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KRT-232 and TKI Study in Chronic Myeloid Leukemia

NCT04835584 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 109

Last updated 2022-03-21

No results posted yet for this study

Summary

This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with Ph+ Chronic Myeloid Leukemia (CML) who have relapsed or are refractory or intolerant to a Tyrosine Kinase Inhibitor (TKI).

This study is a global, open label Phase 1b/2 to determine the efficacy and safety of KRT-232 in patients with chronic phase CML (CML-CP) and accelerated phase (CML-AP) who have failed TKI treatments.

Conditions

  • Chronic Myeloid Leukemia

Interventions

DRUG

KRT-232

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

DRUG

Dasatinib

Dasatinib is a Tyrosine Kinase Inhibitor anticancer drug taken by mouth.

DRUG

Nilotinib

Nilotinib is an Tyrosine Kinase Inhibitor anticancer drug taken by mouth.

Sponsors & Collaborators

  • Kartos Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-07
Primary Completion
2024-12-31
Completion
2026-06-30
FDA Drug
Yes

Countries

  • United States
  • Canada
  • France
  • Italy
  • Poland
  • Russia
  • South Korea
  • Spain

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 NCT04835584 on ClinicalTrials.gov