Table 2. Integrated Efficacy Analysis of ORR for Phases 1 and 2.
| Best Overall Response | Response Data (n = 60) |
|---|---|
| Complete response, No. (%) | 3 (5) |
| Partial response, No. (%) | 8 (13) |
| Stable disease, No. (%)a | 28 (47) |
| Progressive disease, No. (%) | 20 (33) |
| Inconclusive, No. (%)b | 1 (2) |
| ORR, % (90% CI)c | 18 (11-29) |
| DCR, % (90% CI)d | 65 (54-75) |
Abbreviations: DCR, disease control rate; ORR, objective response rate.
a
Four patients had an unconfirmed partial response.
b
One patient had an evaluable postbaseline scan but was not evaluable for response; the postbaseline scan demonstrated stable disease and was therefore included in the efficacy-evaluable analysis set. However, minimum duration requirement of stable disease was not met.
c
Includes patients with complete and partial responses.
d
Includes patients with complete and partial responses and stable disease.