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Protein Kinase Inhibitor

CX-4945 for Medulloblastoma

Phase 1 & 2
Waitlist Available
Led By Ralph Salloum, MD
Research Sponsored by Pediatric Brain Tumor Consortium
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All Phases: Must have a diagnosis of SHH medulloblastoma that is recurrent or progressive which was confirmed histologically and subgrouping was completed using a CLIA certified methylation based test.
Phase II Skeletally-mature: Patients must be skeletally-mature, defined as females with a bone age ≥14 years and males with a bone age ≥ 16 years OR have a chronological age >18 years. Must have bi-dimensionally measurable disease.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years from enrollment
Awards & highlights

Study Summary

This trial is testing a new drug, CX-4945, for patients with a specific type of brain cancer that has come back after treatment.

Who is the study for?
This trial is for patients with recurrent SHH medulloblastoma, a type of brain cancer. Participants must be skeletally mature or over 18 years old, have measurable disease, and have undergone prior treatments including radiation. They should not be nursing mothers or have other cancers (unless in remission for 5+ years), significant unrelated illnesses, certain gastrointestinal disorders, or an abnormal heart rhythm (QTc >480ms).Check my eligibility
What is being tested?
The trial is testing the safety and effects of CX-4945 (silmitasertib sodium) on patients with recurrent SHH medulloblastoma. It includes both Phase I and II stages as well as a surgical study where some participants may undergo surgery.See study design
What are the potential side effects?
While specific side effects are not listed here, common ones associated with cancer drugs like CX-4945 could include nausea, fatigue, liver issues, changes in blood counts leading to increased infection risk or bleeding problems. Patients will be monitored closely for any adverse reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My medulloblastoma is recurring or worsening and was confirmed with specific tests.
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I am an adult or a teen with mature bones and my disease can be measured in two ways.
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I am under 18, my growth plates are not fully developed, and my body size fits the study requirements.
Select...
I need surgery, am over 3 years old, and can take CX-4945 before my surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years from enrollment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years from enrollment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase I: Maximum tolerated dose of CX-4945
Phase I: Plasma pharmacokinetics of CX-4945 in skeletally-immature children
Phase II: Sustained objective response rate (PR-CR) rate in the skeletally mature cohort
+1 more
Secondary outcome measures
Objective response rate in the skeletally-immature cohort
Plasma pharmacokinetics of CX-4945 in skeletally-mature subjects
Progression free survival
+2 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: SurgicalExperimental Treatment1 Intervention
Subjects who are eligible for the Phase I or Phase II arm of the trial and are candidates for surgery, may be enrolled in the surgical arm prior to initiation of the Phase I or Phase II treatment.
Group II: Phase II - Skeletally-matureExperimental Treatment1 Intervention
Skeletally-mature subjects with refractory or recurrent medulloblastoma of the SHH group
Group III: Phase I - Skeletally-immatureExperimental Treatment1 Intervention
Skeletally-immature children with refractory or recurrent medulloblastoma of the SHH group

Find a Location

Who is running the clinical trial?

American Lebanese Syrian Associated Charities (ALSAC)UNKNOWN
8 Previous Clinical Trials
625 Total Patients Enrolled
3 Trials studying Medulloblastoma
367 Patients Enrolled for Medulloblastoma
Pediatric Brain Tumor ConsortiumLead Sponsor
37 Previous Clinical Trials
1,522 Total Patients Enrolled
9 Trials studying Medulloblastoma
547 Patients Enrolled for Medulloblastoma
St. Jude Children's Research HospitalOTHER
427 Previous Clinical Trials
5,306,517 Total Patients Enrolled
13 Trials studying Medulloblastoma
2,836 Patients Enrolled for Medulloblastoma

Media Library

CX-4945 (Protein Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03904862 — Phase 1 & 2
Medulloblastoma Research Study Groups: Phase II - Skeletally-mature, Surgical, Phase I - Skeletally-immature
Medulloblastoma Clinical Trial 2023: CX-4945 Highlights & Side Effects. Trial Name: NCT03904862 — Phase 1 & 2
CX-4945 (Protein Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03904862 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are being helped by this research?

"That is correct, the available information does point to this clinical trial being open for recruitment. The original posting was on March 18th, 2019 with the most recent update coming on August 30th, 2022. They are trying to enroll 60 individuals at 12 different locations."

Answered by AI

Are people still signing up for this experiment?

"The most up-to-date information indicates that this trial is actively recruiting patients. The listing was first posted on March 18th, 2019 and was last updated on August 30th, 2020."

Answered by AI

Are research facilities in Canada actively pursuing this line of inquiry?

"A total of 12 sites are recruiting patients for this clinical trial, with Memorial Sloan-Kettering Cancer Center in New york, Baylor College of Medicine in Houston, and Ann & Robert H. Lurie Children's Hospital of Chicago in Chicago amongst them."

Answered by AI

Do we have any previous data to review for CX 4945?

"So far, CX 4945 has been trialled 3 times with the most recent study taking place at Grenoble Alps Hospital in 2017. Presently, there are 3 more ongoing clinical trials, one of which is based in New york City."

Answered by AI

What are the ultimate goals of this experiment?

"The purpose of this 4-week trial is to study the efficacy of CX-4945 in skeletally-mature subjects with advanced solid tumors. The primary endpoint is response rate, as measured by PR or CR, and secondary objectives include reduction in CK2 activity, percentage of genomic alterations, and plasma drug concentration of CX-4945."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Testing the Safety and Tolerability of CX-4945 in Patients With Recurrent Medulloblastoma Who May or May Not Have Surgery
2019. "Testing the Safety and Tolerability of CX-4945 in Patients With Recurrent Medulloblastoma Who May or May Not Have Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03904862.
~29 spots leftby Dec 2028
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