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

August 14, 2023 updated by: xCures

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.

Study Overview

Status

Available

Conditions

Intervention / Treatment

Study Type

Expanded Access

Expanded Access Type

  • Intermediate-size Population

Contacts and Locations

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

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Available
        • University of Alabama at Birmingham
      • Huntsville, Alabama, United States, 35805
        • Available
        • Clearview Cancer Institute
      • Mobile, Alabama, United States, 36604
        • Available
        • Infirmary Cancer Care
    • California
      • Arroyo Grande, California, United States, 93420
        • Available
        • PCR Oncology
      • Los Angeles, California, United States, 90027
        • Available
        • Kaiser Permanente Los Angeles Medical Center
      • Newport Beach, California, United States, 92663
        • Available
        • Hoag Memorial Hospital Presbyterian
      • San Francisco, California, United States, 94105
        • Available
        • xCures Inc.
      • Santa Monica, California, United States, 90404
        • Available
        • Providence Saint John's Health Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Available
        • MedStar Georgetown University Hospital
    • Florida
      • Orlando, Florida, United States, 32806
        • Available
        • Orlando Health
    • Iowa
      • Des Moines, Iowa, United States, 50309
        • Available
        • Iowa Oncology Research Association
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Available
        • Mary Bird Perkins Cancer Center
    • Maine
      • Bar Harbor, Maine, United States, 04609
        • Available
        • Mount Desert Island Hospital
    • Michigan
      • Sterling Heights, Michigan, United States, 48314
        • Available
        • Oakland Macomb Cancer Specialists
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • Available
        • Cancer Partners of Nebraska
    • New Jersey
      • Long Branch, New Jersey, United States, 07740
        • Available
        • Monmouth Medical Center
      • Mickleton, New Jersey, United States, 08056
        • Available
        • The Minniti Center for Medical Oncology and Hematology
      • Summit, New Jersey, United States, 07901
        • Available
        • Atlantic Health System/Overlook Medical Center
    • New York
      • Stony Brook, New York, United States, 11794
        • Available
        • Stony Brook Cancer Center
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Available
        • The Christ Hospital
      • Toledo, Ohio, United States, 43623
        • Available
        • The Toledo Clinic Cancer Center
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Available
        • Lehigh Valley Health Network
    • Washington
      • Seattle, Washington, United States, 98109
        • Available
        • Seattle Cancer Care Alliance

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.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Description

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.

Study Plan

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

How is the study designed?

Collaborators and Investigators

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

Sponsor

xCures

Collaborators

Cancer Commons

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

First Submitted

September 17, 2020

First Submitted That Met QC Criteria

September 21, 2020

First Posted (Actual)

September 28, 2020

Study Record Updates

Last Update Posted (Actual)

August 21, 2023

Last Update Submitted That Met QC Criteria

August 14, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ULI-EAP-100

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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