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

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NCT04067336 · readout in 789 d

Sponsored by Kura Oncology, Inc. (industry) · KURA — their whole pipeline →.

Phase

Phase 1/2

Status

Active, not recruiting

Study type

Interventional

Design

Randomized · None · Treatment

Enrollment

263estimated

Sites

Countries

Belgium, Canada, France +4

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis

Date

Filed

Basis

What it is

Start

2019-09-12

actual

When the study began enrolling

Primary completion

2028-10-16

estimated

The date the last participant is measured for the primary outcome — the readout window

Study completion

2028-10-16

estimated

The whole study's end, after follow-up

First posted

2019-08-26

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-05-13

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Conditions

Advanced Malignant Neoplasm
Acute Myeloid Leukemia
Mixed Lineage Leukemia
Mixed Lineage Acute Leukemia
Acute Leukemia of Ambiguous Lineage
Mixed Phenotype Acute Leukemia
Acute Lymphoblastic Leukemia

Interventions

Drug: Ziftomenib — also filed as KO-539
Drug: Midazolam — also filed as Seizalam, Hypnovel, Dormicum
Drug: Itraconazole — also filed as Sporanox, Onmel, Tolsura

Primary outcomes

what the primary-completion date above is the date OF

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

measured 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 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 For at least 12 months following end of treatment

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

measured For at least 12 months following end of treatment

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

measured 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 Cycle 1 on Days 1 and 15 at predose and postdose

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

measured 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 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 Cycle 1 on Days 1, 15, and 22 at predose and postdose

Sub-study 2: Maximum observed plasma concentration (Cmax) of ziftomenib and itraconazole

measured Cycle 1 on Days 1, 15, and 22 at predose and postdose

Sub-study 3: Minimum biologically effective dose (MBED) and/or the recommended Phase 2 dose (RP2D)

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

Sub-study 3: Minimum biologically effective dose (MBED) and/or the recommended Phase 2 dose (RP2D)

measured For at least 12 months following end of treatment

Sub-study 3: Change in Eastern Cooperative Oncology Group (ECOG) status

measured Timeframe: from Baseline to End of Treatment

Sub-study 3: Time to observed maximum plasma concentration (Tmax) of ziftomenib

measured Postdose on Cycle 1 Day 1 and Cycle 2 Day 1. Predose at Cycle 2 onwards

Sub-study 3: Area under the plasma concentration-time curve from time 0 to time t (AUC0-t) of ziftomenib

measured Postdose on Cycle 1 Day 1 and Cycle 2 Day 1. Predose at Cycle 2 onwards

Sub-study 3: Maximum observed plasma concentration (Cmax) of ziftomenib

measured Postdose on Cycle 1 Day 1 and Cycle 2 Day 1. Predose at Cycle 2 onwards.

Sub-study 4: Complete remission (CR) and complete remission with partial hematologic recovery (CRh)

measured For at least 12 months following end of treatment

Publications

PMID 40997296 — linked by the registry
PMID 39362248 — linked by the registry
PMID 34267079 — linked by the registry
PMID 33741715 — linked by the registry

Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.

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