Health Trials

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

ConditionsPancreatic CancerSmall Bowel CancerColorectal CancerMelanomaNon Small Cell Lung CancerThyroid CancerBladder CancerHead and Neck CancerGastric CancerEsophageal CancerCholangiocarcinomaOvarian CancerHepatocellular CarcinomaGlioblastomaMAPK Gene MutationKRAS Activating MutationBRAF Gene MutationNRAS Gene MutationHRAS Gene MutationMEK MutationERK Mutation
Trial statusAvailable
Trial phaseNot listed
Trial typeExpanded Access
Biological sexAll
Age12+
SponsorxCures

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Ulixertinib (BVD-523)

Treatment groups

No treatment groups listed

Sponsors and collaborators

xCures

Lead sponsor

Cancer Commons

Collaborator

Source ClinicalTrials.gov