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

NCT04729608 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 366

Last updated 2023-10-30

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Batiraxcept

Batiraxcept is an experimental drug

DRUG

Paclitaxel

Paclitaxel is the standard of care, background therapy

OTHER

Placebo

Matching placebo

Sponsors & Collaborators

  • GOG Foundation

    collaborator NETWORK

  • European Network of Gynaecological Oncological Trial Groups (ENGOT)

    collaborator OTHER

  • Aravive, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-22
Primary Completion
2023-08-04
Completion
2023-08-04
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada
  • China
  • Czechia
  • France
  • Georgia
  • Italy
  • Poland
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04729608 on ClinicalTrials.gov