# KOMET-001 (NCT04067336)

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

No report yet. It can be ordered.

## Registry

- Registry record: https://clinicaltrials.gov/study/NCT04067336
- Phase: PHASE1, PHASE2
- Status: ACTIVE_NOT_RECRUITING
- Sponsor: Kura Oncology, Inc.
- 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: Ziftomenib; Midazolam; Itraconazole
- Enrollment: 263
- Primary outcome: Phase 1a: Maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D)
- Primary outcome: Phase 1b: Number of patients who experience Adverse Events (AEs) and Serious Adverse Events (SAEs)
- Primary outcome: Phase 1b: Minimum biologically effective dose
- Primary outcome: Phase 1a, 1b, and 2: Evidence of anti-leukemia activity
- Primary outcome: Sub-study 1: Time to observed maximum plasma concentration (Tmax) of ziftomenib and midazolam
- Primary outcome: Sub-study 1: Area under the plasma concentration-time curve from time 0 to time t (AUC0-t) of ziftomenib and midazolam
- Primary outcome: Sub-study 1: Maximum observed plasma concentration (Cmax) of ziftomenib and midazolam
- Primary outcome: Sub-study 2: Time to observed maximum plasma concentration (Tmax) of ziftomenib and itraconazole
- Primary outcome: Sub-study 2: Area under the plasma concentration-time curve from time 0 to time t (AUC0-t) of ziftomenib and itraconazole
- Primary outcome: Sub-study 2: Maximum observed plasma concentration (Cmax) of ziftomenib and itraconazole
- Primary outcome: Sub-study 3: Minimum biologically effective dose (MBED) and/or the recommended Phase 2 dose (RP2D)
- Primary outcome: Sub-study 3: Minimum biologically effective dose (MBED) and/or the recommended Phase 2 dose (RP2D)
- Primary outcome: Sub-study 3: Change in Eastern Cooperative Oncology Group (ECOG) status
- Primary outcome: Sub-study 3: Time to observed maximum plasma concentration (Tmax) of ziftomenib
- Primary outcome: Sub-study 3: Area under the plasma concentration-time curve from time 0 to time t (AUC0-t) of ziftomenib
- Primary outcome: Sub-study 3: Maximum observed plasma concentration (Cmax) of ziftomenib
- Primary outcome: Sub-study 4: Complete remission (CR) and complete remission with partial hematologic recovery (CRh)

## Indexed commentary on KOMET-001 so far

Podcasts, YouTube videos and X posts we have indexed that name the trial. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this.

- X threads: 18
- YouTube: 15
- Podcasts: 9
- X videos: 2

## Order

Deep, $1,950, price fixed at order: https://www.erudio.com/contact?report=komet-001-nct04067336

## Free preview

POST https://www.erudio.com/api/trial-requests with {"nct_id": "NCT04067336", "email": "<work email>"}; the inbox owner confirms by the emailed link.