A Study in Leukemia Patients With Karonudib (MAATEO)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04077307|
Recruitment Status : Recruiting
First Posted : September 4, 2019
Last Update Posted : February 4, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Drug: Karonudib||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||9 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||3 different dose cohorts with escalating doses are planned.|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Study in Patients With Hematological Malignancies to Evaluate Safety, Tolerability and Efficacy of Karonudib|
|Actual Study Start Date :||December 3, 2019|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||June 30, 2022|
Experimental: Dose escalation
Karonudib is an oral inhibitor of MTH1 and will be supplied as an oral solution to be taken every other day. There are three planned dose cohorts. Patients will be given every second day dosing.
Dose escalation of administration with Karonudib. Three different dose cohorts are planned.
- Safety of Karonudib (TH1579) [ Time Frame: 28 days, first treatment cycle for the patient. ]Grade and frequency of AE and SAE using the CTCAE version 5.0
- Tolerability of Karonudib (TH1579) [ Time Frame: 28 days, first treatment cycle for the patient. ]Grade and frequency of AE and SAE using the CTCAE version 5.0
- Preliminary signs of clinical efficacy of Karonudib. [ Time Frame: 28 days, first treatment cycle for the patient. ]ELN/IWG response criteria
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04077307
|Contact: Teresa Sandvall, MScemail@example.com|
|Karolinska University Hospital||Recruiting|
|Contact: Stefan Deneberg, MD, PhD|
|Principal Investigator: Stefan Deneberg, MD, PhD|
|Principal Investigator:||Stefan Deneberg, MD||Karolinska University Hospital|