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Alkylating agents

AVB-S6-500 + Paclitaxel + Carboplatin for Ovarian Cancer

Phase 1
Waitlist Available
Led By Katherine C Fuh, M.D., Ph.D.
Research Sponsored by Washington University School of Medicine
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 1 year after debulking surgery (approximately 64 weeks)
Awards & highlights

Summary

The receptor tyrosine kinase AXL is a pathway that plays a crucial role in metastasis and chemoresistance. Overexpression of AXL has been associated with metastasis, recurrence, and chemoresistance in various cancer including ovarian cancer\[16, 17\]}. Targeting AXL is an attractive approach because it is overexpressed among patients with epithelial ovarian cancer and strongly associated with advanced stages, high grade cancer and shorter median survival time. AVB-S6-500 is a potent AXL inhibitor by binding to the ligand Gas6. Pre-clinical studies found that AVB-S6-500 was efficacious in ovarian cancer xenograft tumor models. Interventions which would increase the proportion of patients achieving pCR in this patient population could impact survival favorably and are of interest for study.

Eligible Conditions
  • Ovarian Cancer
  • Peritoneal Carcinoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year after debulking surgery (approximately 64 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year after debulking surgery (approximately 64 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose limiting toxicities (DLTs) of AVB-S6-500 in combination with and following conventional chemotherapy and maintenance
Maximum tolerated dose (MTD) of AVB-S6-500 in combination with and following conventional chemotherapy and maintenance
Secondary outcome measures
Objective clinical response (cOR) of AVB-S6-500 in combination with and following conventional chemotherapy and maintenance
Overall survival (OS) by long-term follow-up of AVB-S6-500 in combination with and following conventional chemotherapy and maintenance
Pathological complete response (pCR) at the time of interval debulking surgery of AVB-S6-500 in combination with and following conventional chemotherapy and maintenance
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: AVB-S6-500 + Paclitaxel + CarboplatinExperimental Treatment8 Interventions
* Paclitaxel will be given intravenously at a dose of 175 mg/m\^2 on an outpatient basis over 3 hours on Day 1 of each 21-day cycle * Carboplatin will be given intravenously at a dose of AUC 6 over 30 minutes on Day 1 of each cycle of chemotherapy * AVB-S6-500 will be given at doses based on the dose escalation schema * The investigators will continue dosing AVB-S6-500 until 1 week prior to surgery and continuing after surgery. Maintenance dosing q2 weeks will begin with Cycle 7A/7B and be given every 2 weeks for 12 months through Cycle 19 (total of 13 maintenance cycles).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
FDA approved
AVB-S6-500
2018
Completed Phase 1
~100
Carboplatin
FDA approved
Peripheral blood
2018
Completed Phase 2
~110

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,970 Previous Clinical Trials
2,308,623 Total Patients Enrolled
6 Trials studying Ovarian Cancer
558 Patients Enrolled for Ovarian Cancer
Aravive, Inc.Industry Sponsor
8 Previous Clinical Trials
624 Total Patients Enrolled
1 Trials studying Ovarian Cancer
53 Patients Enrolled for Ovarian Cancer
Katherine C Fuh, M.D., Ph.D.Principal InvestigatorWashington University School of Medicine
~0 spots leftby Sep 2025
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