Ulixertinib

Generic Name: Ulixertinib

Brand Names: -

Drug Type: Small Molecule

Chemical Formula: C_₂₁H_₂₂Cl_₂N_₄O_₂

CAS Number: 869886-67-9

Unique Ingredient Identifier: 16ZDH50O1U

Background: Ulixertinib is a a novel, reversible, ATP-competitive ERK1/2 inhibitor with high potency and ERK1/2 selectivity . It is currently in clinical trials for the treatment of a wide range of tumors.

Associated Conditions: -

Associated Therapies: -

Clinical Trials

Ulixertinib in People With Histiocytic Neoplasms

Phase 2

Recruiting

Conditions: Histiocytic Neoplasms

Interventions: Drug: Ulixertinib

First Posted Date: 2024-05-13

Last Posted Date: 2024-10-23

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 38

Registration Number: NCT06411821

Locations: 🇺🇸
Memorial Sloan Kettering Basking Ridge (Consent Only), Basking Ridge, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Bergen (Consent Only), Montvale, New Jersey, United States

and more 4 locations

Testing BVD-523FB (Ulixertinib) as Potentially Targeted Treatment in Cancers With Genetic Changes (MATCH - Subprotocol Z1L)

Phase 2

Active, not recruiting

Conditions: Advanced Lymphoma
Advanced Malignant Solid Neoplasm
Refractory Malignant Solid Neoplasm
Refractory Lymphoma
Refractory Multiple Myeloma

Interventions: Procedure: Biopsy
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Procedure: Echocardiography
Procedure: Magnetic Resonance Imaging
Procedure: Radionuclide Imaging
Drug: Ulixertinib

First Posted Date: 2024-05-06

Last Posted Date: 2024-11-06

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 35

Registration Number: NCT06400225

Locations: 🇺🇸
ECOG-ACRIN Cancer Research Group, Philadelphia, Pennsylvania, United States

Open-label Phase 1b Study of Ulixertinib and Cetuximab or Ulixertinib in Combination With Cetuximab and Encorafenib in Patients With Unresectable or Metastatic Colorectal Cancer Who Have Previously Received EGFR or BRAF-directed Therapy

Phase 1

Recruiting

Conditions: Metastatic Colorectal Cancer

Interventions: Drug: Cetuximab
Drug: Ulixertinib
Drug: Encorafenib

First Posted Date: 2023-08-14

Last Posted Date: 2024-08-26

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 27

Registration Number: NCT05985954

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

Window-of-Opportunity Trial of Ulixertinib for MAPK-Activated Low-Grade Gliomas in Adults

Early Phase 1

Recruiting

Conditions: Gliomas

Interventions: Drug: Ulixertinib

First Posted Date: 2023-04-07

Last Posted Date: 2024-11-11

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 20

Registration Number: NCT05804227

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

Trial of Ulixertinib in Combination With Hydroxychloroquine in Patients With Advanced Gastrointestinal (GI) Malignancies

Phase 2

Terminated

Conditions: Tumor, Solid
Gastrointestinal Cancer

Interventions: Drug: Ulixertinib
Drug: Hydroxychloroquine

First Posted Date: 2022-02-02

Last Posted Date: 2024-07-22

Lead Sponsor: BioMed Valley Discoveries, Inc

Target Recruit Count: 47

Registration Number: NCT05221320

Locations: 🇺🇸
Cleveland Clinic, Cleveland, Ohio, United States
🇺🇸
Washington University School of Medicine, Saint Louis, Missouri, United States
🇺🇸
University of California San Francisco, San Francisco, California, United States

and more 6 locations

Study of Ulixertinib for Patients With Advanced Malignancies Harboring MEK or Atypical BRAF Alterations

Phase 2

Terminated

Conditions: Advanced Solid Tumor
BRAF Gene Mutation
BRAF Gene Alteration
MEK Mutation
MEK Alteration
MAP2K1 Gene Mutation
MAP2K1 Gene Alteration
MAP2K2 Gene Mutation
MAP2K2 Gene Alteration

Interventions: Drug: Ulixertinib
Drug: Physician's Choice

First Posted Date: 2020-07-27

Last Posted Date: 2024-06-04

Lead Sponsor: BioMed Valley Discoveries, Inc

Target Recruit Count: 104

Registration Number: NCT04488003

Locations: 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸
Metro-Minnesota Community Oncology Research Consortium (MMCORC), Saint Louis Park, Minnesota, United States
🇺🇸
UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States

and more 17 locations

Ulixertinib (BVD-523) and Hydroxychloroquine in Patients W Advanced MAPK-Mutated Gastrointestinal Adenocarcinomas

Phase 1

Completed

Conditions: Gastrointestinal Neoplasms

Interventions: Drug: Ulixertinib
Drug: Hydroxychloroquine

First Posted Date: 2019-10-30

Last Posted Date: 2024-11-18

Lead Sponsor: University of Utah

Target Recruit Count: 16

Registration Number: NCT04145297

Locations: 🇺🇸
Huntsman Cancer Institute, Salt Lake City, Utah, United States

Ulixertinib in Treating Patients With Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With MAPK Pathway Mutations (A Pediatric MATCH Treatment Trial)

Phase 2

Active, not recruiting

Conditions: Recurrent Glioma
Recurrent Langerhans Cell Histiocytosis
Recurrent Malignant Germ Cell Tumor
Recurrent Malignant Solid Neoplasm
Recurrent Neuroblastoma
Recurrent Osteosarcoma
Refractory Malignant Germ Cell Tumor
Refractory Rhabdomyosarcoma
Refractory Soft Tissue Sarcoma
Wilms Tumor

Interventions: Other: Pharmacokinetic Study
Drug: Ulixertinib

First Posted Date: 2018-10-09

Last Posted Date: 2024-10-01

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 20

Registration Number: NCT03698994

Locations: 🇺🇸
Children's Healthcare of Atlanta - Arthur M Blank Hospital, Atlanta, Georgia, United States
🇺🇸
Children's Hospital of Alabama, Birmingham, Alabama, United States
🇺🇸
Providence Alaska Medical Center, Anchorage, Alaska, United States

and more 105 locations

Ulixertinib/Palbociclib in Patients With Advanced Pancreatic and Other Solid Tumors

Phase 1

Recruiting

Conditions: Tumor, Solid
Pancreatic Cancer
Melanoma

Interventions: Drug: Ulixertinib
Drug: Palbociclib

First Posted Date: 2018-03-05

Last Posted Date: 2024-08-02

Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

Target Recruit Count: 45

Registration Number: NCT03454035

Locations: 🇺🇸
Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States

Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial)

Phase 2

Recruiting

Conditions: Advanced Malignant Solid Neoplasm
Juvenile Xanthogranuloma
Langerhans Cell Histiocytosis
Malignant Glioma
Recurrent Childhood Rhabdomyosarcoma
Recurrent Ewing Sarcoma
Recurrent Osteosarcoma
Recurrent Primary Central Nervous System Neoplasm
Refractory Hepatoblastoma
Refractory Medulloblastoma

First Posted Date: 2017-05-16

Last Posted Date: 2024-12-16

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 2316

Registration Number: NCT03155620

Locations: 🇺🇸
Duke University Medical Center, Durham, North Carolina, United States
🇺🇸
East Carolina University, Greenville, North Carolina, United States
🇺🇸
Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States

and more 169 locations

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