Expanded Access to Ulixertinib (BVD-523) in Patients With Advanced MAPK Pathway-Altered Malignancies (NCT04566393) | Clinical Trial Compass
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Expanded Access to Ulixertinib (BVD-523) in Patients With Advanced MAPK Pathway-Altered Malignancies
United States
Plain-language summary
The objective of this expanded access program is to provide ulixertinib (BVD-523) for compassionate use in advanced cancer patients with MAPK pathway-altered solid tumor(s), including but not limited to KRAS, NRAS, HRAS, BRAF, MEK, and ERK mutations who have incomplete response to or have exhausted available therapies.
Ulixertinib is available for treatment as monotherapy or in combination with other clinically tolerable agent(s), conditionally approved by the drug manufacturer.
Who can participate
Age range
12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. In the opinion of the treating physician, the patient has exhausted or has inadequate response to available anti-cancer treatments.
. In the opinion of the treating physician, the patient has adequate organ function to tolerate ulixertinib as defined in section 6.1
. Male or female patients aged ≥ 12 years.
. Patient must be able to swallow and retain orally administered medication.
. For females, evidence of post-menopausal status or negative urinary or serum pregnancy test for pre-menopausal patients.
. Highly effective contraception for both male and female patients throughout the treatment and for at least 4 months after last treatment administration. In patients under the age of 18, who are not sexually active, abstinence is an acceptable form.
. Toxicities related to any prior treatments are either stable, stable on supportive therapy, resolved, or in the opinion of the treating physician, clinically non-significant
. Ability to understand a written informed consent document, and the willingness to sign it. Assent will be obtained when appropriate based on the patient's age.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1My tumor has a MAPK pathway mutation — could you test or confirm whether I have a specific change like KRAS, BRAF, NRAS, HRAS, MEK, or ERK that would make me a candidate worth discussing for this expanded access program?
2Since this is an expanded access program rather than a standard clinical trial phase, what does that mean for how much is already known about ulixertinib's safety and effectiveness in someone with my type of cancer?
3Given that expanded access is typically considered when other options are limited, do you think I've exhausted enough standard treatments first, or would those still be a better path before exploring this?
4What would my treatment schedule actually look like on ulixertinib — how often would I need to come in, and are there known side effects from this ERK inhibitor that I should weigh against my current quality of life?
5Are there other trials or approved therapies targeting the MAPK pathway that you'd want to compare this expanded access option against before we make a decision?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Patient is already participating in or qualifies for and is able to enroll in a clinical trial of ulixertinib (BVD-523).
. Patient has received systemic therapy with an investigational agent within 5 half-lives or 14 days prior to starting ulixertinib treatment, whichever is shorter.
. Patient has received radiotherapy within 14 days prior to the first dose of ulixertinib treatment other than for the allowable treatment of symptomatic bone metastasis.
. A history of current evidence/risk of retinal vein occlusion (RVO) or central serous retinopathy (CSR)
. Current evidence of uncontrolled, significant intercurrent illness that would, in the treating physician's judgment, contraindicate the patient's treatment with ulixertinib due to safety concerns.
. Patients who, in the opinion of the treating physician, have not fully recovered from recent major surgery to a sufficient extent to tolerate treatment with ulixertinib.
. Known hypersensitivity to ulixertinib or any component in its formulation.
. Patients taking prohibited medications as described in current Investigator's Brochure.