Table 1.
Drug exposure for sunitinib, pemetrexed, and carboplatin
| Planned sunitinib dose (mg) | Planned pemetrexed dose (mg/m2) | Planned carboplatin dose (AUC mg·min/ml) | Patients (n) | Number of sunitinib cycles started | Median no. of sunitinib cycles started (range) | Patients with sunitinib dose reduced (n) | Number of pemetrexed cycles started | Median no. of pemetrexed cycles started (range) | Patients with pemetrexed dose reduced (n) | Number of carboplatin cycles started | Median no. of carboplatin cycles started (range) | Patients with carboplatin dose reduced (n) | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| CDD schedule | |||||||||||||
| Dose level 1B (starting dose) | 37.5 | 400 | 5 | 3 | 16 | 6.0 (4–6) | 2 | 16 | 6.0 (4–6) | 1 | 16 | 6.0 (4–6) | 1 |
| Dose level 2B | 37.5 | 500 | 5 | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A |
| Dose level 3B | 50 | 500 | 5 | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A |
| Total (CDD) | N/A | N/A | N/A | 3 | 16 | N/A | 2 | 16 | N/A | 1 | 16 | N/A | 1 |
| Schedule 2/1 | |||||||||||||
| Dose level B1 (starting dose) | 37.5 | 400 | 5 | 3 | 11 | 3.0 (2–6) | 3 | 10 | 2.0 (2–6) | 2 | 10 | 2.0 (2–6) | 2 |
| Dose level B2 (MTD) | 37.5 | 500 | 5 | 6 | 26 | 5.0 (2–6) | 2 | 26 | 5.0 (2–6) | 3 | 26 | 5.0 (2–6) | 3 |
| Expansion cohort | 37.5 | 500 | 5 | 6 | 18 | 3.5 (1–4) | 4 | 20 | 3.5 (1–6) | 4 | 20 | 3.5 (1–6) | 5 |
| Dose level B3 | 50 | 500 | 5 | 6 | 27 | 5.0 (2–6) | 3 | 27 | 5.0 (2–6) | 5 | 27 | 5.0 (2–6) | 2 |
| Total (Schedule 2/1) | N/A | N/A | N/A | 21 | 82 | N/A | 12 | 83 | N/A | 14 | 83 | N/A | 12 |
| Total (CDD + Schedule 2/1) | N/A | N/A | N/A | 24 | 98 | N/A | 14 | 99 | N/A | 15 | 99 | N/A | 13 |
Continuation data are not included
CDD continuous daily dosing; N/A not applicable