The intention of the study is to demonstrate superiority of AZD5335 versus standard of care by assessment of progression-free survival (PFS) in women with high-grade, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, expressing high or low FRα levels.
Approximately 1100 adult participants will be enrolled after central FRα testing into two independent cohorts (about 550 FRα-high and 550 FRα-low) and randomized 1:1 within each cohort to receive AZD5335 or the relevant standard of care (mirvetuximab soravtansine in FRα-high; investigator's choice single-agent chemotherapy in FRα-low). Participants will remain on assigned treatment and undergo regular tumor evaluations per RECIST v1.1 until disease progression or another reason for treatment discontinuation. All participants will be followed for overall survival. An independent data monitoring committee (IDMC) of external experts will periodically review unblinded safety and interim efficacy to confirm participant safety and study integrity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,100
Progression free Survival (PFS)
PFS is defined as the time from randomization to radiographic progression as assessed by the Investigator per RECIST v1.1, or death due to any cause.
Time frame: Up to approximately 5 years
Overall survival (OS)
OS is defined as the time from randomisation until the date of death due to any cause.
Time frame: Up to approximately 5 years
AstraZeneca Clinical Study Information Center
CONTACT
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chemotherapy
chemotherapy
Research Site
Fort Lauderdale, Florida, United States
NOT_YET_RECRUITINGResearch Site
Jupiter, Florida, United States
RECRUITINGResearch Site
Evanston, Illinois, United States
NOT_YET_RECRUITINGResearch Site
Peoria, Illinois, United States
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Urbana, Illinois, United States
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Towson, Maryland, United States
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Burlington, Massachusetts, United States
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Worcester, Massachusetts, United States
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Minneapolis, Minnesota, United States
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Omaha, Nebraska, United States
NOT_YET_RECRUITING...and 115 more locations