NCT06540963

Tipifarnib and Naxitamab for Relapsed/Refractory Neuroblastoma

Phase II Trial of Tipifarnib and Naxitamab for Relapsed/Refractory Neuroblastoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 98 (estimated)
• Sponsor: Giselle Sholler · Academic / Other
• Sex: All
• Age: 1 Year – 21 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the investigational drug, tipifarnib (a pill taken by mouth), in combination with the Food and Drug Administration (FDA) approved drug, naxitimab, administered intravenously (IV; a liquid that continuously goes into your body through a tube that has been placed during a surgery into one of your veins). Naxitamab is FDA approved for pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy, it may not be approved in the type of disease used in this study. The goals of this part of the study are: * Test the safety and tolerability of tipifarnib in combination with naxitimab in patients with cancer * To determine the activity of study treatments chosen based on: * How each subject responds to the study treatment * How long a subject lives without their disease returning/progressing

Conditions

• Neuroblastoma

Interventions

Type	Name	Description
DRUG	Tipifarnib	Tablet
DRUG	Naxitamab	IV

Timeline

• Start date: 2024-12-06
• Primary completion: 2030-12-01
• Completion: 2035-12-01
• First posted: 2024-08-07
• Last updated: 2026-03-02

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study