Genitourinary & Gynecologic Cancer
A Phase 2 Study of the IDO Inhibitor Epacadostat versus Tamoxifen for Subjects with Biochemical-recurrent-only EOC, PPC or FTC following Complete Remission with First-line Chemotherapy
Clinical Study Purpose
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.
Clinical Study Summary
Clinical Study Locations
Key Inclusion and Exclusion Criteria
Inclusion Criteria
- Subjects who have received first-line chemotherapy, which must have been a platinum-containing regimen.
- Subjects who received maintenance paclitaxel or, bevacizumab, or alternative maintenance therapy (e.g. vaccines) are eligible for enrollment provided they have discontinued therapy at least 4 weeks for prior taxane and, at least 8 weeks for bevacizumab, or received medical monitor approval for time lapse from alternative maintenance therapy prior to randomization and recovered from toxicities to less than Grade 2.
Exclusion Criteria
- Subjects with any evidence of new disease (> 1 cm) including new ascites as confirmed by imaging.
- Any other prior antitumor systemic therapy except for first-line chemotherapy associated with previous CA 125 normalization or maintenance paclitaxel, bevacizumab, or alternative maintenance therapy as approved by the medical monitor.
Protocol Summary
Progression free survival (PFS) using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 definition of progression as determined by the investigator.
Timeframe: 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.
Timeframe: 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.
Timeframe: 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.
Timeframe: 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.
Timeframe: 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.