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A Study in Leukemia Patients With Karonudib

NCT04077307 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2025-12-19

No results posted yet for this study

Summary

The primary objective of this study is to determine safety and tolerability of Karonudib for the treatment of hematological malignancies.

Secondary objectives are to determine a recommended RP2D and schedule for further development of Karonudib, to determine the pharmacokinetics of Karonudib, to look for evidence of treatment efficacy. Overall survival will also be recorded.

Conditions

Interventions

DRUG

Karonudib

First part of the study - four different dose cohorts Extension part of the study - karonudib BID (twice a week) and Idarubicin days 1-3.

Sponsors & Collaborators

  • Thomas Helleday Foundation

    lead OTHER

Principal Investigators

  • Stefan Deneberg, MD · Karolinska University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-03
Primary Completion
2026-12-30
Completion
2026-12-30

Countries

  • Denmark
  • Serbia
  • Sweden

Study Locations

More Related Trials

Entities

Diseases

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 NCT04077307 on ClinicalTrials.gov