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NCT06540963 · ClinicalTrials.gov registry record · Phase 2
Tipifarnib and Naxitamab for Relapsed/Refractory Neuroblastoma
A Phase 2 study of Neuroblastoma, sponsored by Giselle Sholler.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 98
- Enrollment target
- 11
- Study locations
NCT06540963: Recruiting Phase 2 study of Neuroblastoma, sponsored by Giselle Sholler.
NCT06540963 is a Phase 2 study of Neuroblastoma that is actively recruiting participants, run by Giselle Sholler. The registered enrollment target is 98 participants, below the 238-participant average among 94 other Neuroblastoma trials with a reported enrollment target (59% lower). The trial reports 11 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06540963, a Phase 2 study of Neuroblastoma, is actively recruiting participants, sponsored by Giselle Sholler.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 98 participants
- Enrollment target
- 11
- Study locations
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
Primary Outcome
To evaluate the activity of Tipifarnib in combination with Naxitamab based on Overall response rate (ORR)
Conditions Studied
Interventions
- DRUG Naxitamab
- DRUG Tipifarnib
Study Locations (11)
Florida
- Nicklaus Children's Hospital - Miami
- Arnold Palmer Hospital for Children - Orlando
Arkansas
- Arkansas Children's Hospital - Little Rock
Connecticut
- Connecticut Children's Hospital - Hartford
Hawaii
- Kapiolani Medical Center for Women and Children - Honolulu
Missouri
- Cardinal Glennon Children's Medical Center - St Louis
North Carolina
- Duke University - Durham
Oregon
- Randall Children's Hospital - Portland
Pennsylvania
- Penn State Milton S. Hershey Medical Center and Children's Hospital - Hershey
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2024-12-06 |
| Est. Completion | 2035-12-01 |
| Phase | Phase 2 |
What NCT06540963 shows while recruiting
NCT06540963 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, below the 238-participant average among 94 other Neuroblastoma trials with a reported enrollment target (59% lower).
The record links to 1 condition, with Neuroblastoma appearing as the primary indexed condition, and to 2 interventions - of which Naxitamab is the first listed.
NCT06540963 lists 11 locations in 10 states (Florida, Arkansas, Connecticut).
Frequently Asked Questions
What is clinical trial NCT06540963 about?
NCT06540963 is a clinical study titled "Tipifarnib and Naxitamab for Relapsed/Refractory Neuroblastoma". 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 plac...
What is the current status of trial NCT06540963?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 98 participants. The study started on 2024-12-06. Estimated completion is 2035-12-01.
What conditions does trial NCT06540963 study?
This clinical trial studies the following conditions: Neuroblastoma.
What interventions are being tested in trial NCT06540963?
The interventions under investigation include: Naxitamab (DRUG), Tipifarnib (DRUG).
Who is sponsoring clinical trial NCT06540963?
This trial is sponsored by Giselle Sholler, which has 20 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06540963 being conducted?
This trial has 11 study locations across Arkansas, Connecticut, Florida, Hawaii, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Neuroblastoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06540963's enrollment target sits among peer trials
98 30th of 94 higher than 65 of 94 other Neuroblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neuroblastoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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