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.
A Phase 3 study to evaluate the efficacy, safety, and overall clinical benefit of azenosertib (ZN-c3) compared with Investigator's choice of chemotherapy in subjects with Platinum-Resistant, High-Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer. Azenosertib is a selective and orally bioavailable inhibitor of WEE1. In HGSOC, high Cyclin E1 protein drives replication stress and increases tumor reliance on WEE1-mediated G2/M checkpoint control. Treating tumor cells with azenosertib promotes premature cell cycle progression leading to increased replication stress and accumulation of DNA damage pushing cells to mitotic catastrophe resulting in tumor cell death.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
420
The 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 400 mg will be administered orally.
Site 0107
Phoenix, Arizona, United States
NOT_YET_RECRUITINGSite 0110
Antioch, California, United States
NOT_YET_RECRUITINGSite 0115
San Francisco, California, United States
NOT_YET_RECRUITINGSite 0101
Torrance, California, United States
RECRUITINGProgression 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.
Time frame: Up to approximately 24 months from the enrollment of the last subject
Overall survival
Time from randomization until death due to any cause
Time frame: Up to approximately 24 months from the enrollment of the last subject
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.
Time frame: Up to approximately 24 months from the enrollment of the last subject
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
Time frame: Up to approximately 24 months from the enrollment of the last subject
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.
Time frame: Up to approximately 24 months from the enrollment of the last subject
Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire score (EORTC QLQ)-OV28 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.
Time frame: Up to approximately 24 months from the enrollment of the last subject
Change from baseline in EQ-5D-5L score 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.
Time frame: Up to approximately 24 months from the enrollment of the last subject
Number of Subjects experiencing treatment emergent adverse events (TEAEs)
Assess adverse events occurring for the first time or worsening of a pre-existing event during the treatment period until 30 days after the last dose of study drug
Time frame: Up to approximately 24 months and 30 days from the enrollment of the last subject
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Site 0111
Camden, New Jersey, United States
NOT_YET_RECRUITINGSite 0108
Columbus, Ohio, United States
NOT_YET_RECRUITINGSite 0105
Portland, Oregon, United States
NOT_YET_RECRUITINGSite 0109
Philadelphia, Pennsylvania, United States
NOT_YET_RECRUITINGSite 0113
Philadelphia, Pennsylvania, United States
NOT_YET_RECRUITINGSite 0114
Willow Grove, Pennsylvania, United States
NOT_YET_RECRUITING...and 48 more locations