Entrectinib in Combination With ASTX727 for the Treatment of Relapsed/Refractory TP53 Mutated Acute Myeloid Leukemia

StatusActive, Not Recruiting
PhasePhase 1
Started

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Record History

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  1. Study completion pushed from Dec 31, 2026 to Feb 1, 2027
    • Secondary endpoints: details revised at 4 of 8 entries
    • Eligibility criteria expanded, about 1 word
  2. Primary completion date changed from estimate of Dec 31, 2025 to Jun 10, 2024
    • Study completion date: Jun 30, 2026 to Dec 31, 2026
    v10
  3. Trial status: Suspended to Active, Not Recruiting
    • Enrollment target: estimated 12 to confirmed 13
    v9
  4. Trial status: Recruiting to Suspended Sponsor's reason: Pending funding
    • Site details revised
    v8
  5. Primary completion date: Dec 31, 2024 to Dec 31, 2025
    • Study completion date: Jun 30, 2025 to Jun 30, 2026
    v7
Show 5 earlier versionsHide 5 earlier versions
  1. Re-verified, no change to tracked fieldsv6
  2. Primary completion date: Apr 2, 2024 to Dec 31, 2024
    • Study completion date: Oct 2, 2024 to Jun 30, 2025
    v5
  3. Primary completion date: Oct 2, 2023 to Apr 2, 2024v4
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 15, 2022 to Oct 28, 2022
    • Site details revised
    v3
  5. Start date: Jun 15, 2022 to Oct 15, 2022
    • Eligibility criteria revised
    • Collaborators revised (3)
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This phase I trial tests the safety, side effects, and best dose of entrectinib when given with ASTX727 in treating patients with acute myeloid leukemia (AML) that has come back (relapsed) or that does not respond to treatment (refractory) and has a genetic change (mutation) in the TP53 gene. ASTX727 is a combination of cedazuridine and decitabine. Cedazuridine is in a class of medications called cytidine deaminase inhibitors. It prevents the breakdown of decitabine, making it more available in the body so that decitabine will have a greater effect. Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. Entrectinib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps to stop or slow the spread of cancer cells. Giving ASTX727 and entrectinib together may kill more tumor cells in patients with AML.
Trial Details
NCT Number NCT05396859
Lead Sponsor OHSU Knight Cancer Institute
Collaborators: Oregon Health and Science University, Genentech, Inc., Taiho Oncology, Inc.
Conditions
(from sponsor)		 Acute Myeloid Leukemia, Recurrent Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
Related terms Leukemia, Myeloid, Acute
Enrollment 13 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov