| Trial ID # | NCT02101775 |
| Phase | II |
| Drug Class | Cell Cycle Inhibitors: WEE1 |
| Drug Name | Adavosertib |
| Alternate Drug Names | WEE1 inhibitor AZD1775, MK1775, AZD1775 |
| Drugs in Trial | Adavosertib, Gemcitabine |
| Eligible Participant | Platinum resistant ovarian cancer |
| Patients Enrolled | 125 [Gem+Ada, n=65, median 3 prior therapies (1-8); Gem: n=34, median 3 prior therapies (1-9); Gem+Ada for non HGS histologies, n=25] |
| Therapy Setting | Recurrence |
| Study Design | Double Blind, Randomized |
| Endpoints | ORR, DCR, PFS, OS, evaluated per RECIST |
| Efficacy | Gem+Ada (n=65) vs Gem (n=34): ORR: 25 (14PR, n=57) vs 7% (2PR, n=30) (read from poster) |
| Clinically Significant Adverse Events | Gem+Ada vs Gem: |
| Conclusion | Addition of adavosertib to gemzar improves ORR, PFS and OS |
| Reference | Lheureux S et al. A randomized double-blind placebo-controlled phase II trial comparing gemcitabine monotherapy to gemcitabine in combination with adavosertib in women with recurrent, platinum resistant epithelial ovarian cancer: A trial of the Princess Margaret, California, Chicago and Mayo Phase II Consortia. J Clin Oncol (2019) 37(suppl; abstr 5518) Lheureux S et al. Adavosertib plus gemcitabine for platinum-resistant or platinum-refractory recurrent ovarian cancer: a double-blind, randomised, placebo-controlled, phase 2 trial. Lancet (2021) 397(10271):281-292 |
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