Tipifarnib and Naxitamab for Relapsed/Refractory Neuroblastoma
Public ClinicalTrials.gov record NCT06540963. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase II Trial of Tipifarnib and Naxitamab for Relapsed/Refractory Neuroblastoma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT06540963
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 98 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 1 Year to 21 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 5, 2024
- Primary completion
- Nov 30, 2030
- Completion
- Nov 30, 2035
- Last update posted
- Apr 27, 2026
2024 – 2035
United States locations
- U.S. sites
- 12
- U.S. states
- 10
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arkansas Children's Hospital | Little Rock | Arkansas | 72202 | Recruiting |
| Connecticut Children's Hospital | Hartford | Connecticut | 06106 | Recruiting |
| Nicklaus Children's Hospital | Miami | Florida | 33155 | Recruiting |
| Arnold Palmer Hospital for Children | Orlando | Florida | 32806 | Recruiting |
| Kapiolani Medical Center for Women and Children | Honolulu | Hawaii | 96813 | Recruiting |
| Cardinal Glennon Children's Medical Center | St Louis | Missouri | 63104 | Recruiting |
| Duke University | Durham | North Carolina | 27708 | Recruiting |
| Randall Children's Hospital | Portland | Oregon | 97227 | Recruiting |
| Penn State Milton S. Hershey Medical Center and Children's Hospital | Hershey | Pennsylvania | 17033 | Recruiting |
| Monroe Carrell Jr. Children's Hospital at Vanderbilt | Nashville | Tennessee | 37232 | Recruiting |
| Dell Children's Blood and Cancer Center | Austin | Texas | 78723 | Recruiting |
| Children's Medical Center | Dallas | Texas | 75235 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06540963, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 27, 2026 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06540963 live on ClinicalTrials.gov.