A Safety and Tolerability Study of Jaktinib

Study Overview
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Brief Summary
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This research study is studying a drug called Jaktinib as a possible treatment for Myelofibrosis.

Detailed Description
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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

Official Title
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A Phase 1 Dose Escalation, Safety and Tolerability Study of Jaktinib in Patients With Primary Myelofibrosis (PMF) or Post-polycythemia Vera/Post-essential Thrombocythemia Myelofibrosis (Post-PV/ET MF) and Who Are Relapsed/ Refractory to a Marketed JAK Inhibitor

Conditions
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Myelofibrosis

Intervention / Treatment
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* Drug: Jaktinib Hydrochloride Tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of myelofibrosis (primary, post-polycythemia vera, or post-essential thrombocythemia). Relapsed/refractory to a marketed (FDA approved) JAK inhibitor. At least 18 years of age. ECOG PS 0, 1, or 2. Expected life expectancy is greater than 24 weeks. Exclusion Criteria: Any chemotherapy, immunomodulatory therapy, immunosuppressive therapy, corticosteroids, or growth factor treatment within 14 days prior to initiation of study drug. Major surgery or radiation therapy within 28 days prior to initiation of study drug. With suspected allergies to jaktinib or its excipient. Another clinical trial of a new drug or medical instrument within 3 months before screening. Females who are pregnant, currently breastfeeding, planning to become pregnant. Unable to adopt effective contraceptive methods during the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Jaktinib<br> | Drug: Jaktinib Hydrochloride Tablet<br>* Orally administered, twice a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of jaktinib hydrochloride tablets | Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment | 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 | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of jaktinib hydrochloride tablets | reduction of spleen volume of ≥35% | at least 24 weeks, up to approximately 1 year | 
| Efficacy of jaktinib hydrochloride tablets | reduction of total symptoms score (TSS) of ≥50% | at least 24 weeks, up to approximately 1 year | 
| Pharmacokinetic characteristics of jaktinib hydrochloride tablets | Peak Plasma Concentration (Cmax) | 7 days | 
| Pharmacokinetic characteristics of jaktinib hydrochloride tablets | Time to maximum concentration (Tmax) | 7 days | 
| Pharmacokinetic characteristics of jaktinib hydrochloride tablets | Half-life (T1/2) | 7 days | 
| Pharmacokinetic characteristics of jaktinib hydrochloride tablets | Clearance (CL/F) | 7 days | 
| Pharmacokinetic characteristics of jaktinib hydrochloride tablets | Area under Curve (AUCinf) | 7 days | 
| Pharmacokinetic characteristics of jaktinib hydrochloride tablets | Volume of distribution | 7 days |