Avb500-Oc-004 A Phase 3, Randomized, Double-Blind, Adaptive, Placebo/Paclitaxel-Controlled Study Of Avb-S6-500 In Combination With Paclitaxel In Patients With Platinum-Resistant Recurrent Ovarian Cancer
Posted Date: Aug 3, 2021
- Investigator: Thomas Herzog
- Specialties: Gynecologic Oncology, Oncology, Ovarian Cancer
- Type of Study: Drug
The purpose of this study will be to compare efficacy and tolerability of AVB-S6-500 in combination with paclitaxel (Pac) versus placebo versus Pac. This is a Phase 3 study of AVB-S6-500 in combination with Pac in patients with platinum resistant recurrent ovarian cancer. Efficacy will be determined by looking at anti-tumor activity of AVB-S6-500 in combination with Pac measured by progression free survival in patients receiving AVB-S6-500+ Pac versus patients receiving Placebo+Pac.
Only Patients With High-Grade Serous Adenocarcinoma Histology Are Eligible. Eastern Cooperative Oncology Group Performance Status (Ecog-Ps) Of 0 To 1. Patient Must Have Received At Least 1 But Not More Than 4 Prior Therapy Regimens. Patient Must Have Measurable Disease According To Recist V1.1 Criteria. No Tumors In The Breast Or Bone. No Untreated Central Nervous System (Cns) Metastases.No Primary Platinum-Refractory Disease. No Patient That Is Being Treated With Concurrent Anticancer Therapy Or Other Interventional Treatments Administered For Their Underlying Ovarian Cancer.
Phase 3, Ovarian, Gyn Onc
For More Information:
Uc Cancer Center