Table 4.
Summary of best overall response rates in efficacy evaluable patients.
| Dose escalation | RCC cohorts | |||||
|---|---|---|---|---|---|---|
| TID-fasted | BID-fed | All dose expansion | Dose escalation | Dose expansion | All RCC | |
| (N = 27) | (N = 16) | (N = 58) | (n = 8) | (n = 20) | (n = 28) | |
| Partial response | 0 | 0 | 1 (1.7) | 0 | 1 (5.0) | 1 (3.6) |
| Stable disease | 7 (25.9) | 10 (62.5) | 24 (41.4) | 5 (62.5) | 8 (40.0) | 13 (46.4) |
| Progressive disease | 20 (74.1) | 6 (37.5) | 33 (56.9) | 3 (37.5) | 11 (55.0) | 14 (50.0) |
| Disease control ratea | 7 (25.9) | 10 (62.5) | 25 (43.1) | 5 (62.5) | 9 (45.0) | 14 (50.0) |
Note: The efficacy analysis set comprised all patients who completed one post-baseline tumor assessment; patients who discontinued study medication early due to study drug–related toxicity or due to disease-related death or symptomatic deterioration (clinical progression) and had received at least 48 doses TID or 32 doses BID were considered evaluable for efficacy.
Abbreviations: BID, twice daily; RCC, renal cell carcinoma; TID, three times daily.
aDCR, overall response rate + stable disease.