This is an open-label, randomized, phase 2 study of an IDO inhibitor, INCB024360 (epacadostat) versus tamoxifen in biochemical recurrent only ovarian cancer patients following complete remission with first-line chemotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
83
Progression free survival (PFS) using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 definition of progression as determined by the investigator.
Time frame: PFS is defined as the number of days from randomization to the earlier of death or disease progression for up to 36 months.
Safety and tolerability of epacadostat by adverse event assessment.
Time frame: Adverse events assessed every 2 weeks during cycle 1, then every 28 days thereafter until each subject's death or disease progression or for up to 36 months, whichever is longest.
Cancer Antigen (CA) 125 response rate, using Gynaecologic Cancer Intergroup (GCIG) criteria.
Time frame: CA 125 response rate defined as at least 50% reduction on study as compared to pretreatment sample; pre-treatment sample must be at least 2x ULN and response must be sustained for at least 28 days.
Duration of overall survival.
Time frame: Overall survival followed every 12 weeks until last date known to be alive, until subjects withdraw consent or up to 36 months, whichever is longest.
Progression-free survival using RECIST 1.1 definition of objective progression as determined by the central imaging laboratory.
Time frame: Progression free survival defined by central imaging lab using RECIST 1.1 assessed at 8 week intervals, retrospectively, until disease progression, death, subject withdraw of consent or up to 36 months, whichever is longest.
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La Jolla, California, United States
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Los Angeles, California, United States
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San Francisco, California, United States
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Evanston, Illinois, United States
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Joliet, Illinois, United States
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Iowa City, Iowa, United States
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Covington, Louisiana, United States
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Baltimore, Maryland, United States
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Detroit, Michigan, United States
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Minneapolis, Minnesota, United States
...and 39 more locations