NCT03607955

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

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

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Epithelial Ovarian Cancer
• Primary Peritoneal Carcinoma
• Fallopian Tube Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-06-30
• Primary completion: 2024-08-31
• Completion: 2029-08-31
• First posted: 2018-07-31
• Last updated: 2021-09-29

Regulatory

• FDA-regulated drug study