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.
Drug: Ulixertinib (BVD-523)
Ulixertinib (BVD-523) is an oral, first-in-class ERK1/2 inhibitor
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.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Clearview Cancer Institute
Huntsville, Alabama, United States
Infirmary Cancer Care
Mobile, Alabama, United States
PCR Oncology
Arroyo Grande, California, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
xCures Inc.
San Francisco, California, United States
Providence Saint John's Health Center
Santa Monica, California, United States
MedStar Georgetown University Hospital
Washington, District of Columbia, United States
Orlando Health
Orlando, Florida, United States
Iowa Oncology Research Association
Des Moines, Iowa, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States
Mount Desert Island Hospital
Bar Harbor, Maine, United States
Oakland Macomb Cancer Specialists
Sterling Heights, Michigan, United States
Cancer Partners of Nebraska
Lincoln, Nebraska, United States
Monmouth Medical Center
Long Branch, New Jersey, United States
The Minniti Center for Medical Oncology and Hematology
Mickleton, New Jersey, United States
Atlantic Health System/Overlook Medical Center
Summit, New Jersey, United States
Stony Brook Cancer Center
Stony Brook, New York, United States
The Christ Hospital
Cincinnati, Ohio, United States
The Toledo Clinic Cancer Center
Toledo, Ohio, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
xCures Clinical Operations
(707) 641-4475
expandedaccess@xcures.com