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Clinical Trial Record

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Expanded Access to Ulixertinib (BVD-523) in Patients with Advanced MAPK Pathway-Altered Malignancies

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Study Overview

Expanded Access to Ulixertinib (BVD-523) in Patients with Advanced MAPK Pathway-Altered Malignancies

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.

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  • Pancreatic Cancer
  • Small Bowel Cancer
  • Colorectal Cancer
  • Melanoma
  • Non Small Cell Lung Cancer
  • Thyroid Cancer
  • Bladder Cancer
  • Head and Neck Cancer
  • Gastric Cancer
  • Esophageal Cancer
  • Cholangiocarcinoma
  • Ovarian Cancer
  • Hepatocellular Carcinoma
  • Glioblastoma
  • MAPK Gene Mutation
  • KRAS Activating Mutation
  • BRAF Gene Mutation
  • NRAS Gene Mutation
  • HRAS Gene Mutation
  • MEK Mutation
  • ERK Mutation
  • DRUG: Ulixertinib (BVD-523)
  • ULI-EAP-100

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2020-09-17  

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2024-09-19  

2020-09-21  

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2024-09-23  

2020-09-28  

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2024-09  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
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Allocation:
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Interventional Model:
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Masking:
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Arms and Interventions

Participant Group/ArmIntervention/Treatment
Secondary Outcome MeasuresMeasure DescriptionTime Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: xCures Clinical Operations

Phone Number: (707) 641-4475

Email: expandedaccess@xcures.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
12 Years

Accepts Healthy Volunteers:

    Inclusion Criteria:

  • Main Inclusion Criterion:

    • 1. Patient has a MAPK pathway-altered solid tumor(s), including but not limited to KRAS, NRAS, HRAS, BRAF, MEK, and ERK mutations.
  • Other Inclusion Criteria:

    • 1. In the opinion of the treating physician, the patient has exhausted or has inadequate response to available anti-cancer treatments. 2. In the opinion of the treating physician, the patient has adequate organ function to tolerate ulixertinib as defined in section 6.1 3. Male or female patients aged ≥ 12 years. 4. Patient must be able to swallow and retain orally administered medication.
    Note: Ulixertinib is primarily absorbed in the duodenum and therefore patients with any prior stomach or duodenal resection should be evaluated with that understanding. 5. For females, evidence of post-menopausal status or negative urinary or serum pregnancy test for pre-menopausal patients. 6. 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. 7. 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 8. 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:
    1. Patient is already participating in or qualifies for and is able to enroll in a clinical trial of ulixertinib (BVD-523). 2. Patient has received systemic therapy with an investigational agent within 5 half-lives or 14 days prior to starting ulixertinib treatment, whichever is shorter. 3. 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. 4. A history of current evidence/risk of retinal vein occlusion (RVO) or central serous retinopathy (CSR) 5. 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. 6. 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. 7. Known hypersensitivity to ulixertinib or any component in its formulation. 8. Patients taking prohibited medications as described in current Investigator's Brochure.
    Note: Patients who require treatment with Drugs that are strong inhibitors or inducers of CYP1A2, CYP2D6, and CYP3A4 (see Appendix 3) were excluded from the FIH study of ulixertinib and should be discussed with xCures to review if any potential benefits outweigh the potential risks. 9. Patient is actively breastfeeding. 10. Prior stomach or duodenal resection that in the opinion of the treating physician would affect the breakdown and absorption of ulixertinib.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

  • Cancer Commons
  • : ,

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.

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