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P

Prisma Health | Upstate Greenville Memorial Cardiac Research

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

K

Kura Oncology

Status and phase

Enrolling
Phase 1

Conditions

AML
Leukemia, Myeloid, Acute
Leukemia
MLL Rearrangement
Neoplasms by Histologic Type
Hematologic Malignancy
Acute Leukemia
KMT2Ar
NPM1 Mutation
AML With Mutated NPM1
Leukemia, Myeloid
Acute Myeloid Leukemia

Treatments

Drug: Gilteritinib
Biological: Granulocyte colony-stimulating factor
Drug: Idarubicin
Drug: Ziftomenib
Drug: Cytarabine
Drug: Fludarabine

Study type

Interventional

Funder types

Industry

Identifiers

NCT06001788
KO-MEN-008

Details and patient eligibility

About

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.

Enrollment

171 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

  • Has been diagnosed with relapsed/refractory AML.
  • Has a documented NPM1 mutation or KMT2A rearrangement.
  • Has a documented FLT3 mutation (cohort A-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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

171 participants in 2 patient groups

Phase 1a
Experimental group
Description:
Oral ziftomenib; sequential cohorts of escalating dose levels of ziftomenib to identify the safety and tolerability of the combination regimens. Participants will be enrolled in 1 of 5 dose escalation cohorts: A-1: Participants with a NPM1 mutation: ziftomenib plus FLAG-IDA A-2: Participants with a NPM1 mutation: ziftomenib plus low-dose cytarabine (LDAC) A-3: Participants with a NPM1 mutation: ziftomenib plus gilteritinib B-1: Participants with a KMT2A rearrangement: ziftomenib plus FLAG-IDA B-2: Participants with a KMT2A rearrangement: ziftomenib plus low-dose cytarabine (LDAC)
Treatment:
Drug: Fludarabine
Drug: Cytarabine
Drug: Ziftomenib
Drug: Idarubicin
Biological: Granulocyte colony-stimulating factor
Drug: Gilteritinib
Phase 1b
Experimental group
Description:
Oral ziftomenib; Following the determination of the maximum tolerated dose in Phase 1a, participants will be enrolled in 1 of 5 dose validation/expansion cohorts: A-1: Participants with a NPM1 mutation: ziftomenib plus FLAG-IDA A-2: Participants with a NPM1 mutation: ziftomenib plus low-dose cytarabine (LDAC) A-3: Participants with a NPM1 mutation: ziftomenib plus gilteritinib B-1: Participants with a KMT2A rearrangement: ziftomenib plus FLAG-IDA B-2: Participants with a KMT2A rearrangement: ziftomenib plus low-dose cytarabine (LDAC)
Treatment:
Drug: Fludarabine
Drug: Cytarabine
Drug: Ziftomenib
Drug: Idarubicin
Biological: Granulocyte colony-stimulating factor
Drug: Gilteritinib

Trial contacts and locations

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Central trial contact

Clinical Operations

Data sourced from clinicaltrials.gov

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