First in Human Study of Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia

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.”

• Phase 1a: Maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D)

  Measured over: Dose Limiting Toxicities (DLTs) will be evaluated during the first 28 days (1 cycle)

• Phase 1b: Number of patients who experience Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Measured over: During treatment and up to approximately 28 days after treatment discontinuation, or until immediately before the initiation of another anticancer therapy, whichever occurs first.

• Phase 1b: Minimum biologically effective dose

  Measured over: For at least 12 months following end of treatment

• Phase 1a, 1b, and 2: Evidence of anti-leukemia activity

  Measured over: For at least 12 months following end of treatment

• Sub-study 1: Time to observed maximum plasma concentration (Tmax) of ziftomenib and midazolam

  Measured over: Cycle 1 on Days 1 and 15 at predose and postdose

• Sub-study 1: Area under the plasma concentration-time curve from time 0 to time t (AUC0-t) of ziftomenib and midazolam

  Measured over: Cycle 1 on Days 1 and 15 at predose and postdose

• Sub-study 1: Maximum observed plasma concentration (Cmax) of ziftomenib and midazolam

  Measured over: Cycle 1 on Days 1 and 15 at predose and postdose

• Sub-study 2: Time to observed maximum plasma concentration (Tmax) of ziftomenib and itraconazole

  Measured over: Cycle 1 on Days 1, 15, and 22 at predose and postdose

• Sub-study 2: Area under the plasma concentration-time curve from time 0 to time t (AUC0-t) of ziftomenib and itraconazole

  Measured over: Cycle 1 on Days 1, 15, and 22 at predose and postdose

Changes Tremor has spotted