This is a randomized, double-blind Phase 3 study to compare the efficacy and safety of batiraxcept (AVB-S6-500) in combination with paclitaxel (PAC) versus placebo in combination with PAC in patients with platinum resistant recurrent ovarian cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
366
Batiraxcept is an experimental drug
Paclitaxel is the standard of care, background therapy
Matching placebo
Anti-tumor activity of batiraxcept in combination with PAC measured by progression free survival (PFS) in patients receiving batiraxcept + PAC versus patients receiving Placebo+PAC
PFS is the time interval between randomization and radiologically documented disease progression or death, whichever comes first.
Time frame: 4 months
Overall survival
Time following the treatment until death
Time frame: 20 months
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