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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Available

Administrative data

• NCT number: NCT04566393
• Other study ID #: ULI-EAP-100
• Status: Available

Study information

• Verified date: August 2023
• Source: xCures
• Contact: xCures Clinical Operations
• Phone: (707) 641-4475
• Email: expandedaccess[@]xcures.com
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial 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.

Ulixertinib is available for treatment as monotherapy or in combination with other clinically tolerable agent(s), conditionally approved by the drug manufacturer.

Recruitment information / eligibility

• Status: Available
• Enrollment: 0
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bladder Cancer
• BRAF Gene Mutation
• Cholangiocarcinoma
• Colorectal Cancer
• ERK Mutation
• Esophageal Cancer
• Gastric Cancer
• Glioblastoma
• Head and Neck Cancer
• Hepatocellular Carcinoma
• HRAS Gene Mutation
• KRAS Activating Mutation
• MAPK Gene Mutation
• MEK Mutation
• Melanoma
• Non Small Cell Lung Cancer
• NRAS Gene Mutation
• Ovarian Cancer
• Pancreatic Cancer
• Small Bowel Cancer
• Thyroid Cancer

Intervention

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

Locations

Country	Name	City	State
United States	Lehigh Valley Health Network	Allentown	Pennsylvania
United States	PCR Oncology	Arroyo Grande	California
United States	Mount Desert Island Hospital	Bar Harbor	Maine
United States	Mary Bird Perkins Cancer Center	Baton Rouge	Louisiana
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	The Christ Hospital	Cincinnati	Ohio
United States	Iowa Oncology Research Association	Des Moines	Iowa
United States	Clearview Cancer Institute	Huntsville	Alabama
United States	Cancer Partners of Nebraska	Lincoln	Nebraska
United States	Monmouth Medical Center	Long Branch	New Jersey
United States	Kaiser Permanente Los Angeles Medical Center	Los Angeles	California
United States	The Minniti Center for Medical Oncology and Hematology	Mickleton	New Jersey
United States	Infirmary Cancer Care	Mobile	Alabama
United States	Hoag Memorial Hospital Presbyterian	Newport Beach	California
United States	Orlando Health	Orlando	Florida
United States	xCures Inc.	San Francisco	California
United States	Providence Saint John's Health Center	Santa Monica	California
United States	Seattle Cancer Care Alliance	Seattle	Washington
United States	Oakland Macomb Cancer Specialists	Sterling Heights	Michigan
United States	Stony Brook Cancer Center	Stony Brook	New York
United States	Atlantic Health System/Overlook Medical Center	Summit	New Jersey
United States	The Toledo Clinic Cancer Center	Toledo	Ohio
United States	MedStar Georgetown University Hospital	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
xCures	Cancer Commons

Country where clinical trial is conducted

United States,