Table 3.

Antitumor activity in patients with advanced tumors who received rucaparib in part 1 and investigator-assessed response in patients with germline BRCA1/2-mutated ovarian cancer from part 2A

Part 1 (phase I dose escalation) patients with advanced solid tumors (n = 56)
Dose receivedConfirmed CR or PR (RECIST)Duration of response (wk)Type of cancerBRCA MutationPlatinum status
300 mg QDCR111OvarianGermline BRCA1Sensitive
300 mg QDPR15BreastGermline BRCA1NA
360 mg BIDCR60BreastGermline BRCA1NA
360 mg BIDPR28PancreaticGermline BRCA2NA
480 mg BIDPR116BreastGermline BRCA2NA
480 mg BIDPR37OvarianGermline BRCA2Resistant
480 mg BIDPR21BreastTumor BRCA1NA
600 mg BIDPR13OvarianTumor BRCA1Resistant
Part 2A (phase II expansion) patients with germline BRCA1/2–mutated ovarian cancer (n = 42)
RECIST best confirmed response, n [% (95% CI)]
 CR4 (9.5)
 PR21 (50.0)
 SD12 (28.6)
 PD2 (4.8)
 NE3 (7.1)
RECIST ORR, n [% (95% CI)]25 [59.5 (43.3–74.4)]
RECIST/CA-125 ORR, n [% (95% CI)]35 [83.3 (68.6–93.0)]
RECIST ORR by part 2A patient subsets, n/N [% (95% CI)]
BRCA gene mutation
  BRCA119/30 [63.3 (43.9–80.1)]
  BRCA26/12 [50.0 (21.1–78.9)]
 PFI
  6–12 mo17/32 [53.1 (34.7–70.9)]
  >12 mo8/10 [80.0 (44.4–97.5)]
 ≥3 prior chemotherapy regimens9/15 [60.0 (32.3–83.7)]
Duration of response, median (95% CI), mo7.8 (5.6–10.5)
  • Abbreviations: BID, twice daily; NA, not available; NE, not evaluable; PD, progressive disease; QD, once daily.