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MAPK Pathway Inhibitor

Ulixertinib for Cancer

Phase 2

Waitlist Available

Led By Kieuhoa T Vo

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must not have received prior exposure to BVD-523FB (ulixertinib) or other ERK inhibitors

For patients with solid tumors without known bone marrow involvement: Peripheral absolute neutrophil count (ANC) >= 1000/mm^3 (within 7 days prior to enrollment)

Must not have

Patients who have an uncontrolled infection

Patients receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will study ulixertinib in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders that have a mutation in the MAPK pathway.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly listed here, side effects may include typical reactions to cancer medications such as nausea, fatigue, liver issues, skin reactions and potential risks associated with swallowing capsules if there are gastrointestinal complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have never been treated with ulixertinib or similar medications.

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My white blood cell count is healthy for cancer treatment.

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My body surface area is at least 0.54 square meters.

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I am mostly able to care for myself, regardless of my age.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any infections that are currently uncontrolled.

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I am taking medication to prevent graft-versus-host disease after a bone marrow transplant.

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I am not taking medication that strongly affects liver enzyme CYP3A4.

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I am not taking medication that strongly affects CYP1A2 or CYP2D6 enzymes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective Response Rate (ORR = Complete Response [CR] + Partial Response [PR]) in Pediatric Patients Treated With BVD-523FB (Ulixertinib)

Secondary study objectives

Percentage of Patients Experiencing Grade 3 or 4 Adverse Events

Preliminary Estimates of the Pharmacokinetics of Ulixertinib in Children and Adolescents With Relapsed or Refractory Cancer

Progression Free Survival (PFS) in Pediatric Patients Treated With Ulixertinib

Other study objectives

Other Biomarkers as Predictors of Response to Ulixertinib and Whether Tumors That Harbor Different Mutations or Fusions Will Demonstrate Differential Response to Treatment

Profiling Changes in Tumor Genomics Over Time Through Evaluation of Circulating Tumor Deoxyribonucleic Acid (DNA)