RecruitingPhase 1NCT04077307

A Study in Leukemia Patients With Karonudib

A Phase 1 Study in Patients With Hematological Malignancies to Evaluate Safety, Tolerability and Efficacy of Karonudib


Sponsor

Thomas Helleday Foundation

Enrollment

9 participants

Start Date

Dec 3, 2019

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called karonudib in people with blood cancers — including leukemia, lymphoma, multiple myeloma, and high-risk myelodysplastic syndrome — that have returned or are not responding to standard treatment. Karonudib works by targeting a DNA repair mechanism that cancer cells depend on. **You may be eligible if...** - You are between 18 and 75 years old (age range may be extended in some cases) - You have been diagnosed with AML, ALL, DLBCL, Burkitt lymphoma, multiple myeloma, or high-risk MDS according to WHO 2016 criteria (or relapsed/progressive AML or MDS for the expansion cohort) - You have received standard treatments and your cancer has relapsed, progressed, or is refractory with no suitable standard options remaining - You can provide written informed consent **You may NOT be eligible if...** - You still have access to effective standard treatment options - You have not received at least some prior standard of care treatment - You have received more than 70% of your lifetime maximum anthracycline dose (for the expansion cohort only) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGKaronudib

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


Locations(6)

Aarhus University Hospital

Aarhus, Denmark

Rigshospitalet Copenhagen University Hospital

Copenhagen, Denmark

University Clinical Center Belgrade

Belgrade, Serbia

University Clinical Center Kragujevac

Kragujevac, Serbia

Karolinska University Hospital

Huddinge, Sweden

Örebro University Hospital

Örebro, Sweden

View Full Details on ClinicalTrials.gov

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NCT04077307


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