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MEK-hemmer Mirdametinib (PD-0325901) hos pasienter med nevrofibromatose type 1 assosierte plexiforme nevrofibromer (ReNeu)

11. september 2026 oppdatert av: SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany

En fase 2b-studie av MEK 1/2-hemmeren (MEKi) PD-0325901 hos voksne og pediatriske pasienter med nevrofibromatose type 1 (NF1)-assosiert inoperable plexiforme nevrofibromer (PN-er) som forårsaker betydelig sykelighet

This study evaluates mirdametinib (PD-0325901) in the treatment of symptomatic inoperable neurofibromatosis type-1 (NF1)-associated plexiform neurofibromas (PNs). All participants will receive mirdametinib (PD-0325901). Eligible participants may continue in a long-term follow-up phase.

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Neurofibromas are non-malignant peripheral nerve sheath tumors, which are classified as plexiform neurofibromas (PNs) if they extend longitudinally along a nerve and involve multiple fascicles. PNs are a major cause of morbidity and disfigurement in individuals with NF1, and as the tumor growth progresses, can cause a multitude of clinical problems including pain and impaired physical function. PNs have the potential to undergo malignant transformation to Malignant Peripheral Nerve Sheet Tumors (MPNST).

Mirdametinib (PD-0325901) is an orally delivered, highly selective small-molecule inhibitor of the dual specificity kinases, MEK1 and MEK2 (MAPK/ERK Kinase) which prevents the phosphorylation and subsequent activation of mitogen-activated protein kinase (MAPK).

Previous studies of mirdametinib (PD-0325901) demonstrated PN shrinkage and sustained inhibition of pERK. Reduced tumor volume indicated that cell proliferation or cell death may be altered in PNs with administration of mirdametinib (PD-0325901).

Studietype

Intervensjonell

Registrering (Faktiske)

114

Fase

  • Fase 2

Utvidet tilgang

Tilgjengelig utenfor den kliniske utprøvingen. Se utvidet tilgangspost.

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
        • University of Alabama at Birmingham (UAB) - Children's of Alabama
    • Arizona
      • Phoenix, Arizona, Forente stater, 85054
        • Mayo Clinic Arizona
    • Arkansas
      • Little Rock, Arkansas, Forente stater, 72202
        • Arkansas Children's Hospital - University of Arkansas
    • California
      • Los Angeles, California, Forente stater, 90027
        • Children's Hospital Los Angeles
      • Los Angeles, California, Forente stater, 90095
        • University of California, Los Angeles (UCLA)
      • Orange, California, Forente stater, 92868
        • Children's Hospital of Orange County
      • Orange, California, Forente stater, 92868
        • University of California - Irvine Health
      • Palo Alto, California, Forente stater, 94304
        • Lucile Packard Children's Hospital Stanford University
      • Sacramento, California, Forente stater, 95817
        • University of California - Davis
    • Colorado
      • Aurora, Colorado, Forente stater, 80045
        • Children's Hospital Colorado
    • Delaware
      • Wilmington, Delaware, Forente stater, 19803
        • Nemours A. I. duPont Hospital for Children
    • District of Columbia
      • Washington D.C., District of Columbia, Forente stater, 20010
        • Children's National Hospital
    • Florida
      • Gainesville, Florida, Forente stater, 32610
        • University of Florida (UF) - Gainesville
      • Miami, Florida, Forente stater, 33155
        • Nicklaus Children's Hospital
      • Orlando, Florida, Forente stater, 32804
        • Florida Hospital Cancer Institute
      • 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, 33612
        • Moffitt
    • Illinois
      • Chicago, Illinois, Forente stater, 60612
        • University of Illinois Hospital
    • Indiana
      • Indianapolis, Indiana, Forente stater, 46202
        • Indiana University
    • Iowa
      • Iowa City, Iowa, Forente stater, 52242
        • University of Iowa Health Care
    • Michigan
      • Ann Arbor, Michigan, Forente stater, 48109
        • University of Michigan Comprehensive Cancer Center
      • Detroit, Michigan, Forente stater, 48202
        • Henry Ford Hospital
    • Minnesota
      • Minneapolis, Minnesota, Forente stater, 55455
        • University of Minnesota Masonic Cancer Center
      • Rochester, Minnesota, Forente stater, 55905
        • Mayo Clinic
    • Missouri
      • St Louis, Missouri, Forente stater, 63110
        • Washington University
    • New Jersey
      • Paterson, New Jersey, Forente stater, 07503
        • Saint Joseph's Regional Medical Center
    • New York
      • Albany, New York, Forente stater, 12208
        • Albany Medical Center
      • The Bronx, New York, Forente stater, 10467
        • Children's Hospital at Montefiore
    • North Carolina
      • Chapel Hill, North Carolina, Forente stater, 27599
        • University of North Carolina (UNC) Hospitals
      • Durham, North Carolina, Forente stater, 27710
        • Duke University Medical Center
    • Ohio
      • Cincinnati, Ohio, Forente stater, 45229
        • UC Health
      • Columbus, Ohio, Forente stater, 43205
        • Nationwide 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
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forente stater, 15219-2739
        • UPMC Children's Hospital of Pittsburgh
    • Tennessee
      • Nashville, Tennessee, Forente stater, 37232
        • Vanderbilt Children's Hospital
    • Texas
      • Dallas, Texas, Forente stater, 75244
        • University of Texas Southwestern
      • Fort Worth, Texas, Forente stater, 76104
        • Cook Children's Medical Center
      • Houston, Texas, Forente stater, 77030
        • MD Anderson Cancer Center
    • Utah
      • Salt Lake City, Utah, Forente stater, 84108
        • The University of Utah Health Sciences Center
    • Virginia
      • Charlottesville, Virginia, Forente stater, 22903
        • University of Virginia - Emily Couric Cancer Center
      • Norfolk, Virginia, Forente stater, 23510
        • Children's Hospital of The King's Daughters

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

2 år og eldre (Barn, Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Key Inclusion Criteria:

  • Participant has documented NF1 mutation or a diagnosis of neurofibromatosis type 1 (NF1) using National Institute of Health (NIH) Consensus Conference criteria inclusive of the presence of a plexiform neurofibroma (PN).
  • Participant has a PN that is causing significant morbidity.
  • Participant has a PN that cannot be completely surgically removed.
  • Participant has a target tumor that is amenable to volumetric MRI analysis.
  • Participant is willing to undergo a tumor biopsy pre and post treatment if ≥ 18 years of age.
  • Participant has adequate organ and bone marrow function.

Key Exclusion Criteria:

  • Participant has abnormal liver function or history of liver disease.
  • Participant has lymphoma, leukemia or any malignancy within the past 5 years (except for resected basal/squamous skin carcinomas without metastases within 3 years).
  • Participant has breast cancer within 10 years.
  • Participant has active optic glioma or other low-grade glioma requiring treatment.
  • Participant has abnormal QT interval corrected or other heart disease within 6 months.
  • Participant has a history of retinal pathology, risk factors for retinal vein occlusion or has a history of glaucoma.
  • Participant has known malabsorption syndrome or gastrointestinal conditions that would impair absorption of mirdametinib (PD-0325901).
  • Participant has received NF1 PN-targeted therapy within 45 days.
  • Participant previously received or is currently receiving therapy with mirdametinib (PD-0325901) or any other MEK1/2 inhibitor.
  • Participant has received radiation therapy within 6 months or has received radiation to the orbit at any time.
  • Participant is unable to undergo or tolerate MRI.
  • Participant has active bacterial, fungal or viral infection.
  • Participant has experienced other severe acute or chronic medical or psychiatric conditions within 1 year.

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: Mirdametinib (PD-0325901)

Mirdametinib (PD-0325901) capsule or dispersible tablet 2 mg/m^2 (maximum dose of 4 mg) by mouth twice daily
Legemiddel: Mirdametinib (PD-0325901) oral capsule or dispersible tablet

Mirdametinib (PD-0325901) capsule or dispersible tablet

Andre navn:
  • PD-0325901
  • Mirdametinib

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Confirmed Objective Response Rate at the End of the Treatment Phase.
Tidsramme: Up to 24 months

Response will be determined by a blinded centralized review of volumetric MRI. The confirmed objective response rate (complete or partial response) by the end of Treatment Phase (i.e., Cycle 24) is defined as the proportion of participants who have a confirmed ≥ 20% reduction in target tumor volume as compared to baseline as assessed by a BICR, and the response needs to be confirmed by BICR in a consecutive tumor assessment within 2 - 6 months. Partial response is defined as a ≥ 20% reduction in target tumor volume from baseline. Complete response is defined as the complete resolution of the target tumor.
Up to 24 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of Patients With Treatment-Emergent Adverse Events.
Tidsramme: All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment, an average of 1 year and 10 months and up to 3 years and 10 months.

All adverse events were coded using MedDRA Version 24.0. Adverse events will be assessed according to toxicities graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment, an average of 1 year and 10 months and up to 3 years and 10 months.
Duration of Response (DOR) for Participants Who Meet Criteria for Confirmed Objective Response.
Tidsramme: Starting on the onset of confirmed objective response in the Treatment Phase and afterwards on the 15th day of every 4 cycles (each cycle is 28 days) until disease progression or death, whichever comes first, assessed up to approximately 3 years

Duration of response is defined as the time in months between the first instance of response that is subsequently confirmed, until the date of radiographic disease progression or death, whichever occurs first. For participants who enter the LTFU Phase, all MRI assessments in both the Treatment Phase and LTFU Phase will be used to determine duration of response. Participants without radiographic disease progression or death while on study will have their results censored to their most recent adequate (i.e. evaluable) tumor assessment date.
Starting on the onset of confirmed objective response in the Treatment Phase and afterwards on the 15th day of every 4 cycles (each cycle is 28 days) until disease progression or death, whichever comes first, assessed up to approximately 3 years
Change From Baseline on Quality of Life (QOL) as Measured by the Pediatric Quality of Life Inventory (PedsQL) at Cycle 13, Acute Version.
Tidsramme: Baseline and Cycle 13 (1 cycle = 28 days), up to 12 months

The PedsQL consists of a 23-item core measure of global QOL that can be completed in approximately 5 minutes. There is a total score and four subscales: physical functioning, emotional functioning, social functioning and school/work functioning. Participants ≥ 5 years of age complete an age-appropriate self-report; and parents/guardians of children ages 2-17 complete a parent proxy report of the age-specific QOL. The recall period is 7 days. PedsQL items are answered on a Likert scale with responses ranging from 0 to 4 (where 0 means it is never a problem and 4 means it is almost always a problem). These items are then reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. On this scale, higher scores indicate better outcomes. Overall scale scores are calculated as the mean of the scores for the questions in said scale (or of all questions for the total score). The change from baseline is modelled using a mixed-model for repeated measures.
Baseline and Cycle 13 (1 cycle = 28 days), up to 12 months
Change From Baseline in Pain as Measured by the Numeric Rating Scale-11 (NRS-11) at Cycle 13.
Tidsramme: Baseline and Cycle 13 (1 cycle = 28 days), up to 12 months

The NRS-11 is a self-reported 11-point numerical scale that assesses pain severity. Participants ≥ 8 years of age are asked to select a number from 0 (no pain) to 10 (worst pain you can imagine) that best describes their worst pain. The recall period is 24 hours. The change from baseline is modelled using a mixed-model for repeated measures.
Baseline and Cycle 13 (1 cycle = 28 days), up to 12 months
Change From Baseline in Pain as Measured by the Pain Interference Index (PII) at Cycle 13.
Tidsramme: Baseline and Cycle 13 (1 cycle = 28 days), up to 12 months

The PII assesses relevant aspects of one's life, including pain interference with activities, spending time with family/friends, mood, sleep and attention. Participants ≥ 6 years of age complete a self-report, and parents/guardians of children aged 6-17 complete a parent proxy report. The recall period is 24 hours. The PII consists of 6 questions, each asking the responder to select one number from 0 to 6 that best describes how their/their proxy's pain has impacted various items over the past 24 hours with 0 representing "Not at all" and 6 representing "Completely". The mean of the completed items is taken as the PII score for a single assessment. The PII score presented each visit will be taken as the average of the PII scores over the 7 consecutive days up to and including visit day, with no transformation applied. The change from baseline is modelled using a mixed-model for repeated measures.
Baseline and Cycle 13 (1 cycle = 28 days), up to 12 months

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change From Baseline in Localized Strength (Dynamometer) at Cycle 13.
Tidsramme: Baseline and Cycle 13 (1 cycle = 28 days), up to 12 months

Assessment of strength will be conducted only in the area affected by the target tumor. Measurements will be obtained using Medical Research Council (MRC) grading followed by quantitative assessments using the sponsor provided MicroFET2 dynamometer. Dynamometer assessment (in lbs) must be conducted in accordance with the study reference manual. For each participant, the sum of the dynamometer scores for the muscle groups tested will be taken as an overall score for each visit with higher scores indicating better localized strength. To assess the change from baseline at a visit, a participant will need assessments in which all the following categories, as assessed at baseline, match at that visit: side affected, position during assessment (sitting/supine/lateral decubitus), muscle group assessed. The change from baseline in localized strength measured by the sum of the dynamometer scores for the muscle groups tested will be assessed at Cycle 13.
Baseline and Cycle 13 (1 cycle = 28 days), up to 12 months
Change From Baseline in Range of Motion of PN-Associated Functional Impairment at Cycle 13.
Tidsramme: Baseline and Cycle 13 (1 cycle = 28 days), up to 12 months

If motor dysfunction or weakness is evident, range of motion of the affected areas and/or joints will be measured by a goniometer.
Baseline and Cycle 13 (1 cycle = 28 days), up to 12 months
Change From Baseline in Endurance at Cycle 13.
Tidsramme: Baseline and Cycle 13 (1 cycle = 28 days), up to 12 months

If airway or lower extremity motor dysfunction is evident, endurance will be measured by completion of a 6-minute walking test.
Baseline and Cycle 13 (1 cycle = 28 days), up to 12 months
Time to Response Defined as the Time Between First Dose and the First Date of Objective Response That is Subsequently Confirmed.
Tidsramme: Up to 24 months

Response will be determined by a blinded centralized review of volumetric MRI. Time to response is defined as the time in months from the start of treatment to the date of first response that was subsequently confirmed.
Up to 24 months
Time to Progression, From the First Dose to the First Date of a ≥ 20% Increase in Tumor Volume From Baseline.
Tidsramme: On the 15th day of every 4 cycles (each cycle is 28 days) until disease progression is observed, assessed up to approximately 3.5 years

Evidence of progression or tumor growth will be determined by a blinded centralized review of volumetric MRI. Time to progression is defined as the time in months between the first treatment date until the date of radiographic disease progression. For participants who enter the LTFU Phase, all MRI assessments in both the Treatment Phase and LTFU Phase will be used to determine time to progression. Participants without radiographic disease progression will have their results censored to their most recent adequate (i.e. evaluable) tumor assessment date.
On the 15th day of every 4 cycles (each cycle is 28 days) until disease progression is observed, assessed up to approximately 3.5 years
Progression Free Survival, Defined as the Time in Months From the First Dose to the Date of the First ≥ 20% Increase in Tumor Volume From Baseline or Death.
Tidsramme: On the 15th day of every 4 cycles (each cycle is 28 days) until disease progression is observed or death, whichever comes first, assessed up to approximately 3.5 years

Evidence of progression or tumor growth will be determined by a blinded centralized review of volumetric MRI. Progression free survival is defined as the time in months between the first treatment date, until the date of radiographic disease progression or death, whichever occurs first. For participants who enter the LTFU Phase, all MRI assessments in both the Treatment Phase and LTFU Phase will be used to determine progression free survival. Participants without radiographic disease progression or death while on study will have their results censored to their most recent adequate (i.e. evaluable) tumor assessment date.
On the 15th day of every 4 cycles (each cycle is 28 days) until disease progression is observed or death, whichever comes first, assessed up to approximately 3.5 years
Change From Baseline in PN-Associated Disfigurement Using Standardized Photography, Centrally Reviewed.
Tidsramme: Up to 24 months

For participants with a PN that is visible and amenable to photography, changes in visible tumor aspects will be evaluated by a centralized reviewer.
Up to 24 months
Comparison of Tumor Response to Levels of pERK and Biomarkers Indicative of Inhibition of Downstream Targets of MEK (eg, ERK Phosphorylation).
Tidsramme: Up to 24 months

Measured in tumor biopsies in participants ≥ 18 years of age.
Up to 24 months
Acceptability of the Dispersible Tablet Formulation as Measured by the Pediatric Oral Medicine Acceptability Questionnaire (P-OMAQ)
Tidsramme: Completed only once through study completion

The Pediatric Oral Medicine Acceptability Questionnaire (P-OMAQ) uses a 5-point numerical rate scale to measure acceptability of use of the tablet formulation with questions related to taste, smell and administration of study medication. Participants ≥ 8 years of age complete a 12-item self-report; adult parents/caregivers responsible for oversight of study drug administration for participants ages 6 months to 17 years complete a 19-item caregiver report. Each questionnaire is provided with a "past 7 days" recall with all items using a 5-point Numerical Rate Scale (1 to 5) with higher item-scores reflecting greater oral treatment acceptability. The overall P-OMAQ-P (pediatric self-report) and P-OMAQ-C (adult caregiver) scores for a participant in the study will be taken as the mean of all answered questions on the respective questionnaire.
Completed only once through study completion
Change From Baseline in Localized Strength (Medical Research Council (MRC) Scale Grading) at Cycle 13.
Tidsramme: Baseline and Cycle 13 (1 cycle = 28 days), up to 12 months

If motor dysfunction or weakness is evident, strength of the affected muscle groups will be measured by dynamometer and assessed by a muscle grading scale. Medical Research Council (MRC) Scale grading (0-5) must be conducted in accordance with the study reference manual. MRC Grading is assessed on a scale of 0 to 5, with 0 representing no movement being observed, and 5 representing the muscle contracting normally against full resistance. To assess the change from baseline at a visit, a participant will need assessments in which all the following categories, as assessed at baseline, match at that visit: side affected, position during assessment (sitting/supine/lateral decubitus), muscle group assessed. The MRC Grade visit score is calculated for each participant separately, and these scores are then averaged.
Baseline and Cycle 13 (1 cycle = 28 days), up to 12 months
Change From Baseline in Physical Function Status as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) at Cycle 13: Pediatric v2.0 Mobility 8a.
Tidsramme: Baseline and Cycle 13 (1 cycle = 28 days), up to 12 months

PROMIS measures capability of physical functioning, with questions related to daily activities. Participants 8-17 years complete a self-report of physical function in the upper extremity or lower extremity (mobility), depending on the location of the PN. The recall period is 7 days. All PROMIS items are answered on a Likert scale with responses ranging from 1 to 5, with higher scores representing higher reported mobility. The total raw score will be calculated as the sum of the individual item responses at a given visit (total raw scale range 8-40). The total raw scores for the measure will be converted to T-scores using the applicable score conversion table in the user manual and scoring instructions (PROMIS, 2023) ranging from 14 to 59 for self-report, and 14 to 56 for parent proxy with higher scores representing higher reported mobility and better outcomes. A T-score of 50 indicates the population mean with a standard deviation of 10.
Baseline and Cycle 13 (1 cycle = 28 days), up to 12 months
Change From Baseline in Physical Function Status as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) at Cycle 13: Pediatric v2.0 Upper Extremities 8a.
Tidsramme: Baseline and Cycle 13 (1 cycle = 28 days), up to 12 months

PROMIS measures capability of physical functioning, with questions related to daily activities. Participants 8-17 years complete a self-report of physical function in the upper extremity or lower extremity (mobility), depending on the location of the PN. The recall period is 7 days. All PROMIS items are answered on a Likert scale with responses ranging from 1 to 5, with higher scores representing higher physical functioning in the upper extremities. The total raw score will be calculated as the sum of the individual item responses at a given visit (total raw scale range 8-40). The total raw scores for the measure will be converted to T-scores using the applicable score conversion table in the user manual and scoring instructions (PROMIS, 2023) ranging from 10 to 57 for self-report, and 13 to 55 for parent proxy with higher scores representing higher reported physical functioning and better outcomes. A T-score of 50 indicates the population mean with a standard deviation of 10.
Baseline and Cycle 13 (1 cycle = 28 days), up to 12 months
Change From Baseline in Physical Function Status as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) at Cycle 13: Adult v2.0 Physical Function 8b.
Tidsramme: Baseline and Cycle 13 (1 cycle = 28 days), up to 12 months

PROMIS measures capability of physical functioning, with questions related to daily activities. Participants ≥ 18 years with a target PN impacting physical functioning complete a self-report of physical function. The recall period is 7 days. All PROMIS items are answered on a Likert scale with responses ranging from 1 to 5, with higher scores representing higher reported physical capability. The total raw score will be calculated as the sum of the individual item responses at a given visit (total raw scale range 8-40). The total raw scores for the measure will be converted to T-scores using the applicable score conversion table in the user manual and scoring instructions (PROMIS, 2023) ranging from 20.3 to 60.1 with higher scores representing higher reported physical functioning and better outcomes. A T-score of 50 indicates the population mean with a standard deviation of 10.
Baseline and Cycle 13 (1 cycle = 28 days), up to 12 months

Samarbeidspartnere og etterforskere

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

Sponsor

SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany

Etterforskere

  • Studieleder: Medical Responsible, SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany

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

Hjelpsomme linker

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)

29. september 2019

Primær fullføring (Faktiske)

20. september 2023

Studiet fullført (Antatt)

22. desember 2028

Datoer for studieregistrering

Først innsendt

12. april 2019

Først innsendt som oppfylte QC-kriteriene

22. mai 2019

Først lagt ut (Faktiske)

24. mai 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • MEK-NF-201

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

IPD supporting publicly available results will be evaluated for sharing.

IPD-delingstidsramme

IPD from completed trials will be publicly available within 6 months after all of the following events:

  • Approval of a product/new indication by major authorities (FDA, EMA, PMDA if requested) with no pending submissions
  • Public results via primary manuscript or trial registry disclosure
  • Legal authority to share data
  • Privacy protections are in place If approval is not sought or development is globally discontinued, data will be publicly available within 18 months after global trial completion. Further information on how to request data can be found on our website bit.ly/IPD21

Tilgangskriterier for IPD-deling

Qualified researchers may propose access to IPD from sponsored trials via https://vivli.org/members/ourmembers/

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ANALYTIC_CODE
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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