| Trial ID # | NCT02511795 |
| Phase | Ib |
| Drug Class | DNA Damage Repair Pathway Inhibitors: PARP |
| Drug Name | Olaparib |
| Alternate Drug Names | AZD2281, Lynparza |
| Drugs in Trial | Adavosertib, Olaparib |
| Eligible Participant | Recurrent ovarian cancer (no prior PARP inhibitor) |
| Patients Enrolled | 119 (26 ovarian) |
| Therapy Setting | Recurrence |
| Study Design | Open-Label, Non-randomized |
| Endpoints | ORR, DCR, evaluated per RECIST |
| Efficacy | RP2D once daily (qd) dosing: adavosertib 200 mg qd 3/4 days for 2/3 weeks+olaparib 200 mg bid 26 ovarian w/ adavosertib qd or bid dosing: ORR: 15% (3PR - 1 BRCA MUT, n=20) 1 ovarian at qd RP2D dosing: 1SD |
| Clinically Significant Adverse Events | Serious AE: 1 sepsis |
| Conclusion | Olaparib+adavosertib shows antitumor activity, particularly at the twice daily (BID) schedule |
| Reference | Hamilton E et al. Phase Ib study of adavosertib in combination with olaparib in patients with refractory solid tumors: Dose escalation. Cancer Res (2019) 79(13 Suppl):abstr CT025 Hamilton E et al. Phase Ib study of adavosertib in combination with olaparib in patients with refractory solid tumors: Dose escalation. Poster |