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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 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.

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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

Conditions Studied

Neuroblastoma

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

FieldValue
Enrollment Target 98 participants
Start Date 2024-12-06
Est. Completion 2035-12-01
Phase Phase 2

Sponsor

Giselle Sholler

20 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06540963

The ClinicalTrials.gov registry entry for NCT06540963 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 98 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 238-participant average among 94 other Neuroblastoma trials with a reported enrollment target (59% lower). The listed sponsor is Giselle Sholler, which has 20 total studies on file at ClinicalTrials.gov.

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 reports 11 study locations spanning 10 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.