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Paclitaxel + Carboplatin With AVB-S6-500 in Women With Stage III or IV Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Receiving Neoadjuvant Chemotherapy

NCT03607955 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2021-09-29

No results posted yet for this study

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.

Conditions

Interventions

DRUG

AVB-S6-500

AVB-S6-500 is supplied by Aravive Biologics

DRUG

Paclitaxel

Commercially available

DRUG

Carboplatin

Commercially available

PROCEDURE

Tissue from Diagnostic Laparoscopy

-For patients scheduled to undergo a diagnostic laparoscopy for tissue diagnosis prior to neoadjuvant chemotherapy, a tissue biopsy section from the ovary or an intra-abdominal implant will be performed

PROCEDURE

Tissue from Core biopsy

-Standard of care procedure but research specimens will be collected

PROCEDURE

Interval Debulking

* Standard of Care * Research tissue samples will be collected

PROCEDURE

Peripheral blood

-Before initiation of neoadjuvant chemotherapy and at the time of interval debulking surgery either pre-operatively, intraoperatively, or post-operatively.

PROCEDURE

Ascites collection

-A total of 25-100ml of ascites will be collected prior to chemotherapy treatment, if available.

Sponsors & Collaborators

  • Aravive, Inc.

    collaborator INDUSTRY

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Katherine C Fuh, M.D., Ph.D. · Washington University School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-30
Primary Completion
2024-08-31
Completion
2029-08-31
FDA Drug
Yes

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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 NCT03607955 on ClinicalTrials.gov