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Ulixertinib nel trattamento di pazienti con tumori solidi avanzati, linfoma non-Hodgkin o disturbi istiocitici con mutazioni della via MAPK (uno studio di trattamento pediatrico MATCH)

18 settembre 2026 aggiornato da: National Cancer Institute (NCI)

NCI-COG Pediatric MATCH (Analisi molecolare per la scelta della terapia) - Sottoprotocollo di fase 2 di BVD-523FB (ulixertinib) in pazienti con tumori che ospitano mutazioni attivanti del percorso MAPK

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.

Panoramica dello studio

Stato

Attivo, non reclutante

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

Fase

Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

Porto Rico
- - San Juan, Porto Rico, 00926
    - University Pediatric Hospital
  - San Juan, Porto Rico, 00912
    - San Jorge Children's Hospital
Stati Uniti
- Alabama
  - Birmingham, Alabama, Stati Uniti, 35233
    - Children's Hospital of Alabama
- Alaska
  - Anchorage, Alaska, Stati Uniti, 99508
    - Providence Alaska Medical Center
- Arizona
  - Mesa, Arizona, Stati Uniti, 85202
    - Banner Children's at Desert
  - Tucson, Arizona, Stati Uniti, 85719
    - Banner University Medical Center - Tucson
- Arkansas
  - Little Rock, Arkansas, Stati Uniti, 72202-3591
    - Arkansas Children's Hospital
- California
  - Downey, California, Stati Uniti, 90242
    - Kaiser Permanente Downey Medical Center
  - Loma Linda, California, Stati Uniti, 92354
    - Loma Linda University Medical Center
  - Long Beach, California, Stati Uniti, 90806
    - Miller Children's and Women's Hospital Long Beach
  - Los Angeles, California, Stati Uniti, 90027
    - Children's Hospital Los Angeles
  - Los Angeles, California, Stati Uniti, 90095
    - Mattel Children's Hospital UCLA
  - Madera, California, Stati Uniti, 93636
    - Valley Children's Hospital
  - Oakland, California, Stati Uniti, 94609
    - UCSF Benioff Children's Hospital Oakland
  - Oakland, California, Stati Uniti, 94611
    - Kaiser Permanente-Oakland
  - San Francisco, California, Stati Uniti, 94158
    - UCSF Medical Center-Mission Bay
- Colorado
  - Aurora, Colorado, Stati Uniti, 80045
    - Children's Hospital Colorado
  - Denver, Colorado, Stati Uniti, 80218
    - Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
- Delaware
  - Wilmington, Delaware, Stati Uniti, 19803
    - Alfred I duPont Hospital for Children
- District of Columbia
  - Washington D.C., District of Columbia, Stati Uniti, 20010
    - Children's National Medical Center
- Florida
  - Gainesville, Florida, Stati Uniti, 32610
    - UF Health Cancer Institute - Gainesville
  - Jacksonville, Florida, Stati Uniti, 32207
    - Nemours Children's Clinic-Jacksonville
  - Miami, Florida, Stati Uniti, 33155
    - Nicklaus Children's Hospital
  - Miami, Florida, Stati Uniti, 33136
    - University of Miami Miller School of Medicine-Sylvester Cancer Center
  - Orlando, Florida, Stati Uniti, 32827
    - Nemours Children's Hospital
  - Orlando, Florida, Stati Uniti, 32803
    - AdventHealth Orlando
  - Orlando, Florida, Stati Uniti, 32806
    - Arnold Palmer Hospital for Children
  - St. Petersburg, Florida, Stati Uniti, 33701
    - Johns Hopkins All Children's Hospital
  - Tampa, Florida, Stati Uniti, 33607
    - Saint Joseph's Hospital/Children's Hospital-Tampa
  - West Palm Beach, Florida, Stati Uniti, 33407
    - Saint Mary's Medical Center
- Georgia
  - Atlanta, Georgia, Stati Uniti, 30329
    - Children's Healthcare of Atlanta - Arthur M Blank Hospital
  - Savannah, Georgia, Stati Uniti, 31404
    - Memorial Health University Medical Center
- Idaho
  - Boise, Idaho, Stati Uniti, 83712
    - Saint Luke's Cancer Institute - Boise
- Illinois
  - Chicago, Illinois, Stati Uniti, 60637
    - University of Chicago Comprehensive Cancer Center
  - Peoria, Illinois, Stati Uniti, 61637
    - OSF Children's Hospital of Illinois
  - Springfield, Illinois, Stati Uniti, 62702
    - Southern Illinois University School of Medicine
- Indiana
  - Indianapolis, Indiana, Stati Uniti, 46202
    - Riley Hospital for Children
  - Indianapolis, Indiana, Stati Uniti, 46260
    - Ascension Saint Vincent Indianapolis Hospital
- Iowa
  - Des Moines, Iowa, Stati Uniti, 50309
    - Blank Children's Hospital
  - Iowa City, Iowa, Stati Uniti, 52242
    - University of Iowa/Holden Comprehensive Cancer Center
- Louisiana
  - New Orleans, Louisiana, Stati Uniti, 70121
    - Ochsner Medical Center Jefferson
  - New Orleans, Louisiana, Stati Uniti, 70118
    - Children's Hospital New Orleans
- Maine
  - Bangor, Maine, Stati Uniti, 04401
    - Eastern Maine Medical Center
- Maryland
  - Baltimore, Maryland, Stati Uniti, 21287
    - Johns Hopkins University/Sidney Kimmel Cancer Center
  - Baltimore, Maryland, Stati Uniti, 21215
    - Sinai Hospital of Baltimore
- Massachusetts
  - Boston, Massachusetts, Stati Uniti, 02215
    - Dana-Farber Cancer Institute
  - Boston, Massachusetts, Stati Uniti, 02114
    - Massachusetts General Hospital Cancer Center
- Michigan
  - Ann Arbor, Michigan, Stati Uniti, 48109
    - C S Mott Children's Hospital
  - Grand Rapids, Michigan, Stati Uniti, 49503
    - Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
  - Kalamazoo, Michigan, Stati Uniti, 49007
    - Bronson Methodist Hospital
- Minnesota
  - Minneapolis, Minnesota, Stati Uniti, 55404
    - Children's Hospitals and Clinics of Minnesota - Minneapolis
  - Minneapolis, Minnesota, Stati Uniti, 55455
    - University of Minnesota/Masonic Cancer Center
- Mississippi
  - Jackson, Mississippi, Stati Uniti, 39216
    - University of Mississippi Medical Center
- Missouri
  - Kansas City, Missouri, Stati Uniti, 64108
    - Children's Mercy Hospitals and Clinics
  - St Louis, Missouri, Stati Uniti, 63110
    - Washington University School of Medicine
  - St Louis, Missouri, Stati Uniti, 63141
    - Mercy Hospital Saint Louis
  - St Louis, Missouri, Stati Uniti, 63104
    - Cardinal Glennon Children's Medical Center
- Nebraska
  - Omaha, Nebraska, Stati Uniti, 68198
    - University of Nebraska Medical Center
  - Omaha, Nebraska, Stati Uniti, 68114
    - Children's Hospital and Medical Center of Omaha
- New Jersey
  - Hackensack, New Jersey, Stati Uniti, 07601
    - Hackensack University Medical Center
  - Morristown, New Jersey, Stati Uniti, 07960
    - Morristown Medical Center
  - New Brunswick, New Jersey, Stati Uniti, 08901
    - Saint Peter's University Hospital
- New York
  - Albany, New York, Stati Uniti, 12208
    - Albany Medical Center
  - Buffalo, New York, Stati Uniti, 14263
    - Roswell Park Cancer Institute
  - New Hyde Park, New York, Stati Uniti, 11040
    - The Steven and Alexandra Cohen Children's Medical Center of New York
  - New York, New York, Stati Uniti, 10065
    - Memorial Sloan Kettering Cancer Center
  - New York, New York, Stati Uniti, 10032
    - NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
  - New York, New York, Stati Uniti, 10065
    - NYP/Weill Cornell Medical Center
  - New York, New York, Stati Uniti, 10016
    - Laura and Isaac Perlmutter Cancer Center at NYU Langone
  - Rochester, New York, Stati Uniti, 14642
    - University of Rochester
  - Syracuse, New York, Stati Uniti, 13210
    - State University of New York Upstate Medical University
- North Carolina
  - Asheville, North Carolina, Stati Uniti, 28801
    - Mission Hospital
  - Charlotte, North Carolina, Stati Uniti, 28203
    - Carolinas Medical Center/Levine Cancer Institute
  - Durham, North Carolina, Stati Uniti, 27710
    - Duke University Medical Center
- Ohio
  - Cincinnati, Ohio, Stati Uniti, 45229
    - Cincinnati Children's Hospital Medical Center
  - Columbus, Ohio, Stati Uniti, 43205
    - Nationwide Children's Hospital
  - Dayton, Ohio, Stati Uniti, 45404
    - Dayton Children's Hospital
  - Toledo, Ohio, Stati Uniti, 43606
    - ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
- Oklahoma
  - Oklahoma City, Oklahoma, Stati Uniti, 73104
    - University of Oklahoma Health Sciences Center
- Oregon
  - Portland, Oregon, Stati Uniti, 97239
    - Oregon Health and Science University
  - Portland, Oregon, Stati Uniti, 97227
    - Legacy Emanuel Children's Hospital
- Pennsylvania
  - Danville, Pennsylvania, Stati Uniti, 17822
    - Geisinger Medical Center
  - Philadelphia, Pennsylvania, Stati Uniti, 19104
    - Children's Hospital of Philadelphia
  - Pittsburgh, Pennsylvania, Stati Uniti, 15224
    - Children's Hospital of Pittsburgh of UPMC
- South Carolina
  - Greenville, South Carolina, Stati Uniti, 29605
    - BI-LO Charities Children's Cancer Center
- South Dakota
  - Sioux Falls, South Dakota, Stati Uniti, 57117-5134
    - Sanford USD Medical Center - Sioux Falls
- Tennessee
  - Knoxville, Tennessee, Stati Uniti, 37916
    - East Tennessee Childrens Hospital
  - Memphis, Tennessee, Stati Uniti, 38105
    - Saint Jude Children's Research Hospital
  - Nashville, Tennessee, Stati Uniti, 37232
    - Vanderbilt University/Ingram Cancer Center
- Texas
  - Austin, Texas, Stati Uniti, 78723
    - Dell Children's Medical Center of Central Texas
  - Dallas, Texas, Stati Uniti, 75390
    - UT Southwestern/Simmons Cancer Center-Dallas
  - Dallas, Texas, Stati Uniti, 75230
    - Medical City Dallas Hospital
  - Fort Worth, Texas, Stati Uniti, 76104
    - Cook Children's Medical Center
  - Houston, Texas, Stati Uniti, 77030
    - UT MD Anderson Cancer Center
  - Houston, Texas, Stati Uniti, 77030
    - Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
  - San Antonio, Texas, Stati Uniti, 78207
    - Children's Hospital of San Antonio
  - San Antonio, Texas, Stati Uniti, 78229
    - Methodist Children's Hospital of South Texas
  - Temple, Texas, Stati Uniti, 76508
    - Scott and White Memorial Hospital
- Utah
  - Salt Lake City, Utah, Stati Uniti, 84113
    - Primary Children's Hospital
- Vermont
  - Burlington, Vermont, Stati Uniti, 05405
    - University of Vermont and State Agricultural College
- Virginia
  - Norfolk, Virginia, Stati Uniti, 23507
    - Children's Hospital of The King's Daughters
  - Richmond, Virginia, Stati Uniti, 23298
    - VCU Massey Comprehensive Cancer Center
- Washington
  - Seattle, Washington, Stati Uniti, 98105
    - Seattle Children's Hospital
  - Spokane, Washington, Stati Uniti, 99204
    - Providence Sacred Heart Medical Center and Children's Hospital
  - Tacoma, Washington, Stati Uniti, 98431
    - Madigan Army Medical Center
- Wisconsin
  - Madison, Wisconsin, Stati Uniti, 53792
    - University of Wisconsin Carbone Cancer Center - University Hospital
  - Milwaukee, Wisconsin, Stati Uniti, 53226
    - Children's Hospital of Wisconsin

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 1 anno a 21 anni (Bambino, Adulto)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

Patient must have enrolled onto APEC1621SC and must have been given a treatment assignment to MATCH to APEC1621J based on the presence of an actionable mutation.
Patients must have a body surface area >= 0.54 m^2 at the time of study enrollment.
Patients must have radiographically measurable disease at the time of study enrollment. Patients with neuroblastoma who do not have measurable disease but have metaiodobenzylguanidine (MIBG)+ evaluable disease are eligible. Measurable disease in patients with central nervous system (CNS) involvement is defined as tumor that is measurable in two perpendicular diameters on magnetic resonance imaging (MRI) and visible on more than one slice.
- Note: The following do not qualify as measurable disease:
  - Malignant fluid collections (e.g., ascites, pleural effusions)
  - Bone marrow infiltration except that detected by MIBG scan for neuroblastoma
  - Lesions only detected by nuclear medicine studies (e.g., bone, gallium or positron emission tomography [PET] scans) except as noted for neuroblastoma
  - Elevated tumor markers in plasma or cerebrospinal fluid (CSF)
  - Previously radiated lesions that have not demonstrated clear progression post radiation
  - Leptomeningeal lesions that do not meet the measurement requirements for Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Karnofsky >= 50% for patients > 16 years of age and Lansky >= 50 for patients =< 16 years of age. Note: Neurologic deficits in patients with CNS tumors must have been relatively stable for at least 7 days prior to study enrollment. Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment. If after the required timeframe, the numerical eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately.
- Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive.
  - >= 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea).
- Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or ANC counts): >= 7 days after the last dose of agent.
- Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1.
- Corticosteroids: If used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid.
- Hematopoietic growth factors: >= 14 days after the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short-acting growth factor. For growth factors that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur. The duration of this interval must be discussed with the study chair and the study-assigned research coordinator.
- Interleukins, Interferons and Cytokines (other than hematopoietic growth factors): >= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors).
- Stem cell Infusions (with or without total body irradiation [TBI]):
  - Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including DLI or boost infusion: >= 84 days after infusion and no evidence of graft versus host disease (GVHD).
  - Autologous stem cell infusion including boost infusion: >= 42 days.
- Cellular Therapy: >= 42 days after the completion of any type of cellular therapy (e.g. modified T cells, natural killer [NK] cells, dendritic cells, etc.).
- Radiotherapy (XRT)/External Beam Irradiation including Protons: >= 14 days after local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to >= 50% of the pelvis; >= 42 days if other substantial brain metastases (BM) radiation.
  - Note: Radiation may not be delivered to "measurable disease" tumor site(s) being used to follow response to subprotocol treatment.
- Radiopharmaceutical therapy (e.g., radiolabeled antibody, 131I-MIBG): >= 42 days after systemically administered radiopharmaceutical therapy.
- Patients must not have received prior exposure to BVD-523FB (ulixertinib) or other ERK inhibitors.
For patients with solid tumors without known bone marrow involvement: Peripheral absolute neutrophil count (ANC) >= 1000/mm^3 (within 7 days prior to enrollment).
For patients with solid tumors without known bone marrow involvement: Platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment).
Patients with known bone marrow metastatic disease will be eligible for study provided they meet the blood counts (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions). These patients will not be evaluable for hematologic toxicity.
Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 ml/min/1.73 m^2, or (within 7 days prior to enrollment).
A serum creatinine based on age/gender (within 7 days prior to enrollment).
- Age 1 to < 2 years, maximum serum creatinine (mg/dL) male 0.6, female 0.6
- Age 2 to < 6 years, maximum serum creatinine (mg/dL) male 0.8, female 0.8
- Age 6 to < 10 years, maximum serum creatinine (mg/dL) male 1, female 1
- Age 10 to < 13 years, maximum serum creatinine (mg/dL) male 1.2, female 1.2
- Age 13 to < 16 years, maximum serum creatinine (mg/dL) male 1.5, female 1.4
- Age >= 16 years, maximum serum creatinine (mg/dL) male 1.7, female 1.4
Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment).
Serum glutamate-pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 135 U/L. (For the purpose of this study, the ULN for SGPT is 45 U/L.) (within 7 days prior to enrollment).
Serum albumin >= 2 g/dL (within 7 days prior to enrollment).
Shortening fraction of >= 27% by echocardiogram, or (within 7 days prior to enrollment).
Ejection fraction of >= 50% by gated radionuclide study (within 7 days prior to enrollment).
QTc interval =< 480 milliseconds (within 7 days prior to enrollment).
Patients must be able to swallow intact capsules.
All patients and/or their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines.

Exclusion Criteria:

Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events as seen in animal/human studies. Pregnancy tests must be obtained in girls who are post-menarchal. Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method for the duration of study treatment and for 3 months after last dose of BVD-523FB (ulixertinib).
Patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible. If used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid.
Patients who are currently receiving another investigational drug are not eligible.
Patients who are currently receiving other anti-cancer agents are not eligible.
Patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial.
Patients who are currently receiving drugs that are strong inducers or inhibitors of CYP3A4 are not eligible. Strong inducers or inhibitors of CYP3A4 should be avoided from 14 days prior to enrollment to the end of the study. Note: CYP3A4 inducing anti-epileptic drugs and dexamethasone for CNS tumors or metastases, on a stable dose, are allowed.
Patients who are currently receiving drugs that are strong inducers or inhibitors of CYP1A2 and CYP2D6 are not eligible. Strong inhibitors of CYP1A2 (e.g., ciprofloxacin, enoxacin, fluvoxamine, zafirlukast) should be avoided from 14 days prior to enrollment to the end of the study. Strong inhibitors of CYP2D6 (e.g., bupropion, paroxetine, fluoxetine, quinidine, terbinafine) should also be avoided from 14 days prior to enrollment to the end of the study.
Patients with known significant ophthalmologic conditions (uncontrolled glaucoma, history of retinal vein occlusion or retinal detachment, excluding patients with longstanding findings secondary to existing conditions) are not eligible.
Patients who have an uncontrolled infection are not eligible.
Patients who have received a prior solid organ transplantation are not eligible.
Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Scopo principale: Trattamento
Assegnazione: N / A
Modello interventistico: Assegnazione di gruppo singolo
Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm Gruppo di partecipanti / Arm Un gruppo o sottogruppo di partecipanti a uno studio clinico che riceve un intervento/trattamento specifico o nessun intervento, secondo il protocollo dello studio.	Intervento / Trattamento Intervento / Trattamento Un processo o un'azione che è al centro di uno studio clinico. Gli interventi includono farmaci, dispositivi medici, procedure, vaccini e altri prodotti sperimentali o già disponibili. Gli interventi possono anche includere approcci non invasivi, come l'educazione o la modifica della dieta e dell'esercizio fisico.
Sperimentale: Treatment (ulixertinib) Patients receive ulixertinib PO BID. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.	Altro: Pharmacokinetic Study Ancillary studies Altri nomi: FARMACOCINETICA Studio PK Droga: Ulixertinib Given PO Altri nomi: BVD-523 VRT752271

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Objective Response Rate (ORR = Complete Response [CR] + Partial Response [PR]) in Pediatric Patients Treated With BVD-523FB (Ulixertinib) Lasso di tempo: From enrollment to the end of treatment, up to 2 years	ORR will be defined as complete response + partial response and assessed by Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Response rates will be calculated as the percent of evaluable patients who are responders, and confidence intervals will be constructed using the Wilson score interval method.	From enrollment to the end of treatment, up to 2 years

Misure di risultato secondarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Progression Free Survival (PFS) in Pediatric Patients Treated With Ulixertinib Lasso di tempo: From initiation of treatment to disease progression, disease recurrence, or death from any cause assessed up to 2 years	PFS along with the confidence intervals will be estimated using the Kaplan-Meier method.	From initiation of treatment to disease progression, disease recurrence, or death from any cause assessed up to 2 years
Percentage of Patients Experiencing Grade 3 or 4 Adverse Events Lasso di tempo: From enrollment to the end of treatment, up to 2 years	Will be graded according to Common Terminology Criteria for Adverse Events version 5.0. Any eligible patient who receives at least one dose of protocol therapy will be considered in the evaluation of toxicity.	From enrollment to the end of treatment, up to 2 years
Preliminary Estimates of the Pharmacokinetics of Ulixertinib in Children and Adolescents With Relapsed or Refractory Cancer Lasso di tempo: Pre-dose and 1, 2, 4, and 6-8 hours after dose on cycle 1, day 1; and pre-dose on cycle 1, day 2, and cycle 1, day 15	Will be summarized with simple summary statistics, including means, medians, ranges, and standard deviations (if numbers and distribution permit).	Pre-dose and 1, 2, 4, and 6-8 hours after dose on cycle 1, day 1; and pre-dose on cycle 1, day 2, and cycle 1, day 15

Altre misure di risultato

Misura del risultato	Misura Descrizione	Lasso di tempo
Other Biomarkers as Predictors of Response to Ulixertinib and Whether Tumors That Harbor Different Mutations or Fusions Will Demonstrate Differential Response to Treatment Lasso di tempo: Up to 2 years	Will be performed and will be summarized with simple summary statistics. All of these analyses will be descriptive in nature.	Up to 2 years
Profiling Changes in Tumor Genomics Over Time Through Evaluation of Circulating Tumor Deoxyribonucleic Acid (DNA) Lasso di tempo: Up to 2 years	Will be performed and will be summarized with simple summary statistics. All of these analyses will be descriptive in nature.	Up to 2 years

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

National Cancer Institute (NCI)

Investigatori

Investigatore principale: Kieuhoa T Vo, Children's Oncology Group

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

14 novembre 2018

Completamento primario (Effettivo)

31 marzo 2022

Completamento dello studio (Stimato)

30 marzo 2027

Date di iscrizione allo studio

Primo inviato

5 ottobre 2018

Primo inviato che soddisfa i criteri di controllo qualità

5 ottobre 2018

Primo Inserito (Effettivo)

9 ottobre 2018

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

21 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

18 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

NCI-2018-02150
U10CA180886 (Sovvenzione/contratto NIH degli Stati Uniti)
NCI-2018-02150 (Identificatore di registro: CTRP (Clinical Trial Reporting Program))
APEC1621J (Altro identificatore: CTEP)
APEC1621J (Altro identificatore: Children's Oncology Group)

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Ulixertinib nel trattamento di pazienti con tumori solidi avanzati, linfoma non-Hodgkin o disturbi istiocitici con mutazioni della via MAPK (uno studio di trattamento pediatrico MATCH)

NCI-COG Pediatric MATCH (Analisi molecolare per la scelta della terapia) - Sottoprotocollo di fase 2 di BVD-523FB (ulixertinib) in pazienti con tumori che ospitano mutazioni attivanti del percorso MAPK

Panoramica dello studio

Stato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Tipo di studio

Iscrizione (Effettivo)

Fase

Contatti e Sedi

Luoghi di studio

Criteri di partecipazione

Criteri di ammissibilità

Età idonea allo studio

Accetta volontari sani

Sessi ammissibili allo studio

Descrizione

Piano di studio

Come è strutturato lo studio?

Dettagli di progettazione

Numero di armi

Armi e interventi

Gruppo di partecipanti / Arm

Intervento / Trattamento

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato

Misura Descrizione

Lasso di tempo

Misure di risultato secondarie

Misura del risultato

Misura Descrizione

Lasso di tempo

Altre misure di risultato

Misura del risultato

Misura Descrizione

Lasso di tempo

Collaboratori e investigatori

Sponsor

Investigatori

Pubblicazioni e link utili

Pubblicazioni generali

Studiare le date dei record

Studia le date principali

Inizio studio (Effettivo)

Completamento primario (Effettivo)

Completamento dello studio (Stimato)

Date di iscrizione allo studio

Primo inviato

Primo inviato che soddisfa i criteri di controllo qualità

Primo Inserito (Effettivo)

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

Ultimo aggiornamento inviato che soddisfa i criteri QC

Ultimo verificato

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

Informazioni su farmaci e dispositivi, documenti di studio

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