This is a randomized, Phase 3 trial designed to evaluate the efficacy and safety of azenosertib compared to Investigator's choice of chemotherapy in subjects with platinum-resistant ovarian cancer whose tumors are positive for cyclin E1 protein expression.
Female age ≥ 18 years
High-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer
Measurable disease per RECIST Version 1.1
Eastern Cooperative Oncology Group (ECOG) performance status score 0-1
History of another malignancy in the previous 2 years, unless cured by surgery alone and continuously disease-free. Exceptions include appropriately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, Stage 1 uterine cancer, or other malignancies with an expected curative outcome.
Subjects with primary platinum-refractory disease.
Prior therapy with azenosertib or any other WEE1 inhibitor, ATR inhibitor, CHK1/2 inhibitor, or (PKMYT1) inhibitor for PROC.
Clinically or radiographically unstable brain metastases or leptomeningeal disease that requires immediate treatment. Subjects with asymptomatic brain metastases are eligible.
Parallel
Investigator's choice of Chemotherapy
DrugThe investigator will select the chemotherapy in accordance with the protocol defined requirements. The possible choices as defined by the protocol: * Paclitaxel * Gemcitabine * Pegylated liposomal doxorubicin (PLD) * Topotecan The selected chemotherapy will be administered intravenously
Azenosertib
DrugAzenosertib 400 mg will be administered orally.
Progression free survival (PFS) per RECIST v1.1 as assessed by Investigator
Time from randomization to the first documented tumor progression (per RECIST v1.1) or death from any cause, whichever occurs first.
Overall survival
Time from randomization until death due to any cause
PFS per RECIST 1.1 as assessed by blinded independent central review (ICR)
Time from randomization to the first documented tumor progression (per RECIST v1.1) or death from any cause, whichever occurs first.
Objective Response Rate (ORR) per RECIST v1.1 and assessed by Investigator
Proportion of patients who attain a partial response (PR) or complete response (CR) per RECIST v1.1
Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire score (EORTC QLQ)-Core 30 (C30) at each post baseline visit
Assess changes over time in cancer-specific and patient-reported outcome instruments assessing global health status/quality of life, functional domains, and symptom burden.
Click on the lead sponsor to view all of their trials.
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
Lead sponsor
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Collaborator
GOG Foundation
Collaborator
