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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 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.
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 420 participants |
| Start Date | 2023-07-18 |
| Est. Completion | 2030-04 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05735184
The ClinicalTrials.gov registry entry for NCT05735184 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 420 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 114-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (268% higher). The listed sponsor is Kura Oncology, which has 14 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 13 distinct geographic areas - top geographies include 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.
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