Phase 3 Study of Azenosertib Versus Chemotherapy in Platinum-Resistant Ovarian Cancers Positive for Cyclin E1 Protein Expression

INTERVENTION: Product Name: , Product Code:SCP134598913, Pharmaceutical Form: , Other descriptive name: , Strength: , Product Name: Azenosertib (also known as ZN‐c3; KP‐2638), Product Code:PRD9495924, Pharmaceutical Form: FILM‐COATED TABLET, Other descriptive name: , Strength: , Product Name: Azenosertib (also known as ZN‐c3; KP‐2638), Product Code:PRD11601259, Pharmaceutical Form: FILM‐COATED TABLET, Other descriptive name: , Strength: , Product Name: , Product Code:SCP1128788, Pharmaceutical Form: , Other descriptive name: , Strength: , Product Name: Akynzeo 300 mg/0.5 mg hard capsules, Product Code:PRD2825038, Pharmaceutical Form: CAPSULE, HARD, Other descriptive name: , Strength: , Product Name: , Product Code:SCP119562649, Pharmaceutical Form: , Other descriptive name: , Strength: , Product Name: , Product Code:SCP129816, Pharmaceutical Form: , Other descriptive name: , Strength: CONDITION: High‐Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer ; MedDRA version: 21.0Level: LLTClassification code: 10016183Term: Fallopian tube cancer NOS Class: 10029104 ; MedDRA version: 20.0Level: LLTClassification code: 10052171Term: Peritoneal carcinoma Class: 10029104 ; MedDRA version: 20.0Level: LLTClassification code: 10033130Term: Ovarian cancer NOS Class: 10029104 Therapeutic area: Diseases [C] ‐ Neoplasms [C04] PRIMARY OUTCOME: Main Objective: Evaluate PFS in subjects randomized to azenosertib versus Investigator’s choice of chemotherapy Primary end point(s): Progression Free Survival (PFS) per RECIST v1.1 and assessed by Investigator Secondary Objective: 1. Key Secondary Objective: Evaluate OS in subjects randomized to azenosertib versus Investigator’s choice of chemotherapy, 2. Key Secondary Objective: Evaluate ORR in subjects randomized to azenosertib versus Investigator’s choice of chemotherapy, 3. Key Secondary Objective: Evaluate PROs and quality of life in subjects randomized to azenosertib versus Investigator’s choice of chemotherapy, 4. Additional Secondary Objective: Evaluate measures of antitumor activity in subjects randomized to azenosertib versus Investigator’s choice of chemotherapy, 5. Additional Secondary Objective: Evaluate the safety and tolerability in subjects randomized to azenosertib versus Investigator’s choice of chemotherapy SECONDARY OUTCOME: Secondary end point(s):Additional Secondary Endpoint: PFS, ORR, and Duration Of Response (DOR) as defined by RECIST v1.1 and as assessed by BICR • DOR as defined by RECIST v1.1 and as assessed by Investigator • CA‐125 response as defined by GCIG criteria • PFS2 Secondary end point(s):Additional Secondary Endpoint: TEAEs graded according to NCI‐CTCAE v5.0, dose interruptions, dose reductions, and permanent discontinuations of study treatment Secondary end point(s):Key secondary endpoint: Change from baseline in the following: • Abdominal/gastrointestinal symptoms as measured by EORTC‐QLQ‐OV28 (Items 31 to 36) • Remaining PRO symptom scales as measured by EORTC‐QLQ‐OV28 (Items 37 to 49) • Global Health Status and QOL as measured by EORTC‐QLQ‐C30 (Items 29 and 30) and EQ‐5D‐5L VAS Secondary end point(s):Key secondary endpoint: Objective Response Rate (ORR) per RECIST v1.1 and assessed by Investigator Secondary end point(s):Key secondary endpoint: Overall Survival (OS) INCLUSION CRITERIA: 1. Pre‐screening INCLUSION CRITERIA: Provision of evaluable, most recent FFPE tumor tissue block (preferably collected within the previous 3 years; if multiple tissue blocks are available, the most recently collected tissue sample is to be submitted) or 15 serially sectioned slides freshly cut from an FFPE block., 10. Prior mirvetuximab is required if approved and available for eligible subjects, 11. Adequate hematologic and organ function during the Screening Period For the complete Inclusion Criteria, please refer to the study protocol, 2. Provision of signed Main ICF, 3. Female Age =18 years (or age of majority in local region) at the time of informed consent., 4. Performance status: Eastern Cooperative Oncology Group (ECOG) score of = 1, 5. Histologically or cytologically diagnosed high‐grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer, 6. Subjects must have at least one measurable lesion as defined by RECIST Guideline Version 1.1, 7.