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Testing the Safety and Tolerability of CX-4945 in Patients With Recurrent Medulloblastoma Who May or May Not Have Surgery

NCT03904862 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2025-10-30

No results posted yet for this study

Summary

This is a multi center, Phase I, Phase II and surgical study of the CX-4945 drug (silmitasertib sodium) for patients with recurrent SHH (Sonic Hedgehog) medulloblastoma

Conditions

Interventions

DRUG

CX 4945

CX-4945 is supplied as 200 mg capsules delivered orally as a formulated API

Sponsors & Collaborators

  • Senhwa Biosciences, Inc.

    collaborator INDUSTRY

  • National Cancer Institute (NCI)

    collaborator NIH

  • St. Jude Children's Research Hospital

    collaborator OTHER

  • Pediatric Brain Tumor Consortium

    lead NETWORK

Principal Investigators

  • Ralph Salloum, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-25
Primary Completion
2025-08-11
Completion
2025-08-11
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT03904862 on ClinicalTrials.gov