Study of BGB-11417 for Myeloid Malignancies
This study is testing a new drug called BGB-11417, both alone and with another drug called azacitidine, for people with certain blood cancers. These include acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), or myelodysplastic/myeloproliferative neoplasm (MDS/MPN). The main goals are to see how safe BGB-11417 is, what side effects it might cause, and to find the best dose. Researchers will also look at how well the treatment works, for example, if it leads to a complete remission (when signs of cancer disappear). You might be able to join if you are 18 or older, have one of these conditions, and meet other health requirements. The study plans to enroll about 260 participants, but its current status is unclear.
- Study design
- This is an interventional study, meaning participants will receive specific treatments. It aims to enroll 260 participants, but the phase is not specified.
- What's involved
- You would take BGB-11417 by mouth for a set number of days in a 28-day cycle. Some participants might also receive azacitidine by injection or posaconazole by mouth.
- Compensation
- Not stated in the trial record.
- Follow-up
- Researchers will monitor participants for side effects for approximately 24 months. They will also check for complete remission in some groups around 24 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study of BGB-11417 in Participants With Myeloid Malignancies
At a glance
Conditions
Where it's being run
46 sites across 26 statesStudy leadership
- Study Director · STUDY_DIRECTOR · BeOne Medicines
Who to contact
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Do you actually qualify for this trial?
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Inclusion
What this trial measures
- Part 1 And 2: Number Of Participants Experiencing Dose-limiting Toxicities (DLTs)Cycle 1 (Up to 28 days for non-hematologic DLTs and up to 42 days for hematologic DLTs)
- Part 1 And 2: Number Of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)Approximately 24 months
- Part 3 AML Cohort: Complete Remission (CR) Plus CR With Partial Hematologic Recovery (CRh) RateApproximately 24 months
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.
- Part 3 MDS Cohort: Modified Overall Response (mOR) RateApproximately 24 months
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).
- Part 3 AML Cohort (DDI Sub-cohort): Area Under Plasma Concentration-time Curve (AUC) from time 0 to the last quantifiable timepoint (t) (AUC0-t) Of BGB-11417 When Administered Alone and when Co-administered With PosaconazoleCycle 2 Day 12 and Cycle 2 Day 20 (predose and 1, 2, 4, 6, 8, and 24 hours postdose)
- Part 3 AML Cohort (DDI Sub-cohort): Maximum Observed Plasma Concentration (Cmax) Of BGB-11417 When Administered Alone and When Co-administered With PosaconazoleCycle 2 Day 12 and Cycle 2 Day 20 (predose and 1, 2, 4, 6, 8, and 24 hours postdose)
- Part 3 AML Cohort (DDI Sub-cohort): Area Under Plasma Concentration-time Curve (AUC) from time 0 to infinity (AUC0-infinity) Of BGB-11417 When Administered Alone and When Co-administered With PosaconazoleCycle 2 Day 12 and Cycle 2 Day 20 (predose and 1, , 4, 6, 8, and 24 hours postdose)
- Part 3 AML and MDS Cohorts (Treated with Monotherapy): Number Of Participants Experiencing DLTsCycle 2
- Part 3 AML and MDS Cohorts (Treated with Monotherapy): Number of Participants Experiencing TEAEsApproximately 24 months