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

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byKatherine C Fuh, M.D., Ph.D.

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Washington University School of Medicine

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Katherine C Fuh, M.D., Ph.D.

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

Inclusion Criteria

Histologic diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal cancer per pre-treatment biopsies by laparoscopy or interventional radiology or CT-guided core biopsy.

High grade serous adenocarcinoma

Endometrioid adenocarcinoma

See 7 more

Treatment Details

Interventions

AVB-S6-500 (AXL Inhibitor)
Carboplatin (Alkylating agents)
Paclitaxel (Alkylating agents)

Participant Groups

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).

Carboplatin is already approved in Canada for the following indications: