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An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 When Administered Alone and in Combination With Low-Dose Cytarabine (LDAC) or Decitabine in Patients With Acute Myeloid Leukemia (AML)

NCT04113616 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2024-03-22

No results posted yet for this study

Summary

This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, when administered alone and in combination with low-dose cytarabine (LDAC) or Decitabine for the treatment of adults with Acute Myeloid Leukemia (AML) and AML secondary to myeloproliferative neoplasms (MPN). Participants must be relapsed/refractory (having failed prior therapy) and will be assigned to receive monotherapy (KRT-232 alone) or combination therapy (KRT-232 with LDAC or KRT-232 with Decitabine).

Conditions

  • Relapsed or Refractory Acute Myeloid Leukemia (AML)
  • Acute Myeloid Leukemia (AML), Secondary to Myeloproliferative Neoplasms (MPN)

Interventions

DRUG

KRT-232

KRT-232 is an experimental MDM2 inhibitor anti-cancer drug taken by mouth.

DRUG

Cytarabine

Cytarabine is an anti-cancer chemotherapy drug taken via injection.

DRUG

Decitabine

Decitabine is an anti-cancer chemotherapy drug taken via injection.

Sponsors & Collaborators

  • Kartos Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-25
Primary Completion
2023-09-27
Completion
2023-09-27
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Poland
  • South Korea
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04113616 on ClinicalTrials.gov