Ulixertinib for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial investigates how well ulixertinib works for patients with certain advanced cancers, such as solid tumors and non-Hodgkin lymphoma. The focus is on cancers with a specific genetic change in the MAPK pathway, which often leads to cancer cell growth. Ulixertinib aims to stop the growth of these cancer cells. Suitable candidates for this trial include those with advanced cancers that have specific genetic markers and can swallow capsules. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group of people.
Do I need to stop my current medications to join the trial?
The trial requires that you stop taking certain medications, such as other anti-cancer agents, investigational drugs, and specific drugs that affect liver enzymes (CYP3A4, CYP1A2, and CYP2D6) at least 14 days before joining. If you're on corticosteroids, you need to be on a stable or decreasing dose for at least 7 days before enrolling.
Is there any evidence suggesting that ulixertinib is likely to be safe for humans?
Research has shown that ulixertinib, a treatment under study for certain cancers, is generally safe. Earlier studies found that the side effects of ulixertinib were similar to those of other treatments targeting the MAPK pathway, which often plays a role in cancer. Ulixertinib blocks this pathway.
Previous research also found that most patients could tolerate ulixertinib, handling the treatment without severe issues. However, like any cancer treatment, side effects can occur, so patients should discuss potential risks with their doctors.
In summary, while ulixertinib is still under study, earlier findings suggest it is generally safe for humans. It has been tested in various patients and has shown promising results in managing cancer-related pathways.12345Why do researchers think this study treatment might be promising?
Ulixertinib is unique because it targets a specific part of cancer cell growth known as the ERK pathway, which is often active in many types of cancers. Most current treatments for cancer focus on other parts of the cancer cell growth process, like the MEK or RAF pathways. Researchers are excited about ulixertinib because it offers a fresh approach by directly inhibiting ERK, potentially overcoming resistance seen with other treatments. This could mean better results for patients who haven't responded to existing therapies.
What evidence suggests that ulixertinib might be an effective treatment for advanced solid tumors, non-Hodgkin lymphoma, or histiocytic disorders?
Research has shown that ulixertinib, the treatment under study in this trial, may help treat cancers with changes in the MAPK pathway, which is often altered in many cancers and leads to uncontrolled cell growth. Ulixertinib blocks ERK1/2, a key protein in this pathway, which can help stop cancer cells from growing. Previous studies found that ulixertinib is generally well tolerated and led to partial improvements in patients with certain mutations, such as NRAS and BRAF. These findings suggest ulixertinib might be effective for patients with specific genetic changes in their tumors.16789
Who Is on the Research Team?
Kieuhoa T Vo
Principal Investigator
Children's Oncology Group
Are You a Good Fit for This Trial?
This trial is for patients with advanced solid tumors, non-Hodgkin lymphoma, or histiocytic disorders that have MAPK pathway mutations. Participants must be able to swallow capsules and have a body surface area of at least 0.54 m^2. They should not have received prior ERK inhibitors and must meet certain blood count criteria without recent transfusions.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ulixertinib orally twice daily. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity
Pharmacokinetics Assessment
Pre-dose and post-dose pharmacokinetics assessments on cycle 1, day 1; and pre-dose on cycle 1, day 2, and cycle 1, day 15
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Ulixertinib
Trial Overview
The study tests the effectiveness of Ulixertinib in treating cancers with specific genetic changes in the MAPK pathway. It's for those whose cancer has spread or can't be removed by surgery, focusing on how well this drug stops cancer growth.
How Is the Trial Designed?
Patients receive ulixertinib PO BID. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
Ulixertinib is already approved in United States for the following indications:
- None (investigational)
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor
Citations
1.
clinicaltrials.gov
clinicaltrials.gov/study/NCT04488003?cond=(CARDIOFACIOCUTANEOUS%20SYNDROME)%20OR%20(MAP2K1)&rank=1NCT04488003 | Study of Ulixertinib for Patients With ...
Early clinical data have demonstrated anti-tumor activity with ulixertinib treatment and have identified specific groups of patients for whom additional ...
A Phase II Study of ERK Inhibition by Ulixertinib (BVD-523) ...
Median time to progression was 2.0 months. There were eight deaths due to disease progression with a median overall survival of 6.9 months. ...
Updated clinical outcomes from ULI-EAP-100, an ...
Results: As of February 1st, 2022, 48 patients (pts) across 17 sites have been treated with ulixertinib under ULI-EAP-100 including pts with ...
4.
aacrjournals.org
aacrjournals.org/cancerdiscovery/article/8/2/184/6164/First-in-Class-ERK1-2-Inhibitor-Ulixertinib-BVDFirst-in-Class ERK1/2 Inhibitor Ulixertinib (BVD-523) in ...
The ERK inhibitor ulixertinib is well tolerated and achieved partial responses in patients with NRAS-, BRAFV600-, and non-V600 BRAF-mutant advanced solid.
News & Events
Ulixertinib has demonstrated promising early efficacy for patients with tumors harboring alterations in the MAPK pathway, including atypical ...
The first-in-class ERK inhibitor ulixertinib shows promising ...
The first-in-class ERK inhibitor ulixertinib shows promising activity in mitogen-activated protein kinase (MAPK)-driven pediatric low-grade glioma models.
BioMed Valley Discoveries' ulixertinib (BVD-523), a first-in- ...
Results from Phase Ib showed that ulixertinib has an acceptable safety profile and early evidence of clinical activity against a wide range ...
Study Details | NCT01781429 | Phase I Dose-Escalation, ...
This open-label, multi-center Phase 1/2 study will assess the safety, pharmacokinetics, and pharmacodynamics of escalating doses of BVD-523 in patients with ...
A two-part, phase II, multi-center study of the ERK inhibitor ...
This multi-center, phase II study, will be conducted in two parts and assess the clinical benefit, safety, pharmacokinetics, and pharmacodynamics of ulixertinib
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