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ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS

8. november 2026 opdateret af: Washington University School of Medicine

A Phase I Study of ATRN-119, an ATR Inhibitor, in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS

This single-center, open-label, phase I study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antileukemic activity of ATRN-119 (mosipasertib) alone and in combination with decitabine in patients with TP53-mutated AML or higher-risk myelodysplastic syndrome (HR-MDS). The primary objective is to identify the maximum tolerated dose (MTD) and recommended dose(s) for expansion (RDE) of ATRN-119 (mosipasertib) plus decitabine. The study is based on the hypothesis that ATR inhibition with ATRN-119 (mosipasertib) will enhance sensitivity to decitabine in TP53-mutated disease, resulting in deeper and more durable clinical responses.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

36

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • Missouri
      • St Louis, Missouri, Forenede Stater, 63110
        • Rekruttering
        • Washington University School of Medicine
        • Ledende efterforsker:
          • Geoffrey L Uy, MD
        • Underforsker:
          • Daniel C Link, MD
        • Underforsker:
          • J Scott Beeler, MD, PhD
        • Underforsker:
          • Fei Wan, PhD
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Diagnosis of AML or higher-risk MDS (HR-MDS) according to the World Health Organization (WHO) 5th Edition or International Consensus Classification (ICC) 2022 criteria.

    • HR-MDS is defined as:

      • IPSS-R (score > 3.5) or IPSS-M (score > 0.5) OR
      • ≥ 10% bone marrow blasts

  • At least one of the following demonstrated on standard of care testing:

    • A pathogenic or likely pathogenic TP53 mutation with a VAF ≥10%
    • A TP53 or chromosome 17p deletion detected in ≥10% of cells by a cytogenetic assay
    • >20% p53-positive cells by immunohistochemistry

  • Meeting R/R disease criteria for AML or HR-MDS:

    • Patients with R/R AML must have received at least 1 prior AML-directed treatment regimen appropriate for their disease and fitness. Patients with FLT3, IDH1, IDH2, or NPM1 mutations must also have previously received, or been deemed ineligible for, an approved targeted therapy directed against the relevant mutation. In addition, patients must meet at least one of the following criteria:

      • Disease progression during treatment with, or failure to achieve CR, CRh, or CRi after ≥ 2 cycles of a hypomethylating agent (HMA) plus venetoclax.
      • Disease progression during treatment with, or failure to achieve CR, CRh, or CRi after ≥ 4 cycles of HMA-based therapy when venetoclax was contraindicated, not tolerated, or otherwise considered clinically inappropriate.
      • First relapse with an initial remission duration < 12 months
      • First relapse following failed salvage chemotherapy
      • Relapse after allogeneic hematopoietic cell transplant
      • Second or subsequent relapse

    • Patients with R/R HR-MDS must have received at least 1 prior MDS-directed treatment regimen appropriate for their disease and fitness. Patients with IDH1 mutations must also have previously received, or been deemed ineligible for, an approved targeted therapy directed against the relevant mutation. Patients must meet at least one of the following criteria:

      • Disease progression during treatment with, or failure to achieve CR, CRh, or CRi after ≥ 4 cycles of HMA-based therapy or 2 cycles of HMA in combination with another agent, including an investigational agent as part of a clinical trial or in routine clinical care.
      • Relapse after allogeneic hematopoietic cell transplant
      • Second or subsequent relapse

  • At least 18 years of age.

  • ECOG performance status ≤ 2

  • Adequate organ function within 28 days prior to the first dose of mosipasertib as defined below:

    • Total bilirubin ≤ 2.0 x IULN; patients with known or suspected Gilbert's syndrome may have total bilirubin ≤ 3 x IULN
    • AST(SGOT)/ALT(SGPT) ≤ 2.5 x IULN
    • Creatinine clearance ≥ 45 mL/min/1.73 m^2 by Cockcroft-Gault formula

  • The effects of mosipasertib and decitabine on the developing human fetus are unknown. For this reason, people of childbearing potential and people able to father a child must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 6 months after the last dose of mosipasertib or decitabine on study (whichever is later) for people of childbearing potential and 3 monthsafter the last dose of mosipasertib or decitabine on study (whichever is later) for people able to father a child.

  • Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.

Exclusion Criteria:

  • Active CNS involvement by AML requiring therapeutic intervention.
  • Active graft-versus-host disease (GVHD) requiring systemic immunosuppressive therapy except for low-dose steroids (prednisone ≤ 10 mg per day or other steroid equivalent)
  • Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial.
  • Currently receiving any other investigational agents.
  • Concomitant systemic treatment with inhibitors of BCRP, OATP1B1, OATP1B3, OAT1, OAT3, OCT2, MATE1, or MATE2-K. Patients may be eligible after a washout period of at least 7 days or 5 half-lives, whichever is longer, prior to the first dose of ATRN-119.
  • Concomitant systemic treatment with strong inhibitors or inducers of CYP enzymes. Patients may be eligible after a washout period of 5 half-lives or 14 days (whichever is longer) before PK Run-In Day 1 or C1D1 (whichever is applicable) for strong inducers, and 5 half-lives or 7 days (whichever is longer) before PK Run-In Day 1 or C1D1 (whichever is applicable) for strong inhibitors.
  • A history of allergic reactions attributed to or known hypersensitivity to compounds of similar chemical or biologic composition to mosipasertib, decitabine, or other agents used in the study.
  • Persistent corrected QT interval using Fridericia's formula (QTcF) >480 msec (CTCAE v6.0 ≥ grade 2), except in patients with bundle branch block and/or ventricular paced rhythm for whom QTc cannot be reliably assessed using standard correction methods.
  • Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection, clinically significant autoimmune disease requiring systemic therapy, symptomatic congestive heart failure, unstable angina pectoris, or clinically significant or uncontrolled cardiac arrhythmia. Patients with a known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Function Classification; to be eligible for this trial, patients should be a class 2B or better.
  • Conditions that may impair oral drug administration or absorption, including inability to swallow oral medications, malabsorption syndromes, or other clinically significant gastrointestinal disorders.
  • Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 7 days of PK Run-In Day 1/Cycle 1 Day 1.
  • HIV-infected if not on effective anti-retroviral therapy with undetectable viral load for 6 months. Patients with HIV who are receiving effective anti-retroviral therapy and have had an undetectable viral load for at least 6 months are eligible. HIV testing is not required in the absence of known history of infection.
  • Evidence of chronic hepatitis B virus (HBV) that is detectable on suppressive therapy. Patients with evidence of chronic HBV infection with undetectable HBV viral load by PCR on suppressive therapy are eligible. HBV testing is not required in the absence of known history of infection.
  • History of hepatitis C virus (HCV) infection that has not been cured or that has a detectable viral load. Patients with a history of HCV that has been treated and cured are eligible. Patients with HCV infection who are currently on treatment and have an undetectable HCV viral load are eligible. HCV testing is not required in the absence of known history of infection.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Sekventiel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Part A Dose Escalation Dose Level 1: ATRN-119
  • Patients will take ATRN-119 at the assigned dose level by mouth once per day on Days 1-28 of each 28-day cycle.
  • Patients in Part A may (but are not required to) transition to the current dose level being evaluated in Part B (and thus receive decitabine concurrently with mosipasertib) following completion of the Cycle 1 DLT evaluation period for all patients in their assigned dose level, provided that dose level is determined to be safe. In order to transition from Part A to Part B, a patient must have persistent AML or HR-MDS (meaning they must NOT have achieved a CR without MRD) and must meet all eligibility criteria. In addition, both they and their physician must be in agreement that the decision to transition is desired and acceptable.
  • Patients may continue treatment for up to 24 total cycles across Parts A and B unless disease is considered refractory after Cycle 4, or until disease progression, unacceptable toxicity, or withdrawal, whichever occurs first.
Medicin: ATRN-119

Provided in 50 mg and 100 mg capsules or 50 mg and 250 mg tablets and are administered by mouth.

Andre navne:
  • Mosipasertib
Eksperimentel: Part A Dose Escalation Dose Level 2: ATRN-119
  • Patients will take ATRN-119 at the assigned dose level by mouth once per day on Days 1-28 of each 28-day cycle.
  • Patients in Part A may (but are not required to) transition to the current dose level being evaluated in Part B (and thus receive decitabine concurrently with mosipasertib) following completion of the Cycle 1 DLT evaluation period for all patients in their assigned dose level, provided that dose level is determined to be safe. In order to transition from Part A to Part B, a patient must have persistent AML or HR-MDS (meaning they must NOT have achieved a CR without MRD) and must meet all eligibility criteria. In addition, both they and their physician must be in agreement that the decision to transition is desired and acceptable.
  • Patients may continue treatment for up to 24 total cycles across Parts A and B unless disease is considered refractory after Cycle 4, or until disease progression, unacceptable toxicity, or withdrawal, whichever occurs first.
Medicin: ATRN-119

Provided in 50 mg and 100 mg capsules or 50 mg and 250 mg tablets and are administered by mouth.

Andre navne:
  • Mosipasertib
Eksperimentel: Part A Dose Escalation Dose Level 3: ATRN-119
  • Patients will take ATRN-119 at the assigned dose level by mouth once per day on Days 1-28 of each 28-day cycle.
  • Patients in Part A may (but are not required to) transition to the current dose level being evaluated in Part B (and thus receive decitabine concurrently with mosipasertib) following completion of the Cycle 1 DLT evaluation period for all patients in their assigned dose level, provided that dose level is determined to be safe. In order to transition from Part A to Part B, a patient must have persistent AML or HR-MDS (meaning they must NOT have achieved a CR without MRD) and must meet all eligibility criteria. In addition, both they and their physician must be in agreement that the decision to transition is desired and acceptable.
  • Patients may continue treatment for up to 24 total cycles across Parts A and B unless disease is considered refractory after Cycle 4, or until disease progression, unacceptable toxicity, or withdrawal, whichever occurs first.
Medicin: ATRN-119

Provided in 50 mg and 100 mg capsules or 50 mg and 250 mg tablets and are administered by mouth.

Andre navne:
  • Mosipasertib
Eksperimentel: Part B Dose Escalation Dose Level 1: ATRN-119 + Decitabine
  • Patients will take ATRN-119 at the assigned dose level by mouth once per day on Days 1-28 and 20 mg/m^2 of decitabine given intravenously (IV) on Days 1-5 of each 28-day cycle.
  • Patients may continue treatment for up to 24 total cycles unless disease is considered refractory after Cycle 4, or until disease progression, unacceptable toxicity, or withdrawal, whichever occurs first.
Medicin: ATRN-119

Provided in 50 mg and 100 mg capsules or 50 mg and 250 mg tablets and are administered by mouth.

Andre navne:
  • Mosipasertib
Medicin: Decitabine

Decitabine is provided as a 50 mg injection in a single-dose vial.

Andre navne:
  • Dacogen
Eksperimentel: Part B Dose Escalation Dose Level 2: ATRN-119 + Decitabine
  • Patients will take ATRN-119 at the assigned dose level by mouth once per day on Days 1-28 and 20 mg/m^2 of decitabine given intravenously (IV) on Days 1-5 of each 28-day cycle.
  • Patients may continue treatment for up to 24 total cycles unless disease is considered refractory after Cycle 4, or until disease progression, unacceptable toxicity, or withdrawal, whichever occurs first.
Medicin: ATRN-119

Provided in 50 mg and 100 mg capsules or 50 mg and 250 mg tablets and are administered by mouth.

Andre navne:
  • Mosipasertib
Medicin: Decitabine

Decitabine is provided as a 50 mg injection in a single-dose vial.

Andre navne:
  • Dacogen
Eksperimentel: Part B Dose Escalation Dose Level 3: ATRN-119 + Decitabine
  • Patients will take ATRN-119 at the assigned dose level by mouth once per day on Days 1-28 and 20 mg/m^2 of decitabine given intravenously (IV) on Days 1-5 of each 28-day cycle.
  • Patients may continue treatment for up to 24 total cycles unless disease is considered refractory after Cycle 4, or until disease progression, unacceptable toxicity, or withdrawal, whichever occurs first.
Medicin: ATRN-119

Provided in 50 mg and 100 mg capsules or 50 mg and 250 mg tablets and are administered by mouth.

Andre navne:
  • Mosipasertib
Medicin: Decitabine

Decitabine is provided as a 50 mg injection in a single-dose vial.

Andre navne:
  • Dacogen

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number and grade of treatment-emergent adverse events (TEAEs) as assessed via CTCAE v6.0 (All Patients)
Tidsramme: From start of treatment until 30 days after last dose of ATRN-119 (approximately 23 months)
From start of treatment until 30 days after last dose of ATRN-119 (approximately 23 months)
Incidence of dose-limiting toxicities (DLTs) during Cycle 1 as assessed via CTCAE v6.0 (All Patients)
Tidsramme: From Cycle 1 Day 1 to end of Cycle 1 Day 28/Cycle 1 Day 42 (total time 28-42 days)

The DLT evaluation period is 28 days from initiation of study treatment (Cycle 1), except in cases of persistent neutropenia meeting hematologic DLT criteria, for which the observation window will extend to 42 days from treatment initiation. DLTs are defined in the protocol.
From Cycle 1 Day 1 to end of Cycle 1 Day 28/Cycle 1 Day 42 (total time 28-42 days)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Rate of Complete Remission (CR) (All Patients)
Tidsramme: Through completion of treatment (estimated total time 22 months)

European LeukemiaNet (ELN) 2022 Response Criteria assesses AML and the International Working Group (IWG) 2023 Response Criteria assesses Higher-Risk MDS (HR-MDS).

CR AML: Bone marrow blasts < 5%; absence of circulating blasts; absence of extramedullary disease; ANC ≥ 1.0 x 10^9/L (1,000/μL); platelet count ≥ 100 x 10^9/L (100,000/μL).

CR HR-MDS: Bone marrow: < 5% myeloblasts; dysplasia may persist and peripheral blood: hemoglobin ≥ 10 g/dL, platelets ≥ 100 x 10^9/L, neutrophils ≥ 1.0 x 10^9/L, blasts 0%
Through completion of treatment (estimated total time 22 months)
Rate of Complete Remission with partial hematologic recovery (CRh) (All Patients)
Tidsramme: Through completion of treatment (estimated total time 22 months)

European LeukemiaNet (ELN) 2022 Response Criteria assesses AML and the International Working Group (IWG) 2023 Response Criteria assesses Higher-Risk MDS (HR-MDS).

CRh is defined according to the ELN 2022 Response Criteria: ANC ≥ 0.5 x 10^9/L (500 μL) and platelet count ≥ 50 x 10^9/L (50,000/μL), otherwise all other CR criteria met

CRh is defined according to the IWG 2023 Response Criteria: Bone marrow: < 5% myeloblasts; dysplasia may persist; Peripheral blood: not meeting criteria for CR or CRL; no hemoglobin threshold required, platelets ≥ 50 x 10^9/L, neutrophils ≥ 0.5 x 10^9/L, blasts 0%
Through completion of treatment (estimated total time 22 months)
Rate of Partial Remission (PR) (All Patients)
Tidsramme: Through completion of treatment (estimated total time 22 months)

European LeukemiaNet (ELN) 2022 Response Criteria assesses AML and the International Working Group (IWG) 2023 Response Criteria assesses Higher-Risk MDS (HR-MDS).

PR is defined according to the ELN 2022 Response Criteria: All hematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pre-treatment bone marrow blast percentage by at least 50%

PR is defined according to the IWG 2023 Response Criteria: All CR criteria except: Bone marrow blasts decreased by ≥ 50% over pretreatment but still ≥ 5% and Cellularity and morphology not relevant
Through completion of treatment (estimated total time 22 months)
Duration of Response (DoR) (All Patients)
Tidsramme: From first documented response until disease progression or death (up to 48 months)

DoR will be measured from the first documented response until earliest date of disease progression or death from any cause, as defined in the protocol or disease-specific criteria (ELN 2022 for AML and IWG 2023 for HR-MDS). DOR will be summarized among responders only. Individuals who do not exhibit any disease progression or death during the follow-up period are censored at the last date of the response assessment.
From first documented response until disease progression or death (up to 48 months)
Event-free Survival (EFS) (All Patients)
Tidsramme: From Cycle 1 Day 1 to treatment failure, relapse after response, progression, or death (up to 48 months)

EFS will be measured from Cycle 1 Day 1 to treatment failure, relapse after response, progression, or death from any cause, consistent with protocol definitions and disease-specific response criteria (ELN 2022 for AML and IWG 2023 for HR-MDS). EFS will be summarized in the efficacy-evaluable population. Participants without an event will be censored at the last disease assessment date at which they were known to be event-free.
From Cycle 1 Day 1 to treatment failure, relapse after response, progression, or death (up to 48 months)
Overall Survival (OS) (All Patients)
Tidsramme: From Cycle 1 Day 1 to death from any cause (up to 48 months)

OS will be measured from Cycle 1 Day 1 to death from any cause. Participants alive at last follow-up will be censored on the date last known alive. OS will be summarized in all treated participants.
From Cycle 1 Day 1 to death from any cause (up to 48 months)
Rate of Complete Remission with incomplete count recovery (CRi) (AML Patients only)
Tidsramme: Through completion of treatment (estimated total time 22 months)

Response is assessed according to the ELN 2022 Response Criteria for AML.

CRi is defined as all CR criteria except for residual neutropenia < 1.0 x 10^9/L (500/μL) or thrombocytopenia < 100 x 10^9/L (50,000/μL); CRi should only include patients not meeting the definition of CRh.
Through completion of treatment (estimated total time 22 months)
Rate of morphologic leukemia-free state (MLFS) (AML Patients only)
Tidsramme: Through completion of treatment (estimated total time 22 months)

Response is assessed according to the ELN 2022 Response Criteria for AML.

MLFS is defined as bone marrow blasts < 5%; absence of circulating blasts; absence of extramedullary disease; no hematologic recovery required.
Through completion of treatment (estimated total time 22 months)
Rate of composite Complete Remission (cCR) (AML Patients only)
Tidsramme: Through completion of treatment (estimated total time 22 months)

Response is assessed according to the ELN 2022 Response Criteria for AML.

cCR is defined as complete remission (CR) + complete remission with partial hematologic recovery (CRh) + complete remission with incomplete hematologic recovery (CRi)
Through completion of treatment (estimated total time 22 months)
Overall Response Rate (ORR) (AML Patients only)
Tidsramme: Through completion of treatment (estimated total time 22 months)

Response is assessed according to the ELN 2022 Response Criteria for AML. ORR is defined as complete remission (CR) + complete remission with partial hematologic recovery (CRh) + complete remission with incomplete hematologic recovery (CRi) + partial remission (PR) + morphologic leukemia-free state (MLFS)
Through completion of treatment (estimated total time 22 months)
Rate of Complete Remission (CR) equivalent (HR-MDS patients only)
Tidsramme: Through completion of treatment (estimated total time 22 months)

CR is assessed according to the IWG 2023 Response Criteria for HR-MDS.

CR: Bone marrow: < 5% myeloblasts; dysplasia may persist; Peripheral blood: hemoglobin ≥ 10 g/dL, platelets ≥ 100 x 10^9/L, neutrophils ≥ 1.0 x 10^9/L, blasts 0%
Through completion of treatment (estimated total time 22 months)
Rate of Complete Remission with limited count recovery (CRL) (HR-MDS patients only)
Tidsramme: Through completion of treatment (estimated total time 22 months)

CRL is assessed according to the IWG 2023 Response Criteria for HR-MDS.

CRL (CRuni and CRbi): Bone marrow: < 5% myeloblasts; dysplasia may persist; Peripheral blood: blasts 0%; Complete remission unilineage (CRuni): peripheral blood not meeting CR but only one of the following: hemoglobin ≥ 10 g/dL, platelets ≥ 100 x 10^9/L, neutrophils ≥ 1.0 x 10^9/L Complete remission bilineage (CRbi): peripheral blood not meeting CR but only two of the following: hemoglobin ≥ 10 g/dL, platelets ≥ 100 x 10^9/L, neutrophils ≥ 1.0 x 10^9/L
Through completion of treatment (estimated total time 22 months)
Rate of Hematological Improvement (HI) (HR-MDS patients only)
Tidsramme: Through completion of treatment (estimated total time 22 months)

HI is assessed according to the IWG 2018 Response Criteria for HR-MDS.

HI: Not meeting criteria for complete remission (CR) (or CR equivalent) or complete remission unilineage (CRuni) or complete remission with limited count recovery (CRL); HIerythroid (HI-E); HIplatelets (HI-P); HIneutrophils (HI-N).
Through completion of treatment (estimated total time 22 months)
Rate of composite Complete Remission (cCR) (HR-MDS patients only)
Tidsramme: Through completion of treatment (estimated total time 22 months)

cCR is assessed according to the IWG 2023 Response Criteria for HR-MDS.

cCR is defined as complete remission (CR) + complete remission (CR) equivalent + complete remission with limited count recover (CRL) + complete remission with partial hematologic recovery (CRh)
Through completion of treatment (estimated total time 22 months)
Overall Response Rate (ORR) (HR-MDS patients only)
Tidsramme: Through completion of treatment (estimated total time 22 months)

Response is assessed via the IWG 2023 Response Criteria for HR-MDS. ORR is defined as complete remission (CR) + complete remission (CR) equivalent + complete remission with limited count recover (CRL) + complete remission with partial hematologic recovery (CRh) + partial remission (PR) + hematological improvement (HI)
Through completion of treatment (estimated total time 22 months)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Washington University School of Medicine

Samarbejdspartnere

National Cancer Institute (NCI)
Aprea Therapeutics
The V Foundation for Cancer Research

Efterforskere

  • Ledende efterforsker: Geoffrey L Uy, MD, Washington University School of Medicine

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

30. november 2026

Primær færdiggørelse (Anslået)

31. oktober 2029

Studieafslutning (Anslået)

30. november 2031

Datoer for studieregistrering

Først indsendt

20. maj 2026

Først indsendt, der opfyldte QC-kriterier

20. maj 2026

Først opslået (Faktiske)

1. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 202609141
  • P50CA171963 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

De-identified individual participant data underlying the results reported in publications arising from this study will be made available to qualified investigators.

IPD-delingstidsramme

Data will become available beginning 6 months after publication of the primary study results and will remain available for at least 5 years thereafter.

IPD-delingsadgangskriterier

De-identified individual participant data will be made available upon reasonable request to the Principal Investigator following publication of the primary study results. Requests must include a scientifically sound proposal and may require execution of a data use agreement and approval by Washington University and other applicable oversight bodies.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ja

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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