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 received | Confirmed CR or PR (RECIST) | Duration of response (wk) | Type of cancer | BRCA Mutation | Platinum status |
| 300 mg QD | CR | 111 | Ovarian | Germline BRCA1 | Sensitive |
| 300 mg QD | PR | 15 | Breast | Germline BRCA1 | NA |
| 360 mg BID | CR | 60 | Breast | Germline BRCA1 | NA |
| 360 mg BID | PR | 28 | Pancreatic | Germline BRCA2 | NA |
| 480 mg BID | PR | 116 | Breast | Germline BRCA2 | NA |
| 480 mg BID | PR | 37 | Ovarian | Germline BRCA2 | Resistant |
| 480 mg BID | PR | 21 | Breast | Tumor BRCA1 | NA |
| 600 mg BID | PR | 13 | Ovarian | Tumor BRCA1 | Resistant |
| Part 2A (phase II expansion) patients with germline BRCA1/2–mutated ovarian cancer (n = 42) | |||||
| RECIST best confirmed response, n [% (95% CI)] | |||||
| CR | 4 (9.5) | ||||
| PR | 21 (50.0) | ||||
| SD | 12 (28.6) | ||||
| PD | 2 (4.8) | ||||
| NE | 3 (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 | |||||
| BRCA1 | 19/30 [63.3 (43.9–80.1)] | ||||
| BRCA2 | 6/12 [50.0 (21.1–78.9)] | ||||
| PFI | |||||
| 6–12 mo | 17/32 [53.1 (34.7–70.9)] | ||||
| >12 mo | 8/10 [80.0 (44.4–97.5)] | ||||
| ≥3 prior chemotherapy regimens | 9/15 [60.0 (32.3–83.7)] | ||||
| Duration of response, median (95% CI), mo | 7.8 (5.6–10.5) | ||||
Abbreviations: BID, twice daily; NA, not available; NE, not evaluable; PD, progressive disease; QD, once daily.