drugset / Trial / NCT04729608

Batiraxcept (AVB-S6-500)/Placebo in Combination With Paclitaxel in Patients With Platinum-Resistant Recurrent Ovarian Cancer

NCT04729608 ↗

RandomizedParallel-groupTriple-blindTreatment

Summary

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.

Timeline

Start
2021-04-22
Primary completion
2023-08-04
Completion
2023-08-04

Outcome

Outcome not reported

Stopped: “There were no significant differences in median PFS between batiraxcept + paclitaxel or paclitaxel alone arms. There was no detriment to overall survival. No new safety signals were identified.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Batiraxcept Protein / enzyme biologic — —
Background Paclitaxel Small molecule — —

Indications

No indication recorded.