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

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.

Intermediate-size Population
Pancreatic Cancer
Small Bowel Cancer
Colorectal Cancer
Non Small Cell Lung Cancer
Thyroid Cancer
Bladder Cancer
Head and Neck Cancer
Gastric Cancer
Esophageal Cancer
Ovarian Cancer
HepatoCellular Carcinoma
MAPK Gene Mutation
KRAS Activating Mutation
BRAF Gene Mutation
NRAS Gene Mutation
HRAS Gene Mutation
MEK Mutation
ERK Mutation

Drug: Ulixertinib (BVD-523)
Ulixertinib (BVD-523) is an oral, first-in-class ERK1/2 inhibitor

Eligibility Criteria

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.

Eligibility Gender
Eligibility Age
Minimum: 12 Years
United States

University of Alabama at Birmingham
Birmingham, Alabama, 35294


Investigator: Louis B Nabors, MD

Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027


Investigator: Richard M Green, MD

Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663


Investigator: Michael Demeure, MD

xCures Inc.
San Francisco, California, 94105


Providence Saint John's Health Center
Santa Monica, California, 90404


Investigator: Naveed Wagle, MD

University of Colorado Denver Anschutz Medical Campus
Aurora, Colorado, 80045


Investigator: Theresa Medina, MD

MedStar Georgetown University Hospital
Washington, District of Columbia, 20007


Investigator: Benjamin A Weinberg, MD

Harold Alfond Center for Cancer Care
Augusta, Maine, 04330


Investigator: Rachit Kumar, MD

Cancer and Leukemia Center
Sterling Heights, Michigan, 48314


Investigator: Andrew Muskovitz, MD

Nebraska Cancer Specialists
Omaha, Nebraska, 68130


Investigator: Joel M Michalski, MD, PhD

Monmouth Medical Center
Long Branch, New Jersey, 07740


Investigator: Seth Cohen, MD

Stony Brook Cancer Center
Stony Brook, New York, 11794


Investigator: MInsig Choi, MD

Duke Health
Durham, North Carolina, 27710


Investigator: Lars M Wagner, MD

The Christ Hospital
Cincinnati, Ohio, 45219


Investigator: Manish Bhandari, MD

Lehigh Valley Health Network
Allentown, Pennsylvania, 18103


Investigator: Suresh Nair, MD

Texas Oncology - Denton
Denton, Texas, 76201


Investigator: Sharad K Jain, MD

Seattle Cancer Care Alliance
Seattle, Washington, 98109


Investigator: Elena G Chiorean, MD


xCures Clinical Operations
(707) 641-4475

Cancer Commons
NCT Number
MeSH Terms