A Randomized, Open-Label Phase 3 Study of Azenosertib Versus Investigator’s Choice of Chemotherapy in Platinum-Resistant High-Grade Serous Ovarian, Primary Peritoneal, or Fallopian Tube Cancers Positive for Cyclin E1 Protein Expression

Conditions

High-Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Brief summary

Progression Free Survival (PFS) per RECIST v1.1 and assessed by Investigator

Detailed description

Key secondary endpoint: Overall Survival (OS), Key secondary endpoint: Objective Response Rate (ORR) per RECIST v1.1 and assessed by Investigator, 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, 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, Additional Secondary Endpoint: TEAEs graded according to NCI-CTCAE v5.0, dose interruptions, dose reductions, and permanent discontinuations of study treatment

Related papers

No related papers found yet.

Interventions

DRUGTOPOTECAN

DRUGAzenosertib (also known as ZN-c3; KP-2638)

DRUGGEMCITABINE

DRUGAkynzeo 300 mg/0.5 mg hard capsules

DRUGDOXORUBICIN

DRUGPACLITAXEL

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression Free Survival (PFS) per RECIST v1.1 and assessed by Investigator	—

Secondary

Measure	Time frame
Key secondary endpoint: Overall Survival (OS), Key secondary endpoint: Objective Response Rate (ORR) per RECIST v1.1 and assessed by Investigator, 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, 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, Additional Secondary Endpoint: TEAEs graded according to NCI-CTCAE v5.0, dose interruptions, dose reductions, and permanent discontinuations of study treatment	—

Measure

Time frame

Key secondary endpoint: Overall Survival (OS), Key secondary endpoint: Objective Response Rate (ORR) per RECIST v1.1 and assessed by Investigator, 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, 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, Additional Secondary Endpoint: TEAEs graded according to NCI-CTCAE v5.0, dose interruptions, dose reductions, and permanent discontinuations of study treatment

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Outcome results

None listed