drugset / Trial / NCT03639246

Efficacy and Safety Study of AVB-S6-500 in Patients With Platinum-Resistant Recurrent Ovarian Cancer

NCT03639246

Phase 1 Completed 53 enrolled Aravive, Inc.
RandomizedParallel-groupDouble-blindTreatment

Summary

This is a Phase 1b/2 study of AVB-S6-500 in combination with pegylated liposomal doxorubicin (PLD) or paclitaxel (Pac) in patients with platinum resistant recurrent ovarian cancer. The phase 1b portion of the study is open label and patients will receive either AVB-S6-500+PLD or AVB-S6-500+ Pac. The Phase 2 portion of the study is randomized, double-blind, placebo-controlled study to compare efficacy and tolerability of AVB-S6-500 in combination with PLD or Pac versus placebo plus PLD or Pac.

Timeline

Start
2018-12-06
Primary completion
2021-01-08
Completion
2022-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Batiraxcept Protein / enzyme biologic
Background Doxorubicin Other / unclassified
Background Paclitaxel Small molecule

Indications