Table 4.

Confirmed overall response (RECIST-confirmed and CA125; investigator assessed)

Part IPart II
RECISTGCIG CA125RECISTGCIG CA125
CA125ITTCA125 Measurablea
ITTRECIST MeasurableMeasurableaCohort ACohort A
Overall response, n (%)N = 29N = 27N = 25N = 28N = 25
CR002 (8)2 (7)5 (20)
PR7 (24)7 (26)8 (32)7 (25)8 (32)
SDb13 (45)12 (44)11 (44)11 (39)9 (36)
Progressive disease6 (21)6 (22)04 (14)0
Not evaluable3 (10)2 (7)4 (16)4 (14)3 (12)
ORR7 (24)7 (26)10 (40)9 (32)13 (52)
95% CI10.3–43.511.1–46.321.1–61.315.9–52.431.3–72.2
  • Abbreviations: GCIG, Gynecological Cancer Intergroup; ITT, Intention to Treat (all treated patients).

  • aPatients included in the CA125-measurable disease population had a CA125 > 2 × the ULN within 14 days prior to treatment.

  • bSD for ≥63 days.