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MAPK Inhibitor
Ulixertinib for Brain Tumor
Phase 1
Recruiting
Led By Nazanin Majd, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year.
Awards & highlights
Study Summary
This trial tests if a drug can get to brain tumors in people with recurrent cancer.
Who is the study for?
Adults with recurrent low-grade gliomas, a type of brain tumor, who've had prior treatments like radiation or chemotherapy can join. They must have proper organ function and be able to consent (or have a legal representative consent). Pregnant women and those with certain infections or conditions that could interfere with the study are excluded.Check my eligibility
What is being tested?
The trial is testing Ulixertinib's ability to cross the blood-brain barrier in patients with recurring brain tumors. It involves adults who meet specific surgical criteria and have confirmed diagnoses based on histological and molecular standards.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include typical reactions to cancer drugs such as fatigue, nausea, headaches, skin reactions at injection sites, liver toxicity, and increased risk of infection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion; an average of 1 year.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Trial Design
2Treatment groups
Experimental Treatment
Group I: Cohort 2: CIC-mutated oligodendrogliomaExperimental Treatment1 Intervention
Group II: Cohort 1: NF1-muated low-grade gliomaExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ulixertinib
2020
Completed Phase 1
~20
Find a Location
Who is running the clinical trial?
BioMed Valley Discoveries, IncIndustry Sponsor
16 Previous Clinical Trials
718 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,974 Previous Clinical Trials
1,789,456 Total Patients Enrolled
Nazanin Majd, MDPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
29 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I finished my radiotherapy less than 12 weeks ago.I have not been treated with bevacizumab in the last 6 months.My cancer is mainly in my spinal cord.I agree to use effective birth control during and for 3 months after the study.I agree to use contraception during and for 3 months after the study.I have an immune system disorder or have been on immune-weakening medication recently.I cannot have surgery for my condition right now.I have another cancer that is getting worse or needs treatment.I am currently being treated for an infection.I cannot stop taking certain medications that are not allowed in the study.I currently have or had an implanted chemotherapy device.I meet the required imaging and surgical criteria.My cancer's type and genetic features match the study's requirements.I have or am at risk for eye blood vessel blockage or swelling.I have received specific treatments.I am 18 years old or older.I am on a stable or decreasing dose of steroids, not exceeding 16mg of dexamethasone daily.I am mostly able to take care of myself.My recent tests show my organs are functioning well.I haven't had chemotherapy or targeted therapy in the last 3 weeks, or I've recovered from their side effects.I am a woman who can have children and have a recent negative pregnancy test.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1: NF1-muated low-grade glioma
- Group 2: Cohort 2: CIC-mutated oligodendroglioma
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any open opportunities for participants to get involved in this research?
"The information found on clinicaltrials.gov indicates that this research project is no longer enrolling participants, having last been updated on March 27th 2023. However, there are still 365 other studies actively seeking volunteers at the present time."
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