Phase Ib | Phase II | |||
---|---|---|---|---|
(N=42) | Fruquintinib group (N=47) | Placebo group (N=24) | P value | |
Median PFS months, 95% CI | 5.80, 4.01 to 7.60 | 4.73, 2.86 to 5.59 | 0.99, 0.95 to 1.58 | <0.001 |
Median OS months, 95% CI | 8.88, 7.53 to 15.53 | 7.72, 6.90 to 10.28 | 5.52, 3.61 to 11.30 | 0.29 |
CR No. (%) | 0 | 0 | 0 | |
PR No. (%) | 4 (9.5) | 1 (2.1) | 0 | |
SD No. (%) | 28 (66.7) | 31 (66.0) | 5 (20.8) | |
PD No. (%) | 7 (16.7) | 12 (25.5) | 17 (70.8) | |
Not evaluable, No. (%) | 3 (7.1) | 2 (4.3) | 1 (4.2) | |
No post-baseline assessment | 0 | 1 (2.1) | 1 (4.2) | |
ORR No. (%), 95% CI | 4 (9.5) | 1 (2.1), 0.1 to 10.7 | 0, 0.0 to 12.6 | 0.45 |
DCR No. (%), 95% CI | 32 (76.2) | 32 (68.1), 53.6 to 80.8 | 5 (20.8), 8.6 to 40.6 | <0.001 |