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Monoclonal Antibodies

Paclitaxel for Ovarian Cancer (AXLerate-OC Trial)

Phase 3
Waitlist Available
Research Sponsored by Aravive, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 20 months
Awards & highlights

AXLerate-OC Trial Summary

This trial is testing a new cancer drug combination to see if it is more effective and safe than the current standard of care for women with ovarian cancer that has returned despite previous treatment.

Eligible Conditions
  • Platinum-resistant Ovarian Cancer

AXLerate-OC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~20 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 20 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Anti-tumor activity of batiraxcept in combination with PAC measured by progression free survival (PFS) in patients receiving batiraxcept + PAC versus patients receiving Placebo+PAC
Secondary outcome measures
Overall survival
Other outcome measures
Anti-drug antibody (ADA) titers
Area under the batiraxcept concentration-time curve.
Cancer antigen 125 (CA-125) levels
+8 more

AXLerate-OC Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Batiraxcept+PACExperimental Treatment2 Interventions
Combination of batiraxcept and PAC
Group II: Placebo+PACPlacebo Group2 Interventions
Placebo-controlled arm with PAC
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
2011
Completed Phase 4
~5380

Find a Location

Who is running the clinical trial?

GOG FoundationNETWORK
41 Previous Clinical Trials
15,775 Total Patients Enrolled
7 Trials studying Ovarian Cancer
2,679 Patients Enrolled for Ovarian Cancer
European Network of Gynaecological Oncological Trial Groups (ENGOT)OTHER
35 Previous Clinical Trials
16,273 Total Patients Enrolled
10 Trials studying Ovarian Cancer
4,791 Patients Enrolled for Ovarian Cancer
Aravive, Inc.Lead Sponsor
8 Previous Clinical Trials
258 Total Patients Enrolled
1 Trials studying Ovarian Cancer
53 Patients Enrolled for Ovarian Cancer

Media Library

Batiraxcept (AVB-S6-500) (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04729608 — Phase 3
Ovarian Cancer Research Study Groups: Batiraxcept+PAC, Placebo+PAC
Ovarian Cancer Clinical Trial 2023: Batiraxcept (AVB-S6-500) Highlights & Side Effects. Trial Name: NCT04729608 — Phase 3
Batiraxcept (AVB-S6-500) (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04729608 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any patients currently needed to participate in this research?

"The trial, which was first advertised on April 22nd, 2021, is looking for more patients as of October 18th, 2022 according to the website clinicaltrials.gov."

Answered by AI

For what health problem is Batiraxcept most often prescribed as a treatment?

"The use of Batiraxcept has shown to be effective in treating neoplasm metastasis, kaposi sarcoma, and advance directives."

Answered by AI

Does Batiraxcept have any adverse side effects?

"There is a fair amount of clinical data that supports the efficacy of Batiraxcept, as it has progressed to Phase 3. Furthermore, there is a significant amount of data that affirms the safety of the medication, thus it receives a score of 3."

Answered by AI

How many different individuals are enrolled in this clinical trial?

"The clinical trial is still recruiting participants, as of the date of this writing. The first posting was on 4/22/2021, and the most recent update was on 10/18/2022. 350 individuals are needed for the study, which is being conducted at 86 sites."

Answered by AI

Could you tell me how many different locations are conducting this trial?

"86 hospitals, clinics, and medical research institutes are running this trial. While the trial is based in Indianapolis, Morgantown and Milwaukee, there are many other locations across the country. If you are interested in participating, try and select a site near you to limit travel."

Answered by AI

Are there any other drugs in development that work similarly to Batiraxcept?

"Batiraxcept was first pioneered in 1997 by the City of Hope Comprehensive Cancer Center. Since then, there have been a total of 19330 completed studies. Right now, 874 different trials are active, with a large number of these taking place in Indianapolis, Indiana."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+
Recent research and studies
clinicaltrials.govStudy
Batiraxcept (AVB-S6-500)/Placebo in Combination With Paclitaxel in Patients With Platinum-Resistant Recurrent Ovarian Cancer
2021. "Batiraxcept (AVB-S6-500)/Placebo in Combination With Paclitaxel in Patients With Platinum-Resistant Recurrent Ovarian Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04729608.
~93 spots leftby Apr 2025
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