drugset / Trial / NCT03639246
Efficacy and Safety Study of AVB-S6-500 in Patients With Platinum-Resistant Recurrent Ovarian Cancer
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Batiraxcept | Protein / enzyme biologic | — | — |
| Background | Paclitaxel | Small molecule | — | — |
| Background | Pegylated liposomal doxorubicin | Unknown | — | — |