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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2025
  • participants needed
    49
  • sponsor
    National Cancer Institute (NCI)
Updated on 1 August 2021
platelet count
cancer
corticosteroids
ascites
stem cell transplantation
graft versus host disease
total body irradiation
lymphoma
hodgkin's disease
ejection fraction
metastatic disease
nitrosoureas
tumor markers
cytokines
measurable disease
interferon
growth factor
pleural effusion
stem cell infusion
MRI
bone marrow procedure
shortening fraction
glomerular filtration rate
hematopoietic growth factors
cytotoxic chemotherapy
metastasis
neutrophil count
blood transfusion
brain metastasis
cancer treatment
nitrosourea
chemotherapeutic agents
interleukins
cancer therapy
antineoplastic
solid tumour
solid tumor
stem cell transplant
blood count
match treatment
radiopharmaceutical therapy
antibody therapy
cns tumors
platelet transfusion
radiopharmaceutical
131i-mibg
iobenguane
autologous stem cell infusion
pegfilgrastim
myelosuppressive chemotherapy
cellular therapy
platelet transfusions
anti-cancer agents
nervous
cns tumor
pleural effusions
bone marrow infiltration
ulixertinib

Summary

This phase II Pediatric MATCH trial studies how well ulixertinib works in treating patients with solid tumors that have spread to other places in the body (advanced), non-Hodgkin lymphoma, or histiocytic disorders that have a genetic alteration (mutation) in a signaling pathway called MAPK. A signaling pathway consists of a group of molecules in a cell that control one or more cell functions. Genes in the MAPK pathway are frequently mutated in many types of cancers. Ulixertinib may stop the growth of cancer cells that have mutations in the MAPK pathway.

Description

PRIMARY OBJECTIVES:

I. To determine the objective response rate (ORR; complete response + partial response) in pediatric patients treated with BVD-523FB (ulixertinib) with advanced solid tumors (including central nervous system [CNS] tumors), non-Hodgkin lymphomas or histiocytic disorders that harbor activating genetic alterations in the MAPK pathway.

SECONDARY OBJECTIVES:

I. To estimate the progression free survival in pediatric patients treated with BVD-523FB (ulixertinib) with advanced solid tumors (including CNS tumors), non-Hodgkin lymphomas or histiocytic disorders that harbor activating genetic alterations in the MAPK pathway.

II. To obtain information about the tolerability of BVD-523FB (ulixertinib) in children and adolescents with relapsed or refractory cancer.

III. To provide preliminary estimates of the pharmacokinetics of BVD-523FB (ulixertinib) in children and adolescents with relapsed or refractory cancer.

EXPLORATORY OBJECTIVES:

I. To evaluate other biomarkers as predictors of response to BVD-523FB (ulixertinib) and specifically, whether tumors that harbor different mutations or fusions will demonstrate differential response to BVD-523FB (ulixertinib) treatment.

II. To explore approaches to profiling changes in tumor genomics over time through evaluation of circulating tumor deoxyribonucleic acid (DNA).

OUTLINE: This is a dose-escalation study.

Patients receive ulixertinib orally (PO) twice daily (BID). Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up periodically.

Details
Condition Malignant neoplasm of kidney, Hereditary Neoplastic Syndrome, Nephroblastoma, Advanced Solid Tumor, Refractory Non Hodgkin Lymphoma, Advanced Malignant Solid Neoplasm, Recurrent Glioma, Recurrent Malignant Solid Neoplasm, Recurrent Osteosarcoma, Recurrent Neuroblastoma, Recurrent Rhabdomyosarcoma, Refractory Malignant Solid Neoplasm, KRAS Gene Mutation, Recurrent Ewing Sarcoma, NRAS Gene Mutation, BRAF Gene Mutation, Recurrent Hepatoblastoma, NF1 Gene Mutation, Recurrent Medulloblastoma, Refractory Neuroblastoma, Recurrent Langerhans Cell Histiocytosis, Recurrent Peripheral Primitive Neuroectodermal Tumor, Recurrent Rhabdoid Tumor, Recurrent Soft Tissue Sarcoma, Refractory Langerhans Cell Histiocytosis, Refractory Malignant Germ Cell Tumor, Refractory Medulloblastoma, Refractory Osteosarcoma, Refractory Peripheral Primitive Neuroectodermal Tumor, Refractory Rhabdoid Tumor, Refractory Soft Tissue Sarcoma, GNA11 Gene Mutation, GNAQ Gene Mutation, HRAS Gene Mutation, Recurrent Malignant Germ Cell Tumor, Refractory Ependymoma, Refractory Ewing Sarcoma, Refractory Glioma, Refractory Hepatoblastoma, Refractory Rhabdomyosarcoma, Advanced Malignant Solid Tumor, ARAF Gene Mutation, MAP2K1 Gene Mutation, MAPK1 Gene Mutation, Recurrent Ependymal Tumor, Recurrent Histiocytic and Dendritic Cell Neoplasm, Recurrent Malignant Central Nervous System Neoplasm, Recurrent Non-Hodgkin Lymphoma, Refractory Histiocytic and Dendritic Cell Neoplasm, Refractory Malignant Central Nervous System Neoplasm, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Kidney Cancer, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Wilms' Tumor, Hereditary Cancer Syndromes, Renal Cancer, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Primary Malignant Central Nervous System Neoplasm, Refractory Primary Malignant Central Nervous System Neoplasm, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma
Treatment Ulixertinib, Pharmacokinetic Study
Clinical Study IdentifierNCT03698994
SponsorNational Cancer Institute (NCI)
Last Modified on1 August 2021

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note