Table 3.
Best overall response (investigator-assessed).
| Phase 1b | Phase 2 | |||
|---|---|---|---|---|
| 300 mg/day | 500 mg/day | Total | 500 mg/day | |
| (n = 4) | (n = 13) | (N = 17) | (N = 49) | |
| Best overall response; investigator RECIST v1.1 | ||||
| CR, n (%) | 0 | 0 | 0 | 1a (2.0) |
| PR, n (%) | 2 (50.0) | 0 | 2 (11.8) | 3 (6.1) |
| SD, n (%) | 0 | 4 (30.8) | 4 (23.5) | 24 (49.0) |
| PD, n (%) | 1 (25.0) | 8 (61.5) | 9 (52.9) | 15 (30.6) |
| Not evaluable, n (%) | 1 (25.0) | 1 (7.7) | 2 (11.8) | 6 (12.2) |
| ORR, n (%) [90% CI] | 2 (50.0) [9.8, 90.2] | 0 (0.0) [0.0, 26.0] | 2 (11.8) [2.1, 32.6] | 4 (8.2) [2.8, 17.7] |
| DCR, n (%) [90% CI] | 2 (50.0) [9.8, 90.2] | 4 (30.8) [11.3, 57.3] | 6 (35.3) [16.6, 58.0] | 28 (57.1) [44.4, 69.2] |
| Best overall response; investigator mRECIST v1.1 | ||||
| CR, n (%) | 1a (2.0) | |||
| PR, n (%) | 4 (8.2) | |||
| SD, n (%) | 19 (38.8) | |||
| Non-CR/Non-PD, n (%) | 7 (14.3) | |||
| PD, n (%) | 13 (26.5) | |||
| Not evaluable, n (%) | 5 (10.2) | |||
| ORR, n (%) [90% CI] | 5 (10.2) [4.1, 20.3] | |||
| DCR, n (%) [90% CI] | 24 (49.0) [36.5, 61.5] | |||
CI confidence interval, CR complete response, DCR disease control rate, mRECIST modified Response Evaluation Criteria in Solid Tumors, ORR objective response rate, PD progressive disease, PR partial response, RECIST Response Evaluation Criteria in Solid Tumors, SD stable disease.
aCR in a patient with MET amplification.