Health TrialsbyHealthPanel

A Study of BGB-11417 in Participants With Myeloid Malignancies

ConditionsAcute Myeloid LeukemiaMyelodysplastic SyndromesMyelodysplastic/Myeloproliferative Neoplasm
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeOne Medicines

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

AML, nonacute promyelocytic leukemia

MDS

MDS/MPN

Eastern Cooperative Oncology Group performance status of 0 to 2.

Disqualifiers

A diagnosis of acute promyelocytic leukemia.

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)

Antecedent MPN including myelofibrosis, essential thrombocytosis, polycythemia vera, or chronic myelogenous leukemia with or without BCR-ABL1 translocation and AML with BCR-ABL1 translocation.

Prior therapy with a B-cell lymphoma-2 inhibitor

Trial design

Design model

Parallel

Treatments tested in this trial

  • BGB-11417

    Drug

    Oral administration for 10, 21, 14 or 28 days on a 28-day cycle.

  • Azacitidine

    Drug

    Intravenous or subcutaneous administration for 7 days.

  • Posaconazole

    Drug

    Oral administration for 8 days on second cycle only.

  • BGB-11417

    Drug

    Oral administration for 28 days on a 28-day cycle.

  • BGB-11417

    Drug

    Oral administration for 10, 14 or 21 days on a 28-day

Treatment groups

260 Participants
are divided into 4 treatment groups
Group A: Parts 1 and 2: AML CohortsExperimental treatment 2 interventions
Group B: Parts 1 and 2: MDS CohortsExperimental treatment 2 interventions
Group C: Part 3: AML and MDS CohortsExperimental treatment 3 interventions
Group D: Part 3: AML and MDS CohortExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Part 1 And 2: Number Of Participants Experiencing Dose-limiting Toxicities (DLTs)

Time frame
Cycle 1 (Up to 28 days for non-hematologic DLTs and up to 42 days for hematologic DLTs)
2

Part 1 And 2: Number Of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

Time frame
Approximately 24 months
3

Part 3 AML Cohort: Complete Remission (CR) Plus CR With Partial Hematologic Recovery (CRh) Rate

CR plus CRh will be defined as the percentage of participants whose best overall response (BOR) is CR plus CRh. BOR will be defined as the best response recorded from the first dose of study drug until data cut or the initiation of new anticancer treatment.

Time frame
Approximately 24 months
4

Part 3 MDS Cohort: Modified Overall Response (mOR) Rate

The mOR will be defined as the percentage of participants whose BOR is achieving CR, marrow complete remission (mCR), or partial remission (PR) at any time point during the study for myelodysplastic/myeloproliferative neoplasm (MDS/MPN).

Time frame
Approximately 24 months

Secondary outcomes

1

Parts 1 And 2 AML Cohort: Complete remission (CR) + Morphologic CR With Partial Hematologic Recovery (CRh)

Time frame
Approximately 24 months
2

Parts 1 And 2 MDS Cohort: mOR Rate

Time frame
Approximately 24 months
3

Parts 1 And 2: Cmax Of Azacitidine When Coadministered With BGB-11417

Time frame
Day 0 and 4 (Cycle 1) predose and at multiple time points up to 4 hours postdose
4

Parts 1 And 2: Terminal Half-life (t1/2) Of Azacitidine When Coadministered With BGB-11417

Time frame
Day 0 and 4 (Cycle 1) predose and at multiple time points up to 4 hours postdose

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

BeOne Medicines

Lead sponsor

Source ClinicalTrials.gov
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