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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04566393
Expanded Access Status : Available
First Posted : September 28, 2020
Last Update Posted : September 2, 2021
Sponsor:
Collaborator:
Cancer Commons
Information provided by (Responsible Party):
xCures

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.

Condition or disease Intervention/treatment
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 Drug: Ulixertinib (BVD-523)

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Study Type : Expanded Access
Expanded Access Type : Intermediate-size Population
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: Expanded Access to Ulixertinib (BVD-523) in Patients With Advanced MAPK Pathway-Altered Malignancies



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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04566393


Contacts
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Contact: xCures Clinical Operations (707) 641-4475 expandedaccess@xcures.com

Locations
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United States, Alabama
University of Alabama at Birmingham Available
Birmingham, Alabama, United States, 35294
Principal Investigator: Louis B Nabors, MD         
United States, California
Kaiser Permanente Los Angeles Medical Center Available
Los Angeles, California, United States, 90027
Principal Investigator: Richard M Green, MD         
Hoag Memorial Hospital Presbyterian Available
Newport Beach, California, United States, 92663
Principal Investigator: Michael Demeure, MD         
xCures Inc. Available
San Francisco, California, United States, 94105
Providence Saint John's Health Center Available
Santa Monica, California, United States, 90404
Principal Investigator: Naveed Wagle, MD         
United States, Colorado
University of Colorado Denver Anschutz Medical Campus Available
Aurora, Colorado, United States, 80045
Principal Investigator: Rene Gonzalez-Cotarelo, MD         
United States, District of Columbia
MedStar Georgetown University Hospital Available
Washington, District of Columbia, United States, 20007
Principal Investigator: Benjamin A Weinberg, MD         
United States, Indiana
Franciscan Health Available
Indianapolis, Indiana, United States, 46237
Principal Investigator: Meghana Raghavendra, MD         
United States, Maine
Harold Alfond Center for Cancer Care Available
Augusta, Maine, United States, 04330
Principal Investigator: Rachit Kumar, MD         
United States, Michigan
Cancer and Leukemia Center Available
Sterling Heights, Michigan, United States, 48314
Principal Investigator: Andrew Muskovitz, MD         
United States, Nebraska
Nebraska Cancer Specialists Available
Omaha, Nebraska, United States, 68130
Principal Investigator: Joel M Michalski, MD, PhD         
United States, New Jersey
Monmouth Medical Center Available
Long Branch, New Jersey, United States, 07740
Principal Investigator: Seth Cohen, MD         
United States, North Carolina
Duke Health Available
Durham, North Carolina, United States, 27710
Principal Investigator: Lars M Wagner, MD         
United States, Pennsylvania
Lehigh Valley Health Network Available
Allentown, Pennsylvania, United States, 18103
Principal Investigator: Suresh Nair, MD         
United States, Texas
Texas Oncology - Denton Available
Denton, Texas, United States, 76201
Principal Investigator: Sharad K Jain, MD         
United States, Washington
Seattle Cancer Care Alliance Available
Seattle, Washington, United States, 98109
Principal Investigator: Elena G Chiorean, MD         
Sponsors and Collaborators
xCures
Cancer Commons
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Responsible Party: xCures
ClinicalTrials.gov Identifier: NCT04566393    
Other Study ID Numbers: ULI-EAP-100
First Posted: September 28, 2020    Key Record Dates
Last Update Posted: September 2, 2021
Last Verified: September 2020
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Glioblastoma
Thyroid Neoplasms
Cholangiocarcinoma
Neoplasms by Site
Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Endocrine Gland Neoplasms
Endocrine System Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Liver Neoplasms
Liver Diseases
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Head and Neck Neoplasms
Thyroid Diseases