A Multicentre Phase II Study of Adavosertib Plus Chemotherapy in Patients With Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Trial ID # NCT02272790
Phase II
Drug Class Cell Cycle Inhibitors: WEE1
Drug Name Adavosertib
Alternate Drug Names WEE1 inhibitor AZD1775, MK1775, AZD1775
Drugs in Trial Adavosertib, Carboplatin
Eligible Participant

Primary platinum resistant ovarian cancer

Patients Enrolled

35, median 2 prior therapies

Therapy Setting

Recurrence

Study Design

Open-Label, Non-randomized

Endpoints

ORR, DCR, DoR, PFS, evaluated per RECIST

Efficacy

Ada W1+CarboPt: 225 mg Ada BID week 1 (day 1-3)+CarboPt AUC5
Ada W1-3+CarboPt: 225 mg Ada BID weeks 1-3 (day 1-3, 8-10, 15-17)+CarboPt AUC5

AdaW1+CarboPt:
ORR: 30.4% (1CR, 6PR, n=23); DCR: 82.6% (1CR, 6PR, 12SD, n=23); PFS: 4.2 months
Ada W1-3+CarboPt:
ORR: 66.7% (1CR, 7PR, n=12); DCR: 100% (1CR, 7PR, 4SD, n=12); DoR: 10.4 months; PFS: 12.0 months - 3 patients w/ CCNE1 AMP had PR

Clinically Significant Adverse Events

Serious AE:
Grade 3-4AE: W1+C: anemia (56.5%), thrombocytopenia (52.2%), neutropenia (21.7%), diarrhea (17.4%), vomiting (13.0%)
Grade 3-4 AE: W1-3+C: thrombocytopenia (83.3%), neutropenia (75.0%), anemia (58.3%)

Reference

Moore KN et al. Adavosertib with Chemotherapy in Patients with Primary Platinum-Resistant Ovarian, Fallopian Tube, or Peritoneal Cancer: an Open-Label, Four-Arm, Phase II Study. Clin Cancer Res (2022) 28(1):36-44
https://pubmed.ncbi.nlm.nih.gov/34645648/

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