This research study is studying a drug called Jaktinib as a possible treatment for Myelofibrosis.
This study is a Phase 1, single-arm, open-label, dose escalation trial, to evaluate the safety and tolerability of Jaktinib in patients with PMF or Post-PV/ET MF and who are relapsed/refractory to a marketed JAK inhibitor
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Orally administered, twice a day
Site 01
Canton, Ohio, United States
RECRUITINGSafety of jaktinib hydrochloride tablets
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Time frame: At least 24 weeks, up to approximately 1 year for follow-up
Dose-limiting toxicities (DLTs) of jaktinib hydrochloride tablets
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Time frame: 28 days
Efficacy of jaktinib hydrochloride tablets
reduction of spleen volume of ≥35%
Time frame: at least 24 weeks, up to approximately 1 year
Efficacy of jaktinib hydrochloride tablets
reduction of total symptoms score (TSS) of ≥50%
Time frame: at least 24 weeks, up to approximately 1 year
Pharmacokinetic characteristics of jaktinib hydrochloride tablets
Peak Plasma Concentration (Cmax)
Time frame: 7 days
Pharmacokinetic characteristics of jaktinib hydrochloride tablets
Time to maximum concentration (Tmax)
Time frame: 7 days
Pharmacokinetic characteristics of jaktinib hydrochloride tablets
Half-life (T1/2)
Time frame: 7 days
Pharmacokinetic characteristics of jaktinib hydrochloride tablets
Clearance (CL/F)
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Time frame: 7 days
Pharmacokinetic characteristics of jaktinib hydrochloride tablets
Area under Curve (AUCinf)
Time frame: 7 days
Pharmacokinetic characteristics of jaktinib hydrochloride tablets
Volume of distribution
Time frame: 7 days