The objective of this expanded access program is to provide ulixertinib (BVD-523) forcompassionate 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 haveincomplete response to or have exhausted available therapies.Ulixertinib is available for treatment as monotherapy or in combination with otherclinically 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 4049979, Alabama 4829764, United States
Clearview Cancer Institute
Huntsville 4068590, Alabama 4829764, United States
Infirmary Cancer Care
Mobile 4076598, Alabama 4829764, United States
PCR Oncology
Arroyo Grande 5324802, California 5332921, United States
Hoag Memorial Hospital Presbyterian
Newport Beach 5376890, California 5332921, United States
xCures Inc.
San Francisco 5391959, California 5332921, United States
Providence Saint John's Health Center
Santa Monica 5393212, California 5332921, United States
MedStar Georgetown University Hospital
Washington D.C. 4140963, District of Columbia 4138106, United States
Orlando Health
Orlando 4167147, Florida 4155751, United States
Unity Point Health - St. Lukes Hospital
Cedar Rapids 4850751, Iowa 4862182, United States
Iowa Oncology Research Association
Des Moines 4853828, Iowa 4862182, United States
Mary Bird Perkins Cancer Center
Baton Rouge 4315588, Louisiana 4331987, United States
Oakland Macomb Cancer Specialists
Sterling Heights 5011148, Michigan 5001836, United States
Cancer Partners of Nebraska
Lincoln 5072006, Nebraska 5073708, United States
Hunterdon Hematology Oncology
Flemington 5098124, New Jersey 5101760, United States
Monmouth Medical Center
Long Branch 5100619, New Jersey 5101760, United States
The Minniti Center for Medical Oncology and Hematology
Mickleton 4503013, New Jersey 5101760, United States
Atlantic Health System/Overlook Medical Center
Summit 5105127, New Jersey 5101760, United States
Hirschfeld Oncology
Brooklyn 5110302, New York 5128638, United States
Stony Brook Cancer Center
Stony Brook 5139865, New York 5128638, United States
The Christ Hospital
Cincinnati 4508722, Ohio 5165418, United States
Lehigh Valley Health Network
Allentown 5178127, Pennsylvania 6254927, United States
Northwest Medical Specialties
Tacoma 5812944, Washington 5815135, United States
xCures Clinical Operations
(707) 641-4475
expandedaccess@xcures.com