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 tr
| Condition(s) | Leukemia |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: 1. Written informed consent. 2. Age 18-75 years (may be extended to older if deemed fit). 3. The patient has received standard of care treatments and has refractory or relapsed or progressive disease with no suitable standard of care options available. For expansion cohort (Cohort V): Patients can only have received a maximum of 70% of anthracycline lifetime exposure to date of proposed dosing day. Cohorts I-IV: AML, ALL, DLBCL, Burkitt lymphoma, multiple myeloma or high-risk MDS, according to the WHO 2016 criteria. 4. Expansion cohort (Cohort V): Relapsed, Recurrent or Progressive AML or MDS according to the ELN 2017 criteriaWHO 2016 criteria. 5. For expansion cohort (Cohort V): Patients can only have received a maximum of 70% of anthracycline lifetime exposure to date |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Thomas Helleday Foundation |
| Locations | Aarhus, Denmark; Copenhagen, Denmark; Belgrade, Serbia; Kragujevac, Serbia; Huddinge, Sweden; Örebro, Sweden |
| Start date | 2019-12-03 |
| NCT ID | NCT04077307 |
| Official listing | https://clinicaltrials.gov/study/NCT04077307 |