Table 1.
Patient characteristics
| Overall Study (n = 23) | Part A (n = 12) | Part B (n = 11) | |
|---|---|---|---|
| Median age, years (range) | 13.9 (3.9 – 20.6) | 14.5 (10.6 – 20.6) | 11.1 (2.9 – 18.2) |
|
| |||
| Male : Female | 11 : 12 | 8 : 4 | 3 : 8 |
|
| |||
| Diagnosis | |||
| Brain tumor (Part B only) | 8 | 8 | |
| Soft tissue sarcoma | 4 | 3 | 1 |
| Ewing sarcoma | 2 | 2 | |
| Neuroblastoma | 2 | 2 | |
| Osteosarcoma | 2 | 2 | |
| Other | 5* | 3 | 2 |
|
| |||
| Measurable disease by RECIST | 17 | 8 | 9 |
|
| |||
| Bone marrow involved at study entry (Part A only) | 1 | ||
|
| |||
| Prior receptor tyrosine kinase inhibitor | 5** | 3 | 2 |
|
| |||
| Prior anthracycline (Part A only) | 10 | 10 | |
|
| |||
| Prior radiation therapy | 14 | 7 | 7 |
|
| |||
| Open tibial growth plate | 15 | 6 | 9 |
|
| |||
| Median number sunitinib cycles (range) | 1 (1 – 9) | 1 (1 – 4) | 1 (1 – 9) |
*
Includes one patient each with: desmoplastic small round cell tumor (Part A); renal cell carcinoma (Part A); spindle epithelial tumor with thymus like differentiation (Part A); gastrointestinal stromal tumor (Part B); and malignant meningioma (Part B).
**
Includes two patients treated with imatinib (one each on Parts A and B) and one patient each treated with dasatinib (Part A), sorafenib (Part A), and gefitinib (Part B).