Ovarian Cancer Clinical Trial

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

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.

View Eligibility Criteria

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:

In the opinion of the treating physician, the patient has exhausted or has inadequate response to available anti-cancer treatments.
In the opinion of the treating physician, the patient has adequate organ function to tolerate ulixertinib as defined in section 6.1
Male or female patients aged ≥ 12 years.

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.

For females, evidence of post-menopausal status or negative urinary or serum pregnancy test for pre-menopausal patients.
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.
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
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:

Patient is already participating in or qualifies for and is able to enroll in a clinical trial of ulixertinib (BVD-523).
Patient has received systemic therapy with an investigational agent within 5 half-lives or 14 days prior to starting ulixertinib treatment, whichever is shorter.
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.
A history of current evidence/risk of retinal vein occlusion (RVO) or central serous retinopathy (CSR)
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.
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.
Known hypersensitivity to ulixertinib or any component in its formulation.

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.

Patient is actively breastfeeding.
Prior stomach or duodenal resection that in the opinion of the treating physician would affect the breakdown and absorption of ulixertinib.

Study is for people with:

Ovarian Cancer

Study ID:

NCT04566393

Recruitment Status:

Available

Sponsor:

xCures

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There are 25 Locations for this study

See Locations Near You

University of Alabama at Birmingham
Birmingham Alabama, 35294, United States More Info
Louis B Nabors, MD
Principal Investigator
Infirmary Cancer Care
Mobile Alabama, 36604, United States More Info
Jose Galeas, MD
Principal Investigator
PCR Oncology
Arroyo Grande California, 93420, United States More Info
David Palchak, MD
Principal Investigator
Kaiser Permanente Los Angeles Medical Center
Los Angeles California, 90027, United States More Info
Richard M Green, MD
Principal Investigator
Hoag Memorial Hospital Presbyterian
Newport Beach California, 92663, United States More Info
Michael Demeure, MD
Principal Investigator
xCures Inc.
San Francisco California, 94105, United States
Providence Saint John's Health Center
Santa Monica California, 90404, United States More Info
Naveed Wagle, MD
Principal Investigator
University of Colorado Denver Anschutz Medical Campus
Aurora Colorado, 80045, United States More Info
Theresa Medina, MD
Principal Investigator
MedStar Georgetown University Hospital
Washington District of Columbia, 20007, United States More Info
Benjamin A Weinberg, MD
Principal Investigator
Iowa Oncology Research Association
Des Moines Iowa, 50309, United States More Info
Joshua Lukenbill, DO
Principal Investigator
Mary Bird Perkins Cancer Center
Baton Rouge Louisiana, 70809, United States More Info
Jon Olson, MD
Principal Investigator
Harold Alfond Center for Cancer Care
Augusta Maine, 04330, United States More Info
Rachit Kumar, MD
Principal Investigator
Mount Desert Island Hospital
Bar Harbor Maine, 04609, United States More Info
Philip L. Brooks, MD
Principal Investigator
Cancer and Leukemia Center
Sterling Heights Michigan, 48314, United States More Info
Andrew Muskovitz, MD
Principal Investigator
Oakland Macomb Cancer Specialists
Sterling Heights Michigan, 48314, United States More Info
Mohammad Mobayed, MD
Principal Investigator
Metro Minnesota Community Oncology Research Consortium
Saint Louis Park Minnesota, 55416, United States More Info
Craig Mescher, MD
Principal Investigator
Nebraska Cancer Specialists
Omaha Nebraska, 68130, United States More Info
Joel M Michalski, MD, PhD
Principal Investigator
Monmouth Medical Center
Long Branch New Jersey, 07740, United States More Info
Seth Cohen, MD
Principal Investigator
The Minniti Center for Medical Oncology and Hematology
Mickleton New Jersey, 08056, United States More Info
Carl J. Minniti Jr., MD
Principal Investigator
Stony Brook Cancer Center
Stony Brook New York, 11794, United States More Info
MInsig Choi, MD
Principal Investigator
Duke Health
Durham North Carolina, 27710, United States More Info
Lars M Wagner, MD
Principal Investigator
The Christ Hospital
Cincinnati Ohio, 45219, United States More Info
Manish Bhandari, MD
Principal Investigator
Lehigh Valley Health Network
Allentown Pennsylvania, 18103, United States More Info
Suresh Nair, MD
Principal Investigator
Avera Cancer Institute
Sioux Falls South Dakota, 57105, United States More Info
Ryan Vaca, MD
Principal Investigator
Texas Oncology - Denton
Denton Texas, 76201, United States More Info
Sharad K Jain, MD
Principal Investigator
Seattle Cancer Care Alliance
Seattle Washington, 98109, United States More Info
Elena G Chiorean, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Study ID:

NCT04566393

Recruitment Status:

Available

Sponsor:


xCures

How clear is this clinincal trial information?

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