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Ulixertinib i behandling av pasienter med avanserte solide svulster, non-Hodgkin-lymfom eller histiocytiske lidelser med MAPK Pathway-mutasjoner (A Pediatric MATCH Treatment Trial)

18. september 2026 oppdatert av: National Cancer Institute (NCI)

NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Fase 2-underprotokoll av BVD-523FB (Ulixertinib) hos pasienter med svulster som har aktiverende MAPK-banemutasjoner

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.

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

20

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

1 år til 21 år (Barn, Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Annen: Pharmacokinetic Study

Ancillary studies

Andre navn:
  • FARMAKOKINETISK
  • PK-studie
Legemiddel: Ulixertinib

Given PO

Andre navn:
  • BVD-523
  • VRT752271

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Objective Response Rate (ORR = Complete Response [CR] + Partial Response [PR]) in Pediatric Patients Treated With BVD-523FB (Ulixertinib)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Progression Free Survival (PFS) in Pediatric Patients Treated With Ulixertinib
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Other Biomarkers as Predictors of Response to Ulixertinib and Whether Tumors That Harbor Different Mutations or Fusions Will Demonstrate Differential Response to Treatment
Tidsramme: 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)
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

National Cancer Institute (NCI)

Etterforskere

  • Hovedetterforsker: Kieuhoa T Vo, Children's Oncology Group

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

14. november 2018

Primær fullføring (Faktiske)

31. mars 2022

Studiet fullført (Antatt)

30. mars 2027

Datoer for studieregistrering

Først innsendt

5. oktober 2018

Først innsendt som oppfylte QC-kriteriene

5. oktober 2018

Først lagt ut (Faktiske)

9. oktober 2018

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

21. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

18. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • NCI-2018-02150
  • U10CA180886 (U.S. NIH-stipend/kontrakt)
  • NCI-2018-02150 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))
  • APEC1621J (Annen identifikator: CTEP)
  • APEC1621J (Annen identifikator: Children's Oncology Group)

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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