A Study of BGB-11417 in Participants With Myeloid Malignancies

No strong warning signs right now. The score counts warning signs; it is not a prediction.

Why this score

Score over time

What counts as success

The trial's main goal(s), called the “primary outcome.”

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

  Measured over: 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)

  Measured over: Approximately 24 months

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

  Measured over: Approximately 24 months

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

  Measured over: Approximately 24 months

• 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 Posaconazole

  Measured over: Cycle 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 Posaconazole

  Measured over: Cycle 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 Posaconazole

  Measured over: Cycle 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 DLTs

  Measured over: Cycle 2

• Part 3 AML and MDS Cohorts (Treated with Monotherapy): Number of Participants Experiencing TEAEs

  Measured over: Approximately 24 months

Changes Tremor has spotted