A Study in Leukemia Patients With Karonudib

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.

Trial Details

NCT ID

NCT04077307

Phase

PHASE1

Sponsor

Thomas Helleday Foundation

Status

RECRUITING

Cancer Type

Leukemia

Interventions

Karonudib

Locations (sample)

Aarhus, Denmark|56.15674,10.21076
Copenhagen, Denmark|55.67594,12.56553
Belgrade, Serbia|44.80401,20.46513
Belgrade, Serbia|44.80401,20.46513
Kragujevac, Serbia|44.01667,20.91667

Key Eligibility Criteria

Written informed consent.
Age 18-75 years (may be extended to older if deemed fit).
The patient has received standard of care treatments and has refractory or relapsed or progressive disease with no suitable standard of care option…
For expansion cohort (Cohort V): Patients can only have received a maximum of 70% of anthracycline lifetime exposure to date of proposed dosing day.

For full eligibility, visit ClinicalTrials.gov.

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