Dose of epertinib | Arm A | Arm B | Arm C | |
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Epertinib + T | Epertinib + T + V | Epertinib + T + C | |
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400mg | 600mg | 800mg | 200mg | 400mg | 200mg | 400mg | 600mg | Overall |
---|
N=5 | N=9 | N=7 | N=5 | N=2 | N=4 | N=9 | N=4 | N=45 |
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BOR |
CR | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
PR | 0 | 6 (66.7%) | 1 (14.3%) | 0 | 2 (100%) | 0 | 5 (55.6%) | 2 (50.0%) | 16 (35.6%) |
SD ≥ 6 months | 2 (40.0%) | 0 | 1 (14.3%) | 4 (80.0%) | 0 | 1 (25.0%) | 0 | 1 (25.0%) | 9 (20.0%) |
CBR | 2 (40.0%) | 6 (66.7%) | 2 (28.6%) | 4 (80.0%) | 2 (100%) | 1 (25.0%) | 5 (55.6%) | 3 (75.0%) | 25 (55.6%) |
PD | 2 (40.0%) | 1 (11.1%) | 2 (28.6%) | 0 | 0 | 1 (25.0%) | 1 (11.1%) | 1 (25.0%) | 8 (17.8%) |
- Clinical benefit is defined as objective response plus SD at 6 months
- Abbreviations: T trastuzumab, V vinorelbine, C capecitabine, BOR best overall response, CR complete response, PR partial response, SD stable disease, CBR clinical benefit rate, PD progressive disease