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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Unknown
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Expanded Access
Eligible Ages 12 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04566393
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

xCures
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry, Other
Overall Status Available
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Alabama at Birmingham, Birmingham, Alabama

Status

Available

Address

University of Alabama at Birmingham

Birmingham, Alabama, 35294

Clearview Cancer Institute, Huntsville, Alabama

Status

Available

Address

Clearview Cancer Institute

Huntsville, Alabama, 35805

Infirmary Cancer Care, Mobile, Alabama

Status

Available

Address

Infirmary Cancer Care

Mobile, Alabama, 36604

PCR Oncology, Arroyo Grande, California

Status

Available

Address

PCR Oncology

Arroyo Grande, California, 93420

Los Angeles, California

Status

Available

Address

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, 90027

Hoag Memorial Hospital Presbyterian, Newport Beach, California

Status

Available

Address

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663

xCures Inc., San Francisco, California

Status

Available

Address

xCures Inc.

San Francisco, California, 94105

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

Status

Available

Address

Providence Saint John's Health Center

Santa Monica, California, 90404

MedStar Georgetown University Hospital, Washington, District of Columbia

Status

Available

Address

MedStar Georgetown University Hospital

Washington, District of Columbia, 20007

Orlando Health, Orlando, Florida

Status

Available

Address

Orlando Health

Orlando, Florida, 32806

Iowa Oncology Research Association, Des Moines, Iowa

Status

Available

Address

Iowa Oncology Research Association

Des Moines, Iowa, 50309

Mary Bird Perkins Cancer Center, Baton Rouge, Louisiana

Status

Available

Address

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, 70809

Mount Desert Island Hospital, Bar Harbor, Maine

Status

Available

Address

Mount Desert Island Hospital

Bar Harbor, Maine, 04609

Oakland Macomb Cancer Specialists, Sterling Heights, Michigan

Status

Available

Address

Oakland Macomb Cancer Specialists

Sterling Heights, Michigan, 48314

Cancer Partners of Nebraska, Lincoln, Nebraska

Status

Available

Address

Cancer Partners of Nebraska

Lincoln, Nebraska, 68510

Monmouth Medical Center, Long Branch, New Jersey

Status

Available

Address

Monmouth Medical Center

Long Branch, New Jersey, 07740

Mickleton, New Jersey

Status

Available

Address

The Minniti Center for Medical Oncology and Hematology

Mickleton, New Jersey, 08056

Summit, New Jersey

Status

Available

Address

Atlantic Health System/Overlook Medical Center

Summit, New Jersey, 07901

Stony Brook Cancer Center, Stony Brook, New York

Status

Available

Address

Stony Brook Cancer Center

Stony Brook, New York, 11794

The Christ Hospital, Cincinnati, Ohio

Status

Available

Address

The Christ Hospital

Cincinnati, Ohio, 45219

The Toledo Clinic Cancer Center, Toledo, Ohio

Status

Available

Address

The Toledo Clinic Cancer Center

Toledo, Ohio, 43623

Lehigh Valley Health Network, Allentown, Pennsylvania

Status

Available

Address

Lehigh Valley Health Network

Allentown, Pennsylvania, 18103

Seattle Cancer Care Alliance, Seattle, Washington

Status

Available

Address

Seattle Cancer Care Alliance

Seattle, Washington, 98109

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