A Study of BGB-11417 in Participants With Myeloid Malignancies

Sponsor: BeiGene

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04771130

Provider View

This study evaluates the safety, tolerability, and efficacy of BGB-11417 alone and with azacitidine in AML, MDS, or MDS/MPN patients. Eligible participants must have adequate organ function, a life expectancy over 12 weeks, and no recent malignancies. Interventions include oral BGB-11417 and azacitidine, with posaconazole in the second cycle.

Patient Parameters

Program Overview

The study will determine the safety, tolerability, recommended Phase 2 dose (RP2D) and preliminary efficacy of BGB-11417 as monotherapy and in combination with azacitidine in participants with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)or MDS/myeloproliferative neoplasm (MPN) .

Eligibility Criteria

Inclusion Criteria

  1. Confirmed diagnosis of one of the following by 2016 World Health Organization criteria:

    • AML, nonacute promyelocytic leukemia
    • MDS
    • MDS/MPN

  2. Eastern Cooperative Oncology Group performance status of 0 to 2.

  3. Adequate organ function defined as:

    • Creatinine clearance ≥ 50 milliliters/minute (mL/min) (or between 30 and 49 mL/min in unfit AML cohort)
    • Adequate liver function

  4. Life expectancy of > 12 weeks.

  5. Ability to comply with the requirements of the study.

Key

Exclusion Criteria

  1. A diagnosis of acute promyelocytic leukemia.
  2. History of prior malignancy, with the exception of either a history of MDS or MDS/MPN that has transformed to AML, or other prior malignancy that was treated with a full curative intent and no evidence of recurrence within the past 2 years (eg, localized skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score ≤ 6 prostate cancer)
  3. Antecedent MPN including myelofibrosis, essential thrombocytosis, polycythemia vera, or chronic myelogenous leukemia with or without BCR-ABL1 translocation and AML with BCR-ABL1 translocation.
  4. Prior therapy with a B-cell lymphoma-2 inhibitor
  5. Known central nervous system involvement by leukemia.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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