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Tipifarnib and Naxitamab for Relapsed/Refractory Neuroblastoma

NCT06540963 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2026-04-28

No results posted yet for this study

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

Interventions

DRUG

Tipifarnib

Tablet

DRUG

Naxitamab

IV

Sponsors & Collaborators

  • Giselle Sholler

    lead OTHER

Principal Investigators

  • Valerie Brown, MD, PhD · Beat Childhood Cancer

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-06
Primary Completion
2030-12-01
Completion
2035-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT06540963 on ClinicalTrials.gov