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.
Four patients had an unconfirmed partial response.
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.
Includes patients with complete and partial responses.
Includes patients with complete and partial responses and stable disease.