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NCT05735184 · ClinicalTrials.gov registry record · Phase 1

A Study to Investigate the Safety and Tolerability of Ziftomenib in Combination With Venetoclax/Azacitidine, Venetoclax, 7+3, or 7+3+Quizartinib in Patients With AML

A Phase 1 study of Acute Myeloid Leukemia and Acute Myeloid Leukemia, in Relapse, sponsored by Kura Oncology.

Recruiting
Registry status
Phase 1
Development phase
420
Enrollment target
20
Study locations

NCT05735184: Recruiting Phase 1 study of Acute Myeloid Leukemia and Acute Myeloid Leukemia, in Relapse, sponsored by Kura Oncology.

NCT05735184 is a Phase 1 study of Acute Myeloid Leukemia and Acute Myeloid Leukemia, in Relapse that is actively recruiting participants, run by Kura Oncology. The registered enrollment target is 420 participants, above the 114-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (268% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05735184, a Phase 1 study of Acute Myeloid Leukemia and Acute Myeloid Leukemia, in Relapse, is actively recruiting participants, sponsored by Kura Oncology.

RECRUITING
Registry status
Phase 1
Development phase
420 participants
Enrollment target
20
Study locations

Study Summary

Ziftomenib is an investigational drug in development for the treatment of patients with acute myeloid leukemia (AML) with certain genetic alterations. This protocol has 3 separate arms that will investigate the benefits and risks of adding ziftomenib to standard-of-care (SOC) drug treatments in patients who have AML with certain genetic mutations. Both newly diagnosed and relapsed refractory patients with AML will be assigned to different cohorts based on specific study criteria and physician discretion. The purpose of this study is to assess the safety, tolerability, and early signs of efficacy of ziftomenib in combination with SOC drugs to treat AML.

Primary Outcome

Assessed by the NCI-CTCAE v5.0

Conditions Studied

Acute Myeloid Leukemia Acute Myeloid Leukemia, in Relapse Myeloid Sarcoma Acute Myeloid Leukemia Recurrent Refractory AML NPM1 Mutation AML With Mutated NPM1 KMT2Ar Mixed Lineage Leukemia Gene Mutation Nucleophosmin 1-mutated Acute Myeloid Leukemia

Interventions

  • DRUG Venetoclax
  • DRUG Azacitidine
  • DRUG Cytarabine
  • DRUG Daunorubicin
  • DRUG Ziftomenib

Study Locations (20)

California

  • Moores UC San Diego Cancer Center - La Jolla
  • USC / Norris Comprehensive Cancer Center - Los Angeles
  • UCLA - Bowyer Oncology Center - Los Angeles
  • UC Irvine Health Chao Family Comprehensive Cancer Center - Orange

Colorado

  • University of Colorado - Aurora
  • Colorado Blood Cancer Institute - Denver

Georgia

  • Emory Healthcare - The Emory Clinic - Atlanta
  • Georgia Cancer Center at Augusta University - Augusta

Illinois

  • Robert H. Lurie Comprehensive Cancer Center of Northwestern University - Chicago
  • Loyola University Medical Center - Maywood

Kentucky

  • University of Kentucky Markey Cancer Center - Louisville
  • Norton Cancer Institute - St. Matthews - Louisville

Arizona

  • Mayo Clinic - Phoenix - Phoenix

Connecticut

  • Yale Cancer Center and Smilow Cancer Hospital - New Haven

Florida

  • Mayo Clinic Jacksonville - Jacksonville

Trial Details

FieldValue
Enrollment Target 420 participants
Start Date 2023-07-18
Est. Completion 2030-04
Phase Phase 1
Kura Oncology

14 total trials

What NCT05735184 shows while recruiting

NCT05735184 is an interventional study that assigns participants to a tested intervention. The registered 420 participants enrollment target is mid-sized for trials with a published cap, above the 114-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (268% higher).

The record links to 10 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Venetoclax is the first listed.

NCT05735184 names 20 study sites across 13 states, led by California, Colorado, Georgia.

Frequently Asked Questions

What is clinical trial NCT05735184 about?

NCT05735184 is a clinical study titled "A Study to Investigate the Safety and Tolerability of Ziftomenib in Combination With Venetoclax/Azacitidine, Venetoclax, 7+3, or 7+3+Quizartinib in Patients With AML". Ziftomenib is an investigational drug in development for the treatment of patients with acute myeloid leukemia (AML) with certain genetic alterations. This protocol has 3 separate arms that will investigate the benefits and risks of adding ziftomenib to standard-of-care (SOC) drug treatments in pat...

What is the current status of trial NCT05735184?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 420 participants. The study started on 2023-07-18. Estimated completion is 2030-04.

What conditions does trial NCT05735184 study?

This clinical trial studies the following conditions: Acute Myeloid Leukemia, Acute Myeloid Leukemia, in Relapse, Myeloid Sarcoma, Acute Myeloid Leukemia Recurrent, Refractory AML.

What interventions are being tested in trial NCT05735184?

The interventions under investigation include: Venetoclax (DRUG), Azacitidine (DRUG), Cytarabine (DRUG), Daunorubicin (DRUG), Ziftomenib (DRUG).

Who is sponsoring clinical trial NCT05735184?

This trial is sponsored by Kura Oncology, which has 14 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05735184 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Acute Myeloid Leukemia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05735184's enrollment target sits among peer trials

420 13th of 306 higher than 294 of 306 other Acute Myeloid Leukemia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Acute Myeloid Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT05735184

Source: ClinicalTrials.gov NCT05735184, the US trial registry maintained by the National Library of Medicine. NCT05735184 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.