||||
| Patient 6 | 130 | A1 | Evaluable | Arg1275Leu | SD | 4 |
| Patient 12 | 100 | A2 | Measurable | Phe1245Cys | PD | 2 |
| Patient 23 | 165 | A2 | Evaluable | Arg1275Gln | PD | 3 |
| Patient 24 | 165 | A2 | Measurable | Phe1174Leu | PD | 1 |
| Patient 40 | 165 | A2 | Measurable | Arg1275Gln† | SD | >25* |
| Patient 25 | 215 | A1 | Evaluable | Arg1275Gln | PD | 2 |
| Patient 51 | 215 | A2 | Evaluable | Phe1174Leu | SD | 13 |
| Patient 56 | 365 | A1 | Measurable | Arg1275Gln† | CR (3) | 8 |
| Patient 76 | 280 | A2 | Measurable | Phe1174Leu | PD | 1 |
| Patient 77 | 280 | A2 | Evaluable | Phe1174Leu | PD | 1 |
| Patient 79 | 280 | A2 | Evaluable | Tyr1278Ser | PD | 3 |
|
| ||||||
|
Neuroblastoma ALK status unknown (n=23)
| ||||||
| Patient 1 | 100 | A1 | Evaluable | Not known | PD | 1 |
| Patient 7 | 130 | A1 | Measurable | Not known | PD | 3 |
| Patient 19 | 130 | A3 | Measurable | Not known | PD | 1 |
| Patient 21 | 130 | A3 | Measurable | Not known | PD | 1 |
| Patient 13 | 165 | A1 | Evaluable | Not known | SD | >39* |
| Patient 14 | 165 | A1 | Measurable | Not known | PD | 2 |
| Patient 16 | 165 | A1 | Measurable | Not known | PD | 1 |
| Patient 26 | 165 | A3 | Evaluable | Not known | PD | 1 |
| Patient 32 | 165 | A3 | Evaluable | Not known | CR (8) | 26 |
| Patient 35 | 165 | A3 | Measurable | Not known | PD | 3 |
| Patient 44 | 215 | A1 | Measurable | Not known | SD | >20* |
| Patient 53 | 215 | A3 | Measurable | Not known | SD | 5 |
| Patient 54 | 215 | A3 | Evaluable | Not known | PD | 1 |
| Patient 55 | 215 | A3 | Evaluable | Not known | SD | 10 |
| Patient 46 | 280 | A1 | Evaluable | Not known | PD | 3 |
| Patient 47 | 280 | A1 | Measurable | Not known | SD | >19* |
| Patient 49 | 280 | A1 | Measurable | Not known | PD | 1 |
| Patient 50 | 280 | A1 | Evaluable | Not known | PD | 1 |
| Patient 61 | 280 | A3 | Evaluable | Not known | PD | 1 |
| Patient 64 | 365 | A1 | Evaluable | Not known | PD | 1 |
| Patient 65 | 280 | A3 | Measurable | Not known | PD | 3 |
| Patient 66 | 280 | A3 | Evaluable | Not known | PD | 1 |
| Patient 58 | 365 | A1 | Evaluable | Not known | PD | 1 |
SD=stable disease. CR=complete response. PD=progressive disease.
Patient still on protocol therapy.
Germline.