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NCT06541262 · ClinicalTrials.gov registry record · Phase 1
Silmitasertib (CX-4945) in Combination With Chemotherapy for Relapsed Refractory Solid Tumors
A Phase 1 study of Neuroblastoma and Osteosarcoma, sponsored by Milton S. Hershey Medical Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 104
- Enrollment target
- 20
- Study locations
NCT06541262 is a Phase 1 study of Neuroblastoma and Osteosarcoma that is actively recruiting participants, run by Milton S. Hershey Medical Center. The registered enrollment target is 104 participants, below the 238-participant average among 94 other Neuroblastoma trials with a reported enrollment target (56% lower). The trial reports 20 study locations across 15 states.
The verdict
NCT06541262, a Phase 1 study of Neuroblastoma and Osteosarcoma, is actively recruiting participants, sponsored by Milton S. Hershey Medical Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 104 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the investigational drug, silmitasertib (a pill taken by mouth), in combination with FDA approved drugs for solid tumors. An investigational drug is one that has not been approved by the U.S. Food \& Drug Administration (FDA), or any other regulatory authorities around the world for use alone or in combination with any drug, for the condition or illness it is being used to treat. The goals of this part of the study are: * Establish a recommended dose of silmitasertib in combination with chemotherapy * Test the safety and tolerability of silmitasertib in combination with chemotherapy in subjects 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
Interventions
- DRUG Temozolomide
- DRUG Vincristine
- DRUG Silmitasertib
- DRUG Irinotecan
Study Locations (20)
Florida
- University of Florida - Gainesville
- Nicklaus Children's Hospital - Miami
- Arnold Palmer Hospital for Children - Orlando
- St. Joseph's Children's Hospital - Tampa
California
- UCSF Benioff Children's Hospital Oakland - Oakland
- Rady Children's Hospital - San Diego
Missouri
- Children's Mercy Hospitals and Clinics - Kansas City
- Cardinal Glennon Children's Medical Center - St Louis
Alabama
- University of Alabama/Children's of Alabama - Birmingham
Arizona
- Phoenix Children's Hospital - Phoenix
Hawaii
- Kapiolani Medical Center for Women and Children - Honolulu
Kentucky
- Norton Children's Research Institute/Affiliated with University of Louisville School of Medicine - Louisville
New Jersey
- Hackensack University Medical Center - Hackensack
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 104 participants |
| Start Date | 2024-10-30 |
| Est. Completion | 2035-11-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06541262
The ClinicalTrials.gov registry entry for NCT06541262 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 104 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 (56% lower). The listed sponsor is Milton S. Hershey Medical Center, which has 396 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Neuroblastoma appearing as the primary indexed condition, and to 4 interventions - of which Temozolomide is the first listed.
NCT06541262 reports 20 study locations spanning 15 distinct geographic areas - top geographies include Florida, California, Missouri.
Frequently Asked Questions
What is clinical trial NCT06541262 about?
NCT06541262 is a clinical study titled "Silmitasertib (CX-4945) in Combination With Chemotherapy for Relapsed Refractory Solid Tumors". The purpose of this study is to evaluate the investigational drug, silmitasertib (a pill taken by mouth), in combination with FDA approved drugs for solid tumors. An investigational drug is one that has not been approved by the U.S. Food \& Drug Administration (FDA), or any other regulatory authorit...
What is the current status of trial NCT06541262?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 104 participants. The study started on 2024-10-30. Estimated completion is 2035-11-01.
What conditions does trial NCT06541262 study?
This clinical trial studies the following conditions: Neuroblastoma, Osteosarcoma, Rhabdomyosarcoma, Ewing Sarcoma, Liposarcoma.
What interventions are being tested in trial NCT06541262?
The interventions under investigation include: Temozolomide (DRUG), Vincristine (DRUG), Silmitasertib (DRUG), Irinotecan (DRUG).
Who is sponsoring clinical trial NCT06541262?
This trial is sponsored by Milton S. Hershey Medical Center, which has 396 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06541262 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Hawaii. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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.