Clinical Trials Logo

Clinical Trial Summary

To learn if the study drug, ulixertinib, can cross over the blood-brain barrier in patients with recurrent brain tumors


Clinical Trial Description

Primary Objective: 1. To evaluate the ability of ulixertinib to penetrate the BBB in patients with recurrent MAPK-activated LGG (ulixertinib tumor concentration, tumor/plasma ratio and tumor/cerebrospinal fluid (CSF) ratio) Secondary Objectives: 1. To assess anti-tumor activity of ulixertinib for patients with recurrent lower grade MAPK-activated gliomas after surgical resection based on: 1. Median progression-free-survival (mPFS) 2. Objective response rate (ORR) at 12 months 3. Disease control rate (DCR) at 12 months 4. Duration of response (DOR) 5. Time to response (TTR) 6. Time to next intervention 2. To assess safety and tolerability of ulixertinib in MAPK-activated LGG ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05804227
Study type Interventional
Source M.D. Anderson Cancer Center
Contact Nazanin Majd, MD
Phone (713) 792-4515
Email nkmajd@mdanderson.org
Status Recruiting
Phase Early Phase 1
Start date April 20, 2023
Completion date September 22, 2027

See also
  Status Clinical Trial Phase
Recruiting NCT03952598 - Studying the Biology of IDH-mutant Gliomas Via Longitudinal Observation of 2-hydroxyglutarate (2-HG) Using MR Spectroscopy N/A
Not yet recruiting NCT01445691 - More Complete Removal of Malignant Brain Tumors by Fluorescence-Guided Surgery Phase 2
Terminated NCT01251913 - A Pilot Study of Inpatient Hospice With Procurement of Brain Tumor Tissue on Expiration for Research Purposes
Withdrawn NCT01961934 - C11-Sodium Acetate PET/CT Imaging Evaluation in Brain Glioma, Post Therapy Necrosis and Pseudo-progression Phase 2/Phase 3
Active, not recruiting NCT03557359 - Nivolumab for Recurrent or Progressive IDH Mutant Gliomas Phase 2
Recruiting NCT01655927 - Efficacy of Tranexamic Acid in Brain Tumor Resections Phase 3
Completed NCT01144247 - Cellular Immunotherapy Study for Brain Cancer Phase 1
Completed NCT01225003 - Advanced MR Techniques in Detection of Tumor Infiltration and Grading in Gliomas N/A
Completed NCT00967577 - 177Lu-J591 Antibody in Patients With Nonprostate Metastatic Solid Tumors Phase 1
Terminated NCT01517776 - Cilengitide and Metronomic Temozolomide for Relapsed or Refractory High Grade Gliomas or Diffuse Intrinsic Pontine Gliomas in Children and Adolescents Phase 2
Completed NCT00832598 - [18F] FACBC and [18F] FLT PET Imaging in Central Nervous System Tumors N/A
Completed NCT00589706 - A Phase II Study of Adjuvant Use of Anti-Epidermal Growth Factor Receptor EGFR-425 in High Grade Gliomas Phase 2
Completed NCT03154996 - Chronic Convection Enhanced Delivery of Topotecan Phase 1
Withdrawn NCT05054400 - Study of Laser Interstitial Thermal Therapy (LITT) Treatment Response Assessment With Fluciclovine PET MR Early Phase 1
Recruiting NCT03091270 - ZOOMit-fMRI Identifies Motor Functional Cortex
Completed NCT00200161 - Temozolomide & RT Followed by Dose Dense vs Temozolomide & Retinoic Acid in Pts w/Glioblastoma Phase 2
Terminated NCT02332889 - Phase I/II: Decitabine/Vaccine Therapy in Relapsed/Refractory Pediatric High Grade Gliomas/Medulloblastomas/CNS PNETs Phase 1/Phase 2