Safety and Tolerability of Ziftomenib Combinations in Patients With Relapsed/Refractory Acute Myeloid Leukemia

Phase 1RecruitingNCT06001788

Kura Oncology, Inc.171 enrolled

Overview

The safety, tolerability, and antileukemic response of ziftomenib in combination with standard of care treatments for patients with relapsed/refractory acute myeloid leukemia will be examined with the following agents: FLAG-IDA, low-dose cytarabine, and gilteritinib.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

171

Conditions

AML AML With Mutated NPM1 Hematologic Malignancy KMT2Ar NPM1 Mutation MLL Rearrangement

Interventions

ZiftomenibDRUG

Oral administration

FludarabineDRUG

Intravenous infusion

IdarubicinDRUG

Intravenous infusion

CytarabineDRUG

Intravenous Infusion

GilteritinibDRUG

Oral administration

Granulocyte colony-stimulating factorBIOLOGICAL

Subcutaneous injection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * Has been diagnosed with relapsed/refractory AML. * Has a documented NPM1 mutation or KMT2A rearrangement. * Has a documented FLT3 mutation (cA-3 only). * Has an Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2. * Has adequate hepatic and renal function as defined per protocol. * Has an ejection fraction above a protocol defined limit. * Participant, or legally authorized representative, must be able to understand and provide written informed consent prior to the first screening procedure. * Has agreed to use contraception as defined per protocol. Key Exclusion Criteria: * Has a diagnosis of acute promyelocytic leukemia or blast chronic myeloid leukemia. * Has clinically active central nervous system leukemia. * Has an active and uncontrolled infection. * Has a mean corrected QT interval (QTcF) \> 480ms. * Has uncontrolled intercurrent illness, including, but not limited to protocol defined cardiac disease. * Has received radiation, chemotherapy, immunotherapy, or any other anticancer therapy including investigational therapy \<14 days or within 5 drug half-lives prior to the first dose of study intervention. * Has had major surgery within 4 weeks prior to the first dose of study intervention. * Has received a hematopoietic stem cell transplant (HSCT) and has not previously had adequate recovery per protocol defined criteria. * Has active graft-versus-host disease (GvHD) and or on immunosuppressive drugs for the treatment of GvHD * Participant is pregnant or lactating.

Locations (44)

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

RECRUITING

USC Norris Comprehensive Cancer Center

Los Angeles, California, United States

RECRUITING

UCLA Health - Bowyer Oncology Center

Los Angeles, California, United States

RECRUITING

UC Irvine Health Chao Family Comprehensive Cancer Center

Orange, California, United States

Outcomes

Primary Outcomes

Rate of dose limiting toxicities (DLTs) per dose level

Assessed by the NCI-CTCAE v5.0

Time frame: During the first 28 days of ziftomenib in combination with SOC treatment (1 cycle)

Descriptive statistics of adverse events

Assessed by the NCI-CTCAE v5.0

Time frame: First dose of ziftomenib up to and including 28 days after last dose of ziftomenib, or if the patient is lost to follow-up, whichever comes first