Acute Myeloid Leukemia Clinical Trial

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

Summary

This Phase 1 study will assess the safety, tolerability, and preliminary antileukemic activity of ziftomenib in combination with venetoclax and azacitidine (ven/aza), ven, and 7+3 for two different molecularly-defined arms, NPM1-m and KMT2A-r.

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

Patients must have a documented NPM1 mutation or KMT2A rearrangement and have either newly diagnosed or relapsed/refractory AML
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Adequate liver, renal, and cardiac function according to protocol defined criteria
A female of childbearing potential must agree to use adequate contraception from the time of screening through 180 days following the last dose of study intervention. A male of childbearing potential must agree to use abstinence or adequate contraception from the time of screening through 90 days following the last dose of study intervention

Key Exclusion Criteria:

Diagnosis of either acute promyelocytic leukemia or blast chronic myelomonocytic leukemia
Known history of BCR-ABL alteration
Advanced malignant hepatic tumor [for patients receiving ven/aza combination]
Administration of live attenuated vaccines within 14 days prior to, during, or after treatment until B-cell recovery
Active central nervous system (CNS) involvement by AML.
Clinical signs/symptoms of leukostasis or WBC > 25,000 / microliter. Hydroxyurea and/or leukapheresis are permitted to meet this criterion
Not recovered to Grade ≤1 (NCI-CTCAE v5.0) from all nonhematological toxicities except for alopecia
Known clinically active human immunodeficiency virus, active hepatitis B or active hepatitis C infection
For newly diagnosed cohorts: received prior chemotherapy for leukemia, except hydroxyurea and/or leukapheresis to control leukocytosis, prior treatment with all-transretinoic acid for initially suspected acute promyelocytic leukemia, or non-HMA therapy for prior myelodysplastic syndrome
For relapsed/refractory cohorts: received chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy that is considered to be investigational < 14 days prior to the first dose of ziftomenib or within 5 drug half-lives prior to the first dose of study drug
Uncontrolled intercurrent illness including, but not limited to, cardiac illness as defined in the protocol
Mean corrected QT interval corrected for heart rate by Fredericia's formula (QTcF) >480 ms on triplicate ECGs
Uncontrolled infection
Women who are pregnant or lactating
An active malignancy and currently receiving chemotherapy for that malignancy or disease that is uncontrolled/progressing

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

212

Study ID:

NCT05735184

Recruitment Status:

Recruiting

Sponsor:

Kura Oncology, Inc.

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There are 28 Locations for this study

See Locations Near You

Moores UC San Diego Cancer Center
La Jolla California, 92093, United States More Info
Krisma Montalvo
Contact
[email protected]
USC University of Southern California / Norris Comprehensive Cancer Center
Los Angeles California, 90033, United States More Info
Christine Duran
Contact
323-865-0371
[email protected]
UCLA - Bowyer Oncology Center
Los Angeles California, 90095, United States More Info
Bruck Habtemariam
Contact
310-794-0242
[email protected]
UCI Health Chao Family Comprehensive Cancer Center
Orange California, 92868, United States More Info
Deepa Jeyakumar, MD
Contact
877-827-8839
[email protected]
UC Health Blood Disorders and Cell Therapies Center - Anschutz Medical Campus
Aurora Colorado, 80045, United States More Info
Christine McMahon, MD
Contact
[email protected]
Colorado Blood Cancer Institute
Denver Colorado, 80218, United States More Info
Marcello Rotta, MD
Contact
720-754-4800
[email protected]
Yale Cancer Center and Smilow Cancer Hospital
New Haven Connecticut, 06510, United States More Info
Christina Wiess
Contact
203-737-3472
[email protected]
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago Illinois, 60611, United States More Info
The University of Kansas Cancer Center
Fairway Kansas, 66205, United States More Info
Thania Medrano
Contact
[email protected]
Norton Cancer Institute - St. Matthews
Louisville Kentucky, 40207, United States More Info
Ochsner MD Anderson Cancer Center
Jefferson Louisiana, 70121, United States More Info
Amanda Woolery, RN
Contact
504-842-0275
[email protected]
Massachusetts General Hospital
Boston Massachusetts, 02114, United States More Info
Amir Fathi, MD
Contact
617-724-1124
Karmanos Cancer Institute
Detroit Michigan, 48201, United States More Info
Karmanos Cancer Institute
Contact
800-527-6266
University of Minnesota
Minneapolis Minnesota, 55455, United States More Info
Mark Juckett, MD
Contact
[email protected]
Rutgers Cancer Institute
New Brunswick New Jersey, 08903, United States More Info
Anita Trupiano
Contact
[email protected]
Roswell Park Comprehensive Cancer Center
Buffalo New York, 14203, United States More Info
Amaris Pilcher
Contact
716-845-5602
[email protected]
New York - Presbyterian / Weill Cornell Medicine
New York New York, 10021, United States More Info
Tania J Curcio
Contact
[email protected]
Mount Sinai - Ruttenberg Treatment Center
New York New York, 10029, United States More Info
Marina Kremyanskaya, MD, PhD
Contact
[email protected]
Stony Brook Cancer Center
Stony Brook New York, 11794, United States More Info
Zita Makselyte
Contact
[email protected]
Duke Blood Cancer Center
Durham North Carolina, 27705, United States More Info
Quinna Lawson
Contact
[email protected]
Cleveland Clinic
Cleveland Ohio, 44195, United States More Info
Anjali Advani, MD
Contact
[email protected]
OU Health Stephenson Cancer Center
Oklahoma City Oklahoma, 73104, United States More Info
Cynthia Lowery
Contact
[email protected]
Hospital of the University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States More Info
Jessica Ritter
Contact
[email protected]
TriStar Bone Marrow Transplant
Nashville Tennessee, 37203, United States More Info
Ask Sarah
Contact
844-482-4812
Sarah Cannon Research Institute - St. David's South Austin Medical Center / Texas Oncology South Austin
Austin Texas, 78704, United States
UT Southwestern - Simmons Cancer Center
Dallas Texas, 75235, United States More Info
Yazan Madanat, MD
Contact
833-722-6237
[email protected]
MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Ramya Ganesh
Contact
713-792-5640
[email protected]
Ghayas Issa, MD
Principal Investigator
UW Health - Carbone Cancer Center
Madison Wisconsin, 53792, United States More Info
UW Cancer Connect
Contact
800-622-8922
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

212

Study ID:

NCT05735184

Recruitment Status:

Recruiting

Sponsor:


Kura Oncology, Inc.

How clear is this clinincal trial information?

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