このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

進行性固形腫瘍、非ホジキンリンパ腫、または MAPK 経路変異を伴う組織球性疾患の患者の治療におけるウリクセルチニブ (小児 MATCH 治療試験)

2026年9月18日 更新者：National Cancer Institute (NCI)

NCI-COG Pediatric MATCH (治療選択のための分子解析) - 活性化 MAPK 経路変異を有する腫瘍患者における BVD-523FB (ウリキセルチニブ) の第 2 相サブプロトコル

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.

調査の概要

状態

積極的、募集していない

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (実際)

20

段階

  • フェーズ2

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

1年～21年 (子、大人)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：なし
  • 介入モデル：単一グループの割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
他の：Pharmacokinetic Study

Ancillary studies

他の名前：
  • 薬物動態
  • PK研究
薬：Ulixertinib

Given PO

他の名前：
  • BVD-523
  • VRT752271

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Objective Response Rate (ORR = Complete Response [CR] + Partial Response [PR]) in Pediatric Patients Treated With BVD-523FB (Ulixertinib)
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Progression Free Survival (PFS) in Pediatric Patients Treated With Ulixertinib
時間枠：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
時間枠：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
時間枠：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

その他の成果指標

結果測定
メジャーの説明
時間枠
Other Biomarkers as Predictors of Response to Ulixertinib and Whether Tumors That Harbor Different Mutations or Fusions Will Demonstrate Differential Response to Treatment
時間枠：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)
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

National Cancer Institute (NCI)

捜査官

  • 主任研究者：Kieuhoa T Vo、Children's Oncology Group

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2018年11月14日

一次修了 (実際)

2022年3月31日

研究の完了 (推定)

2027年3月30日

試験登録日

最初に提出

2018年10月5日

QC基準を満たした最初の提出物

2018年10月5日

最初の投稿 (実際)

2018年10月9日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月21日

QC基準を満たした最後の更新が送信されました

2026年9月18日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • NCI-2018-02150
  • U10CA180886 (米国 NIH グラント/契約)
  • NCI-2018-02150 (レジストリ識別子：CTRP (Clinical Trial Reporting Program))
  • APEC1621J (その他の識別子：CTEP)
  • APEC1621J (その他の識別子：Children's Oncology Group)

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

購読する