TerminatedPhase 1

Combination of Fedratinib and Decitabine for Myeloproliferative Neoplasms (MPN)- Accelerated Phase (AP)/Blast Phase (BP)

Stopped: Closed by Sponsor

United States2 participantsStarted 2022-01-28

Plain-language summary

The purpose of this research is to study the safety and tolerability and to establish the maximum tolerated dose (MTD) of the combination of two drugs, fedratinib and decitabine, for the treatment of advanced-phase MPNs.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Estimated creatinine clearance (by Cockcroft-Gault Equation) of ≥ 50 mL/min
✓. Serum total bilirubin ≤ 1.5 × ULN (unless attributable to Gilbert's disease or hemolysis, in which case the direct bilirubin level must be ≤ 1.5 × upper limit of normal (ULN)).
✓. Alkaline phosphatase, serum aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤ 2.5 × ULN.

What they're measuring

Maximum Tolerated Dose (MTD) of Decitabine and Fedratinib

Timeframe: Up to 8 weeks for each dosing cohort

Trial details

NCT IDNCT05524857

SponsorJoseph Jurcic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-04-09

View on ClinicalTrials.gov More Myeloproliferative Neoplasm trials