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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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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 outcome measures

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)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (ulixertinib)Experimental Treatment2 Interventions

Patients receive ulixertinib PO BID. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ulixertinib

2020

Completed Phase 1

~20

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,658 Previous Clinical Trials

40,924,469 Total Patients Enrolled

23 Trials studying Hepatoblastoma

4,651 Patients Enrolled for Hepatoblastoma

Kieuhoa T VoPrincipal InvestigatorChildren's Oncology Group

Media Library

Ulixertinib (MAPK Pathway Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03698994 — Phase 2

Hepatoblastoma Research Study Groups: Treatment (ulixertinib)

Hepatoblastoma Clinical Trial 2023: Ulixertinib Highlights & Side Effects. Trial Name: NCT03698994 — Phase 2

Ulixertinib (MAPK Pathway Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03698994 — Phase 2

Frequently Asked Questions

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

To what age group is the eligibility of this trial restricted?

"Those meeting the age criteria of one year or older, but under 21 years old, can join this clinical trial."

Answered by AI

What is the cap for total enrolment in this trial?

"Currently, this research is not taking any new enrollees. It was initially shared on October 1st 2018 and updated lastly on October 19th 2022. If you are looking for alternative trials, there are 5682 studies actively enrolling patients with Wilms Tumor and 7 that focus on Ulixertinib's efficacy actively seeking participants."

Answered by AI

Has Ulixertinib been the subject of past research endeavors?

"At the present time, there are 7 ongoing trials examining Ulixertinib with no Phase 3 studies underway. The majority of these investigations are based in Salt Lake City yet 1765 other sites around the world have joined this research effort."

Answered by AI

Has the FDA approved Ulixertinib for therapeutic use?

"Ulixertinib has been assessed to be at a safety level of 2 due to Phase 2 trial data showing the drug's protection, yet lacking efficacy evidence."

Answered by AI

Does my profile fit the criteria for participation in this research?

"To qualify for this medical study, individuals must be diagnosed with wilms tumor and between the ages of 12 months to 21 years old. The trial is looking to enroll a maximum of 20 participants."

Answered by AI

Is this experimental treatment currently enrolling new participants?

"This trial, initially posted on October 1st 2018 and last edited on October 19th 2022 is not presently open for recruitment. However, there are 5689 other clinical trials currently accepting patients into their studies."

Answered by AI

Are there any Canadian-based locations conducting this clinical experiment?

"Several medical institutions are presently running this trial, including the University of Wisconsin Hospital and Clinics in Madison, Kaiser Permanente Downey Medical Center in California, as well as Miller Children's and Women's Hospital Long Beach situated in Washington D.C., among a hundred other sites."

Answered by AI

Recent research and studies

Expert Opinion on Emerging DrugsJournal

An Update on Emerging Drugs in Osteosarcoma: Towards Tailored Therapies?

Hattinger, Claudia Maria, Maria Pia Patrizio, Federica Magagnoli, Silvia Luppi, and Massimo Serra. 2019. “An Update on Emerging Drugs in Osteosarcoma: Towards Tailored Therapies?”. Expert Opinion on Emerging Drugs. Informa UK Limited. doi:10.1080/14728214.2019.1654455.

clinicaltrials.govStudy

Ulixertinib in Treating Patients With Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With MAPK Pathway Mutations (A Pediatric MATCH Treatment Trial)

2018. "Ulixertinib in Treating Patients With Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With MAPK Pathway Mutations (A Pediatric MATCH Treatment Trial)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03698994.

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