Trials / Available
AvailableNCT04566393
Expanded Access to Ulixertinib (BVD-523) in Patients With Advanced MAPK Pathway-Altered Malignancies
- Status
- Available
- Phase
- —
- Study type
- Expanded Access
- Enrollment
- —
- Sponsor
- xCures · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- —
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.
Conditions
- 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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ulixertinib (BVD-523) | Ulixertinib (BVD-523) is an oral, first-in-class ERK1/2 inhibitor |
Timeline
- First posted
- 2020-09-28
- Last updated
- 2026-01-28
Locations
27 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT04566393. Inclusion in this directory is not an endorsement.